THE DRUGS AND COSMETICS ACT 1940 [FREE DOWNLOAD]

1
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health)
THE DRUGS AND COSMETICS ACT AND RULES
THE DRUGS AND COSMETICS ACT, 1940
as amended by
the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960,
the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendments)
Act, 1964, the Drugs and Cosmetics (Amendments) Act, 1972, the Drugs and
Cosmetics (Amendments) Act, 1982, the Drugs and Cosmetics (Amendments)
Act, 1986 and the Drugs and Cosmetics (Amendments) Act, 1995.
AND
THE DRUGS AND COSMETICS RULES, 1945
as corrected up to the 30th April, 2003

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CONTENTS

The Drugs and Cosmetics Act, 1940,
as amended by the Drugs (Amendment) Act, 1955,
the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962,
the Drugs and Cosmetics (Amendment) Act,1964,
the Drugs andCosmetics (Amendment) Act, 1972,
the Drugs and Cosmetics (Amendment) Act, 1982,
the Drugs and Cosmetics (Amendment) Act, 1986
and the Drugs and Cosmetics (Amendment) Act,1995.. . . .
The Drugs and Cosmetics Rules, 1945 as corrected upto 30.04.2003
Notification issued under the Drugs and Cosmetics Act . . . .
3
LIST OF AMENDING ACTS AND ADAPTATION ORDER
1. The Repealing and Amending Act, 1949 (40 of 1949).
2. The Adaptation of Laws Order, 1950.
3. The Part B States (Laws) Act, 1951 (3 of 1951)
4. The Drugs (Amendment) Act, 1955 (11 of 1955)
5. The Drugs (Amendment) Act, 1960 (35 of 1960)
6. The Drugs (Amendment) Act, 1962 (21 of 1962)
7. The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)
8. The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972).
9. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)
10. The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986)
11. The Drugs and Cosmetics (Amendment) Act, 1995 (22 of 1995)
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LIST OF ABBREVIATIONS USED
A.O. 1950 . . . . . . . for Adaptation of Laws Order, 1950.
Cl. . . . . . . Clause
Ins. . . . . . . inserted
P. . . . . . . Page
Pt. . . . . . . Part
Reg. . . . . . . Regulation.
Rep. . . . . . . Repealed.
S. . . . . . . Section
Sch. . . . . . . Schedule.
Sec. . . . . . . Section
Subs. . . . . . . Substituted
w.e.f. . . . . . . with effect from.
G.O.I . . . . . . Government of India.
dt. . . . . . . date/dated
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THE DRUGS AND COSMETICS ACT, 1940
________
ARRANGEMENT OF SECTIONS
________
CHAPTER I
INTRODUCTORY
SECTIONS
1. Short title, extent and commencement.
2. Application of other laws not barred.
3. Definitions
3A. Construction of references to any law not in force or any
functionary not in existence in the State of Jammu and
Kashmir.
4. Presumption as to poisonous substances.
CHAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS
LABORTORY AND THE DRUGS CONSULTATIVE COMMITTEE
5. The Drugs Technical Advisory Board.
6. The Central Drugs Laboratory.
7. The Drugs Consultative Committee.
7A. Section 5 and 7 not to apply Ayurvedic, Siddha or Unani drugs.
CHAPTER III
IMPORT OF DRUGS AND COSMETICS
8. Standards of quality
9. Misbranded drugs
9A. Adulterated drugs
9B. Spurious drugs.
9C. Misbranded cosmetics.
9D. Spurious cosmetics
10 Prohibition of import of certain drugs or cosmetics.
10A. Power of Central Government to prohibit import of drugs and
cosmetics in public interest.
11. Application of law relating to sea customs and powers of
Customs officers.
12 Power of Central Government to make rules.
13 Offences.
14 Confiscation
15. Jurisdiction
6
CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS
SECTIONS
16. Standards of quality.
17. Misbranded drugs.
17A. Adulterated drugs.
17B. Spurious drugs.
17C. Misbranded cosmetics.
17D. Spurious cosmetics.
18. Prohibition of manufacture and sale of certain drugs and
cosmetics.
18A. Disclosure of the name of the manufacturer ,etc.
18B. Maintenance of records and furnishing of information.
19. Pleas .
20. Government Analysts.
21. Inspectors.
22. Powers of Inspectors.
23. Procedure of Inspectors.
24. Persons bound to disclose place where drugs or cosmetics are
manufactured or kept.
25. Reports of Government Analysts.
26. Purchaser of drug or cosmetic enabled to obtain test or analysis.
26A. Power of Central Government to prohibit manufacture etc. of
drug and cosmetic in public interest.
27. Penalty for manufacture, sale, etc., of drugs in contravention of
this Chapter.
27A. Penalty for manufacture, sale, etc., of cosmetics in
contravention of this Chapter.
28. Penalty for non-disclosure of the name of the manufacturer, etc.
28A. Penalty for not keeping documents, etc., and for non-disclosure
of information.
28B Penalty for manufacture, etc. of drugs or cosmetics in
contravention of section 26A.
29. Penalty for use of Government Analyst’s report for advertising.
30. Penalty for subsequent offences.
31. Confiscation.
31A. Application of provisions to Government departments.
32. Cognizance of offences.
32A. Power of Court to implead the manufacturer, etc.
33. Power of Central Government to make rules .
33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.
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CHAPTER IVA
PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS
SECTIONS
33B. Application of Chapter IVA.
33C. Ayurvedic, Siddha and Unani Drugs Technical Advisory
Board.
33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.
33E. Misbranded drugs.
33EE. Adulterated drugs.
33EEA. Spurious drugs.
33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and
Unani drugs.
33EEC. Prohibition of manufacture and sale of certain Ayurvedic,
Siddha and Unani drugs.
33EED. Power of Central Government to prohibit manufacture etc., of
Ayurvedic, Siddha or Unani drugs in public interest.
33F. Government Analysts.
33G. Inspectors .
33H. Application of provisions of sections 22, 23, 24 and 25.
33I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha
or Unani drugs in contravention of this Chapter.
33J. Penalty for subsequent offences.
33K. Confiscation .
33L. Application of provisions to Government departments.
33M. Cognizance of offences.
33N. Power of Central Government to make rules.
33O. Power to amend First Schedule.
CHAPTER V
MISCELLANEOUS
33P. Power to give directions.
34. Offences by companies.
34A. Offences by Government departments.
34AA. Penalty vexatious search or seizure.
35. Publication of sentences passed under this Act.
36. Magistrate’s power to impose enhanced penalties.
36A. Certain offences to be tried summarily.
37. Protection of action taken in good faith.
38. Rules to be laid before Parliament.
THE FIRST SCHEDULE
THE SECOND SCHEDULE
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THE DRUGS AND COSMETICS ACT, 1940
23 OF 19401
[10th April, 1940]
[PASSED BY THE INDIAN LEGISLATURE]
(Received the assent of the Governor General on the 10th April, 1940)
As Amended by Act No. II of 1955
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 15th April, 1955)
As Amended by Act No. 35 of 1960
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 15th September, 1960)
As Amended by Act No. 21 of 1962
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 27th June, 1962)
As Amended by Act No. 13 of 1964
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 12th May, 1964)
As Amended by Act No.19 of 1972
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 31st May, 1972)
___________________________________________________________________________ 1
For Statement of Object and Reasons, see Gazette of India, 1940, Pt. V, p.34; for the Report of the
Select Committee, see ibid., p. 143.
The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa
Government Notification No. 3358-LSG., dated the 25th August, 1941.

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As Amended by Act No.68 of 1982
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 13th November, 1982)
As Amended by Act No. 71 of 1986
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the 24th December, 1986)

As Amended by Act 22 of 1995.
[PASSED BY THE INDIAN PARLIAMENT]
(Received the assent of the President on the )

An Act to regulate the import, manufacture, distribution and sale of drugs 1
[and
cosmetics];
WHEREAS it is expedient to regulate the 2
[import, manufacture, distribution and
sale] of drugs 1
[and cosmetics];
AND WHEREAS the Legislature of all the Provinces have passed resolutions in
terms of section 103 of the Government of India Act, 1935 26 Geo. 5,c.2, in
relation to such of the above-mentioned matters and matters ancillary thereto as
are enumerated in List II of the Seventh Schedule to the said Act;
___________________________________________________________________________
1
Ins. By Act 21of 1962, s. 2(w.e.f. 27-7-1964).
2
Subs. By the A.O. 1950 for certain words.
10
It is hereby enacted as follows: —
CHAPTER I

INTRODUCTORY
1. Short title, extent and commencement. –(1) This Act may be called the Drugs 1
[and
Cosmetics] Act, 1940.
(2) It extends to the whole of India 2
* * *
(3) It shall come into force at once; but Chapter III shall take the effect only from
such 3
date as the Central Government may, by notification in the Official Gazette, appoint
in this behalf, and Chapter IV shall take effect in a particular State only from such 3
date as
the State Government may, by like notification, appoint in this behalf:
4
[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take
effect only from such date after the commencement of the Drugs and Cosmetics
(Amendment) Act, 1972 19of 1972, as the Central Government may, by notification in the
Official Gazette, appoint in this behalf.]
2. Application of other laws not barred. —The provisions of this Act shall be in
addition to and not in derogation of, the Dangerous Drugs Act, 1930 2 of 1930,and any
other law for the time being in force.
3.Definitions. —In this Act, unless there is anything repugnant in the subject or
context,–
5
[(a) “Ayurvedic, Siddha6
or Unani drug” includes all medicines intended for internal
or external use for or in the diagnosis, treatment, mitigation or prevention of
5
[disease or disorder in human beings or animals, and manufactured] exclusively
in accordance with the formulae described in, the authoritative books of
Ayurvedic, Siddha6
and Unani (Tibb) systems of medicine], specified in the First
Schedule;]
___________________________________________________________________________
1Ins. By Act 21of 1962, s. 2(w.e.f. 27-7-1964)
2The words “except the State of Jammu & Kashmir” omitted by Act 19 of 1972, s .2.
31st April, 1947; see Notification No. F. 28 (10) (3) 45-H (1), dated the 2nd September 1946, Gazette
of India, 1946, Pt, I, p.1349.
Chapter IV came into force in the States of Delhi, Ajmer and Coorg on the 1st April, 1947, see ibid.,
Chapters III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal,
Tripura, Vindhya Pradesh and Manipur on the 1st April, 1953, vide Notification No. S.R.O. 663,
dated the 30th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451.
Chapter IV came into force in the Unoin territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968,
see Notification No. ADM/Law/117(74) dated the 20th July, 1968, Gazette of India, Pt. III, Sec. 3,
p.128.The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, s.2 and Sch. I; to
Pondicherry by Reg. 7 of 1963. s. 3 and Sch. I; to Goa, Daman and Diu, by Reg. 11 of 1963, s. 3 and
Sch. and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965. s.3 and Sch.
4
Added by Act 19 of 1972, s. 2.
5
Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
6
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983).
11
1
[(aa) “the Board” means—
(i) in relation to Ayurvedic, Siddha2
or Unani drug, the Ayurvedic, Siddha2

or Unani Drugs Technical Advisory Board] constituted under section 33C; and
(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory
Board constituted under section 5;]
3
[
4 (aaa) ] “cosmetic” means any article intended to be rubbed, poured, sprinkled or
sprayed on, or introduced into, or otherwise applicated to, the human body or any part
thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance,
and includes any article intended for use as a component of cosmetic ,2
* * * ;]
5[(b) “drug” includes—
(i) all medicines for internal or external use of human beings or
animals and all substances intended to be used for or in the diagnosis,
treatment, mitigation or prevention of any disease or disorder in human
beings or animals, including preparations applied on human body for the
purpose of repelling insects like mosquitoes;
(ii) such substances (other than food) intended to affect the structure
or any function of human body or intended to be used for the destruction
of 6
(vermin) or insects which cause disease in human beings or animals, as
may be specified from time to time by the Central Government by
notification in the Official Gazette;]
2
[(iii) all substances intended for use as components of a drug
including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the
diagnosis, treatment, mitigation or prevention of disease or disorder in
human beings or animals, as may be specified from time to time by the
Central Government by notification in the Official Gazette, after
consultation with the Board ;]
7
[(c) “Government Analyst” means—
(i) in relation to Ayurvedic, Siddha2
or Unani drug, a Government Analyst
appointed by Central Government or a State Government under section
33F; and
(ii) in relation to any other drug or cosmetic , a Government Analyst appointed
by the Central Government or a State Government under section 20;]
__________________________________________________________________________ 1
Original cl. (a) was relettered as cl. (aa) and subs. by s. 2, ibid. (w.e.f. 15-9-1964). 2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Ins. as ci. (aa) by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).
4
Relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
5
Subs. by Act 11 of 1955, s. 2, for cl. (b).
6
Subs. By s. 2, ibid., for “vermins” (w.e.f. 15-9-1964). 7
Subs. By s. 2, ibid., for cl. ( c) (w.e.f. 15-9-1964).
12
1
* * * * *
2
[(e) “Inspector” means—
(i) in relation to Ayurvedic, Siddha3
or Unani drug, an Inspector appointed by
the Central Government or a State Government under section 33G; and
(ii) in relation to any other drug or cosmetic, an Inspector appointed by the
Central Government or a State Government under section 21;]
4
[
5
(f) “manufacture” in relation to any drug 6
[or cosmetic] includes any process or part
of a process for making, altering, ornamenting, finishing, packing, labelling,
breaking up or otherwise treating or adopting any drug 6
[or cosmetic] with a view
to its 3
[sale or distribution] but does not include the compounding or dispensing
7
[of any drug, or the packing of any drug or cosmetic,] in the ordinary course of
retail business; and “to manufacture” shall be construed accordingly;]
8
[(g)] “to import”, with its grammatical variations and cognate expressions means to
bring into 9
[India];
3
[
8
[(h)] “patent or proprietary medicine” means, —
(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurveda, Siddha or Unani Tibb
systems of medicine specified in the First Schedule, but does not include a
medicine which is administered by parenteral route and also a formulation
included in the authoritative books as specified in clause (a);
(ii) in relation to any other systems of medicine, a drug which is a remedy or
prescription presented in a form ready for internal or external
administration of human beings or animals and which is not included in
the edition of Indian Pharmacopoeia for the time being or any other
Pharmacopoeia authorized in this behalf by Central Government after
consultation with the Drugs Technical Advisory Board constituted under
section 5;]]
10[
8
[(i)] “prescribed” means prescribed by rules made under this Act.]
___________________________________________________________________________ 1
Cl. (d) omitted by Act 19 of 1972, s 3.
2
Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).
3
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
4
Cl. (bbb) ins. by Act 11 of 1955, s. 2. 5
Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961). 6
Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).
7
Subs. by s. 4, ibid., for “or the packing of any drug “. 8
Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f.
16-3-1961).
9
Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
10Subs. by Act 11 of 1955, s. 2, for original cl. (e).
13
1
* * * * * *
2
3A. Construction of references to any law not in force or any functionary not in
existence in the State of Jammu and Kashmir. –Any reference in this Act to any law which is
not in force, or any functionary not in existence, in the State of Jammu and Kashmir, shall, in
relation to that State, be construed as a reference to the corresponding law in force, or to the
corresponding functionary in existence, in that State.]
4. Presumption as to poisonous substances. —Any substance specified as poisonous by
rule made under Chapter III or Chapter IV 3
[or Chapter IVA] shall be deemed to be a
poisonous substance for the purposes of Chapter III or Chapter IV 3
[or Chapter IVA], as the
case may be.
CHAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS
LABOURATORY AND THE DRUGS CONSULTATIVE COMMITTEE
5. The Drugs Technical Advisory Board. — (1) The Central Government shall, as soon as
may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the
Central Government and the State Governments on technical matters arising out of the
administration of this Act and to carry out the other functions assigned to it by this Act.
4[(2) The Board shall consist of the following members, namely: —
(i) the Director General of Health Services, ex officio, who shall be
Chairman;
(ii) the Drugs Controller, India, ex officio;
(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;
(iv) the Director of the Central Research Institute, Kasauli, ex officio;
(v) the Director of Indian Veterinary Research Institute, Izatnagar, ex
officio;
(vi) the President of Medical Council of India, ex officio;
(vii) the President of the Pharmacy Council of India, ex officio;
(viii) the Director of Central Drug Research Institute, Lucknow, ex officio;
(ix) two persons to be nominated by the Central Government from among
persons who are in charge of drugs control in the States;
(x) one person, to be elected by the Executive Committee of the Pharmacy
Council of India, from among teachers in pharmacy or pharmaceutical chemistry
or pharmacognosy on the staff of Indian University or a college affiliated thereto;
1
Cl. (f), ins. by the A.O. 1950, omitted by Act 3 of 1951, s. 3 and Sch.
2
Ins. by Act 19 of 1972, s. 4.
3
Ins. by Act 13 of 1964, s. 3 (w.e.f. 15-9-1964).
4
Subs. by Act 13 of 1964, s. 4 , for sub-section (2)(w.e.f. 15-9-1964).
14
(xi) one person, to be elected by the Executive Committee of the Medical
Council of India,from among teachers in medicine or therapeutics on the staff of
an Indian University or a college affiliated thereto;
(xii) one person to be nominated by the Central Government from the
pharmaceutical industry;
(xiii) one pharmacologist to be elected by the Governing Body of the Indian
Council of Medical Research;
(xiv) one person to be elected by the Central Council of the Indian Medical
Association;
(xv) one person to be elected by the Council of the Indian Pharmaceutical
Association;
(xvi) two persons holding the appointment of Government Analyst under
this Act, to be nominated by the Central Government.]
(3) The nominated and elected members of the Board shall hold office for three years,
but shall be eligible for re-nomination and re-election:
1
[Provided that the person nominated or elected, as the case may be, under clause (ix) or
clause (x) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for, so long as he
holds the appointment of the office by virtue of which he was nominated or elected to the
Board.]
(4) The Board may, subject to the previous approval of the Central Government, make
bye-laws fixing a quorum and regulating its own procedure and the conduct of all business
to be transacted by it.
(5) The Board may constitute sub-committees and may appoint to such sub-committees
for such periods, not exceeding three years, as it may decide, or temporarily for the
consideration of particular matters, persons who are not members of the board.
(6) The functions of the Board may be exercised notwithstanding any vacancy therein.
(7) The Central Government shall appoint a person to be Secretary of the Board and
shall provide the Board with such clerical and other staff as the Central Government
considers necessary.
6. The Central Drugs Laboratory. — (1) The Central Government shall, as soon as may
be, established a Central Drugs Laboratory under the control of a Director to be appointed
by the Central Government, to carry out the functions entrusted to it by this Act or any rules
made under this Chapter:
______________________________________________________________________ 1
Subs. by s. 4, ibid, for the proviso (w.e.f. 15-9-1964).
15
Provided that, if the Central Government so prescribes, the functions of the Central
Drugs Laboratory in respect of any drug or class of drugs 1
[or cosmetic or class of
cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other
prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in
respect of such drug or class of drugs 1
[or such cosmetic or class of cosmetics] shall be
exercised by the Director of that Institute or of that other Laboratory, as the case may be.
(2) the Central Government may, after consultation with the Board, make rules
prescribing—
(a) the functions of the Central Drugs Laboratory;
2
* * * * * *
(d) the procedure for the submission to the said Laboratory 3
[under Chapter IV
or Chapter IVA]of samples of drugs 1
[or cosmetics] for analysis or test, the forms of
Laboratory’s reports thereon and the fees payable in respect of such reports;
(e) such other matters as may be necessary or expedient to enable the said
Laboratory to carry out its functions;
(f) the matters necessary to be prescribed for the purpose of the proviso to subsection (1).
7. The Drugs Consultative Committee. —(1) The Central Government may constitute an
advisory committee to be called “the Drugs Consultative Committee” to advise the Central
Government, the State Governments and the Drugs Technical Advisory Board on any other
matter tending to secure uniformity throughout 4
[India] in the administration of this Act.
(2) The Drugs Consultative Committee shall consist of two representatives of the Central
Government to be nominated by that Government and one representative of each State
Government to be nominated by the State Government concerned.
(3) The Drugs Consultative Committee shall meet when required to do so by the Central
Government and shall have power to regulate its own procedure.
5
[7A. Sections 5 and 7 not apply to Ayurvedic, Siddha6
or Unani drugs. — Nothing
contained in sections 5 and 7 shall apply to Ayurvedic, Siddha6
or Unani drugs.]
__________________________________________________________________________ 1
Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964).
2
Cls. (b) and (c) omitted by Act 11 of 1955, s. 4.
3
Subs. by Act 13 of 1964, s. 5, for “under Chapter IV” (w.e.f. 15-9-1964).
4
Subs. by Act 3 of 1951, s. 3 and Sch., or “the States”.
5
Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964).
6
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
16
CHAPTER III
1
[IMPORT OF DRUGS AND COSMETICS]
8. Standards of quality. —(1) For the purposes of this Chapter, the expression “standard
quality” means—
(a) in relation to a drug, that the drug complies with the standard set out in
2
[the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic compiles with such standard as may
be prescribed.]
(2) The Central Government, after consultation with the Board and after giving by
notification in the Official Gazette not less than three months’ notice of its intention so to do,
may by a like notification add to or otherwise amend 2
[the Second Schedule], for the purpose
of this Chapter, and thereupon 2
[the Second Schedule] shall be deemed to be amended
accordingly.
9. Misbranded drugs. —For the purposes of this Chapter a drug shall be deemed to be
misbranded—
1
[(a) if it is so coloured, coated, powdered or polished that damage is concealed or if
it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or misleading
in any particular; ]
1
[9A. Adulterated drugs. — For the purposes of this Chapter, a drug shall be deemed to be
adulterated,–
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance;
or
(b) if it has been prepared, packed or stored under insanitary conditions whereby it
may have been contaminated with filth or whereby it may have been rendered injurious to
health; or
(c) if its container is composed in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of colouring only, a colour other than one
which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to
health; or
(f) if any substance has been mixed therewith so as to reduce its quality or
strength.
1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
2
Subs. by Act 13 of 1964, s. 7, for “the Schedule” (w..e.f. 15-9-1964).
17
9B. Spurious drugs. — For the purposes of this Chapter, a drug shall be deemed to be
spurious—
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of , or a substitute for, another drug or resembles another
drug in a manner likely to deceive or bears upon it or upon its label or container the name
of another drug unless it is plainly and conspicuously marked so as to reveal its true
character and its lack of identity with such other drug ; or
(c) if the label or the container bears the name of an individual or company
purporting to be the manufacturer of the drug, which individual or company is fictitious
or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a
product .
9C.Misbranded cosmetics. —For the purposes of this chapter, a cosmetic shall be deemed
to be misbranded—
(a) if it contains a colour which is not prescribed ; or
(b) if it is not labelled in a prescribed manner; or
(c) if the label or container or anything accompanying the cosmetic bears any
statement which is false or misleading in any particular.
9D. Spurious cosmetics. –For the purposes of this Chapter, a drug shall be deemed to be
spurious, —
(a) if it is imported under the name which belongs to another cosmetic; or
(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles
another cosmetic in a manner likely to deceive or bears upon it or upon its label or
container the name of another cosmetic, unless it is plainly or conspicuously marked so as
to reveal its true character and its lack of identity with such other cosmetic; or
(c) if the label or the container bears the name of an individual or company
purporting to be the manufacturer of the cosmetic, which individual or company is
fictitious or does not exist; or
(d) if it purports to be the product of a manufacturer of whom it is not truly a
product].
10. Prohibition of import of certain drugs or cosmetics. —From such 1
date as may be
fixed by the Central Government by notification in the Official Gazette in this behalf, no
person shall import—
(a) any drug 2
[or cosmetic] which is not of standard quality;
___________________________________________________________________________ 1
1st April, 1947 for cls. (a), (b), (c), (e) and (f) and 1st April 1949 for cl. (d) see Notification No. 18-
12/46-D (I), dated on 11th February 1947, Gazette of India, 1947, Pt. 1, P. 189 as amended by
Notification No.F.1-2/48-D (1), dated 29th September,1948.
1st April, 1953 for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal,Tripura, Vindhya Pradesh
and Manipur; vide Notification No. S.R.O. 666, dated the 30th March, 1953, Gazette of India, 1953, Pt.
II, Sec. 3, p.451.
2
Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964).
18
1
[(b) any misbranded drug or misbranded 2
(or spurious) cosmetic;]
3
[(bb) any adulterated 2
(or spurious) drug;]
(c) any drug 4
[or cosmetic] for the import of which a licence is prescribed, otherwise
than under, and in accordance with, such licence;
5
[(d) any patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof 2
(the true formula or list of active ingredients
contained in it, together with the quantities thereof);]

(e) any drug which by means of any statement, design or device accompanying it or
by any other means, purports or claims to cure or mitigate any such disease or ailment, or
to have any such other effect, as may be prescribed;
4
[(ee) any cosmetic containing any ingredient which may render it unsafe or harmful
for use under the directions indicated or recommended;]
(f) any drug 4
[or cosmetic] the import of which is prohibited by rule made under this
Chapter:
Provided that nothing in this section shall apply to the import, subject to prescribed
conditions, of small quantities of any drug for the purpose of examination, test or analysis or
for personal use:
Provided further that the Central Government may, after consultation with the Board ,by
notification in the Official Gazette, permit, subject to any conditions specified in the
notification, the import of any drug or class of drugs not being of standard quality.
2* * * * * *
5
[10A. Power of Central Government to prohibit import of drugs and cosmetics in public
interest. — Without prejudice to any other provision contained in this Chapter, if the Central
Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to
human beings or animals or that any drug does not have the therapeutic value claimed for it
or contains ingredients and in such quantity for which there is no therapeutic justification and
that in the public interest it is necessary or expedient so to do then, that Government may, by
notification in the Official Gazette, prohibit the import of such drug or cosmetic.]
___________________________________________________________________________

1Subs. by s.8, ibid,. for cl. (b) (w.e.f. 27-7-1964). 2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964).
4
Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964).
5
Subs. by Act 11 of 1955, s. 5, for cl. (d).
19
11. Application of law relating to sea customs and powers of Customs Officers. – (1) The
law for the time being in force relating to sea customs and to goods, the import of which is
prohibited by section 18 of the Sea Customs Act, 18781 (8 of 1878) shall, subject to the
provisions of section 13 of this Act, apply in respect of drugs 2
[and cosmetics] the import of
which is prohibited under this Chapter, and officers of Customs and officers empowered
under that Act to perform the duties imposed thereby on a Customs Collector and other
officers of Customs, shall have the same powers in respect of such drugs 2
[and cosmetics] as
they have for the time being in respect of such goods as aforesaid.
3
[(2) Without prejudice to the provisions of sub-sections (1), the Customs Collector
or any other officer of the Government authorized by the Central Government in this behalf,
may detain any imported package which he suspects to contain any drug 2
[or cosmetic] the
import of which is prohibited under this Chapter and shall forthwith report such detention to
the Drugs Controller, India, and, if necessary, forward the package or sample of any
suspected drug 2
[or cosmetic] found therein to the Central Drugs Laboratory.]
12. Power of Central Government to make rules. —(1) The Central Government may,
after consultation with 4
(or on the recommendation of the Board) and after previous
publication by notification in the Official Gazette, make rules for the purpose of giving effect
to the provisions of this Chapter:
5
[Provided that consultation with the Board may be dispensed with if the Central
Government is of opinion that circumstances have arisen which render it necessary to make
rules without such consultation, but in such a case the Board shall be consulted within six
months of the making of the rules and the Central Government shall take into consideration
any suggestions which the Board may make in relation to the amendment of the said rules.]
(2) Without prejudice to the generality of the forgoing power, such rules may—
(a) specify the drugs or classes of drugs 6
[or cosmetics or classes of cosmetics] for
the import of which a licence is required, 4
[and prescribe the form and conditions of such
licences, the authority empowered to issue the same, the fees payable therefor and
provide for the cancellation, or suspension of such licence in any case where any
provision of this Chapter or the rules made thereunder is contravened or any of the
conditions subject to which the licence is issued is not complied with];
(b) prescribe the methods of test or analysis to be employed in determining whether
a drug 6
[or cosmetic] is of standard quality;
(c) prescribe, in respect of biological and organometallic compounds, the units or
methods of standardization;
1
Now see the Customs Act 1962
2
Ins. by Act 21of 1962, s. 9 (w.e.f. 27-7-1964).
3
Subs. by Act 11 of 1955, s. 6, for sub-section (2).
4
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
5
Ins. by Act 11 of 1955, s. 7.
6
Ins. by Act 21of 1962, s. 10 (w.e.f. 27-7-1964).
20
1
[(cc) prescribe under clause (d) of 2
(section 9A) the colour or colours which a
drug may bear or contain for purposes or colouring;]
(d) specify the diseases or ailments which an imported drug may not purport or
claim 3
[to prevent, cure or mitigate] and such other effects which such drug may not
purport or claim to have;
(e) prescribe the conditions subject to which small quantities of drugs, the
import of which is otherwise prohibited under this Chapter, may be imported for the
purpose of examination, test or analysis or for personal use;
(f) prescribe the places at which drugs 4
[or cosmetics] may be imported, and
prohibit their import at any other place;
(g) require the date of manufacture and the date of expiry of potency to be
clearly and truly stated on the label or container of any specified imported drug or class
of such drugs, and prohibit the import of the said drug or class of drugs after the expiry
of a specified period from the date of manufacture;
(h) regulate the submission by importers, and the securing, of samples of drugs
4
[or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and
prescribe the fees, if any, payable for such examination, test or analysis;
(i) prescribe the evidence to be supplied, whether by accompanying documents
or otherwise, of the quality of drugs 4
[ or cosmetics] sought to be imported, the
procedure of officers of Customs in dealing with such evidence, and the manner of
storage at places of import of drugs 4
[ or cosmetics] detained pending admission;
(j) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter and the rules made thereunder of drugs 4
[or cosmetics]
imported for the purpose only of transport through, an export from, 5
[India];
(k) prescribe the conditions to be observed in the packing in bottles, packages or
other containers, of imported drugs 2
[including the use of packing material which comes
into direct contact with the drugs] 4
[or cosmetics];
(l) regulate the mode of labeling drugs 4
[or cosmetics] imported for sale in
packages, and prescribe the matters which shall or shall not be included in such labels;
(m) prescribe the maximum proportion of any poisonous substance which may
be added to or contained in any imported drug, prohibit the import if any drug in which
that proportion is exceeded, and specify substances which shall be deemed to be
poisonous for the purposes of this Chapter and the rules made thereunder;
(n) require that accepted scientific name of any specified drug shall be displayed
in the prescribed manner on the label or wrapper of any imported, patent or proprietary
medicine containing such drug;
(o) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter or the rules made thereunder of any specified drug or class of
drugs 4
[or cosmetic or class of cosmetics].
1
Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964)
2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Subs. by Act 11 of 1955, s. 7, for “to cure or mitigate”.
4
Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964).
5
Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
21
1
[13. Offences. —(1) Whoever himself or by any other person on his behalf imports,-
(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious
drug under section 9B or any spurious cosmetic referred to in section 9D or any
cosmetic of the nature referred to in clause (ee) of section 10 shall be punishable
with imprisonment for a term which may extend to three years and a fine which
extend to five thousand rupees;]
1
[(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the
import of which is prohibited under section 10, or any rule made under this Chapter,
shall be punishable with imprisonment for a term which may extend to six months,
or with fine which extend to five thousand rupees or both;

(c) any drug or cosmetic in contravention of the provision of any notification issued
under section 10A, shall be punishable with imprisonment for a term which may
extend to three years, or with fine which extend to five thousand rupees, or both;

(2) Whoever having been convicted of an offence—
(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence
under that clause, shall be punishable with imprisonment for a term which may
extend to ten thousand rupees, or with both;
(b) under clause (b) of sub-section (1),is again convicted of an offence under that
clause, shall be punishable with imprisonment for a term which may extend to one
year, or with fine which may extend to one thousand rupees, or with both
(3) The punishment provided by this section shall be in addition to any penalty to which
the offender may be liable under the provision of section 11.]

14.Confiscation. —Where any offence punishable under section 13 has been committed,
the consignment of the drugs 2
[or cosmetics] in respect of which the offence has been
committed shall be liable to confiscation.
15.Jurisdiction. —No Court inferior to that of a 1
[Metropolitan] Magistrate or of a
1
[Judicial] Magistrate of the first class shall try an offence punishable under section 13.
CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1
[AND COSMETICS]
16.Standards of quality. —3
[(1) For the purposes of this Chapter, the expression “standard
quality” means—
(a) in relation to a drug, that the drug complies with the standard set out in 4
[the
Second Schedule], and
__________________________________________________________________________ 1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
2
Ins. by Act 21 of 1962, s. 11 (w.e.f.27-7-1964)
3
Subs. by s. 12, ibid., for sub-section (1), (w.e.f. 27-7-64). 4
Subs. Act 13 of 1964, s. 11, for “the Schedule” (w.e.f 15-9-1964).
22
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may
be prescribed.]
(2) The 1
[Central Government], after consultation with the Board and after giving by
notification in the Official Gazette not less than three months’ notice of its intention so to do,
may by a like notification add to or otherwise amend 2
[the Second Schedule] for the purpose
of this Chapter, and thereupon 2
[the Second Schedule] shall be deemed to be amended
accordingly.
3
[17. Misbranded drugs. —For the purposes of this Chapter a drug shall be deemed to be
misbranded—
(a) if it is so coloured, coated, powdered or polished that damage is concealed, or if
it is made to appear of better or greater therapeutic value that it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or
misleading in any particular.
17A. Adulterated drugs. — For the purpose of this Chapter, a cosmetic shall be deemed
to be adulterated, —
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed
substance; or
(b) if has been prepared, packed or stored under insanitary conditions whereby it
may have been contaminated with filth or whereby it may have been rendered injurious
to health; or
(c) if its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health; or
(d) if it bears or contains, for the purpose of colouring only, a colour other than
one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to
health; or
(f) if any substance has been mixed therewith so as to reduce its quality or
strength.
17B.Spurious drugs. –For the purposes of this Chapter a drug shall be deemed to be
spurious,-
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an intimation of, or is a substitute for, another drug or resembles
another drug in a manner likely to deceive or bear upon it or upon its label or container
the name of another drug unless it is plainly and conspicuously marked so as to reveal
its true character and its lack identity with such other drug ; or
(c) if the label or container bears the name of an individual or company
purporting to be the manufacturer of the drug , which individual or company is fictitious
or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
___________________________________________________________________________ 1
Subs. by Act 11 of 1955, s. 8, for “State Government.”
2
Subs. Act 13 of 1964, s. 11, for “the Schedule” (w.e.f 15-9-1964).
3
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
23
(e) if it purports to be the product of a manufacturer of whom it is not truly a
product.
17C. Misbranded cosmetics. —For the purposes of this Chapter, a cosmetic shall be
deemed to be misbranded, —
(a) if it contains a colour which is not prescribed; or
(b) if it is not labelled in the prescribed manner; or
(c) the label or any container or anything accompanying the cosmetic bears any
statement which is false or misleading in any particular.
17D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed
to be spurious,–
(a) if it is manufactured under a name which belongs to another cosmetic; or]
(b) if it is an intimation of , or a substitute for , another cosmetic or resembles
another cosmetic in a manner likely to deceive or bear upon it or upon its label or
container the name of another cosmetic unless it is plainly and conspicuously marked so
as to reveal its true character and its lack of identity with such other cosmetic; or
(c) if the label or container bears the name of an individual or a company
purporting to be the manufacturer of the cosmetic which individual or company is
fictitious or does not exist; or
(d) if it purports to be the product of a manufacturer of whom it is not truly a
product.]
18. Prohibition of manufacture and sale of certain drugs and cosmetics. —From such
1
date as may be fixed by the State Government by notification in the Official Gazette in this
behalf ,no person shall himself or by any other person on his behalf—
(a) manufacture for sale 2
[or for distribution] ,or sell, or stock or exhibit 2
[or
offer for sale]—
2
[(i) any drug which is not of a standard quality, or is misbranded,
adulterated or spurious;
(ii) any cosmetic which is not of a standard quality or is misbranded or
spurious;]
3
[(iii) any patent or proprietary medicine, unless there is displayed in the
prescribed manner on the label or container thereof the true formula or list of
2
[active ingredients contained in it together with the quantities thereof;]]
(iv) any drug which by means of any statement, design or device
accompanying it or by any other means ,purport or claims 4
[to prevent ,cure or
mitigate ] any such disease or ailment ,or to have any such other effect as may
be prescribed;
___________________________________________________________________________ 1
1st April,1947 for sub-clauses (i), (ii), (iv) and (v) of clause (a) and clauses (b) and (c) ; 1st April, 1949
for sub-clause (iii) of clause (a) in so far as it takes effect in Delhi, Ajmer and Coorg, see Notification
No. 18-12/46-D. II, dated 11th February, 1947. Gazette of India, 1947, Pt.I, p.189; as amended by
Notification No.F. 1-2/48-D(II), dated 29th September, 1948; 1st April, 1953 for the States of Himchal
Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide Notification No.
S.R.O. 664, dated 30th March,1953, Gazette of India,1953, Pt. II,Sec. 3, p. 451. 2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Subs. by Act 11 of 1955, s. 9, for sub-clause (iii)
4
Subs. by s. 9,ibid., for “to cure or mitigate”.
24
1[(v) any cosmetic containing any ingredient which may render it unsafe
or harmful for use under the directions indicated or recommended;
(vi) any drug or cosmetic in contravention of any of the provisions of this
Chapter or any rule made thereunder;]
(b) sell, or stock or exhibit 2
[or offer] for sale, or distribute any drug 3
[or cosmetic]
which has been imported or manufactured in contravention of any of the provisions of
this Act or any rule made thereunder;
(c) manufacture for sale 2
[or for distribution], or sell, or stock or exhibit 2
[or offer]
for sale, or distribute any drug 4
[or cosmetic],except under, and in accordance with the
conditions of, a licence issued for such purpose under this Chapter :

Provided that nothing in this section shall apply to the manufacture, subject to prescribed
condition of small quantities of any drug for the purpose of examination, test or analysis:
Provided further that the 5
[Central Government] may, after consultation with the Board,
by notification in the Official Gazette, permit, subject to any conditions specified in the
notification, the 2
[manufacture for sale, or for distribution, sale, stocking or exhibiting or
offering for sale or distribution] of any drug or class of drugs not being of standard quality.
6
* * * * * *
7
[18A. Disclosure of the name of the manufacturer, etc.—Every person, not being the
manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so
required, disclose to the Inspector the name, address and other particulars of the person from
whom he acquired the drug or cosmetic.]
8
[18B. Maintenance of records and furnishing of information. —Every person holding a
licence under clause (c) of section 18 shall keep and maintain such records, registers and
other documents as may be prescribed and shall furnish to any officer or authority exercising
any power or discharging any function under this Act such information as is required by such
officer or authority for carrying out the purposes of this Act.]
19.Pleas. —(1) Save as hereinafter provided in this section, it shall be no defence in a
prosecution under this Chapter to prove merely that the accused was ignorant of the nature,
substance or quality of drug 7
[or cosmetic] in respect of which the offence has been
committed or of the circumstances of its manufacture or import, or that a purchaser, having
bought only for the purpose of test or analysis, has not been prejudiced by the sale.
___________________________________________________________________________ 1
Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964).
2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Ins. by s. 14, ibid. (w.e.f. 27-7-1964). 4
Ins. by Act 21 of 1962, s. 14 (w.e.f. 27-7-1964).
5
Subs. by Act 11 of 1955, s. 9, for “State Government”.
6
Explanation Omitted as per Act 68 of 1982 (w.e.f. 01-02-1983) 7
Ins. by Act 13 of 1964, s. 14 (w.e.f. 15-9-1964)
8
Ins. by Act 68 of 1982 (w.e.f. 01-02-1983)
25
(2) 1
[For the purposes of section 18 a drug shall not be deemed to be misbranded or
adulterated 2
[or spurious] or to be below standard quality nor shall a cosmetic be deemed to
be misbranded or to be below standard quality] only by reason of the fact that—
(a) there has been added thereto some innocuous substance or ingredient because the
same is required for manufacture or preparation of the drug 3
[or cosmetic] as an article of
commerce in a state fit for carriage or consumption, and not to increase the bulk, weight
or measure of the drug 3
[or cosmetic]or to conceal its inferior quality or other defects; or
4
* * * * * *
(b) in the process of manufacture, preparation or conveyance some extraneous
substance has unavoidably become intermixed with it: Provided that this clause shall not
apply in relation to any sale or distribution of the drug 3
[or cosmetic] occurring after the
vendor or distributor became aware of such intermixture.
5
[(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the
distribution thereof, shall not be liable for a contravention of section 18 if he proves—
(a) that he acquired the drug or cosmetic from a duly licensed manufacturer,
distributor or dealer thereof;
(b) that he did not know and could not ,with reasonable diligence, have ascertained
that the drug or cosmetic in any way contravened the provisions of that section ;and
(c) that the drug or cosmetic, while in his possession, was properly stored and
remained in the same state as when he acquired it .]
6
[20.Government Analysts. — (1) The State Government may, by notification in the
Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to
be Government Analysts for such areas in the state and in respect of such drugs or 7
[classes
of drug or such cosmetics or classes of cosmetics] as may specified in the notification.
(2) The Central Government may also, by notification in the Official Gazette, appoint
such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts
in respect of such drugs or 7
[classes of drugs or such cosmetics or classes of cosmetics] as
may be specified in the notification.
___________________________________________________________________________ 1
Subs. by Act 13 of 1964, s. 15, for certain words (w.e.f. 15-9-1964).
2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
4
Cl.(aa)ins. by Act 11 of 1955, s. 10, omitted by Act 13 of 1964, s. 15 (w.e.f. 15-9-1964).
5
Subs.by Act 13 of 1964, s. 15, for sub-section (3) (w.e.f. 15-9-1964).
6
Subs. by Act 35 of 1960, s. 4, for the original ss.20 and 21 (w.e.f. 16-3-1961)
7
Subs. by Act 21 of 1962, s. 16, for “class of drugs” (w.e.f. 27-7-1964).
26
(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), neither
the Central Government nor a State Government shall appoint as a Government Analyst any
official not serving under it without the previous consent of the Government under which he
is serving.
1
[(4) No person who has any financial interest in the import, manufacture or sale of drugs
or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or subsection (2) of this section.]
21. Inspectors. —(1) The Central Government or a State Government may, by notification
in the Official Gazette, appoint such person as it thinks fit, having the prescribed
qualification, to be Inspectors for such areas as may be assigned to them by the Central
Government or State Government, as the case may be.
(2) The powers which may be exercised by an Inspector and the duties which may be
performed by him, the drugs or 2
[classes of drugs or cosmetics or classes of cosmetics] in
relation to which and the conditions, limitations or restrictions subject to which, such powers
and duties may be exercised or performed shall be such as may be prescribed.
(3) No person who has any financial interest 3
[in the import, manufacture or sale of drugs
or cosmetics] shall be appointed to be an Inspector under this section.]
4
[(4) Every Inspector shall be deemed to be public servant within the meaning of section
21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such authority
5
[having the prescribed qualification] as the Government appointing him may specify in this
behalf.]
6
[22. Powers of Inspectors—(1) Subject to the provisions of section 23 and of any rules
made by the Central Government in this behalf, an Inspector may, within the local limits of
the area for which he is appointed, —
5
[(a) inspect, —
(i) any premises wherein any drug or cosmetic is being manufactured and the
means employed for standardizing and testing the drug or cosmetic;
(ii) any premises wherein any drug or cosmetic is being sold, or stocked or
exhibited or offered for sale, or distributed ;
(b) take samples of any drug or cosmetic,–
(i) which is being manufactured or being sold or is stocked or exhibited or
offered for sale, or is being distributed;
(ii) from any person who is in the course of conveying, delivering or preparing to
deliver such drug or cosmetic to a purchaser or a consignee;
1
Ins. by Act 68 of 1982 (w.e.f. 01-02-1983)
2
Subs. by s.17, ibid. ,for “class of drugs” (w.e.f. 27-7-1964). 3
Subs. by Act 21of 1962, s.17, for “in the manufacture, import or sale of drugs” (w.e.f 27-7-1964).
4
Subs. by Act 35 of 1960, s. 4, for the original ss.20 and 21 (w.e.f. 16-3-1961)
5
Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
6
Subs. by Act 11of 1955, s. 11, for s.22.
27
(c) at all reasonable times, with such assistance, if any, as he considers necessary,–
(i) search any person, who, he has reason to believe, has secreted about his
person, any drug or cosmetic in respect of which an offence under this
Chapter has been, or is being, committed; or
(ii) enter and search any place in which he has reason to believe an offence under
this Chapter has been, or is being committed; or
(iii) stop and search any vehicle, vessel, or other conveyance which, he has reason
to believe, is being used for carrying any drug or cosmetic in respect of which
an offence under this Chapter has been, or is being, committed,
and order in writing the person in possession of the drug or cosmetic in respect of which
the offence has been, or is being, committed, not to dispose of any stock of such drug or
cosmetic for a specified period not exceeding twenty days, or, unless the alleged offence
is such that the defect may be removed by the possessor of the drug or cosmetic, seize the
stock of such drug or cosmetic and any substance or article by means of which the
offence has been ,or is being, committed or which may be employed for the commission
of such offence;]
1
[(cc) examine any record, register, document or any other material object found
2
[with any person, or in place, vehicle, vessel or other conveyance referred to in
clause (c)], and seize the same if he has reason to believe that it may furnish
evidence of the commission of an offence punishable under this Act or the Rules
made thereunder;]
2
[(cca) require any person to produce any record, register, or other document relating
to the manufacture for sale or for distribution, stocking, exhibition for sale, offer
for sale or distribution of any drug or cosmetic in respect of which he has reason
to believe that an offence under this Chapter has been, or is being, committed;
(d) exercise such other powers as may be necessary for carrying out the purposes of
this Chapter or any rules made there under.
(2) The provisions of the Code of Criminal Procedure, 2
[1973 (2 of 1974)] shall, so far as
may be, apply to any search or seizure under this Chapter as they apply to any search or
seizure made under the authority of a warrant issued under section 2
[94] of the said Code.
2
[(2A) Every record, register or other document seized under clause (cc) or produced
under clause (cca) shall be returned to the person, from whom they were seized or who
produce the same, within a period of twenty days of the date of such seizure or production, as
the case may be, after copies thereof or extracts there from certified by that person, in such
manner as may be prescribed, have been taken.]
1
Ins.by Act 35 of 1960, s. 5(w.e.f. 16-3-1961)
2
Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
28
(3) If any person willfully obstructs an Inspector in the exercise of the powers conferred
upon him by or under this Chapter 1
[or refuses to produce any record, register or other
document when so required under clause (cca) of sub-section (1)], he shall be punishable
with imprisonment which may extend to three years, or with fine, or with both.]
23. Procedure of Inspectors. —(1) Where an Inspector takes any sample of a drug 2
[or
cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written
acknowledgement therefor.
(2) Where the price tendered under sub-section (1) is refused, or where the Inspector
seizes the stock of any drug 2
[or cosmetic] under clause (c) of section 22, he shall tender a
receipt therefore in the prescribed form.
(3) Where an Inspector takes a sample of a drug 2
[or cosmetic] for the purpose of test or
analysis, he shall intimate such purpose in writing in the prescribed form to the person from
whom he takes it and, in the presence of such person unless he willfully absents himself, shall
divide the sample into four portions and effectively seal and suitably mark the same and
permit such person to add his own seal and mark to all or any of the portions so sealed and
marked:
Provided that where the sample is taken from premises whereon the drug 2
[or cosmetic] is
being manufactured, it shall be necessary to divide the sample into three portions only:
Provided further that where the drug 2
[or cosmetic] is made up in containers of small
volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 2
[or
cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall,
take three or four, as the case may be, of the said containers after suitably marking the same
and, where necessary, sealing them.
(4) The Inspector shall restore one portion of a sample so divided or one container, as the
case may be, to the person from whom he takes it, and shall retain the remainder and dispose
of the same as follows: —
(i) one portion or container he shall forthwith send to the Government Analyst for
test or analysis;
(ii) the second he shall produce to the Court before which proceedings, if any, are
instituted in respect of the drug 2
[or cosmetic];
3
[(iii) the third, where taken, he shall send to the person, if any, whose name,
address and other particulars have been disclosed under section 18A.]
(5) Where an Inspector takes any action under clause (c) of section 22, —
1
Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
2
Ins.by Act 21 of 1962, s.15 (w.e.f. 27-7-1964).
3
Subs. by Act 13 of 1964, s.16, for cl. (iii) (w.e.f.15-9-1964).
29
(a) he shall use all despatch in ascertaining whether or not the drug 1
[or cosmetic]
contravenes any of the provisions of the section 18 and, if it is ascertained that the drug
1
[or cosmetic] does not so contravene, forthwith revoke the order passed under the said
clause or, as the case may be take , such action as may be necessary for the return of the
stock seized;
(b) if he seizes the stock of the drug 1
[or cosmetic], he shall as soon as may be,
inform a 2
[Judicial] Magistrate and take his orders as to the custody thereof;
(c) without prejudice to the institution of any prosecution, if the alleged
contravention be such that the defect may be remedied by the possessor of the drug 1
[or
cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith
revoke his order under the said clause.
3
[(6) Where an Inspector seizes any record, register, document or any other material
object under clause (cc) of sub-section (1) of section 22,he shall, as soon as may be, inform a
2
[Judicial] Magistrate and take his orders as to the custody thereof.]
24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept.
—Every person for the time being in charge of any premises whereon any drug 1
[or cosmetic]
is being manufactured or is kept for sale or distribution shall, on being required by an
Inspector so to do, be legally bound to disclose to the Inspector the place where the drug 1
[or
cosmetic] is being manufactured or is kept, as the case may be.
25.Reports of Government Analysts. —(1) The Government Analyst to whom a sample of
any drug 1
[or cosmetic] has been submitted for test or analysis under sub-section (4) of
section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the
prescribed form.
(2)The Inspector on receipt thereof shall deliver one copy of the report to the person from
whom the sample was taken 4
[and another copy to the person, if any, whose name, address
and other particulars have been disclosed under section 18A], and shall retain the third copy
for use in any prosecution in respect of the sample.

(3)Any document purporting to be a report signed by a Government Analyst under this
Chapter shall be evidence to the facts stated therein, and such evidence shall be conclusive
unless the person from whom the sample was taken 5
[or the person whose name, address and
other particulars have been disclosed under section 18A] has, within twenty-eight days of the
receipt of a copy of the report, notified in writing the Inspector or the Court before which any
proceedings in respect of the sample are pending that he intends to adduce evidence in
controversion of the report.
1
Ins by 21 of 1962 s.15 (w.e.f.27-7-1964)
2
Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
3
Ins by Act 35 of 1960,s.6(w.e.f.16-3-1961).
4
Subs.by Act 13 of 1964,s.17, for certain words (w.e.f.15-9-1964).
5
Subs. By s.17, ibid., for “or the said warrantor”(w.e.f..15-9-1964).
30
(4) Unless the sample has already been tested or analysed in the Central Drugs
Laboratory, where a person has under sub-section (3) notified his intention of adducing
evidence in controversion of a Government Analyst’s report, the Court may, of its own
motion or in its discretion at the request either of the complainant or the accused, cause the
sample of the drug 1
[or cosmetic] produced before the Magistrate under sub-section (4) of
section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or
analysis and report in writing signed by, or under the authority of, the Director of the Central
Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts
stated therein.

(5) The cost of a test or analysis made by the Central Drugs Laboratory under subsection (4) shall be paid by complainant or accused as the Court shall direct.
26. Purchaser of drugs or cosmetics enabled to obtain test or analysis.— Any person 2
[or
any recognized consumer association, whether such person is a member of that association or
not] shall, on application in prescribed manner and on payment of prescribed fee, be entitled
to submit for test or analysis to a Government Analyst any drug 1
[or cosmetic] purchased by
him 3
[or it] and to receive a report of such test or analysis signed by the Government Analyst.
2
[Explanation. —For the purposes of this section and section 32, “recognized consumer
association” means a voluntary consumer association registered under the Companies Act,
1956 or any other law for the time being in force.]
4
[26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic
in public interest. —Without prejudice to any other provision contained in this Chapter, if the
Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any
risk to human beings or animals or that any drug does not have the therapeutic value claimed
or purported to be claimed for it or contains ingredients and in such quantity for which there
is no therapeutic justification and that in the public interest it is necessary or expedient so to
do, then, that Government may, by notification in the Official Gazette, prohibit the
manufacture, sale or distribution of such drug or cosmetic]
4
[27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter. —
Whoever, himself or by any other person on his behalf, manufactures for sale or for
distribution, or sells, or stocks or exhibits or offers for sale or distributes, —
(a) any drug deemed to be adulterated under section 17A or spurious under section
17B or which when used by any person for or in the diagnosis, treatment, mitigation, or
prevention of any disease or disorder is likely to cause his death or is likely to cause such
harm on his body as would amount to grievous hurt within the meaning of section 320 of
the Indian Penal Code, solely on account of such drug being adulterated or spurious or not
___________________________________________________________________________ 1
Ins. by Act 21 of 1962, s.15 (w.e.f.27-7-1964).
2
Ins. by Act 71 of 1986
3
Amended. by Act 68 of 1982 (w.e.f. 01-02-1983)
31
of standard quality, as the case may be, shall be punishable with imprisonment for a term
which shall not be less than five years but which may extend to a term of life and with fine
which shall not be less than ten thousand rupees;]
1
[(b) any drug—
(i) deemed to be adulterated under section 17A, but not being a drug referred to
in clause (a), or
(ii) without a valid licence as required under clause (c) of section 18,
shall be punishable with imprisonment for a term which shall not be less than one year but
which may extend to three years and with fine which shall not be less than five thousand
rupees;
Provided that the Court may, for any adequate and special reasons to be recorded in the
judgment, impose a sentence of imprisonment for a term of less than one year and of fine of
less than five thousand rupees;
(c) any drug deemed to be spurious under section 17B, but not being a drug referred
to in clause (a) shall be punishable with imprisonment for a term which shall not be less
than five years and with fine which shall not be less than five thousand rupees;

Provided that the Court may, for any adequate and special reasons, to be recorded in the
judgment, impose a sentence of imprisonment for a term of less than three years but not less
than one year;
(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in
contravention of any other provision of this Chapter or any rule made thereunder, shall be
punishable with imprisonment for a term which shall not be less than one year but which
may extend to two years and with fine;

Provided that the Court may, for any adequate and special reasons, to be recorded in the
judgment impose a sentence of imprisonment for a term of less than one year.
27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter. —
Whoever himself or by any other person on his behalf manufactures for sale or for
distribution, or sells, or stocks or exhibits or offers for sale—
(i) any cosmetic deemed to be spurious under section 17D shall be punishable with
imprisonment for a term which may extend to three years and with fine;
(ii) any cosmetic other than a cosmetic referred to in clause (i) above in contravention
of any provision of this Chapter or any rule made thereunder shall be punishable
with imprisonment for a term which may extend to one year or with fine which
may extend to one thousand rupees or with both.]
1
Amended. by Act 68 of 1982 (w.e.f. 01-02-1983)
32
1
[28.Penalty for non-disclosure of the name of the manufacturer, etc.— Whoever
contravenes the provisions of section 18A 2
[or section 24] shall be punishable with
imprisonment for a term which may extend to one year, or with fine which may extend to
2
[one thousand rupees], or with both.]
2
[28A. Penalty for not keeping documents, etc., and for non-disclosure of information. —
Whoever without reasonable cause or excuse, contravenes the provision of section 18B shall
be punishable with imprisonment for a term which may extend to one year or with fine which
may extend to one thousand rupees or both.
28B.Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A.
—Whoever himself or by any other person on his behalf manufactures or sells or distributes
any drug or cosmetic in contravention of the provisions of any notification issued under
section 26A, shall be punishable with imprisonment for a term which may extend to three
years and shall also be liable to fine which may extend to five thousand rupees.]
29 Penalty for use of Government Analyst’s report for advertising. —Whoever uses any
report of a test or analysis made by the Central Drugs Laboratory or by a Government
Analyst, or any extract from such report, for the purpose of advertising any drug 3
[or
cosmetic], shall be punishable with fine, which may extend to five hundred rupees.
4
[30.Penalty for subsequent offences. –. 5
[
2
[(1) whoever having been convicted of an
offence-
(a) under clause (b) of section 27 is again convicted of an offence under that clause,
shall be punishable with imprisonment for a term which shall not be less than two years
but which may extend to six years with fine which shall not be less than ten thousand
rupees:
Provided that the Court may, for any adequate and special reasons to be mentioned in the
judgment, impose a sentence of imprisonment for a term of less than two years and of fine of
less than ten thousand rupees;
(b) under clause (c) of section 27, is again convicted of an offence under that clause
shall be punishable with imprisonment for a term which shall not be less than six years
but which may extend to ten years and with fine which shall not be less than ten thousand
rupees;
(c) under clause (d) of section 27, is again convicted of an offence under that clause
shall be punishable with imprisonment for a term which shall not be less than two years
but which may extend to four years or with fine which shall not be less than five thousand
rupees, or with both;]] __________________________________________________________________________________________________________________________________________
1
Subs. by Act 13 of 1964,s.19,for s.28 (w.e.f.15-9-1964).
2
Amended. by Act 68 of 1982 (w.e.f. 01-02-1983)
3
Ins by Act 21 of 1962, s.15(w.e.f.27-7-1964)
4
Subs. by Act 11 of 1955, s. 14, for s. 30
5
Subs. by Act 35 of 1960
33
1
[(1A).Whoever, having been convicted of an offence under section 27A is again
convicted under that section, shall be punishable with imprisonment for a term which may
extend to two years, or with fine which may extend to 2
[two thousand rupees], or with both.]
(2) Whoever, having been convicted of an offence under 3
* * * section 29 is again
convicted of an offence under the same section shall be punishable with imprisonment which
may extend to 4
[ten years] or with fine, or with both.]
31. Confiscation. 5
[(1)] Where any person has been convicted under this Chapter for
contravening any such provision of this Chapter or any rule made thereunder as may be
specified by rule made in this behalf, the stock of the drug 6
[or cosmetic] in respect of which
the contravention has been made shall be liable to confiscation 7
[and if such contravention is
in respect of—
2
[(i) manufacture of any drug deemed to be misbranded under section 17,
adulterated under section 17A or spurious under section 17B; or
(ii) manufacture for sale, or for distribution ,sale, or stocking or exhibiting or
offering for sale, or distribution of any drug without a valid licence as required under
clause (c) of section 18;]
any implements or machinery used in such manufacture, sale or distribution and any
receptacles, packages or coverings in which such drug is contained and the animals, vehicles,
vessels or other conveyances used in carrying such drug shall also be liable to confiscation.]
8
[(2) Without prejudice to the provisions contained in sub-section (1) where the Court is
satisfied, on the application of an Inspector or otherwise and after such inquiry as may be
necessary that the drug or cosmetic is not of standard quality 2
[or is misbranded, adulterated
or spurious drug or misbranded or spurious cosmetic], such drug or, as the case may be, such
cosmetic shall be liable to confiscation.]
9
[31A. Application of provisions to Government departments. — The provisions of this
Chapter except those contained in section 31 shall apply in relation to the manufacture, sale
or distribution of drugs of any department of Government as they apply in relation to the
manufacture, sale or distribution of drugs by any other person.]
32.Cognizance of offence. —(1) No prosecution under this Chapter shall be instituted
except by an Inspector 10[or by the person aggrieved or by a recognised consumer association
__________________________________________________________________________________________ 1
Ins.by Act 21 of 1962, s. 20 (w.e.f.27-7-1964).
2
Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
3
The words and figures “ section 28 or” omitted by Act 13 of 1964
4
Subs.by s.20,ibid.,for “two years.” 5
Re-numbered as sub section (1) by Act 35 of 1960, s. 9.(w.e.f.16-3-1961).
6
Ins.by Act 21 of 1962, s. 21 (w.e.f. 27-71964).
7
Added by Act 13 of 1964, s. 21 (w.e.f.15-9-1964).
8
Ins.by Act 21 of 1962 s, 18 (w.e.f.27-7-1964).
9
Ins by Act 13 of 1964, s. 22(w.e.f.15-9-1964).
10Ins. by Act 71 of 1986.
34
whether such person is a member of that association or not.]
(2) No court inferior to that of a 1
[Metropolitan] Magistrate or of a 1
[Judicial] Magistrate
of the first class shall try an offence punishable under this Chapter.
(3) Nothing contained in this Chapter shall be deemed to prevent any person from being
prosecuted under any other law for any act or omission which constitutes an offence against
this Chapter.
2
[32A.Power of Court to implead the manufacturer, etc.—Where, at any time during the
trial of any offence under this Chapter alleged to have been committed by any person, not
being the manufacturer of a drug or cosmetic or his agent for the distribution thereof the
Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also
concerned in that offence, then, the court may, notwithstanding anything contained in 1
[subsections (1), (2) and (3) of section 319 of the Code of Criminal Procedure,1973 (2 of 1974)]
proceed against him as though a prosecution had been instituted against him under section
32.]
33.3
[Power of Central Government to make rules. —(1) The Central Government may
after consultation with, 1
[or on the recommendation of,] the Board and after previous
publication by notification in the Official Gazette, make rules for the purposes of giving
effect to the provisions of this chapter:
Provided that consultation with the Board may be dispensed with if the Central
Government is of opinion that circumstances have arisen which render it necessary to make
rules without such consultation, but in such a case the Board shall be consulted within six
months of making of the rules and the Central Government shall take into consideration any
suggestions which the Board may make in relation to the amendment of the said rules.]

(2) Without prejudice to the generality of the foregoing power, such rules may—
(a) provide for the establishment of laboratories for testing and analyzing drugs
4
[or cosmetics];
(b) prescribed the qualifications and duties of Government Analysts and the
qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining
whether a drug 4
[or cosmetic] is of standard quality;
(d) prescribe, in respect of biological and organometallic compounds, the units
or methods of standardization;
5
[(dd) prescribe under clause (d) of section 1
[17A] the colour or colours which a drug may
bear or contain for purposes of colouring;]
___________________________________________________________________________ 1
Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
2
Ins.by s. 23, ibid (w.e.f.15-9-1964). 3
Subs. by Act 11 of 1955, s. 15, for sub-section (1).
4
Ins. by Act 21 of 1962, s. 22 (2.e.f. 27-7-1964)
5
Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964)
35
(e) prescribe the forms of licences for the manufacture for sale 1
[or distribution],
for the sale and for the distribution of drugs or any specified drug or class of drugs
2
[or of cosmetic or any specified cosmetic or class of cosmetics], the form of
application for such licences, the conditions subject to which such licences may be
issued, the authority empowered to issue the same, 1
[the qualification of such
authority] and the fees payable therefor 1
[and provided for the cancellation or
suspension of such licences in any case where any provision of this Chapter or the
rules made thereunder is contravened or any of the conditions subject to which they
are issued is not complied with;]
1
[(ee) prescribe the records, registers or other documents to be kept and
maintained under section 18B;
(eea) prescribe the fees for the inspection (for the purposes of grant or renewal
of licence) of premises, wherein any drug or cosmetic is being or is proposed to be
manufactured;
(eeb) prescribe the manner in which copies are to be certified under sub-section
(2A) of section 22;]
(f) specify the diseases or ailments which a drug may not purport or claim 3
[ to
prevent, cure or mitigate] and such other effects which a drug may not purport or
claim to have;
(g) prescribe the conditions subject to which small quantities of drugs may be
manufactured for the purpose of examination, test or analysis;
(h) require the date of manufacture and the date of expiry of potency to be
clearly or truly stated on the label or container of any specified drug or class of
drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the
said drug or class of drugs after the expiry of a specified period from the date of
manufacture or after the expiry of the date of potency;
(i) prescribe the conditions to be observed in the packing in bottles, packages,
and other containers of drugs 2[or cosmetics] ,1
[including the use of packing
material which comes into direct contact with the drugs]and prohibit the sale,
stocking or exhibition for sale, or distribution of drugs 2
[or cosmetics] packed in
contravention of such conditions;
(j) regulate the mode of labelling packed drugs 2
[or cosmetics], and prescribe
the matter which shall or shall not be included in such labels;
(k) prescribe the maximum proportion of any poisonous substance which may be
added or contained in any drug, prohibit the manufacture, sale or stocking or
exhibition for sale, or distribution of any drug in which that proportion is exceeded,
and specify substances which shall be deemed to be poisonous for the purposes of
this Chapter and the rules made thereunder;
(l) require that the accepted scientific name of any specified drug shall be
displayed in the prescribed manner on the label or wrapper of any patent or
proprietary medicine containing such drug;
___________________________________________________________________________ 1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
2
Ins. by Act 21 of 1962, s. 22 (2.e.f. 27-7-1964)
3
Subs. By Act 11 of 1955, s. 15, for “to cure or mitigate”.
36
1
* * * * * *
2
[(n) prescribe the powers and duties of Inspectors 3
[and the qualifications of the
authority to which such Inspectors shall be subordinate] and 4
[specify the drugs or
classes of drugs or cosmetics or classes of cosmetics] in relation to which and the
conditions, limitations or restrictions subject to which, such powers and duties may
be exercised or performed;]
(o) prescribe the forms of report to be given by Government Analysts, and the
manner of application for test or analysis under section 26 and the fees payable
therefor;
5[(p) specify the offences against this Chapter or any rule made thereunder in
relation to which an order of confiscation may be made under section 31;] and
(q) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter or the rules made thereunder, of any specified drug or
class of drugs 2
[or cosmetic or class of cosmetics];
6
* * * * * *

7
[33A. Chapter not to apply to Ayurvedic, 3
[Siddha] or Unani drugs. —Save as otherwise
provided in this Act, nothing contained in this Chapter shall apply to Ayurvedic, 3[Siddha] or
Unani drugs.]
8
[CHAPTER IVA]
PROVISIONS RELATING TO AYURVEDIC, 3
[SIDDHA] AND UNANI DRUGS
33B. Application of Chapter IVA—This Chapter shall apply only to Ayurvedic, 3
[Siddha]
and Unani drugs.
33C. Ayurvedic, 3
[Siddha] and Unani Drugs Technical Advisory Board.—(1) The Central
Government shall, by notification in the Official Gazette and with effect from such date as
may be specified therein, constitute a Board (to be called the Ayurvedic, 3
[Siddha] and Unani
Drugs Technical advisory Board) to advise the Central Government and the State
Governments on technical matters arising out of this Chapter and to carry out the other
functions assigned to it by this Chapter
(2) The Board shall consist of the following members, namely: —
___________________________________________________________________________ 1
Cl. (m) omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1965)
2
Subs. by Act 35 of 1960, s. s. 10, for cl. (n) (w.e.f.16-3-1961)
3
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
4
Subs. by Act 21 of 1962, s. 22, for “ the drugs or class of drugs” (w.e.f. 27-7-1964)
5
Subs, by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964)
6
Sub-section (3) ins. by Act 35 of 1960, omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964)
7
Ins. by Act 13 of 1964, s. 25 (w.e.f.1-2-1969)
8
Ins. by Act 13 of 1964, s. 26, (w.e.f. 8-12-1969)
37
(i) the Director General of Health Services, ex officio;
(ii) the Drugs Controller, India ex officio;
1
[(iii) the principal officer dealing with Indian systems of medicine in the Ministry
of Health, ex-officio;]
(iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio;
(v) one person holding the appointment of Government Analyst under section
33F,to be nominated by the Central Government;
(vi) one Pharmacognocist to be nominated by the Central Government;
(vii) one Phyto-chemist to be nominated by the Central Government;
1
[(viii) four persons to be nominated by the Central Government, two from amongst
the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the
members of the Unani Pharmacopoeia Committee and one from amongst the members of
the Siddha Pharmacopoeia Committee;]
(ix)one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the
Central Government;
(x)one teacher in Ilm-Ul-Advia and Taklis-Wa-Dawa-sazi,to be nominated by the
Central Government;
1
[(xi) one teacher in Gunapadam to be nominated by the Central Government;
(xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug
industry, to be nominated by the Central Government;
(xiii) three persons, one each from among the practitioners of Ayurvedic, Siddha
and Unani Tibb system of medicine to be nominated by the Central Government.]
(3) The central Government shall appoint a member of the Board as its Chairman.
(4) The nominated members of the Board shall hold office for three years but shall be
eligible for renomination.
(5) The Board may, subject to the previous approval of the Central Government, make
bye- laws fixing a quorum and regulating its own procedure and conduct of all business to be
transacted by it.
(6) The functions of the Board may be exercised notwithstanding any vacancy therein.
(7) The Central Government shall appoint a person to be Secretary of the Board and shall
provide the Board with such clerical and other staff as the Central Government considers
necessary.
1
[33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee. —(1) The
Central Government may constitute an Advisory Committee to be called the Ayurvedic,
Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State
Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any
matter for the purpose of securing uniformity throughout India in the administration of this
Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.
(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two
persons to be nominated by the Central Government as representatives of that Government
and not more than one representative of each State to be nominated by the State Government
concerned.
__________________________________________________________________________________________________________________________________________
1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
38
(3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when
required to do so by the Central Government and shall regulate its own procedure.
33E. Misbranded drugs. — For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be misbranded–
(a) if it is so coloured, coated, powered or polished that damage is concealed, or if it
is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labeled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design device which makes any false claim for the drug or which is false or misleading in
any particular.
33EE. Adulterated Drugs. —For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be adulterated, —
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance;
or
(b) if it has been prepared, packed or stored under insanitary conditions whereby it
may have been contaminated with filth or whereby it may have been rendered injurious to
health; or
(c) if its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of coloring only, a colour other than one
which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to
health; or
(f) if any substance has been mixed therewith so as to reduce its quality or strength.

Explanation. —For the purpose of clause (a), a drug shall not be deemed to consist, in
whole or in part, of any decomposed substance only by reason of the fact that such
decomposed substance is the result of any natural decomposition of the drug:
Provided that such decomposition is not due to any negligence on the part of
manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to
health.
33EEA. Spurious drugs. — For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be spurious–
(a) if it is sold, or offered or exhibited for sale, under a name which belongs to
another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another
drug in a manner likely to deceive, or bears upon it or upon its label or container the name
of another drug, unless it is plainly and conspicuously marked so as to reveal its true
character and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting
to be the manufacturer of the drug, which individual or company is fictitious or does not
exist; or
(d) if it has been substituted wholly or in part by any other drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a
39
product.
33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs. —No
person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug
except in accordance with such standards, if any, as may be prescribed in relation to that
drug.

33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani
drug. From such date as the State Government may, by notification in the Official Gazette,
specify in this behalf, no person, either by himself or by any other person on his behalf,
shall—
(a) manufacture for sale or for distribution–
(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs;
(ii) any patent or proprietary medicine, unless there is displayed in the
prescribed manner on the label or container thereof the true list of all the
ingredients contained in it; and
(iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the
provisions of this Chapter or any rule made thereunder;
(b) sell, stock or exhibit or offer for sale or for distribution, any Ayurvedic, Siddha
or Unani drug which has been manufactured in contravention of any of the provisions of
this Act, or any rule made thereunder;
(c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug,
except under, and in accordance with the conditions of, a licence issued for such purpose
under this Chapter by the prescribed authority;
Provided that nothing in this section apply to Vaidyas and Hakims who manufacture
Ayurvedic, Siddha or Unani drug for the use of their own patients;
Provided further that nothing in this section shall apply to the manufacture, subject to the
prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the
purpose of examination, test or analysis.
33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic,
Siddha or Unani drugs in public interest. – Without prejudice to any other provision
contained in this Chapter, if the Central Government is satisfied on the basis of any evidence
or other material available before it that the use of any Ayruvedic, Siddha or Unani drug is
likely to involve any risk to human beings or animals or that any such drug does not have the
therapeutic value claimed or purported to be claimed for it and that in the public interest it is
necessary or expedient so to do then, that Government may, by notification in the Official
Gazette, prohibit the manufacture, sale or distribution of such drug.]
33F. Government Analysts. —(1) The Central Government or a State Government may,
by notification in the Official Gazette, appoint such person as it thinks fit, having the
prescribed qualification, to be Government Analysts for such areas as may be assigned to
them by the Central Government or the State Government ,as the case may be.

40
(2) Notwithstanding anything contained in sub-section(1),neither the Central Government
nor a State Government shall appoint as a Government Analyst any official not serving
under it without the previous consent of the Government under which he is serving.
1
[(3) No person who has any financial interest in the manufacture or sale of any drug
shall be appointed to be a Government Analyst under this section.]
33G. Inspectors. —(1) The Central Government or a State Government may, by
notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed
qualification, to be Inspectors for such areas as may be assigned to them by Central
Government or the State Government as the case may be.
(2) The powers which may be exercised by an Inspector and the duties which may be
performed by him and the conditions, limitations or restrictions subject to which such powers
and duties may be exercised or performed shall be such as may be prescribed.

(3) No person who has any financial interest in the manufacture or sale of any drug shall
be appointed to be an Inspector under this section.
(4) Every Inspector shall be deemed to be a public servant within meaning of section 21
of the Indian Penal Code (45 of 1860) and shall be officially subordinate to such authority as
the Government appointing him may specify in this behalf.
33H. Application of provisions of section 22, 23, 24 and 25. —The provisions of section
22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in
relation to an Inspector and a Government Analyst appointed under this Chapter as they apply
in relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to
the modification that the references to “drug” in the said section, shall be constructed as
references to “Ayurvedic, 1
[Siddha] or Unani Drugs.”
1
[33I . Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in
contravention of this Chapter. —Whoever himself or by any other person on his behalf—
(1) manufactures for sale or for distribution,–
(a) any Ayurvedic, Siddha or Unani drugs–
(i) deemed to be adulterated under section 33EE, or
(ii) without a valid licence as required under clause (c) of section 33EEC,
shall be punishable with imprisonment for a term which may extend to one year and
with fine which shall not be less than two thousand rupees;
(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under section
33EEA, shall be punishable with imprisonment for a term which shall not be less than one
year but which may extend to three years and with fine which shall not be less than five
thousand rupees:
Provided that the Court may, for any adequate and special reasons to be mentioned in the
judgment, impose a sentence of imprisonment for a term of less than one year and of fine of
less than five thousand rupees; or
(2) contravenes any other provisions of this Chapter or of section 24 as applied by
________________________________________________________________________
1Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
41
section 33H or any rule made under this Chapter, shall be punishable with
imprisonment for a term which may extend to three months and with fine which shall
not be less than five hundred rupees.
33J. Penalty for subsequent offences. —Whoever being convicted of an offence, —
(a) under clause (a) of sub-section (1) of section 33I is again convicted of an
offence under that clause, shall be punishable with imprisonment for a term which may
extend to two thousand rupees;
(b) under clause (a) of sub-section (1) of section 33I is again convicted of an
offence under that clause, shall be punishable with imprisonment for a term which shall
not be less than two years but which may extend to six years and with fine which shall not
be less than five thousand rupees;
Provided that the Court may, for any adequate or special reasons to be mentioned in the
judgment, impose a sentence of imprisonment for a term of less than two years and of fine of
less than five thousand rupees;
(c) under sub-section (2) of section 33-I is again convicted of an offence under that
sub-section , shall be punishable with imprisonment for a term which may extend to six
months and with fine which shall not be less than one thousand rupees.]
33K. Confiscation. — Where any person has been convicted under this Chapter, the
stock of the Ayurvedic,1
[Siddha] or Unani drug, in respect of which the contravention has
been made, shall be liable to confiscation.

33L. Application of provisions to Government departments.– The provisions of this
Chapter except those contained in section 33K shall apply in relation to the manufacture for
sale, sale or distribution of any Ayurvedic,
1
[Siddha] or Unani drug by any department of
Government as they apply in relation to the manufacture for sale, sale or distribution of such
drug by any other person.
33M. Cognizance of offences. —(1) No prosecution under this Chapter shall be
instituted except by an Inspector 1
[with the previous sanction of the authority specified under
sub-section (4) of section 33G.]
(2) No Court inferior to that of a 1
[Metropolitan Magistrate] or of a 1
[Judicial
Magistrate] of the first class shall try an offence punishable under this Chapter.
33N. Power of Central Government to make rules. —(1) The Central Government may,
1
[ after consultation with, or on the recommendation of, the Board] and after previous
publication by notification in the Official Gazette, make rules for the purpose of giving effect
to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with if the Central
Government is of opinion that circumstances have arisen which render it necessary to make
rules without such consultation, but in such a case, the Board shall be consulted within six
months of the making of the rules and the Central Government shall take into consideration
________________________________________________________________________ 1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
42
any suggestions which the Board may make in relation to the amendment of the said rules.

(2) Without prejudice to the generality of the foregoing power, such rules may-
(a) provide for the establishment of laboratories for testing and analysing
Ayurvedic,1
[Siddha] or Unani drugs;
(b) prescribe the qualification and duties of Government Analysts and the
qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining whether
any Ayurvedic,1
[Siddha] or Unani drug is labelled with the true list of the ingredients
which it is purported to contain;
(d) specify any substance as a poisonous substance;
(e) prescribe the forms of licences for the manufacture for sale of
Ayurvedic,1
[Siddha] or Unani drugs,1
[and for sale of processed Ayurvedic, Siddha or
Unani drugs,] the form of application for such licences, the conditions subject to which
such licences may be issued, the authority empowered to issue the same and the fees
payable therefor; 1
[and provide for the cancellation or suspension of such licences in any
case where any provision of this Chapter or rules made thereunder is contravened or any
of the conditions subject to which they are issued is not complied with;]
1
[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha
and Unani drugs including the use of packing material which comes into direct contact
with the drugs, regulate the mode of labelling packed drugs and prescribe the matters
which shall or shall not be included in such labels;]
(g) prescribe the conditions subject to which small quantities of Ayurvedic
1
[Siddha] or Unani drugs may be manufactured for the purpose of examination, test or
analysis; and
1
[(gg) prescribe under clause (d) of section 33EE the colour or colours which an
Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;
(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under section
33EEB;]
(h) any other matter which is to be or may be prescribed under this Chapter.

33O. Power to amend First Schedule. —The Central Government, after consultation
with the Board and after giving, by notification in the Official Gazette, not less than three
months’ notice of its intention so to do, may, by a like notification, add to or otherwise amend
the First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be
deemed to be amended accordingly.
___________________________________________________________________________ 1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
43
1
[CHAPTER V
MISCELLANEOUS
2
[
3
33P.] Power to give directions. The Central Government may give such directions to
any State Government as may appear to the Central Government to be necessary for carrying
into execution in the State any of the provisions of this Act or of any rule or order made
thereunder.]
34. Offences by companies. (1) Where an offence under this Act has been committed by
a company, every person who at the time the offence was committed, was in charge of, and
was responsible to the company for the conduct of business of the company, as well as the
company shall be deemed to be guilty of the offence and shall be liable to be proceeded
against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable
to any punishment provided in this Act if he proves that the offence was committed without
his knowledge or that he exercised all due diligence to prevent the commission of such
offence.

(2) Notwithstanding anything contained in sub-section (1), where an offence under this
Act has been committed by a company and it is proved that the offence has been committed
with the consent or connivance of, or is attributable to any neglect on the part of, any director,
manager, secretary or other officer of the company, such director, manager, secretary or other
officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded
against and punished accordingly:

Explanation. —For the purposes of this section–

(a) “company” means a body corporate, and includes a firm or other association
of individuals; and
(b) “director” in relation to a firm means a partner in the firm.
4
[34A. Offences by Government departments. Where an offence under Chapter1V or
Chapter 1VA has been committed by any department of Government, such authority as is
specified by the Central Government to be in charge of manufacture, sale or distribution of
drugs or where no authority is specified, the head of the department, shall be deemed to be
guilty of the offence and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this section shall render any such authority or person
liable to any punishment provided in Chapter1V or Chapter 1VA, as the case may be, if such
authority or person proves that the offence was committed without its or his knowledge or
that such authority or person exercised all due diligence to prevent the commission of such
offence.]
___________________________________________________________________________ 1
Subs. by Act 11 of 1955, s. 16, for s. 34
2Ins. by act 35 of 1960, s. 11 (w.e.f. 16-3-1961).
3
S. 33A re-numbered as s. 33P by Act 13 of 1964, s. 27 (w.e.f. 15-9-1964)
4
Ins. by Act 13 of 1964, s. 28, (w.e.f. 15-9-1964)
44
1
[34AA. Penalty vexatious search or seizure. Any Inspector exercising powers under
this Act or the rules made thereunder, who,–
(a) without reasonable ground of suspicion searches any place, vehicle, vessel or
other conveyance; or
(b) vexatiously and unnecessarily searches any person; or
(c) vexatiously and unnecessarily seizes any drug or cosmetic, or any substance or
article, or any record, register, document or other material object; or
(d) commits, as such Inspector, any other act, to the injury of any person without
having reason to believe that such act is required for the execution of his duty, shall be
punishable with fine which may extend to one thousand rupees.]
35. Publication of sentences passed under this Act. (1) If any person is convicted of an
offence under this Act, [ the court before which the conviction takes place shall, on
application made to it by the Inspector, cause] the offender’s name, place of residence, the
offence of which he has been convicted and the penalty which has been inflicted upon him, to
be published at the expense of such person in such newspapers or in such other manner as the
Court may direct.
(2) The expenses of such publication shall be deemed to form part of the cost relating to
the conviction and shall be recoverable in the same manner as those costs are recoverable.
36. Magistrate’s power to impose enhanced penalties. — Notwithstanding anything
contained 2
* * * 1
[the Code of Criminal Procedure, 1973,] it shall be lawful for any
1
[Metropolitan Magistrate or any Judicial Magistrate of the first class] to pass any sentence
authorized by this Act in excess of his powers under 2
* * * the said Code.
1
[36A. Certain offences to be tried summarily. —Notwithstanding anything contained
in the Code of Criminal Procedure, 1973, all offences under this Act, punishable with
imprisonment for a term not exceeding three years, other than an offence under clause (b) of
sub-section (1) of section 33I, shall be tried in a summary way by a Judicial Magistrate of the
first class specially empowered in this behalf by the State Government or by a Metropolitan
Magistrate and the provisions of section 262 to265 (both inclusive) of the said Code shall, as
far as may be, apply to such trial:

Provided that, in the case of any conviction in a summary trial under this section, it
shall be lawful for the Magistrate to pass a sentence of imprisonment for a term not exceeding
one year:
Provided further that when at the commencement of, or in the course of, a summary
trial under this section, it appears to the Magistrate that the nature of the case is such that a
sentence of imprisonment for a term exceeding one year may have to be passed or that it is,
for any other reason, undesirable to try the case summarily, the Magistrate shall, after hearing
the parties, record an order to that effect and thereafter recall any witness who has been
examined and proceed to hear or rehear the case in the manner provided by the said Code.]
___________________________________________________________________________ 1
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
2
The words and figures “section 32 of” omitted by Act13 of 1964. 29, (w.e.f.15-9-1964)
45
37. Protection of action taken in good faith. —No suit, prosecution or other legal
proceeding shall lie against any person for anything which is in good faith done or intended
to be done under this Act.
1
[38. Rules to be laid before Parliament. —Every rule made under this Act shall be laid
as soon as may be after it is made before each House of Parliament while it is in session for a
total period of thirty days which may be comprised in one session or in two or more
successive sessions, 1
[and if, before the expiry of the session immediately following the
session or the successive sessions aforesaid], both Houses agree in making any modification
in the rule or both Houses agree that the rule should not be made, the rule shall thereafter
have effect only in such modified from or be of no effect, as the case may be, so however that
any such modification or annulment shall be without prejudice to the validity of anything
previously done under that rule.]
___________________________________________________________________________ 1
Ins. by s.30, ibid (w.e.f. 15-9-1964)
46
1
[THE FIRST SCHEDULE]
[See section 3(a)]
A. —AYURVEDIC AND 2
SIDDHA SYSTEMS
Serial No. Name of book
Ayurveda
1. Arogya Kalpadruma
2. Arka Prakasha
3. Arya Bhishak
4. Ashtanga Hridaya
5. Ashtanga Samgraha
6. Ayurveda Kalpadruma
7. Ayurveda Prakasha
8. Ayurveda Samgraha
9. Bhaishajya Ratnavali
10. Brihat Bhaishajya Ratnakara
11. Bhava Prakasha
12. Brihat Nighantu Ratnakara
13. Charaka Samihita
14. Chakra Datta
15. Gada Nigraha
16. Kupi Pakva Rasayana
17. Nighantu Ratnakara
18. Rasa Chandanshu
19. Rasa Raja Sundara
20. Rasaratna Samuchaya
21. 3
[Rasatantra Sara Va Siddha Prayoga Sangraha—Part 1]
22. Rasa Tarangini
23. Rasa Yoga Sagara
24. Rasa Yoga Ratnakara
25. Rasa Yoga Samgraha
26. Rasendra Sara Samgraha
27. Rasa Pradipika
28. Sahasrayoga
29. Sarvaroga Chikitsa Ratnam
30. Sarvayoga Chikitsa Ratnam
31. Sharangadhara Samhita
32. Siddha Bhaishajya Manimala
33. Sidha Yoga Samgraha
1
Subs. by Act 13 of 1964, s. 31, for the Schedule. First Schedule came into force w.e.f. 1-2-
1969 and the Second Schedule came into force w.e.f. 15-9-1964
2
Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)
3
Subs. by Notification No. G.S R. 658 (E) dated 31-08-94
47
Serial No. Name of book
34. Sushruta Samhita
35. Vaidya Chintamani
36. Vaidyaka Shabda Sindu
37. Vaidyaka Chikitsa Sara
38. Vidya Jiwan
39. Vasava Rajeeyam
40. Yoga Ratnakara
41. Yoga Tarangini
42. Yoga Chintamani
43. Kashyapasamhita
44. Bhelasamhita
45. Vishwanathachikitsa
46. Vrindachikitsa
47. Ayurvedachintamani
48. Abhinavachintamani
49. Ayurveda-Ratnakara
50. Yogaratnasangraha
51. Rasamrita
52. Dravyagunanighantu
53. Rasamanijari
54. Banagasena
1
[54A Ayurvedic Formulary of India (Part-I)
54B Ayurveda Sara Samgraha]
254C Ayurvedic Pharmacopoeia of India
Siddha
55 Siddha Vaidya Thirattu
56 Therayar Maha Karisal
57 Brahma Muni Karukkadai (300)
58 Bhogar (700)
59 Pulippani (500)
60 Agasthiyar Paripuranam (400)
61 Therayar Yamagam
62 Agasthiyar Chenduram (300)
63 Agasthiyar (1500)
64 Athmarakshamrutham
65 Agasthiyar Pin (80)
66 Agasshiyar Rathna Chrukkam
67 Therayar Karisal (300)
68 Veeramamuni Nasa Kandam
69 Agasthiyar (600)
70 Agasthiyar Kanma Soothiram
71 18 Siddar’s Chillarai Kovai
1
Ins. by Notification No. G.S.R. 735 (E) dated 28th August 1987
2Inserted by Notification No. G.S.R. 423(E)dated 11th june 2002
48
72 Yog Vatha Kaviyam
73 Therayar Tharu
74 Agasthiyar Vaidya Kaviyam (1500)
75 Bala Vagadam
76 Chimittu Rathna (Rathna) Churukkam
77 Nagamuni (200)
78 Agasthiyar Chillarai Kovai
79 Chikicha Rathna Deepam
80 Agasthiyar Nayana Vidhi
81 Yugi Karisal (151)
82 Agasthiyar Vallathi (600)
83 Therayar Thaila Varkam
1
[84 Siddha Formulary of India (Part I)]
B.—UNANI 2
TIBB SYSTEM
Serial No. Name of book
1 Karabadin Qadri
2 Karabadin Kabir
3 Karabadin Azam
4 Ilaj-ul-Amraz
5 Al Karabadin
6 Biaz Kabir Vol. II
7 Karabadin Jadid
8 Kithalf-ul-Taklis
9 Sanat-ul-Taklis
10 Mifta-ul-Khazain
11 Madan-ul-Aksir
12 Makhzan-ul-murabhat
1[13 National Formulary of Unani Medicine (Part I)]
1
Ins. by Notification No. G.S.R. 735 (E) dated 28th August 1987
2
Amendment as per Act 68 of 1982 (w.e.f. 01-02-1983)
49
THE SECOND SCHEDULE
(See section & 8 and 16)
STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS
MANUFACTURED FOR SALE, VOLD, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED

Class of drug Standard to be complied with
1 2
Patent or proprietary medicines1
[other
than Homoeopathic medicines]
2. 2
[Substances commonly known as
vaccines, sera toxins, toxoids, antitoxins
and antigens and biological products of
such nature for human use or for
veterinary use.
3. 3* * *
4.Substances (other than food) intended to
affect the structure or any function of
the human body or intended to be used
for the destruction or vermin or insect
which cause disease in human beings or
animals.
* *4-A. Homoeopathic Medicines :
(a) Drugs included in the Homoeopathic
Pharmacopacia of India.

The formula of list of ingredients displayed
in the prescribed manner on the label of the
container and such other standards as may
be prescribed.
The standards maintained at the
International Laboratory for Biological
Standards, Stantans Serum Institute,
Copenhagen and at the Central Veterinary
Laboratory, Weybridge Surrey, U.K., and
such other laboratories recognized by the
World Health Organization from time to
time, and such further standards of strength,
quality and purity, as may be prescribed.]
Such standards may be prescribed.
Standards of identity, purity and strength
specified in the edition of the
Homoeopathic Pharmacopoeia of the India
for the time being and such other standards
as may be prescribed.
___________________________________________________________________________ 1
Ins. by Notification No. S.O. 887 ,dated 19th March 1966, Gazette of India , Pt. II, Sec. 3 (ii), p. 819 2
Subs. by Notification No. G.S.R. 299(E) dated 23rd April 1984 3
Omitted by Notification No. G.S.R. 299(E) dated 23rd April 1984
** Amended by Ministry of Health and Family Welfare Notification No. X-1101/3/77-D/M/S & PFA
dated 6th June 1978
50
(b) Drugs not included in the
Homoeopathic Pharmacopoeia of
India, but which are included in the
Homoeopathic Pharmacopoeia of
United States of America or the United
Kingdom or the German Homoeopathic
Pharmacopoeia
(c) Drugs not included in the
Homoeopathic Pharmacopoeia of India
or the United States of America, or the
United Kingdom or the German
Homoeopathic Pharmacopoeia
1
[5. Other drugs
(a) Drugs included in the Indian
Pharmacopoeia
(b) Drugs not included in the Indian
Pharmacopoeia but not included in
the official Pharmacopoeia of any
other country.
Standards of identity, purity and strength
prescribed for the drug in the edition of
such Pharmacopoeia for the time being in
which they are given and such other
standards as may be prescribed.
The formula of list of ingredients displayed
in the prescribed manner on the label of the
container and such other standards as may
be prescribed by the Central Government.
Standards of identity, purity and strength
specified in the edition of the Indian
Pharmacopoeia for the time being in force
and such other standards as may be
prescribed.
In case the standards of identity, purity and
strength for drugs are not specified in the
edition of the Indian Pharmacopoeia for the
time being in force but are specified in the
edition of the Indian pharmacopoeia
immediately preceding, the standards of
identity, purity and strength shall be those
occurring in such immediately preceding
edition of the Indian Pharmacopoeia and
such other standards as may be prescribed.
Standards of identity, purity and strength
specified for drugs in the edition of such
official Pharmacopoeia of any other
country for the time being in force and such
other standards as may be prescribed.
___________________________________________________________________________ 1
Subs. by Notification No. G.S.R. 885 dated 18-8-73, Gazette of India Pt. II S.3(i)
51
In case the standards of identity, purity and
strength for drugs are not specified in the
edition of the official Pharmacopoeia for the
time being in force but are specified in the
edition immediately preceding, the standards
of identity, purity and strength shall be those
occurring in such immediately preceding
edition of the official Pharmacopoeia and
such other standards as may be prescribed.]
52
THE DRUGS AND COSMETICS RULES,
1945
as corrected up to the 30th
November, 2004
53
DEPARTMENT OF HEALTH
NOTIFICATION
New Delhi, the 21st December 1945
No. F. 28-10/45-H (1). __
In exercise of the powers conferred by Sections 6(2), 1
[12, 33 and
33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central Government is pleased
to make the following Rules: __
RULES
PART I__PRELIMINARY
1. Short title, extent and commencement.
___(1) These Rules may be called the Drugs and
Cosmetics Rules, 1945.
2
(2) They extend to the whole of India.
2. Definitions.
___ In these Rules, unless there is anything repugnant in the subject or context___
(a)“the Act” means the Drugs and Cosmetics Act, 1940 (XXIII of 1940) as amended
from time to time;
3
(b)“Central Licence Approving Authority” means the Drugs Controller, India,
appointed by the Central Government.
(c)“Director” means the Director of the Central Drugs Laboratory;
(d) “From” means a form set forth in Schedule A;
4
(dd)Homoeopathic medicines include any drug which is recorded in
Homoeopathicproving or therapeutic efficacy of which has been established
through long clinical experience as recorded in authoritative Homoeopathic
literature of India and abroad and which is prepared according to the techniques of
Homoeopathic pharmacy and covers combination of ingredients of such
Homoeopathic medicines but does not include a medicine which is administered by
parenteral route.
(e) “Laboratory” means the Central Drugs Laboratory;
1Amended by G.O.I. Notification No.G.S.R. 370(E) dated 07-04-1994
2Amended by G.O.I Notification No.G.S.R. 358 dated 15-3-1975 (Govt. of India Notification No. X
11011/3/72-D & MS dated 5-3-1975).
3Amended by G.O.I. Notification No. G.S.R. 923(E) dated 14-12-1992
4Added under Government of India Notification No. F. 1-59 / 68-D, dated 19th Nov. 1969.
54
1
[(ea) “registered Homeopathic medical practitioner” means a person who is registered
in the Central Register or State Register of Homeopathy;]
2
[(ee) “Registered medical practitioner” means a person__
(i)holding a qualification granted by an authority specified or notified under
Section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified In
the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or

(ii) registered or eligible for registration in a medical register of a State meant for the
registration of persons practicing the modern scientific system of medicine
3
excluding the Homoeopathic system of medicine; or
(iii) registered in a medical register, 3
other than a register for the registration of
Homoeopathic practitioner, of a State, who although not falling within subclause (i) or sub-clause (ii) declared by a general or special order made by the
State Government in this behalf as a person practicing the modern scientific
system of medicine for the purposes of this Act; or
(iv) registered or eligible for registration in the register of dentists for a State under
the Dentists Act, 1948 (16 of 1948); or
(v) who is engaged in the practice of veterinary medicine and who possesses
qualification approved by the State Government.
4
(f)‘retail sale’ means a sale 5
[whether to a hospital, or dispensary, or a medical,
educational or research institute or to any other person] other than a sale by way of
wholesale dealing;

5
(g) ‘sale by way of wholesale dealing’ means sale to a person for the purpose of selling
again and includes sale to a hospital, dispensary, medical, educational or research
institution.
________________________________________________________
1
Ins by G.O.I Notification No. G.S.R 680 (E) dated 5-12-1980
2Added by Government of India, Notification No. F. 1-22 / 59-D, dated 9 th April, 1960.
3Amended by S. O. No. 2139 dated 12-8-1972 (Govt. of India Notification No. X. 11014/12/72-D, dated
the 5 th June, 1972).
4Amended or added under Government of India Notification No. F. 1-3/51-DS., Dated 15 th October, 1954.
5Amended by G.O.I. Notification No. G.S.R 681 (E) dated 6-6-1988

55
1
(h) “Schedule” means a Schedule to these Rules.
2
(i)State Government in relation to a Union Territory means the Administrator thereof.
(j)‘Poisonous substance’ means a substance specified in Schedule E.
PART II___THE CENTRAL DRUGS LABORATORY
3. Functions.
____It shall be the function of the Laboratory___
(i)to analyse or test such samples of drugs as may be sent to it under sub-section (2) of
Section 11, or under sub-section (4) of Section 25 of the Act;
(ii) 2* * *
(iii) to carry out such other duties as may be entrusted to it by the Central Government
or, with the permission of the Central Government, by a State Government after
consultation with the Drugs Technical Advisory Board.
3
3A(1)The functions of the Laboratory in respect of the following drugs or classes of drugs
shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in
respect of the said drugs or classes of drugs shall be exercised by the Director of the said
Institute :___
(1) Sera
(2) Solution of serum proteins intended for injection
(3) Vaccines
(4) Toxins
(5) Antigens
(6) Anti-toxins
(7) Sterilized surgical ligature and sterilized surgical suture.
(8) Bacteriophages.
1Amended by Government of India Notification No. F.28-10/45-H (1), dated 31st March 1957.
2Amended or omitted by Government of India Notification No. F-1-16/57-D, dated 15th June, 1957.
3Amended by Government of India Notification No. F. 4-1 / 60-D, dated 15th May, 1961
56
1
[Provided that the functions of the Director in respect of Oral Polio Vaccine shall be
exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of
Central Research Institute, Kasauli only.]
2[(1A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out
by the following Institutes and the functions of the Director in respect of the said drugs shall be
exercised by Director of the respective Institutes :–
(a)Pasteur Institute of India, Coonoor.
(b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute
Compound, Parel, Bombay-400012.]
3
[(c) The National Institute of Biologicals, NOIDA.]
4
(2) The functions of the Laboratory in respect of the following drugs or classes of drugs shall
be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the
functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the
Director of either of the said institutes.
(1) Anti-sera for veterinary use.
(2) Vaccines for veterinary use.
(3) Toxoids for veterinary use.
(4) Diagnostic Antigens for veterinary use.
5
(3) The functions of the laboratory in respect of condoms shall be carried out at the Central
Indian Pharmacopoeia Laboratory, Ghaziabad, and the functions of the Director in respect of the
said condoms shall be exercised by the Director of the said Laboratory.
6
[(4) The functions of the Laboratory in respect of the following drug shall be carried out at
the Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta
and the functions of the Director in respect of the said drug shall be performed by the Serologist
and Chemical Examiner of the said Laboratory :__
VDRL Antigen.
________________________________________________________________
1 Ins. by G.O.I.Notification No. G.S.R.62(E) dt 15.02.1982 and amended by notification no.G.S.R.445(E)
dated 30-04-1992
2Added by Notification No.G.S.R. 445(E) dated 30-04-1992
3Amended by Notification No. G.S.R.249(E) dated 04-04-2002
4Amended by Govt. of India, Ministry of Health, F P&W.H. & U.D. Notification No. F.-1-6/62-D, dated
the 2 nd July, 1969.
5Amended by S. O. No. 2139 dated 12-8-1972 (Govt. of India Notification NO. X. 11014/12/72-D, dated
the 5 th June, 1972).
6 Sub rule (4) omitted and subrule (5) renumbered as (4) by G.O.I. by Notification No. G.S.R. 62(E) dated
15-02-1982
57
1
[(5) The function of the Laboratory in respect of Intra-Utrine Devices and falope Rings shall
be carried out at the Central Drug Testing Laboratory, Thane, Maharashtra and the functions of
the Director in respect of the said devices shall be exercised by the Director of the said
Laboratory.]
2
[(6) The functions of the Laboratory in respect of human blood and human blood products
including components, to test for freedom of HIV antibodies, shall be carried out by the
following Institutes, Hospitals and the functions of the Director in respect of the above
mentioned products shall be exercised by the head of the respective Institutes, namely:–
(a) National Institutes of Communicable Disease, Department of Microbiology, Delhi.
(b) National Institute of Virology, Pune
(c) Centre of Advanced Research in Virology, Christian Medical College, Vellore.]
3
[(7) The functions of the Laboratory in respect of Homoeopathy shall be carried out at the
Homoeopathy Pharmacopoeia Laboratory, Ghaziabad and the function of the director in respect
of the Homeopathic medicine shall be exercised by the Director of the laboratory.]
4
[(8) The functions of the Laboratory in respect of Blood Grouping reagent and diagnostic kits
for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus shall be
carried out at the National Institute of Biologicals, NOIDA and the functions of the Director in
respect of the said drugs shall be exercised by the Director of the said laboratory.]
4. Despatch of samples for test or analysis.
__ (1) Samples for test or analysis under subsection (4) of Section 25 of the Act shall be sent by registered post in a sealed packet, enclosed,
together with a memorandum in Form 1, in an outer cover addressed to the Director.
(2)The packet as well as the outer cover, shall be marked with a distinguishing number.
(3)A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal
the packet shall be sent separately by registered post to the Director.
5. Recording of condition of seals.
__ On receipt of the packet, it shall be opened by an officer
authorized in writing in that behalf by the Director who shall record the condition of the seal on
the packet.
_________________________________________________________________
1
Ins by G.O.I. Notification GSR No. 865 (E) dt 25.10.1990 and subs. by G.O.I. Notification No. G.S.R
242(E) dated 18-03-1998
2
Ins. By G.O.I. Notification No. G.S.R 16(E) dated 10-01-1990
3
Ins. by G.O.I. Notification No. G.S.R 246(E) dated 1-5-1991
4 Ins. by G.O.I. Notification G.S.R. No.249(E) dated 04.04.2001
58
6. Report of result of test or analysis.
__ After test or analysis the result of the test or analysis,
together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form
2.
7. Fees.
__ The fees for test and analysis shall be those specified in Schedule B.
8. Signature of certificates.
__ Certificates issued under these Rules by the Laboratory shall be
signed by the Director or by an officer authorized by the Central Government by notification in
the official Gazette to sign such certificates.
1
PART III (Rules 9 to 20)
PART IV ___IMPORT 2[AND REGISTERATION]
21. In this Part____
4[(a)“import licence” means a licence in Form 10 to import drugs 3
* * *; excluding
those specified in Schedule X, or a licence in Form 10-A to import drugs
specified in Schedule X.]
(b)“licensing authority” means the authority appointed by the Central Government to
perform the duties of the licensing authority under these Rules and includes any
person to whom the powers of a licensing authority may be delegated under Rule
22;
(c)“licence for examination, test or analysis” means a licence in Form 11 to import
small quantities of drugs the import of which is otherwise prohibited, for the
purpose of examination, test or analysis.
2
[(d) “manufacturer” includes a manufacturer of drugs, who may be a Company or a
unit or a body corporate or any other establishment in a country other than India,
having its drug manufacturing facilities duly approved by the National Regulatory
Authority of that country, and who also has a free sale approval of the drugs
approved by the said authority in the concerned country, and /or in other major
countries:
(e)”Registration Certificate” means a certificate issued under rule 27A by the
licensing authority in Form 41 for registration of the premises and the drugs
manufactured by the manufacturer meant for import into and use in India.]
22.The licensing authority may with the approval of the Central Government by an order in
writing delegate the power to sign licences and 2
[Registration Certificate and] such other powers
as may be specified in the order to any other person under his control.
___________________________________________________________
1Omitted by Government of India Notification No. F. 1-16/57-D, dated 15 th June, 1957.
2 Ins. by G.O.I. Notification No. G.S.R 604(E) dated 24-08-2001
3Omitted by G.O.I. Notification No. G.S.R 604(E) dated 24-08-2001
4
Subs. By Govt of India Notification no.462 (E) dt.22.06.1982
59
1
[23.Import licences.__ An import licence in Form 10 shall be required for the import of 2
drugs,
excluding those specified in Schedule X, and an import licence in Form 10 A shall be required
for the import of drugs specified in Schedule X.]
2
[24 Form and manner of application for import licence. __ (1) An application for an import
licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in
Schedule X, and in Form 8-A for drugs specified in Schedule X, either by manufacturer himself
having a valid wholesale licence for sale or distribution of drugs under these rules, or by the
manufacturer’s agent in India either having a valid licence under the rules to the manufacture for
sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these
rules, and shall be accompanied by a licence fee of one hundred rupees for a single drug and an
additional fee at the rate of one thousand rupees for each additional drug and by an undertaking
in Form 9 duly signed by or on behalf of the manufacturer:
Provided that in the case of any subsequent application made by the same importer for import
licence for drugs manufactured by the same manufacturer, the fee to accompany each such
application shall be one hundred rupees for each drug.
(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be
accompanied by a copy of Registration Certificate issued in Form 41 under rule 27-A:
Provided that in case of emergencies the licensing authority may, with the approval of the
Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the
issuance of Registration Certificate under rule 27-A, for reasons to be recorded in writing.”
(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence
issued under this rule, if the original is defaced, damaged or lost.
24-A. Form and manner of application for Registration Certificate. — (1) An application for
issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by
the manufacturer himself, having a valid whole sale licence for sale or distribution of drugs
under these rules, or by his authorized agent in India, either having a valid licence under the rules
to manufacture for sale of a drug or having a valid whole sale licence for sale or distribution of
drugs under these rules, and shall be accompanied by the fee specified in sub-rule (3) and the
informations and undertakings specified in Schedules D-I and D-II duly signed by or on behalf
of the manufacturer.
1
Subs. By G.O.I. Notification No. G.S.R 462(E) dated 22-06-1982
2Amended by Notification No. G.S.R 604(E) dated 24-08-2001
60
(2) The authorization by the manufacturer of his agent in India shall be documented by a
power of attorney executed and authenticated either in India before a First Class Magistrate, or in
the country of origin before such an equivalent authority, the certificate of which is attested by
the Indian Embassy of the said country, and the original of the same shall be furnished along
with the application for Registration Certificate.
(3) (i) A fee of one thousand and five hundred US dollars shall be paid alongwith the
application in Form 40 as registration fee for his premises meant for manufacturing of drugs
intended for import into and use in India
(ii) A fee of one thousand US dollars shall be paid along with the application in Form 40 for
the registration of a single drug meant for import into and use in India and an additional fee at
the rate of one thousand US dollars for each additional drug.
Provided that in the case of any subsequent application for registration of additional drugs by
the same manufacturer, the fee to accompany shall be one thousand US dollars for each drug.
(4)The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg,
New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as
notified, from time to time, by the Central Government, to be credited under the Head of
Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines”:
Provided that in the case of any direct payment of fees by a manufacturer in the country of
origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the
country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the
Electronic Code of the bank in the Head of Account “0210-Medical and Public Health, 04-
Public Health, 104- Fee and Fines”, and the original receipt of the said transfer shall be treated as
an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have
received the payment.”
(5) The applicant shall be liable for the payment of a fee of five thousand US dollars for
expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by
the licensing authority or by any other persons to whom powers have been delegated in this
behalf by the licensing authority under rule 22:
(6) The applicant shall be liable for the payment of testing fees directly to a testing laboratory
approved by the Central Government in India or abroad, as may be required for examination,
tests and analysis of drug.

(7) A fee of three hundred US dollars shall be paid for a duplicate copy of the Registration
Certificate, if the original is defaced, damaged or lost.
(8) No Registration Certificate shall be required under these rules in respect of an inactive
bulk substance to be used for a drug formulation with or without pharmacopoeal conformity.]
61
25.Licences for import of drugs manufactured by one manufacturer___
(1) A single application may be made, and a single licence may be issued, in respect of the
import of more than one drug or class of drugs manufactured by the same manufacturer:
1Provided that the drugs or classes of drugs are manufactured at one factory or more than one
factory functioning conjointly as a single manufacturing unit;
Provided further that if a single manufacturer has two or more factories situated in different
places manufacturing the same or different drugs a separate licence shall be required in respect
of the drugs manufactured by each such factory.
(2) 2 * * *
3
25A.Condition to be satisfied before a licence in Form 10 or Form 10-A is granted.
___
(1) A licence in Form 10 or in Form 10-A shall be granted by the licensing authority having
regard to–
(i) the premises, where the imported substances will be stocked are equipped with proper
storage accommodation for preserving the properties of the drugs to which the licence applies;
and
(ii) the occupation, trade or business ordinarily carried out by the applicant;
Provided that the licensing authority may refuse to grant a licence in Form 10-A in respect of
any applicant where he is satisfied,–
(a) that the applicant has not complied with the provisions of the Act or these rules or
(b) that by reasons of— 4[(i) his conviction under the Act or these rules or the Narcotic Drugs and
Psychotropic Substances Act, 1985 (61 of 1985) or the rules made thereunder.]

(ii) previous suspension or cancellation of the licence granted to him;
he is not a fit person to whom licence shall be granted.

(2)Any person who is aggrieved by the order passed by the licensing authority under this
rule may, within thirty days of the receipt of the order, appeal to the Central Government and the
Central Government may after such enquiry in to the matter as it considers necessary and after
giving the appellant an opportunity for making a representation in the matter, make such orders
in relation thereto as it thinks fit.
1Added under Government of India Notification No. F. 1-19/48-D, dated 27 th October, 1949.
2Added or omitted under Government of India Notification No.F. 1-16/57-D, dated 15th June, 1957.
3
Subs. by G.O.I. Notification No. G.S.R 462(E) dated 22-06-1982
4
Subs. by G.O.I. Notification No. G.S.R 604(E) dated 24-08-2001
62
1
[25B. Registration Certificate for import of drugs manufactured by one manufacturer:–(1)
A single application may be made, and a single Registration Certificate in Form 41 may be
issued in respect of the import of more than one drug or class of drugs, manufactured by the
same manufacturer:
Provided that the drug or classes of drugs, are manufactured at one factory or more than one
factory functioning conjointly as a single manufacturing unit:
Provided further that if a single manufacturer has two or more factories situated in different
places manufacturing the same or different drugs, separate Registration Certificates shall be
required in respect of the drugs manufactured by each such factory.]
26. Conditions of import licence. ____An import licence shall be subject to the following
conditions:
(i) the manufacturer shall at all times observe the undertaking given by him or on his
behalf in Form 9;
(ii) the licensee shall allow any Inspector authorized by the licensing authority in that
behalf to enter with or without notice any premises where the imported substance is
stocked, to inspect the means, if any, employed for testing the substance and to take
samples;
(iii) the licensee shall on request furnish to the licensing authority from every batch of
each substance or from such batch or batches as the licensing authority may from
time to time specify a sample of such amount as the licensing authority may
consider adequate for any examination required to be made, and the licensee shall, if
so required, furnish full protocols of the tests, if any, which have been applied.
(iv) if the licensing authority so directs the licensee shall not sell or offer for sale any
batch in respect of which a sample is or protocols are furnished under the last
preceding subrule until a certificate authorizing the sale of the batch has been issued
to him by or on behalf of the licensing authority;
(v) the licensee shall, on being informed by the licensing authority that any part of any
batch of the substance has been found by the licensing authority not to conform with
the standards of strength, quality and purity prescribed by Chapter III of the Act, or
the Rules thereunder and on being directed so to do withdraw the remainder of that
batch from sale and, so far as may in the particular circumstances of the case be
practicable, recall the issues already made from that batch;
1 Ins. by G.O.I. Notification G.S.R.No.604(E) dated 24.08.2001
63
(vi) the licensee shall maintain a record of all sales by him of substances for the import
of which a licence is required, showing particulars of the substance and of the
person to whom sold and such further particulars, if any, as the licensing authority
may specify and such record shall be open to the inspection of any Inspector
authorised in that behalf by the licensing authority;
1
[ Provided that in respect of the sale or distribution of drugs specified in Schedule
X, the licensee shall maintain separate record or register showing the following
particulars, namely;
1. Name of the Drug,
2. Batch number,
3. Name and address of the manufacturer,
4. Date of transaction,
5. Opening stock on the business day,
6. Quantity of drug received, if any, and the source from which received,
7. Name of the purchaser, his address and licence number,
8. Balance quantity of drug at the end of the business day,
9. Signature of the person under whose supervision the drugs have been supplied]
(vii)the licensee shall comply with such further requirements, if any, applicable to the
holders of import licenses, as may be specified in any Rules, subsequently made
under Chapter III of the Act and of which the licensing authority has given to him
not less than four months’ notice.
27.Grant of import licence.
____On receipt of an application for an import licence in the form
and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if
granted, the conditions of the licence will be observed, issue an import licence in Form 10 1
[or
From 10-A, as the case may be.]
2
[27-A Grant of Registration Certificate:– (1) On receipt of an application for Registration
Certificate in the Form and manner specified in rule 24-A, the licensing authority shall, on being
satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a
Registration Certificate in Form 41:
Provided further that if the application is complete in all respects and informations specified
in Schedules D-1 and D-11 are in order, the licensing authority shall, within nine months from
the date of receipt of an application, issue such Registration Certificate, and in exceptional
circumstances and for reasons to be recorded in writing, the Registration Certificate may be
issued within such extended period, not exceeding three months as the licensing authority, may
deem fit.
______________________________________________________________
1Amended by Notification No. G.S.R 462(E) dated 22-06-1982
2
Inserted by Notification No. G.S.R 604(E) dated 24-08-2001
64
(2) If the applicant does not receive the Registration Certificate within the period as specified
in the proviso to sub rule (1), he may appeal to the Central Government and the Central
Government may after such enquiry into the matter, as it considers necessary, may pass such
orders in relation thereto as it thinks fit.]
1
28. Duration of import licence. __A licence unless, it is sooner suspended or cancelled, shall
be valid 2
[for a period of three years from the date of its issue]
Provided that if application for a fresh licence is made three months before the expiry of the
existing licence the current licence shall be deemed to continue in force until orders are passed
on the application.
3
28-A. Duration of Registration Certificate. – A Registration Certificate, unless, it is sooner
suspended or cancelled, shall be valid for a period of three years from the date of its issue:
Provided that if the application for a fresh Registration Certificate is made nine months
before the expiry of the existing certificate, the current Registration Certificate shall be deemed
to continue in force until orders are passed on the application.
29. Suspension and cancellation of import licence.
__ If the manufacturer or licensee fails to
comply with any of the conditions of an import licence, the licensing authority may after giving
the manufacturer or licensee an opportunity to show cause why such an order should not be
passed, by an order in writing stating the reasons therefore, suspend or cancel it for such period
as it thinks fit, either wholly or in respect of some of the substances to which it relates:
4
[Provided that a person who is aggrieved by the order passed by the licensing authority
under this rule may, within thirty days of the receipt of the order, appeal to the Central
Government, and the Central Government may, after such enquiry into the matter, as it considers
necessary and after giving the said appellant an opportunity for representing his views, pass such
orders in relation thereto as it thinks fit.]
3
[29-A. Suspension and cancellation of Registration Certificate. —If the manufacturer fails to
comply with any of the conditions of the Registration Certificate, the licensing authority may
after giving him an opportunity to show cause why such an order should not be passed, by an
order in writing stating the reasons therefore, suspend or cancel the Registration Certificate for
such period as it thinks fit either wholly or in respect of some of the substances to which it
relates:
______________________________________________________________
1Amended by Government of India Notification No. F. 1-10/62-D, dated 19th April, 1964.
2Amended by G.O.I. Notification No. G.S.R 604(E) dated 24-08-2001
3
Inserted by G.O.I. Notification No. G.S.R 604(E) dated 24-08-2001
4
Subs. by G.O.I.Notification No. G.S.R 604(E) dated 24-08-2001
65
Provided that a person, who is aggrieved by the order passed by the licensing authority under
this rule may, within thirty days of the receipt of the order, appeal to the Central Government,
and the Central Government may, after such enquiry into the matter as it considers necessary and
after giving the appellant an opportunity for representing his views in the matter, pass such
orders in relation thereto as it thinks fit.]
30. Prohibition of import after expiry of potency. —No biological or other special product
specified in Schedule C or C (1) shall be imported after the date shown on the label, wrapper or
container of the drug as the date up to which the drug may be expected to retain a potency not
less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted
by the prescribed test.
1* * * * *
30AA.Import of New Homoeopathic medicine: __
(1) No new Homoeopathic medicine shall be imported except under and in accordance with
the permission in writing of the Licensing Authority.
(2) The importer of a New Homoeopathic medicine when applying for permission shall
produce before the Licensing Authority such documentary and other evidence as may be
required by the Licensing Authority for assessing the therapeutic efficacy of the medicine
including the minimum provings carried out with it.
2
[Explanation. —For the purpose of this rule, ‘New Homoeopathic Medicine’ means—
(i) a Homoeopathic medicine which is not specified in the Homoeopathic
Pharmacopoeia of India or United States of America or of the United Kingdom or the
German Homoeopathic Pharmacopoeia; or
(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under
the conditions recommended; or
(iii)a combination of Homoeopathic medicines containing one or more medicines which
are not specified in any of the Pharmacopoeias referred to in clause (i) as
Homoeopathic medicines and also not recognized in authoritative Homoeopathic
literature as efficacious under the conditions recommended.]
3
30-B. Prohibition of import of certain drugs.
___ No drug, the manufacture, sale or
distribution of which is prohibited in the country of origin, shall be imported under the same
name or under any other name except for the purpose of examination, test or analysis.
_________________________________________________________________
1 Section 30A omitted by G.O.I. Notification No. G.S.R. 944 (E) dated 21-09-1998.
2Amended as per G.O.I. Notification No. G.S.R. 680(E) dated 5-12-1980
3Amended under Government of India Notification No. F. 1-45 4th January, 1951
66
1
[31. Standard for certain imported drugs. —No drug shall be imported unless it complies
with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall
be applicable for determining whether any such imported drug complies with the said standard:
Provided that the drugs intended for veterinary use, the standards of strength, quality and
purity, if any, shall be those that are specified in Schedule F (1) and the test prescribed in that
Schedule shall be applicable for determining whether any such imported drug complies with the
said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the
standards for such drug shall be those specified in the current edition, for the time being in force,
of the British Pharmacopoeia Veterinary:
Provided further that the licensing authority shall not allow the import of any drug having
less than sixty percent residual shelf-life period as on the date of import:
Provided also that in exceptional cases the licensing authority may, for reasons to be recorded
in writing, may allow, the import of any drug having lesser shelf-life period, but before the date
of expiry as declared on the container of the drug.]
2
32.Packing and labeling of imported drugs. __No drug shall be imported unless it is packed
and labeled in conformity with the rules in Parts IX and X 3
* * * and further conform to the
standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the
packing and labeling shall conform to the rules in Parts IX and X and Schedule F(1).
4
32-A Packing and Labelling of Homoeopathic medicine.–No Homoeopathic medicine shall
be imported unless it is packed and labeled in conformity with the rules in Part IX-A
33. Import of drugs for examination, test or analysis.____ Small quantities of drugs the
import of which is otherwise prohibited under Section 10 of the Act may be imported for the
purpose of examination, test or analysis subject to the following conditions:__

a) No drug shall be imported for such purpose except under a licence in form 11;
b)the licensee shall use the substances imported under the licence exclusively for
purposes of examination, test or analysis and shall carry on such examination, test or
analysis in the place specified in the licence, or in such other places as the licensing
authority may from time to time authorize;
________________________________________________________________________
1
Substituted as per G.O.I. Notification No.G.S.R. 604 (E) dated 24-08-2001
2Amended by Govt. of India, Ministry of Health, F. P. & W. H. & U. D. Notification No. F. 1-6/62-D.
dated 2-7-1969.
3Omitted under G.O.I. Notification No. G.S.R.663(E) dated 3-7-1992
4Amended by S. O. No. 2139 dated 12-8-1972 (Govt of India Notification No. X. 11014/12/72-D, dated the
5
th June, 1972).
67
c)the licensee shall allow any Inspector authorized by the licensing authority in this
behalf to enter, with or without prior notice, the premises where the substances are
kept, and to inspect the premises, and investigate the manner in which the substance
are being used and to take samples thereof;
d)the licensee shall keep a record of, and shall report to the licensing authority, the
substances imported under the licence, together with the quantities imported, the date
of importation and the name of the manufacturer;
e)the licensee shall comply with such further requirements, if any applicable to the
holders of licences for examination, test or analysis as may be specified in any rules
subsequently made under Chapter III of the Act and of which the licensing authority
has given to him not less than one month’s notice.
1
[33-A Import of drugs by a Government Hospital or Autonomous Medical Institution for the
treatment of patient.—Small quantities of new drug, as defined in rule 122-E, the import of
which is otherwise prohibited under this section 10 of the Act, may be imported for treatment of
patients suffering from life threatening diseases, or diseases causing serious permanent disability,
or such disease requiring therapies for unmet medical needs, by a Medical Officer of a
Government Hospital or an Autonomous Medical Institution providing tertiary care, duly
certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous
Medical Institution, subject to the following conditions, namely:-

(a) no new drug shall be imported for the said purpose except under a licence in Form
11-A, and the said drug has been approved for marketing in the country of origin;
(b) the licence shall use the substances or drugs imported under the licence exclusively
for the purpose of treatment of patients suffering from life threatening diseases, or
diseases causing serious permanent disability, or such diseases requiring therapies for
unmet medical needs, under the supervision of its own Medical Officers at the place,
specified in the licence or at such other places, as the licensing authority, may from
time to time authorize;
(c) the licencee shall allow an Inspector authorised by the licensing authority in this
behalf to enter, with or without prior notice, the premises where the substances or
drugs are stocked, and to inspect the premises and relevant records and investigate
the manner in which the substances or drugs are being used and to take, if
necessary, samples thereof ;
(d) the licencee shall keep a record of, and shall submit the said report half yearly to the
licensing authority, the substances or drugs imported under the licence, together with
the quantities imported and issued to the patients, the date of importation, the name
of the manufacturer, the name and address of the patient for whom the drug is
prescribed and the name of disease;
____________________________________________________________
1
Inserted by G.O.I.Notification No. G.S.R 604(E) dated 24-08-2001
68
(e) the licencee shall comply with such other requirements, if any, applicable to the
holders of import licences for import of new drugs for treatment of patients by
Government Hospitals, as may be specified from time to time in any rule
subsequently made under Chapter 111 of the Act and of which the licensing
authority has given to him not less than one month’s notice;
(f)the drug shall be stocked under proper storage conditions and shall be dispensed
under the supervision of a registered pharmacist;
(g) the quantity of any single drug so imported shall not exceed 100 average dosages
per patient:
Provided that the licensing authority may, in exceptional circumstances, sanction the import
of drug a large quantity.]
34. Application for licence for examination, test or analysis.____(1) An application for a
licence for examination, test or analysis shall be made in Form 12 and shall be made or
countersigned by the head of the institution in which, or by a proprietor or director or the
company or firm by which the examination, test or analysis will be conducted.
(2)The licensing authority may require such further particulars to be supplied as he may
consider necessary.
1
[(3) Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a
single drug and an additional fee of fifty rupees or each additional drug.
(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg,
New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as
notified, from time to time, by the Central Government, to be credited under the Head of
Account 0210-Medical and Public Health, 04- Public Health, 104- Fees and Fines.]
2
[34-A. Application for licence to import small quantities of new drugs by a Government
Hospital or Autonomous Medical Institution for the treatment of patients.—(1) An application
for an import licence for small quantities of a new drug, as defined in rule 122-E for the purpose
of treatment of patients suffering from life threatening diseases, or diseases causing serious
permanent disability, or such diseases requiring therapies for unmet medical needs, shall be
made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical
Institution, which shall be certified by the Medical Superintendent of the Government Hospital
or Head of the Autonomous Medical Institution, as the case may be.
___________________________________________________________________________
1
Substituted by Notification No. G.S.R 604(E) dated 24-08-2001
2 Inserted by G.O.I.Notification No. G.S.R 604(E) dated 24-08-2001
69
(2) The licensing authority may require such further particulars to be supplied, as he may
consider necessary.
(3) Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees
for a single drug and an additional fee of fifty rupees for each additional drug.
(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg,
New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as
notified, from time to time, by the Central Government, to be credited under the Head of
Account 0210- Medical and Public Health, 04- Public Health, 104- Fees and Fine.]

35. Cancellation of licence for examination, test or analysis.___(1) A licence for examination,
test or analysis may be cancelled by the licensing authority for breach of any of the conditions
subject to which the licence was issued.
(2) A licensee whose licence has been cancelled may appeal to the Central Government
within three months of the date of the order
1
[35A. Cancellation of licence for import of small quantities of new drugs.–(1) A licence for
import of small quantities of a new drug, defined in rule122-E, for the purpose of the treatment
of patients suffering from life threating diseases, or diseases causing serious permanent
disability, or such diseases requiring therapies for unmet medical needs, by a Government
Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for
breach of any of the conditions subject to which the licence was issued or for contravention of
any of the provisions of the Act and rules made thereunder.
(2) A licencee whose licence has been cancelled may appeal to the Central Government
within three months from the date of the receipt of the order, and the Central Government may
after such enquiry into the matter, as it considers necessary and after giving the appellant an
opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit.]
36. Import of drugs for personal use.
__ Small quantities of drugs, the import of which is
otherwise prohibited under Section 10 of the Act, may be imported for personal use subject to
the following conditions: __
(i) the drugs shall form part of a passenger’s bona fide baggage and shall be the
property of, and be intended for, the exclusive personal use of the passenger;
(ii) the drugs shall be declared to the Customs authorities if they so direct;
(iii) the quantity of any single drug so imported shall not exceed one hundred average
doses :
_________________________________________________________________
1
Inserted by G.O.I.Notification No. G.S.R 604(E) dated 24-08-2001
70
Provided that the licensing authority may in an exceptional case in any individual case
sanction the import of a large quantity:
1
Provided further that any drug, imported for personal use but not forming part of bona fide
personal baggage, may be allowed to be imported subject to the following conditions, namely:–
(i)the licensing authority, on an application made to it in Form 12-A is satisfied that the
drug is for bona fide personal use;
(ii)the quantity to be imported is reasonable in the opinion of the licensing authority and
is covered by prescription from a registered medical practitioner ; and
(iii)the licensing authority grants a permit in respect of the said drug in Form 12-B.
2
37. Packing of patent or proprietary medicine. —Patent or proprietary medicines shall be
imported in containers intended for retail sale.
3
Provided that such medicines may be imported in bulk containers by any person who holds a
licence to manufacture, if such person has obtained permission in writing to import such
medicines from the licensing authority at least three months prior to the date of import and the
imports are made within a period of twelve months from the date of issue of such permission.
38. Statement to accompany imported drugs.
___ All consignments of drugs sought to be
imported shall be accompanied by an invoice or other statement showing the name and address
of the manufacturer and the name and quantities of the drugs.
39. Documents to be supplied to the Customs Collector. ___Before drugs for the import of
which a licence is not required are imported a declaration signed by or on behalf of the
manufacturer or by or on behalf of the importer that the drugs comply with the provisions of
Chapter III of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall be supplied to
the Customs Collector.
4
40. Procedure for the import of drugs. ____(1) If the Customs Collector has reason to doubt
whether any drugs comply with the provisions of Chapter III of the Act and Rules thereunder he
may, and if requested by an officer appointed for this purpose by the Central Government shall,
take samples of any drugs in the consignment and forward them to the Director of the laboratory
appointed for this purpose by the Central Government and may detain the drugs in the
consignment of which samples have been taken until the report of the Director of the said
laboratory or any other officer empowered by him on this behalf, subject to the approval of the
Central Government, on such samples is received :
____________________________________________________________________________
1Amended under Government of India Notification No.F-1-36/54-D.S.,dated 3rd March,1955.
2Amended under Government of India Notification No.F-1-3/51-D.S.,dated 15th October,1954
3Amended under Government of India Notification No.F-1-45/58-D, dated 4th January,1961
4Amended by the Government of India Notification No. F. 1-99/52-D.S., dated 3rd November, 1953
71
Provided that if the importer gives an undertaking in writing not to dispose of the drugs
without the consent of the Customs Collector and to return the consignment or such portion
thereof as may be required, the Customs Collector shall make over the consignment to the
importer.
(2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required
by the Customs Collector to return the consignment or any portion thereof he shall return the
consignment or portion thereof within ten days of receipt of the notice.
1
41. (1) If the Director of the laboratory appointed for the purpose by the Central Government
or any other officer empowered by him on this behalf, subject to the approval of the Central
Government, reports to the Customs Collector that the samples of any drug in a consignment are
not of standard quality, or that the drug contravenes in any other respect the provisions of
Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be
remedied by the importer, the Customs Collector shall communicate the report forthwith to the
importer who shall, within two months of his receiving the communication either export all the
drugs of that description in the consignment, to the country in which they were manufactured or
forfeit them to the Central Government which shall cause them to be destroyed :
Provided that the importer may within fifteen days of receipt of the report make a
representation against the report to the Customs Collector, and the Customs Collector shall
forward the representation with a further sample to the licensing authority, who after obtaining, if
necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon
which shall be final.
2
(2) If the Director of the laboratory appointed for the purpose by the Central Government or
any other officer empowered by him on this behalf, subject to the approval of the Central
Government reports to the Customs Collector that the samples of any drug contravene in any
respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention
is such that it can be remedied by the importer, the Customs Collector shall communicate the
report forthwith to the importer and permit him to import the drug on his giving an undertaking
in writing not to dispose of the drug without the permission of the officer authorized in this
behalf by the Central Government.
42. 3* * *
_________________________________________________________________
1Amended by Government of India Notification No. F. 7-7/47-D, dated 5th January, 1954
2Added under Government of India Notification No. 7-11/47-D, dated 5th October, 1951.
3Omitted by Government of India Notification No. F. 1-9/52-DS., dated 3rd November, 1953
72
43. The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of
the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in
that Schedule.
1
[43A. No drug shall be imported into India except through one of the following places,
namely: __
Freozepore Cantonment and Amritsar Railway Stations:
In respect of drugs imported by rail across the frontier with Pakistan.
Ranaghat, Bongaon and Mohiassan Railways Stations:
In respect of drugs imported by rail across the frontier with Bangladesh
2
[Raxaul: In respect of drugs imported by road and railway lines connecting Raxaul in India
and Birganj in Nepal]
3
[Chennai, Kolkata, Mumbai and Cochin, Nhava Sheva and Kandla]:
In respect of drugs imported by sea into India.
4
[Chennai, Kolkata, Mumbai, Delhi, Ahemdabad and Hyderabad]:
In respect of drugs imported by sea into India.
5
43-B.Drugs, consignments of which are in transit through India to foreign countries and
which shall not be sold or distributed in India shall be exempted from the requirements of
Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder.
Provided that if the Government of the countries to which the drugs are consigned regulate
their import by the grant of import licences, the importer shall at the time of import into India,
produce such import licences.
_________________________________________________________________
.
1 Subs. by G.O.I. Notification No. G.S.R 478(E) dated 6th August, 1981
2
Ins. by G.O.I.Notification No. G.S.R 120(E) dated 05-03-1998
3Amended by Notification No. G.S.R 504(E) dated 18-07-2002
(Also, the word Calcutta substituted with a word ‘Kolkata’ as per this notification).
4Amended by Notification No. G.S.R 647(E) dated 28-10-1998
5Added under Government of India Notification No. E. 1-60/D, dated 19th March, 1964.
73
PART V—1
[GOVERNMENT ANALYSTS, INSPECTORS, LICENCING AUTHORITIES AND
CONTROLLING AUTHORITIES]
2
44. Qualifications of Government Analyst.
____ A person appointed as a Government Analyst
under the Act shall be a person who____
(a) is a graduate in medicine or science or pharmacy or pharmaceutical chemistry of a
4
[University established in India by law or has an equivalent qualification recognized
by the Central Government for such purpose] and has had not less than five years’
post-graduate experience in the testing of drugs in a laboratory under control of (i) a
Government Analyst appointed under the Act, or (ii) the head of an Institution or
testing laboratory approved for the purpose by the appointing authority, 3
[ or has
completed training on testing of drugs, including items stated in Schedule C, in
Central Drugs Laboratory], or
(b) possesses a post-graduate degree in medicine or science or pharmacy or
Pharmaceutical chemistry of a 4
[University established in India by law or has an
equivalent qualification recognized by the Central Government for such purpose]or
possesses the Associateship Diploma of the Institution of Chemists (India) obtained
by passing the said examination with “Analysis of Drugs and Pharmaceuticals’ as one
of the subjects and has had after obtaining the said post-graduate degree or diploma
not less than three years’ experience in the testing of drugs in a laboratory under the
control of (i) a Government Analyst appointed under the Act, or (ii) the head of an
Institution or testing laboratory approved for the purpose by the appointing authority
3
[or has completed training on testing of drugs, including items stated in Schedule C,
in Central Drugs Laboratory];
Provided that3
[(i) for purpose of examination of items in Schedule C, —
(ia) the persons appointed under clause (a) or (b) and having degree in Medicine,
Physiology, Pharmacology, Microbiology, Pharmacy should have experience
or training in testing of said items in an institution or laboratory approved by
the appointing authority for a period of not less than six months;
(ib) the person appointed under clause(a) or (b) but not having degree in the above
subjects should have experience or training in testing of said Schedule C drugs
for a period of not less than three years in an institution or laboratory approved
by the appointing authority or have completed two years training on testing of
drugs including items stated in Schedule C in Central Drugs Laboratory;]
_____________________________________________________________________________
1 Subs. by G.O.I. Notification No. G.S.R 443(E) dated 12-04-1989
2Amended by G.S.R. No. 1427 dated 22-10-77 (Govt. of India Notification No. X. 11013/2/76-D & MS
dated the 10th October, 1977)
3
Ins. by G.O.I. Notification No. G.S.R 697(E) dated 26-10-1995
4.Subss. by G.O.I. Notification No. G.S.R.71(E) dated30.01.1987
74
(ii) for a period of four years from the date on which Chapter IV of the Act takes effect in
the States, persons whose training and experience are regarded by the appointing
authority as affording, subject to such further training, if any, as may be considered
necessary, a reasonable guarantee of adequate knowledge and competence, may be
appointed as Government Analysts. The persons so appointed may, if the appointing
authority so desires, continue in service after the expiry of the said period of four
years :
(iii) no person who is engaged directly or indirectly in any trade or business connected
with the manufacture of drugs shall be appointed as a Government Analyst for any
area :
Provided further that for the purpose of examination of Anti-sera, Toxoid and Vaccines and
Diagnostic Antigens for Veterinary use, the person appointed shall be a person who is a graduate
in Veterinary Science, or general science, or medicine or pharmacy and has had not less than five
years’ experience in the standardization of biological products or person holding a post-graduate
degree in Veterinary Science, or general science, or medicine or pharmacy or pharmaceutical
chemistry with an experience of not less than three years in the standardization of biological
products :
Provided also that persons, already appointed as Government Analysts may continue to
remain in service, if the appointing authority so desires, notwithstanding the fact that they do not
fulfil the qualifications as laid down in clause (a), clause (b) or the preceding proviso.
45. Duties of Government Analysts. __(1) The Government Analyst shall cause to be
analysed or tested such samples or drugs 1
and cosmetics as may be sent to him by Inspectors or
other persons under the provisions of Chapter IV of the Act and shall furnish reports of the
results of test or analysis in accordance with these Rules.
(2)A Government Analyst shall from time to time forward to the Government reports giving
the result of analytical work and research with a view to their publication at the discretion of
Government.
46. Procedure on receipt of sample. On receipt of a package from an Inspector containing a
sample for test or analysis, the Government Analyst shall compare the seals on the packet 2
[or on
portion of sample or container] with the specimen impression received separately and shall note
the condition of the seals on the 2
[packet or on portion of sample or container]. After the test or
analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in
Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis
applied:
__________________________________________________________________________
1
Ins. by G.O.I. Notification No. S.O. 2139 dt 12.8.1972
2
Ins./ Subs. by G.O.I. Notification No. GSR 59(E) dt 7.2.1995.
75
1Explanation.
____It shall be deemed to be full and sufficient compliance with the requirement
of the rule in respect of the supply of “protocols of the tests or analysis applied”, if____
(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the
official pharmacopoeia are followed, references to the specific tests or analysis in the
pharmacopoeias are given in the report;
(2)for patent or proprietary medicines for which the tests and methods prescribed in any
of the official pharmacopoeias are applicable and are followed, references to the
specific tests or analysis in the pharmacopoeias are given in the report;
(3)for patent or proprietary medicines containing pharmacopoeial drugs for which the
official tests or analysis or methods of assays are modified and applied, a description
of the actual tests or, as the case may be, analysis or methods of assays so applied is
given in the report;
(4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of
analysis are available or can be applied but for which tests or methods of analysis
given in standard books or journals are followed, a description of such tests or methods
of analysis applied together with the reference to the relevant books or journals from
which the tests or methods of analysis have been adopted, is given in the report;
(5) for those drugs for which methods of test are not available and have been evolved by
the Government Analyst, a description of tests applied is given in the report.
47. Report of result of test or analysis.
___ An application from a purchaser for test or analysis
of a drug under Section 26 of the Act shall be made in Form 14 A and the report of test or
analysis of the drug made on such application shall be supplied to the applicant in Form 14-B.
48. Fees.
___ The fees to be paid by a person submitting to the Government Analyst under
Section 26 of the Act for test or analysis of a drug purchased by him shall be those specified in
Schedule B.
2
[49. Qualifications of Inspectors. —A person who is appointed an Inspector under the Act
shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with
specialisation in clinical Pharmacology or Microbiology from a University established in India
by law:
Provided that only those Inspectors: —
__________________________________________________________________________
1
Ins. under Government of India Notification No. F. 1-60/61-D, dated 12th July, 1962.
2
Substituted by G.O.I. Notification No. G.S.R 658(E) dated 19-10-1993
76
(i) Who have not less than 18 months’ experience in the manufacture of atleast one of the
substances specified in Schedule C, or
(ii) Who have not less than 18 months’ experience in testing of atleast one of the
substances in Schedule C in a Laboratory approved for this purpose by the licensing
authority, or
(iii) Who have gained experiences of not less than three years in the inspection of firms
manufacturing any of the substances specified in Schedule C during the tenure of their
services as Drugs Inspector; shall be authorised to inspect the manufacture of the
substances mentioned in Schedule C.]
1
[Provided further that the requirement as to the academic qualification shall not apply to the
persons appointed as Inspectors on or before the 18th day of October, 1993.]
2
[ 49A. Qualification of a Licensing Authority.—
No person shall be qualified to be a Licensing Authority under the Act unless:–
(i) he is a graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with
specialization in clinical pharmacology or microbiology from a University established
in India by law; and
(ii) he has experience in the manufacture or testing of drugs or enforcement of the
provisions of the Act for a minimum period of five years:]
3
[ Provided that the requirements as to the academic qualification shall not apply to those
inspectors and the Government Analysts who were holding those positions on the 12th day of
April,1989.
4
50.Controlling authority.
__(1) All Inspectors appointed by the Central Government shall be
under the control of an officer appointed in this behalf by the Central government.
(2) All Inspectors appointed by the State Government shall be under the control of an
officer appointed in this behalf by the State Government.
(3) For the purposes of these rules an officer appointed by the Central Government under
sub-rule (1), or as the case may be, an officer appointed by the State Government
under sub-rule (2), shall be a controlling authority.
__________________________________________________________________________
1
Ins. by G.O.I. by Notification No. G.S.R 552(E) dated 04-12-1996
2 Ins. by G.O.I. Notification No. GSR 443(E) dt 12.4.1989.
3
Sub. By G.O.I. Notification No. GSR 532 (E) dt 14.8.1991.
4. Amended by G.O.I. Notification No. S.O. 2139 dt 12.8.1972.
77
1
[50A. Qualification of a Controlling Authority.—
(1) No person shall be qualified to be a controlling Authority under the Act unless.–
(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with
specialization in clinical Pharmacology or microbiology from a University
established in India by law and
(ii)he has experience in the manufacture or testing of drugs or enforcement of the
provisions of the Act for a minimum period of five years:
2
[Provided that the requirements as to the academic qualifications shall not apply to those
Inspectors and the Government Analysts who were holding those positions on the 12th day of
April, 1989.]
51. Duties of Inspectors of premises licensed for sale.
___ Subject to the instructions of the
controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for
the sale of drugs____
(1) to inspect 3
[not less than once a year] all establishments licensed for the sale of
drugs within the area assigned to him;
(2) to satisfy himself that the conditions of the licences are being observed;
(3) to procure and send for test or analysis, if necessary, imported packages which he
has reason to suspect contain drugs being sold or stocked or exhibited for sale in
contravention of the provisions of the Act or Rules thereunder;
(4) to investigate any complaint in writing which may be made to him;
(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder;
(6) to maintain a record of all inspections made and action taken by him in the
performance of his duties, including the taking of samples and the seizure of
stocks, and to submit copies of such record to the controlling authority;
(7) to make such enquiries and inspections as may be necessary to detect the sale of
drugs in contravention to the Act;
__________________________________________________________________
1 IIns. by G.O.I.Notification No. G.S.R 443(E) dated 12-04-1989
2
Subs. by Notification No. G.S.R 532(E) dated 14-8-1991
3
Subs. by G.O.I. Notification GSR 700 (E) dt 28.9.2001.
78
(8) when so authorized by the State Government, to detain imported packages which
he has reason to suspect contain drugs, the import of which is prohibited.
52.Duties of Inspectors specially authorized to inspect the manufacture of 1
[drugs or
cosmetics].__ Subject to the instructions of the controlling authority it shall be the duty of an
Inspector authorized to inspect the manufacture of drugs____
(1) to inspect 2
[not less than once a year], all premises licensed for manufacture of
1
[drugs or cosmetics] within the area allotted to him to satisfy himself that the
conditions of the licence and provisions of the Act and Rules thereunder are being
observed;
(2) in the case of establishments licensed to manufacture products specified in
Schedule C and C(1) to inspect the plant and the process of manufacture, the
means employed for standardizing and testing the 2
[drugs or cosmetics], the
methods and place of storage, the technical qualifications of the staff employed
and all details of location, construction and administration of the establishment
likely to affect the potency or purity of the product;
(3) to send forthwith the controlling authority after each inspection a detailed report
indicating the conditions of the licence and provisions of the Act and Rules
thereunder which are being observed and the conditions and provisions, if any,
which are not being observed.
(4) to take samples of the 1
[drugs or cosmetics] manufactured on the premises and
send them for test or analysis in accordance with these Rules;
(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder.
53. Prohibition of disclosure of information.
___ Except for the purposes of official business or
when required by a Court of Law, an Inspector shall not, without the sanction in writing of his
official superior, disclose to any person any information acquired by him in the course of his
official duties.
54. Form of order not to dispose of stock.– An order in writing by an Inspector under clause
(c) of Section 22 of the Act requiring a person not to dispose of any stock in his possession shall
be in Form 15.
__________________________________________________________________
1Amended by G.O.I. Notification No. G.S.R 504(E) dated 18-07-2002
2Amended by G.O.I. Notification No. G.S.R 700(E) dated 28-9-2001
79
1
54-A.Prohibition of sale.
__ No person in possession of a 2
[drug or cosmetic] in respect of
which an Inspector has made an order under clause (c) of sub-section (i) of Section 22 of the Act
shall in contravention of that order sell or otherwise dispose of any stock of such 2
[drug or
cosmetic].
3
55. Forms of receipts for seized drug, cosmetic, record register, document or any other
material object.– A receipt by an Inspector for the stock of any drug or cosmetic or for any
record, register, document or any other material object seized by him under clause (c) or clause
(cc) of sub-section (1) of Section 22 of the Act shall be in Form 16.
4 [55A . Manner of certifying copies of seized documents.—The Drugs Inspector shall return
the documents , seized by him under clause (cc) or produced before him under clause (cca), of
sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such
seizure or production, to the person from whom they have seized or, as the case may be, the
person who produced them, after copies thereof extracts therefrom have been singed by the
concerned Drug Inspector and the person from whom they have seized , or, as the case may be ,
who produced such records.]
56.Form of intimation of purpose of taking samples.
__ When an Inspector takes a sample of a
drug for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to
the person from whom he takes it.
5
[56A . Form or receipt for samples of drugs where fair price tendered is refused.—Where
the fair price, for the samples of drugs taken for the purpose of test or analysis, tendered under
sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the
person from whom the said samples have been taken as specified in Form 17-A;]
57. Procedure for dispatch of sample to Government Analyst.__(1) The portion of sample or
the container sent by an Inspector to the Government Analyst for test or analysis under subsection (4) of Section 23 of the Act shall be sent by registered post or by hand in a sealed packet,
enclosed together with a memorandum in Form 18, in an outer cover addressed to the
Government Analyst.
(2)A copy of the memorandum and a specimen impression of the seal used to seal the packet
shall be sent to the Government Analyst separately by registered post or by hand.
__________________________________________________________________
1Added under G.O.I. Notification No. F. 1-19/59-D, dated 13 th June, 1961.
2Amended by G.O.I. Notification No. G.S.R 850(E) dated 07-12-1994
3Amended by GSR No. 926 dated 16-7-1977 (Govt. of India Notification No. X. 11014/6/76-D & MS dated
24-6-1977).
4
Inserted by G.O.I. Notification No. G.S.R 89(E) dated 16-2-1981
5
Inserted by G.O.I. Notification No. G.S.R 292(E) dated 29-5-1997
80
1
58. Confiscation of drugs, implements, machinery etc.
____
1) Where any person has been convicted for contravening any of the provisions of
Chapter IV of the Act or any rule made thereunder, the stock of the drug in
respect of which the contravention has been made shall be liable to confiscation.
2) Where any person has been convicted for the manufacture of any drug deemed
to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) or
clause (g) of section 17 of the Act, or adulterated drug under section 17 B of the
Act, or for manufacture for sale, or stocking or exhibiting for sale or distribution
of any drug without a valid licence as required under clause (c) of section 18 of
the Act, any implements or machinery used in such manufacture, sale or
distribution and any receptacle, packages, or coverings in which such drug is
contained and the animals, vehicles, vessels or other conveyances used in
carrying such drug shall also be liable to confiscation.
2
58-A. Procedure for disposal of confiscated drugs.____(1) The Court shall refer the
confiscated drugs to the Inspector concerned for report as to whether they are of standard quality
or contravene the provisions of the Act or the Rules in any respect.
(2) If the Inspector, on the basis of Government Analyst’s report finds the confiscated drugs
to be not of standard quality or to contravene any of the provisions of the Act or the Rules made
thereunder, he shall report to the Court accordingly. The Court shall thereupon order the
destruction of the drugs. The destruction shall take place under the supervision of the Inspector
in the presence of such authority, if any, as may be specified by the Court.
(3) If the Inspector finds that the confiscated drugs are of standard quality and do not
contravene the provisions of the Act or the Rules made thereunder, he shall report to the Court
accordingly. 3
[The Court may then order the Inspector to give the stocks of confiscated drugs to
hospital or dispensary maintained or supported by the Government or by Charitable Institution.]
__________________________________________________________________
1Amended by S. O. No. 289, dated 3-2-1973 ( G.O.I. Notification No. X. 11014/17/72__D, dated the 20th
December, 1972).
2Added under G.O.I. No. F. 1-9/62-D, dated 2nd Dec. 1964.

3 Subs. by G.O.I. Notification No. GSR 59(E) dt 7.2.1995.
81
PART VI ____ SALE OF DRUGS OTHER THAN HOMOEOPATHIC
MEDICINES
59. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part
for such areas as may be specified.
1
(2) Applications for the grant or renewal of a licence 2
[to sell, stock, exhibit or offer for sale
or distribute] drugs, other than those included in Schedule X, 3
[shall be made in Form 19
accompanied by a fee of rupees one thousand and five hundred or Form 19-A. accompanied by a
fee of rupees five hundred, as the case may be, or in the case of drugs included in Schedule X
shall be made in Form 19-C accompanied by a fee of rupees five hundred, to the licensing
authority:]
Provided that in the case of an itinerant vendor or an applicant who desires to establish a shop
in a village or town having population of 5,000 or less, the application in Form 19-A shall be
accompanied by a fee of rupees ten .

(3)3
[A fee of rupees one hundred and fifty] shall be paid for a duplicate copy of a licence 4
[to
sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X,
or for a licence 4
[ to sell, stock, exhibit or offer for sale or distribute] drugs, included in Schedule
X, if the original is defaced, damaged or lost;
Provided that in the case of itinerant vendor or an applicant who desires to established a shop
in a village or town having a population of 5,000 or less, the fee for a duplicate copy of a licence
if the original is defaced, damaged or lost, shall be rupees two.
(4) Application for renewal of a licence 4
[to sell, stock, exhibit or offer for sale or distribute]
drugs, after its expiry but within six months of such expiry 3[shall be accompanied by a fee of
rupees one thousand and five hundred plus an additional fee at the rate of rupees five hundred
per month or part thereof in Form 19, rupees five hundred plus an additional fee at the rate of
rupees two hundred fifty per month or part thereof in Form 19-A and rupees five hundred plus an
additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19-
C:]
Provided that in the case of an itinerant vendor or an applicant desiring to open a shop in a
village or town having a population of 5,000 or less the application for such renewal shall be
_________________________________________________________________
1Substituded by G.O.I. Notification No. G.S.R 462(E) dated 22-6-1982
2Amended by G.O.I. Notification No. G.S.R 778(E) dated 10-10-1985
3Amended by G.O.I. Notification No. G.S.R 601(E) dated 24-08-2001
4 Subs. by G.O.I. Notification No. GSR 778(E) dt 10.1.1985.
82
accompanied by a fee of rupees ten, plus an additional fee at the rate of rupees eight per month
or part thereof.]
1
60. A licensing authority may with the approval of the State Government by an order in
writing delegate the power to sign licences and such other powers as may be specified in the
order to any other person under his control.
2
[61. Forms of licences to sell drugs.
__ (1) a licence 3
[ to sell, stock, exhibit or offer for sale
or distribute] drugs other than those specified in Schedule C, C (1) and X and by retail on
restricted licence or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 –B, as the
case may be:
Provided that a licence in Form 20-A shall be valid for only such drugs as are specified in the
licence.
(2) A licence 3
[to sell, stock, exhibit or offer for sale or distribute] drugs specified in
Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted licence or
by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be.
4
[Provided that a licence in Form 21-A shall not be granted for drugs specified in Schedule C
and shall be valid for only such Schedule C (1) drugs as are specified in the licence.]

(3)A licence 3
[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedule
X by retail or by wholesale shall be issued in Form 20-F or Form 20-G as the case may be.]
62. Sale at more than one place.__ If drugs are sold or stocked for sale at more than one place,
separate application shall be made, and a separate licence shall be issued, in respect of each such
place:
5
Provided that this shall not apply to itinerant vendors who have no specified place of
business and who will be licensed to conduct business in a particular area within the jurisdiction
of the licensing authority
__________________________________________________________________
1Amended by G.O.I. No. F. 1-16/57-D, dated 15th June, 1957
2
Subs by G.O.I.Notification No. G.S.R 462(E) dated 22-6-1982
3Amended by G.O.I. Notification No. G.S.R 788(E) dated 10-10-1985
4
Substituded by G.O.I.Notification No. G.S.R 487(E) dated 2-7-1984
5Added under Government of India Notification No. F. 10-21/49-D, dated 10th March, 1953
83
1
62A. Restricted licences in Forms 20-A and 21-A.
__ (a) Restricted licences in Forms 20-A
and 21-A shall be issued subject to the discretion of the Licensing Authority, to dealers or
persons in respect of drugs whose sale does not require the supervision of a qualified person.
(b)Licences to itinerant vendors shall be issued only in exceptional circumstances for bona
fide traveling agents of firms dealing in drugs or for a vendor who purchases drugs from a
licensed dealer for distribution in sparsely populated rural areas where other channels of
distribution of drugs are not available.
(c)The licensing authority may issue a licence in Form 21-A to a travelling agent of a firm
but to no other class of itinerant vendors for the specific purpose of distribution to medical
practitioners or dealers, samples of biological and other special products specified in Schedule C:
Provided that traveling agents of licensed manufacturers, agents, of such manufacturers and
importers of drugs shall be exempted from taking out licence for the free distribution of samples
of medicines among members of the medical profession, hospitals, dispensaries and the medical
institution or research institutions.
2
62-B.Conditions to be satisfied before a licence in Form 20-A or Form 21-A is granted.
__
(1) A licence in Form 20-A or Form 21-A shall not be granted to any person, unless the authority
empowered to grant the licence is satisfied that the premises in respect of which the licence is to
be granted are adequate and equipped with proper storage accommodation for preserving the
properties of drugs to which the licence applies:
Provided that this condition shall not apply in the case of licence granted itinerant vendors.
(2)In granting a licence under Rule 62-A the authority empowered to grant it shall have
regard to :____
(i) the number of licences granted in the locality during one year immediately preceding;
and
(ii) the occupation, trade or business carried on by such applicant :
__________________________________________________________________
1Added under Government of India Notification No. F. 10-21/49-D, dated 10th March, 1953.
2 Added under Government of India Notification No. F. 1-9/60-D, dated 3rd July, 1961.
84
Provided that the licensing authority may refuse to grant or renew a licence to any applicant
or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under
the Act or these Rules or the previous cancellation or suspension of any licence granted
thereunder, he is not a fit person to whom a licence should be granted under this Rule.
(3) Any person who is aggrieved by the order passed by the licensing authority in sub-rule (1)
may, within 30 days from the date of the receipt of such order appeal to the State Government
and the State Government may, after such enquiry into the matter as it considers necessary and
after giving the appellant an opportunity for representing his views in the matter make such order
in relation thereto as it thinks fit.
1
62C.Application for licence to sell drugs by wholesale or to distribute the same from a
motor vehicle: ___
(1)Application for the grant or renewal of a licence to sell by wholesale or to distribute from
a motor vehicle shall be made to the Licensing Authority in Form 19-AA and shall be
accompanied by 2
[a fee of rupees five hundred]:
Provided that if the applicant applies for the renewal of a licence after its expiry but within
six months of such expiry , the fee payable for renewal of such licence shall be 2
[rupees five
hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part
thereof].
(2) A fee of 2
[rupees one hundred fifty] shall be paid for a duplicate copy of a licence issued
under this rule, if the original is defaced, damaged or lost.
1
62D.Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicles.
A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of
drugs other than those specified in Schedule and Schedule C(1) in Form 20BB and of drugs
specified in Schedule C and Schedule C(1) in Form 21BB :
Provided that such a licence shall not be required in a case where a public carrier or a hired
vehicle is used for transportation or distribution of drug.
3
63.Duration of licence.
__ An original licence or a renewed licence to sell drugs, unless
sooner suspended or cancelled, shall be 2
[valid for a period of five years on and from the date on
which] it is granted or renewed :
__________________________________________________________________
1Added by G.O.I. Notification No. X11013/7/76__DGHS dated the 25th January 1979.
2Amended by G.O.I. Notification No. G.S.R 601(E) dated 24-08-2001
3Amended by G.O.I. Notification No. F. 1-10/62-D, dated 10th April, 1964.
85
1
Provided that if the application for renewal of licence in force is made before its expiry or
if the application is made within six months of its expiry, after payment of additional fee, the
licence shall continue to be in force until orders are passed on the application. The licence shall
be deemed to have expired if application for its renewal is not made within six months after its
expiry.
2
63A.Certificate of renewal of a sale licence.
__ The certificate of renewal of a sale licence in
Forms 20, 20-A, 20-B,3
[20-F, 20-G], 21, 21-A and 21-B shall be issued in Form 21-C.
4
63B. Certificate of renewal of licence.
__ A certificate of renewal of a licence in Form 20BB
or Form 21BB shall be issued in Form 21-CC.;
5
64.Conditions to be satisfied before a licence in Form3
[20, 20-B, 20-F,20-G 21 or 21-B] is
granted .
__(1)A licence in Form 3
[20, 20-B, 20-F,20-G, 21 or 21-B] 6
[to sell, stock, exhibit or
offer for sale or distribute]drugs shall not be 7
[granted or renewed] to any person unless the
authority empowered to grant the licence is satisfied that the premise in respect of which the
licence is to be 7
[granted or renewed] are adequate, equipped with proper storage
accommodation for preserving the properties of the drugs to which the licence applies and are in
charge of a person competent in the opinion of the licensing authority to supervise and control
the sale, distribution and preservation of drugs :
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be 7
[granted or
renewed] unless the licensing authority is satisfied that the requirements prescribed for a
pharmacy in Schedule N have been complied with.
3
[Provided further that licence in Form 20-F shall be 7
[granted or renewed] only to a
pharmacy and in areas where a pharmacy is not operating, such licence may be 7
[granted or
renewed] to a chemist and druggist]
Explanation.
__ For the purpose of this rule the term ‘Pharmacy’ shall be held to mean to
include every store or shop or other place : (1) where drugs are dispensed, that is, measured or
weighed or mode up and supplied : or (2), where prescriptions are compounded; or (3) where
drugs are prepared; or (4) which has upon it or displayed within it, or affixed to or used in
connection with it, a sign bearing the word or words “Pharmacy”, “Pharmacist,” “Dispensing
Chemist” or “Pharmaceutical Chemist”; or (5) which, by sign, symbol or indication within or.
__________________________________________________________________
1Amended by S. O. No. 2139, dated 12th August, 1972 (Govt. of India Notification No. X. 11014/12/72-D,
dated the 5th June, 1972).
2Added under Government of India Notification No. F. 1-10/62-D, dated 10th April, 1964.
3
Inserted by Notification No. G.S.R 462(E) dated 22-6-1982
4Added by Govt. of India Notification No. X11013/7/76__DGHS dated the 25th January 1979.
5Amended by Government of India Notification No. F. 1-16/57-D, dated 15th June 1957 and No. F. 1-19/59-
D, dated 13th June, 1961
6Amended by G.O.I. Notification No. G.S.R 778(E) dated 10-10-1985
7Amended by G.O.I. Notification No. G.S.R 681(E) dated 6-6-1988
86
upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in
the premises; or (6) which is advertised in terms referred to in (4) above
(2)In granting a licence under sub-rule (1) the authority empowered to grant it shall have
regard____
1
(i)to the average number of licences granted during the period of 3 years immediately
preceding, and
(ii)to the occupation, trade or business ordinarily carried on by such applicant during the
period aforesaid :
Provided that the licensing authority may refuse to grant or renew a licence to any applicant
or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under
the Act or these Rules, or the previous cancellation or suspension of any licence granted
thereunder, he is not a fit person to whom a licence should be granted under this rule. Every
such order shall be communicated to the licensee as soon as possible.
2
[ Provided further that in respect of an application for the grant of a licence in form 20-B or
form 21-B or both, the licensing authority shall satisfy himself that the premises in respect of
which a wholesale licence is to be granted are:–
(i) of an area of not less than ten square meters; and]
3
[(ii) in the charge of a competent person, who—
(a) is a Registered Pharmacist, or,
(b) has passed the matriculation examination or its equivalent examination from a
recognised Board with the four years experience in dealing with sale of drugs, or;
(c) holds a degree of a recognised University with one year’s experience in dealing
with drugs]
4
[Provided also that,–
(i) in respect of an application for the grant of a licence in Form 20 or Form 21 or both,
the licensing authority shall satisfy itself that 5
[the premises are of an area] of not less
than 10 square meters, and
(ii) in respect of an application for the grant of a licence–
(A)In Form 20 or Form 21 or both, and
(B)In Form 20 B or Form 21B or both,
the licensing authority shall satisfy itself that the premises are of an area not less
than 15 square meter;
__________________________________________________________
1Amended by Government of India Notification No. F. 1-19/59-D, dated 13th June, 1961
2
Ins. by G.O.I. Notification No. G.S.R 681(E) dated 5-12-1980
3Amended by G.O.I. Notification No. G.S.R 351(E) dated 26-4-2000
4
Ins. by G.O.I.Notification No. G.S.R 91(E) dated 25-2-1997
5Amended by Corrigendum G.S.R. 121 (E) dated 5-3-1998
87
Provided also that the provisions of the preceding proviso shall not apply to the premises for
which licences have been issued by the licensing authority before the commencement of the
Drugs and Cosmetic (1st Amendment) Rules, 1997]
6
[(3) Any person who is aggrieved by the order passed by the licensing authority in sub-rule
(1) may, within 30 days from the date of receipt of such order, appeal to the State Government
and the State Government may, after such enquiry into the matter as it considers necessary and
after giving the appellant an opportunity for representing his views in the matter, make such an
order in relation thereto as it thinks fit.]
65. Condition of licences. __ Licences in 1
[Form 20, 20-A, 20-B, 20-F, 20-C, 21, and 21-B]
shall be subject to the conditions stated therein and to the following general conditions___
1
[(1) Any drug shall, if compounded or made on the licensee’s premises be compounded or
made under the direct and personal supervision of a 2
[registered Pharmacist]
(2)The supply, otherwise than by way of wholesale dealing, 3
[* * *] of any drug supplied on
the prescription of a Registered Medical Practitioner shall be effected only by or under the
personal supervision of a 2
[registered Pharmacist].
4
(3) (1) The supply of any drug 1
[other than those specified in Schedule X] on a prescription
of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription
register specially maintained for the purpose and the serial number of the entry in the register
shall be entered on the prescription. The following particulars shall be entered in the register: _
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the prescriber,
5(d) the name and address of the patient, or the name and address of the owner of
the animal if the drug supplied is for veterinary use.
(e) the name of the drug or preparation and the quantity or in the case of a
medicine made up by the licensee, the ingredients and quantities thereof,
(f) in the case of a drug specified in 1
[Schedule C or Schedule H] the name of the
manufacturer of the drug, its batch number and the date of expiry of potency,
if any,
(g) the signature of the 2
[registered Pharmacist] by or under whose supervision the
medicine was made up or supplied.
________________________________________________________________
1
Subs. by G.O.I. Notification No. G.S.R 462(E) dated 22-6-1982
2
Subs. by G.O.I.Notification No. G.S.R 676(E) dated 06-09-1994
3Omitted by G.O.I.Notification No. G.S.R 462(E) dated 22-6-1982
4Amended by S. O. No. 2139, dated 12-8-1972 (Govt. of India Notification No. X. 11014/12/72-D, dated
the 5th June, 1972.)
5Amended by GSR No. 926 dated 16-7-1977, (Govt. of India Notification No. X. 11014/6/76-D & M.S.
dated 24-6-77).
6Amended by G.O.I. Notification No. F.1-9/60-D dated 3rd July,1961.
88
Provided that in the case of drugs which are not compounded in the premises and which are
supplied from or in the original containers, the particulars specified in items (a) to (g) above may
be entered in a cash or credit memo book, serially numbered and specially maintained for this
purpose:
Provided further that if the medicine is supplied on a prescription on which the medicine has
been supplied on a previous occasion and entries made in the prescription register, it shall be
sufficient if the new entry in the register includes a serial number, the date of supply, the quantity
supplied and a sufficient reference to an entry in the register recording the dispensing of the
medicine on the previous occasion.
Provided further that it shall not be necessary to record the above details in the register or in
the cash or credit memo particulars in respect of: ___
(i) any drugs supplied against prescription under the Employees State Insurance
Scheme if all the above particulars are given in that prescription, and
(ii) any drug other than that specified in 1
[Schedule C or Schedule H] if it is supplied
in the original unopened container of the manufacturer and if the prescription is
duly stamped at the time of supply with the name of the supplier and the date on
which the supply was made and on condition that the provisions of sub rule (4)
(3) of this rule are complied with.
(2) The option to maintain a prescription register or a cash or credit memo book in respect of
drugs and medicines which are supplied from or in the original container, shall be made in
writing to the Licensing Authority at the time of application for the grant or renewal of the
licence to sell by retail.
Provided that the Licensing Authority may require records to be maintained only in
prescription register if it is satisfied that the entries in the carbon copy of the cash or credit memo
book are not legible.
2
(4) (1) The supply by retail, otherwise than on a prescription of a drug specified in Schedule
C 3
[* * *] shall be recorded at the time of supply either :
_________________________________________________________________
1
Subs. by G.O.I.Notification No. G.S.R 462(E) dated 22-6-1982
2
Ins. by Government of India Notification No. 1-63/61-D, dated 17th July, 1963.
3Omitted by Notification No. G.S.R 462(E) dated 22-6-1982
89
(i) in a register specially maintained for the purpose in which the following particulars shall
be entered :____
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the purchaser,
(d) the name of the drug and the quantity thereof,
(e) in the case of a drug specified in Schedule C, the name of the manufacturer, the
batch number and the date of expiry of potency,
(f) the signature of the person under whose supervision the sale was effected, or
(ii) in a cash or credit memo book, serially numbered containing all the particulars specified
in items (b) to (f) of sub clause (i) above.
NOTE:__ The entries in the carbon copy of the cash or credit memo which is retained by the
licensee shall be maintained in a legible manner.
(2) The option to maintain a register or a cash or credit memo book shall be made in writing
to the Licensing Authority at the time of application for the grant or renewal of a licence to sell
by retail:
Provided that the Licensing Authority may require records to be maintained in a register if it
is satisfied that the entries in the carbon copy of the cash/credit memo book are not legible.
(3)(i) The supply by retail of any drug shall be made against a cash/credit memo which shall
contain the following particulars :____
(a) Name, address and sale licence number of the dealer,
1
(b) Serial number of the cash/credit memo,
(c) the name and quantity of the drug supplied.
(ii)Carbon copies of cash/credit memos shall be maintained by the licensee as record.
__________________________________________________________________
1
Ins. by G. S. R. No. 245 dated 21-2-1976 (Govt. of India Notification No X. 11013/5/72-D&M.S. dated
the 3rd, February, 1976).
90
1
[(4)(i) Records of purchase of a drug intended for sale or sold by retail shall be maintained
by the licensee and such records shall show the following particulars, namely:–
(a) the date of purchase,
(b)the name and address of the person from whom purchased and the number of the
relevant licence held by him,
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.

(ii) Purchase bills including cash or credit memo shall be serially numbered by the licensee
and maintained by him in a chronological order,]
2
(5)(1) Subject to the other provisions of these rules the supply of a drug by wholesale shall
be made against a cash or credit memo bearing the name and address of the licensee and his
licence number under the Drugs and Cosmetics Act in which the following particulars shall be
entered____
(a) the date of sale.
(b) the name, address of the licensee to whom sold and his sale licence number. In case
of sale to an authority purchasing on behalf of Government, or to a hospital, medical,
educational or research institution or to a Registered Medical Practitioner for the
purpose of supply to his patients the name and address of the authority, institution or
the Registered Medical Practitioner as the case may be,
(c) the name of the drug, the quantity and the batch number,
(d) the name of the manufacturer.
3
[(e) the signature of the competent person under whose supervision the sale was effected.]
(2)Carbon copies of cash or credit memos specified in clause (1) shall be preserved as records
for a period of three years from the date of the sale of the drug.
__________________________________________________________________
1
Ins. by G.O.I.Notification No. G.S.R 1242(E) dated 17-9-1979
2Amended by G.O.I. No. F. 1-63/62-D, dated 17th July, 1963.
3
Ins. by G.O.I. Notification No. G.S.R 496(E) dated 9-6-1995
91
1
[(3) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be
maintained by the licensee and such records shall show the following particulars, namely:–
(a) the date of purchase,
(b) the name, address and the number of the relevant licence held by the person from
whom purchased,
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.
(ii) Purchase bills including cash or credit memos shall be serially numbered by the licensee
and maintained by him in a chronological order.]
(6) The licensee shall produce for inspection by an Inspector appointed under the Act on
demand all registers and records maintained under these Rules, and shall supply to the Inspector
such information as he may require for the purpose of ascertaining whether the provisions of the
Act and Rules thereunder have been observed.
(7) Except where otherwise provided in these Rules, all registers and records maintained
under these Rules shall be preserved for a period of not less than two years from the date of the
last entry therein.
(8)Notwithstanding anything contained in this Rule it shall not be necessary to record
particulars in a register specially maintained for the purpose if the particulars are recorded in any
other register specially maintained under any other law for the time being in force.
2
[(9) (a) Substances specified in Schedule H or Schedule X shall not be sold by retail except
on and in accordance with the prescription of a Registered Medical Practitioner and in the case of
substances specified in schedule X, the prescriptions shall be in duplicate,one copy of which
shall be retained by the licensee for a period of two years.
(b)The supply of drugs specified in Schedule H or Schedule X to Registered Medical
Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only
against the signed order in writing which shall be preserved by the licensee for a
period of two years;]

_________________________________________________________________
1
Subs. by G.O.I.Notification No. G.S.R 1242(E) dated 17-9-1979
2
Ins. by G.O.I. Notification No. G.S.R 462(E) dated 22-6-1982
92
(10) For the purposes of clause (9) a prescription shall____
(a) be in writing and be signed by the person giving it with his usual signature and be
dated by him;
1
(b) specify the name and address of the person for whose treatment it is given, or the
name and address of the owner of the animal if the drug is meant for veterinary use;
(c) indicate the total amount of the medicine to be supplied and the dose to be taken.
(11) The person dispensing a prescription containing a drug specified in Schedule H 2
[and
Schedule X] shall comply with the following requirements in addition to other requirements of
these Rules____
(a) the prescription must not be dispensed more than once unless the prescriber has
stated thereon that it may be dispensed more than once;
(b) if the prescription contains a direction that it may be dispensed a stated number of
times or at stated intervals it must not be dispensed otherwise than in accordance
with the directions;
(c) at the time of dispensing there must be noted on the prescription above the signature
of the prescriber the name and address of the seller and the date on which the
prescription is dispensed.
3
(11-A) No person dispensing a prescription containing substances specified in 2
[Schedule
H or X], may supply any other preparation, whether containing the same substance or not, in lieu
thereof.
2
[(12) Substances specified in Schedule X kept in retail shop or premises used in connection
therewith shall be stored—
(a) under lock and key in cupboard or drawer reserved solely for the storage of these
substances ;or
(b) in a part of the premises separated from the remainder of the premises and to which
only responsible persons have access;]
__________________________________________________________________
1Amended by G. S. R. No. 926, dated 16-7-1977 (Govt. of India Notification No. X. 11014/6/76-D & M. S.
dated 24/6/1977).
2
Ins./amended/subs by Notification No. G.S.R 462(E) dated 22-6-1982
3Amended by G. S. R. No. 926, dated 16-7-1977 (Govt. of India Notification No. X. 11014/6/76-D & M. S.
dated 24/6/1977).
93
(13) 1 * * *
(14) 1 * * *
2
(15) (a) The description “Drugstore” shall be displayed by such licensees who do not
require the services of a qualified person.
(b) The description “Chemists and Druggists” shall be displayed by such licensees who
employ the services of a “3
[registered Pharmacist]” but who do not maintain a “Pharmacy” for
compounding against prescriptions:
(c) The description “Pharmacy”, “Pharmacist”, “Dispensing Chemist” or “Pharmaceutical
Chemist” shall be displayed by such licensees who employ the services of a “
3
[registered
Pharmacist]” and maintain a “Pharmacy” for compounding against prescriptions:
4
[Explanation:– for the purpose of this rule,—
(i) “registered Pharmacist” means a person who is a registered Pharmacist as
defined in clause (i) of Section (2) of the Pharmacy Act, 1948 (Act No. 8 of
1948).
Provided that the provisions of sub-clause (i) shall not apply to those persons
who are already approved as “qualified person” by the Licensing authority on or
before 31st December 1969.
(ii) Date of Expiry of potency means the date that is recorded on the container,
label or wrapper as the date up to which the substance may be expected to
retain potency not less than or not to acquire toxicity greater than that
required or permitted by the prescribed test.
5
(16) The license shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.
__________________________________________________________________
1Omitted by Notification No. G.S.R 462(E) dated 22-6-1982
2Amended by the Government of India Notification No. F. 1-16/57-D, dated 15th June, 1957.
3
Substituted by Notification No. G.S.R 676(E) dated 06-09-1994
4
Subs. by Notification No. G.S.R 676(E) dated 06-09-1994
5Amended by Government of India Notification No. F. 1-14/68-D dated 26-10-1968.
94
1
(17) No drug shall be sold or stocked by the licensee after the date of expiration of potency
recorded on its container, label or wrapper, or in violation of any statement or direction recorded
on such container, label or wrapper;
Provided that any such drugs in respect of which the licensee has taken steps with the
manufacturer or his representative for the withdrawal, reimbursement or disposal of the same,
may be stocked after the date of expiration of potency pending such withdrawal, reimbursement
or disposal, as the case may be, subject to the condition that the same shall be stored separately
from the trade stocks 2
and all such drugs shall be kept in packages or cartons, the top of which
shall display prominently, the words “Not for sale”.
3
(18) No drug intended for distribution to the medical profession as free sample which bears a
label on the container as specified in clause (viii) of sub-rule (1) of rule 96, and no drug meant
for consumption by the Employees’ State Insurance Corporation, the Central Government Health
Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other
Government institutions, which bears a distinguishing mark or any inscription on the drug or on
the label affixed to the container thereof indicating this purpose shall be sold or stocked by the
licensee on his premises.
4
[ Provided that this sub- rule shall not be applicable to licensees who have been appointed as
approved chemists, by the State Government in writing, under the employees’ State Insurance
Scheme, or have been appointed as authorized agent or distributor, by the manufacturer in
writing, for drugs meant for consumption under the Central Government Health Scheme, the
Government Medical Stores Depots, the Armed Forces Medical Stores or other Government
Institutions for drugs meant for consumption under those schemes 5
[or have been appointed as
authorized Depots or Carrying and Forwarding agent by the manufacturer in writing, for storing
free samples meant for distribution to medical profession.] subject to the conditions that the
stock shall be stored separately from the trade stocks and shall maintain separate records of the
stocks received and distributed by them.]
__________________________________________________________________
1Added under Government of India Notification No. F. 1-55/61-D, dated 22nd August, 1964.
2Added by S. O. No. 903, dated 28-2-1976 (Govt. of India Notification No. X. 11013/2/75-D & MS. Dated
10-2-1976).
3Added under Government of India, Ministry of Health, F. P., W. H. and U. D. Notification No. 1-113/69-
D, dated 23-12-69.
4
Substituted by Notification No. G.S.R 496(E) dated 09-06-1995
5
Inserted by G.O.I. Notification No. G.S.R 352(E) dated 26-04-2000
95
1
(19) The supply by retail of any drug in a container other than the one in which the
manufacturer has marketed the drug, shall be made only by dealers who employ the services of a

2
[registered Pharmacist]” and such supply shall be made under the direct supervision of the

2
[registered Pharmacist]” in an envelope or other suitable wrapper or container showing the
following particulars on the label :
(a) name of the drug,
(b) the quantity supplied,
(c) the name and address of the dealer.
3
(20) The medicines for treatment of animals kept in a retail shop or premises shall be labeled
with the words ‘Not for human use__ for treatment of animals only’ and shall be stored____
(a) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or
(b) in a part of the premises separated from the remainder of the premises to which
customers are not permitted to have access.
4
[(21) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply
in a register (bound and serially page numbered) specially maintained for the purpose and
separate pages shall be allotted for each drug.
(b) The following particulars shall be entered in the said register, namely:–
(i) Date of transaction;
(ii) Quantity received, if any, the name and address of the supplier and the
number of the relevant licence held by the supplier;
(iii) Name of the drug;
(iv) Quantity supplied;
(v) Manufacturer’s name;
(vi) Batch No. or Lot No;
(vii) Name and address of the patient purchaser;
(viii) Reference Number of the prescription against which supplies were made.
(ix) Bill No and date in respect of purchases and supplies made by him;
(x) Signature of the person under whose supervision the drugs have been
supplied.]
__________________________________________________________________
1Added by G. S. R. No. 444 dated 28-4-1973 [Govt. of India Notification No. X. 11014/4/72-D (Pt.) dated
the 31st March, 1973].
2
Substituted by G.O.I.Notification No. G.S.R 676(E) dated 06-09-1994
3Added by G. S. R. No. 926 dated 16-7-1977 (Govt. of India Notification No. X. 11014/6/76-D & MS.
Dated 24-6-1977).
4Added by G.O.I. Notification No. G.S.R 462(E) dated 22-6-1982
96
66. Cancellation and suspension of licences.
__ (1) The Licensing Authority may, after giving
the licensee an opportunity to show cause why such an order should not be passed by an order in
writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such
period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if
in his opinion, the licensee has failed to comply with any of the conditions of the licence or with
any provisions of the Act or Rules thereunder:

1
Provided that, where such failure or contravention is the consequence of an act or omission
on the part of an agent or employee, the licence shall not be cancelled or suspended if the
licensee proves to the satisfaction of the licensing authority:___
(a) that the act or omission was not instigated or connived at by him or, if the licensee
is a firm or company by a partner of the firm or a director of the company, or
(b) that he or his agent or employee had not been guilty of any similar act or omission
within twelve months before the date on which the act or omission in question took
place, or where his agent or employee had been guilty of any such act or omission
the licensee had not or could not reasonably have had, knowledge of that previous
act or omission, or
(c) if the act or omission was a continuing act or omission, he had not or could not
reasonable have had knowledge of that previous act or omission, or
(d) that he had used due diligence to ensure that the conditions of the licence or the
provisions of the Act or the Rules thereunder were observed.
2
(2)A licensee whose licence has been suspended or cancelled may, within three months of
the date of order under sub-rule (1), prefer an appeal against that order to the State Government,
which shall decided the same.
3
[66A. Procedure for disposal of drugs in the event of cancellation of licence.—(1) In case a
licensee, whose licence has been cancelled, desires to dispose of drugs he has in his possession in
the premises in respect of which the licence has been cancelled, he shall apply in writing to the
licensing authority for this purpose, giving the following particulars, namely:—
(a)the name and address of the person to whom the drugs are proposed to be sold or
supplied together with the number of the licence for sale or manufacture as the case
may be held by him.
_________________________________________________________________
1Added by S. O. No. 2139, dated 12-8-1972 (Govt. of India Notification No. 9-817DGHS/77
2Amended by G. S. R. No. 926 dated 16-7-1977 (Govt. of India Notification No. X. 11014/6/76-D& M.S.
dated 24-6-1977).
3
Inserted by G.O.I. Notification No. G.S.R 1242(E) dated 17-9-1979
97
(b) the names of drugs together with their quantities, batch numbers, the names and
addresses of their manufacturers and the dates of their expiry, if any, proposed to be
sold to the person mentioned in clause (a).
(2) The licensing authority may, after examination of the particulars referred to in sub- rule
(1) and, if necessary, after inspection by an Inspector of the premises where the drugs are
stocked, grant the necessary permission for their disposal.]
PART VI-A – SALE OF HOMEOPATHIC MEDICINES
1
67-A. (1) The State Government shall appoint Licensing Authorities for the purpose of this
Part for such areas as may be specified.
(2) Application for the grant or renewal of a licence 2
[to sell, stock or exhibit or offer for sale
or distribute] Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority
and shall be accompanied by a 3
[fee of rupees two hundred and fifty];
4
Provided that if the applicant applies for renewal of licence after its expiry but within six
months of such expiry the fee payable for renewal of such licence shall be 3
[rupees two hundred
and fifty plus an additional fee at the rate of rupees fifty or part thereof].
5
(3) If the original licence is either defaced, damaged or lost, a duplicate copy thereof may be
issued on payment of a 3
[fee of rupees fifty.]
67-B. A Licensing Authority may, with the approval of the State Government, by an order in
writing, delegate the power to sign licences and such other powers, as may be specified, to any
other person under his control.
67-C. Forms of licences to sell drugs.
__ (1) A licence 2
[to sell, stock or exhibit or offer for
sale or distribute] Homoeopathic medicines by retail or by wholesale shall be issued in Form 20-
C or 20-D as the case may be.
__________________________________________________________________
1Added under Government of India Notification No. F. 1-35/64-D, dated 18th August, 1964.
2Amended by G.O.I. Notification No. G.S.R 788(E) dated 10-10-1985
3Amended by G.O.I. Notification No. G.S.R 601(E) dated 24-8-2001
4Amended by S. O. No. 2139 dated 12-8-1972 (Govt. of India Notification No. X. 11014/12/72-D dated the
5th June, 1972).
5Added by G. S. R. No. 665, dated 28-5-77 (Govt. of India Notification No. X. 11014/2/77-D & M. S.,
dated 6-5-1977).
98
67-D. Sale at more than one place.
__ If drugs are sold or stocked for sale at more than one
place, a separate application shall be made and a separate licence shall be obtained in respect of
each place.
67-E. Duration of licences.
__ An original licence or a renewed licence unless it is sooner
suspended or cancelled shall be 1
[valid for a period of five years on and from the date on which]
it is granted or renewed :
2
Provided that if the application for renewal of a licence in force is made before its expiry or
if the application is made within six month of its expiry, after payment of additional fee, the
licence shall continue to be in force until orders are passed on the application and the licence
shall be deemed to have expired if application for its renewal is not made within six months after
its expiry.
3
67-EE. Certificate of renewal.
__ The certificate of renewal of a sale licence in Forms 20-C
and 20-D shall be issued in Form 20-E.
67-F. Condition to be satisfied before a licence in Form 20-C or Form 20-D is granted.
(1) A licence in Form 20-C or Form 20-D to 4
[to sell, stock or exhibit or offer for sale or
distribute] Homoeopathic medicines shall not be granted to any person unless the authority
empowered to grant the licence is satisfied that the premises in respect of which the licence is to
be granted are clean and in the case of a licence in Form 20-C the sale premises is in charge of a
person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the
Licensing Authority competent to deal in Homoeopathic medicines.
5
[Provided that no registered Homeopathic medical practitioner who is practicing
Homeopathy in the premises where Homeopathic medicines are sold shall deal in Homeopathic
medicines;]
(2) Any person who is aggrieved by the order passed by the Licensing Authority under subrule (1) may within 30 days from the date the receipt of such order appeal to the State
Government and the State Government may, after such enquiry into the matter as it considers
necessary and after giving the appellant an opportunity for representing his case, make such
order in relation thereto as it thinks fit.
__________________________________________________________________
1Amended by G.O.I. Notification No. G.S.R 601(E) dated 24-8-2001
2Amended by S. O. No. 2139 dated 12-8-1972 (Govt. of India Notification No. X. 11014/12/72-D dated the
5th June, 1972).
3Added under Government of India, Ministry of Health, F. P., W. H. and U. D. Notification
No. F. 1-14/67-D, dated the 3rd February, 1969.
4Amended by G.O.I. Notification No. G.S.R 788(E) dated 10-10-1985
5
Ins. by Notification No. G.S.R 680(E) dated 5-12-1980
99
67-G. Conditions of licence.
__ Licence in Form 20-C or 20-D shall be subject to the
conditions stated therein and to the following further conditions, namely:___
(1) The premises where the Homoeopathic medicines are stocked for sale or sold
are maintained in a clean condition.
(2) The sale of Homoeopathic medicines shall be conducted under the supervision
of a person, competent to deal in Homoeopathic medicines.
(3) The licensee shall permit an Inspector to inspect the premises and furnish such
information as he may require for ascertaining whether the provisions of the Act
and the Rules made thereunder have been observed.
(4) The licensee in Form 20-D shall maintain records of purchase and sale of
Homoeopathic medicines containing alcohol together with names and addresses
of parties to whom sold.
1
(5) The licensee in Form 20-C shall maintain records of purchase and sale of
Homoeopathic medicines containing alcohol. No records of sale in respect of
Homoeopathic potentised preparation in containers of 30 ml. or lower capacity
and in respect of mother tinctures made up in quantities upto 60 ml. need be
maintained.
2
[(6) The licensee shall maintain an Inspection Book in Form 35 to enable an
Inspector to record his impressions and the defects noticed.]
3
67-GG. Additional information to be furnished by an applicant for licence or a licensee to
the Licensing Authority :____
The applicant for the grant of a licence or any person granted a licence under this Part
shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the
period the licence is in force as the case may be, documentary evidence in respect of the
ownership or occupation or rental or other basis of the premises, specified in the application for
licence or in the licence granted, constitution of the firm, or any other relevant matter, which
may be required for the purpose of verifying the correctness of the statements made by the
applicant or the licensee, while applying for or after obtaining the licence, as the case may be.
__________________________________________________________________
1Added under Government of India, Ministry of Health, F. P. , W. H. and U. D. Notification No. F. 1-59/68-
D, dated the 19th November, 1969.
2
Ins. by G.O.I. Notification No. G.S.R 351(E) dated 8-5-1984
3Added by S. O. No. 2139 dated 12-8-1972 (Govt. of India Notification No. X. 11014/12/72-D dated the 5th
June, 1972).
100
67-H.Cancellation and suspension of licences____
(1)The Licensing Authority may, after giving the licensee an opportunity to show cause why
such an order should not be passed by an order in writing stating the reasons therefor, cancel a
licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the
licensee has failed to comply with any of the conditions of the licence or with any provisions of
the Act or Rules made thereunder :
1
Provided that, where such failure or contravention is the consequence of an act or omission
on the part of an agent or employees, the licence shall not be cancelled or suspended if the
licensee proves to the satisfaction of the Licensing Authority :___
(a) that the act or omission was not instigated or connived at by him or, if the licensee
is a firm or company, by a partner of the firm or a director of the company, or
(b) that he or his agent or employee had not been guilty of any similar act or omission
within twelve months before the date on which the act or omission in question took
place, or where his agent or employee had been guilty of any such act or omission,
the licensee had not or could not reasonably have had, knowledge of that previous
act or omission, or
(c) if the act or omission was a continuing act or omission that he had not or could not
reasonably have had knowledge of that previous act or omission, or
(d) that he had used due diligence to ensure that the conditions of the licence or the
provisions of the Act or the Rules thereunder were observed.
2
(2) A licensee whose licence has been suspended or cancelled may, within three months of
the date of the order under sub-rule (1), prefer an appeal against that order to the State
Government, which shall decide the same.
__________________________________________________________________
1Added by S. O. No. 2139 dated 12-8-1972 (Govt. of India Notification No. X. 11014/12/72-D dated the 5th
June, 1972).
2Amended by G.S.R. No. 926 dated 16/7/1977 (Govt. of India Notification No. X. 11014/6/76-D & M. S.
dated 24-6-1977)
101
PART VII ___ 1
[MANUFACTURE FOR SALE OR FOR DISTRIBUTION] OF DRUGS OTHER
THAN HOMOEOPATIC MEDICINES
68. Manufacture on more than one set of premises.
__ If drugs are manufactured on more than
one set of premises a separate application shall be made and a separate licence shall be issued in
respect of each such set of premises.
2[68-A Grant or Renewal of Licences by the Central Licence Approving Authority.— (1)
Notwithstanding anything contained in this part, on and from the commencement of the Drugs
and Cosmetics( Ninth Amendment) Rules.1992, a licence for the manufacture for sale or
distribution of drugs as specified from time to time by the Central Government by notification in
the Official Gazette, for the purpose of this rule, shall be granted or renewed, as the case maybe,
by the Central Licence Approving Authority (appointed by the Central Government.)

Provided that the application for the grant or renewal of such licence shall be made to the
licensing Authority.
(2) On receipt of the application for grant or renewal of a licence, the licensing authority
shall,–
(i) verify the statement made in the application Form;
(ii) cause the manufacturing and testing establishment to be inspected in accordance
with the provisions of rule 79; and
(iii) in case the application is for the renewal of licence, call(s) for the informations of
the past performance of the licensee.
(3) If the licensing authority is satisfied that the applicant is in a position to fulfill the
requirements laid down as in these rules, he shall prepare a report to that effect and forward it
3
[along with the application and the licence (in triplicate) to be granted and renewed , duly
completed] to the Central Licence Approving Authority :
Provided that if the licensing authority is of the opinion that the applicant is not in a position
to fulfil the requirements laid down in these rules, he may, by order, for reasons to be recorded in
writing, refuse to grant or renew the licence as the case may be.
(4) If on receipt of the application and the report of the licensing authority referred to in subrule (3) and after taking such measures including inspection of the premises by the Inspector,
appointed by the Central Government under section 21 of the Act, with or without
__________________________________________________________________
1Amended by G.O.I. Notification No. G.S.R 788(E) dated 10-10-1985
2
Ins. by Notification No. G.S.R 923(E) dated 14-12-1992
3Amended by Notification No. G.S.R 89(E) dated 14-2-1996
102
an expert in the concerned field if deemed necessary, the Central Licence Approving Authority,
is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules,
he may grant or renew the licence, as the case may be:
Provided that if the Central Licence Approving Authority is of the opinion that the applicant
is not in a position to fulfill the requirements laid down in these rules, he may, not withstanding
the report of the licensing authority, by order, for reasons to be recorded in writing, reject the
application for grant or renewal of licence as the case may be.
68-B. Delegation of Powers by the Central Licence Approving Authority.—The Central
Licence Approving Authority may with the approval of the Central Government, by notification
delegate his powers of signing licences and any other powers under the rules to any person under
his control having same qualifications as prescribed for controlling authority under rule 50A for
such areas and for such periods as may be specified. ]
1
69. Application for licence to manufacture drugs other than those specified in Schedules C
and C(1) to the Drugs and Cosmetics Rules.
___
2
[(1) Application for grant or renewal of 4
[licence to manufacture for sale or for
distribution]of drugs, other than those specified in Schedule C and C (1) shall be made to the
licensing authority appointed by the State Government for the purpose of this part (hereinafter in
this part referred to as the licensing authority) and shall be made–
(a) in the case of repacking of drugs excluding those specified in Schedule X for sale or
distribution in Form24-B;
(b) in the case of manufacture of drugs included in Schedule X in Form24-F;
(c) in any other case, in Form 24.]
3
[( 2)(a) Every application in Form24-B shall be made up to ten items for each category of
drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees five
hundred plus and an inspection fee of rupees two hundred for every inspection or for the purpose
of renewal of the licence.
__________________________________________________________________
1Amended by Government of India Notification No. F. 1-22/59-D, dated 9th April, 1960.
2Amended by G.O.I. Notification No. G.S.R 462(E) dated 22-06-1982
3Amended by G.O.I.Notification No. G.S.R 601(E) dated 24-8-2001
4
Subs.by G.O.I.Notification No.G.S.R.788(E) dt 10.10.1995.
103
(b) Every application in Form 24F shall be made up to ten items for each category of drugs
categorized in Schedule M and shall be accompanied by a licence fee of rupees six thousand and
an inspection fee of rupees one thousand and five hundred for every subsequent inspection or for
the purpose of renewal of licence.

(c) Every application in Form 24 shall be made up to ten items for each category of drugs
catogarised in Schedule M and Schedule M-III and shall be accompanied by a licence fee of
rupees six thousand and an inspection fee of one thousand and five hundred for every inspection
or for the purpose of renewal of the licence;]
1
[(3) If a person applies for the renewal of a licence after the expiry thereof but within six
months of such expiry the fee payable for the renewal of such licence shall be:–]
2
[(i) in the case of Form 24-B a licence fee of rupees five hundred plus an additional fee
at the rate of rupees two hundred and fifty per month or part thereof in addition to
an inspection fee of rupees two hundred;

(ii) in the case of Form 24-F a licence fee of rupees six thousand plus an additional fee
at the rate of rupees one thousand per month or part thereof in addition to an inspection
fee of rupees one thousand;
(iii) in the case of Form 24 a licence fee of rupees six thousand plus an additional fee at
the rate of rupees one thousand per month or part thereof in addition to an
inspection fee of rupees one thousand and five hundred;]
1
[(4) A fee 2
[rupees one thousand shall be paid] for a duplicate copy of the licence issued
under clause (a), clause (b) or clause (c) of sub-rule (1) if the original is defaced, damaged or
lost.]
2
[(5) Applications by licensees to manufacture additional items of drugs shall, in the case of a
licence to manufacture for sale and distribution for repacking and other than those specified in
Schedule C and Schedule C (1), be made to the licensing Authority. Such applications shall, if
the additional items of drugs applied for belong to categories which are not already included in
the licence, be accompanied by an additional fee at the rate of rupees one hundred for each
additional items of drug for repacking and rupees three hundred per additional item of drugs
categorized in Schedule M and Schedule M-111.]
__________________________________________________________________
1Amended by Notification No. G.S.R 462(E) dated 22-06-1982
2
Subs by Notification No. G.S.R 601(E) dated 24-8-2001
104
1
[(6) Where an application under this rule is for the manufacture of drug formulations falling
under the purview of new drug as defined in rule 122-E, such application shall also be
accompanied with approval, in writing in favour of the applicant, from the licensing authority as
defined in clause (b) of rule21.]
Explanation.
___ For the purpose of these rules, the term ‘repacking’ means the process of
breaking up any drug from a bulk container into small package and the labeling of each such
package with a view to its sale and distribution, but does not include the compounding or
dispensing or the packing of any drug in the ordinary course of the retail business.
2
69-A. Loan Licences.
3
[(1) Application for the grant or renewal of loan licences to
manufacture for sale or for distribution of drugs other than those specified in Schedule C,
Schedule C (1) and Schedule X shall be made up to ten items for each category of drugs
categorised in Schedule M and Schedule M-111 and shall be made in Form 24-A accompanied
by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five
hundred to the licensing authority:
Provided that if the applicant applies for the renewal of a licence after, its expiry but within
six months of such expiry, the fee payable for renewal of such licence shall be accompanied by a
licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred
plus an additional fee at the rate of rupees one thousand per month or part thereof.]
Explanation.
___ For the purpose of this rule a loan licence means a licence which a licensing
authority may issue to an applicant who does not have his own arrangements for manufacture but
who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.
(2) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the
manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for
testing, to undertake the manufacture on behalf of the applicant for a loan licence.
3
[(3) subject to the provisions of sub-rule (2), application for manufacture of more than ten
items for each category of drug on a loan licence shall be accompanied by an addition fee of
rupees three hundred per additional item specified in Schedule M and Schedule M-111]
_________________________________________________________________
1
Ins. by G.O.I.Notification No. G.S.R 311(E) dated 1-5-2002
2Amended by the Government of India Notification No. F. 1-16/57-D, dated 15th June, 1957.
3
Subs by G.O.I. by Notification No. G.S.R 601(E) dated 24-8-2001
105
1
(4)If the Licensing Authority is satisfied that a loan licence is defaced, damaged or lost or
otherwise rendered useless, he may, on payment of a 2
[fee of rupees one thousand] issue a
duplicate licence.
69-B. [ * * *] Omitted as per G.O.I. Notification No. GSR 944(E) dt 21.9.1988.
3
[70. Form of licence to repack or manufacture drugs other than those specified in Schedules
C and C(1).- Licences for repacking of drugs against application in Form 24-B shall be granted
in Form 25-B, licences for manufacture of drugs included in Schedule X and against application
in Form 24-F shall be granted in Form 25-F and licences for manufacture of drugs against
application in Form 24 shall be granted in form 25].
4
70-A. Form of loan5
[licence to manufacture for sale or for distribution] of drugs other
than those 6
[specified in Schedules C, C(1) and X].- A loan 5
[licence to manufacture for sale or
for distribution] or drugs other than those 6
[specified in Schedules C, C(1) and X] shall be issued
in Form 25-A.
7
71. Conditions for the grant or renewal of a licence in Form 25 or 6
[Form 25-F].- Before a
licence in Form 25 6
[or Form 25-F] is granted or renewed, the following conditions shall be
complied with by the applicant.-
(1)The manufacture shall be conducted under the active direction and personal supervision
of competent technical staff consisting at least of one person who is a whole-time employee and
who is____
(a) a graduate in Pharmacy or Pharmaceutical Chemistry of 8
[a University established
in India by law or have an equivalent qualification recognized and notified by the
Central Government for such purpose] of this rule and has had at least eighteen
months practical experience after the graduation in the manufacture of drugs. This
period of experience may, however, be reduced by six months if the person has
undergone training in manufacture of drugs for a period of six months during his
University course; or
(b) a graduate in Science of 8
[a University established in India by law or have an
equivalent qualification recognized and notified by the Central Government for
such purpose] of his degree has studied Chemistry as a principal subject and has
___________________________________________________________________________________
1
Ins. by G.O.I. Notification No. F.1-20/64-D dt 26.10.1968.
2
Subs. by G.O.I. Notification No. GSR 601(E0 dt 24.8.2001.
3
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
4
Ins. by G.O.I. Notification No. F.1-16/57 D dt 15.6.1957 & No. F.1/22/59-D dt 9.4.1960.
5
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
6
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
7Amended by G.O.I. Notification No. F.1-16/57-D dt 15.6.1957
8
Subs. by G.O.I. Notification No. GSR 71(E) dt 30.1.1987.
106
had at least three years practical experience in the manufacture of drugs after his
graduation; or
(c) a graduate in Chemical Engineering or Chemical Technology or Medicine of 1
[a
University established in India by law or have an equivalent qualification
recognized and notified by the Central Government for such purpose] with general
training and practical experience, extending over a period of not less than three
years in the manufacture of drugs, after his graduation; or
2
(d) holding any foreign qualification the quality and content of training of which are
comparable with those prescribed in clause (a), clause (b) or clause (c) and is
permitted to work as competent technical staff under this rule by the Central
Government :
Provided that any person who was immediately before the 29th June, 1957, actively directing
and personally supervising the manufacture of drugs and whose name was accordingly entered in
any licence granted in Form 25 3
[or Form 25-F] as it existed before the date shall be deemed to
be qualified for the purposes of this rule.
4
[Provided further that for drugs other than those specified in Schedule C, C(1) and X and
meant for veterinary use, the whole-time employee under whose supervision the manufacture is
conducted shall be graduate in veterinary Science or Pharmacy or General Science or Medicine
of a University recognized by the Central Government and who has had at least three years
practical experience in the manufacture of drugs excluding graduate in Pharmacy who shall have
at least eighteen months practical experience in the manufacture of drugs].
5
Provided 4
[also] that the Licensing Authority may, in the matter of manufacture of
disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non chemical contraceptives,
plaster of Paris and surgical dressings, for the manufacture of which the knowledge of
Pharmaceutical chemistry or Pharmacy is not essential, permit the manufacture of the substance
under the active direction and personal supervision of the competent technical staff, who,
although not having any of the qualifications included in clauses (a), (b) or (c) of this rule, has, in
the opinion of the Licensing Authority, adequate experience in the manufacture of such
substance.
______________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 71(E) dt 30.1.1987.
2Added under Government of India Notification NO. F. 1-19/59-D, dated 13-6-1961.
3
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
4 Ins. by G.O.I. Notification No. GSR 93(E) dt 24.2.1999.
5 Added under Government of India, Ministry of Health, F. P. and U. D. Notification No. F. 1-14/68-D, dated the 26-
10-1968.
107
(2)The factory premises shall comply with the conditions prescribed in Schedule M.
(3)The applicant shall provide adequate space, plant and equipment for the manufacturing
operations; the space, plant and equipment recommended for various operations are given in
Schedule M.
1
(4)The applicant shall provide and maintain adequate staff, premises and laboratory
equipment for carrying out tests of the strength, quality and purity of the substances at a testing
unit, which shall be separate from the manufacturing unit and the head of the testing unit shall be
independent of the head of the manufacturing unit :
Provided that the manufacturing units, which, before the commencement of the Drugs and
Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by
the Licensing Authority for such tests to be carried out on their behalf may continue such
arrangements upto the 30th June, 1977 :
Provided further that for tests requiring sophisticated instrumentation techniques or biological
or microbiological methods other than sterility the Licensing Authority may permit such tests to
be conducted by institutions approved by it under Part XV(A) of these rules for this purpose.
2
[(4A). The head of the testing unit referred to in condition (4) shall possess a degree in
Medicine or Science or Pharmacy or Pharmaceutical chemistry of a University recognized for
this purpose and shall have experience in the testing of drugs, which in the opinion of the
licensing authority is considered adequate.]
(5)The applicant shall make adequate arrangements for the storage of drugs manufactured by
him.
3
(6)The applicant shall, while applying for a licence to manufacture patent or proprietary
medicines, furnish to the Licensing Authority evidence and data justifying that the patent or
proprietary medicines____
(i) contain the constituent ingredients in therapeutic / prephylactic quantities as
determined in relation to the claims or conditions for which the medicines are
recommended for use or claimed to be useful;
____________________________________________________________________________
1Amended by G.O.I. Notification No. GSR 926 dt 16.7.1977.
2
Ins. by G.O.I. Notification No. GSR 681(E) dt 5.12.1980.
3
Ins. by G.O.I. Notification No. GSR 515 dt 10.4.1976.
108
(ii) are safe for use in the context of the vehicles, excipients, additives and
pharmaceutical aids used in the formulation and under the conditions in which the
formulation for administration and use are recommended;
(iii) are stable under the conditions of storage recommended; and
(iv) contain such ingredients and in such quantities for which there is therapeutic
justification.
1
[v) have the approval, in writing, in favour of the applicant to manufacture drugs
formulations falling under the purview of new drug as defined in rule 122-E, from
the Licensing Authority as defined in Clause (b) of Rule 21.]
2
[(7) The licensee shall comply with the requirements of Good Manufacturing practices as
laid down in Schedule M.
3
71A. Conditions for the grant or renewal of a licence in Form 25B.
____Before a licence in
Form 25-B is granted or renewed the following conditions shall be complied with by the
applicant :____

(1) the repacking operation shall be carried out under hygienic conditions and under the
supervision of a competent person;
4
(2) the factory premises shall comply with the conditions prescribed in Schedule M; and
5
(3) the applicant shall have adequate arrangements in his own premises for carrying out
tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from
the repacking unit;
Provided that the repacking units, which before the commencement of the Drugs and
Cosmetics (Second Amendment) Rules, 1977, were making arrangements with institutions
approved by the licensing authority for such tests to be carried out on their behalf, may continue
such arrangements upto the 31st July, 1977;
______________________________________________________________________________
1
Ins, by G.O.I. Notification No. GSR 311(E) dt 1.5.2002.
2
Ins. by G.O.I. Notification No. GSR 735(E) dt 24.6.1988.
3
Ins. by G.O.I. Notification No. F.1-22/59-D dt 9.4.1960.
4Amended by G.O.I. Notification No. S.O.2139 dt 12.8.1972.
5Amended by G.O.I. Notification No. GSR 926 dt 16.7.1977. .
109
Provided further that for tests requiring sophisticated instrumentation techniques or biological
or microbiological methods the licensing authority may permit such test to be conducted by
institutions approved by it under Part XV(A) of these rules for this purpose.
Explanation.
____A person who satisfies the following minimum qualifications shall be
deemed to be a “competent person” for the purposes of rules 71-A or 74-A of these rules,
namely:-
(a) a person who holds the Diploma in Pharmacy approved by the Pharmacy Council of
India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is registered
under the said Act, or
(b) a person who has passed the Intermediate examination with Chemistry as one of the
principal subjects or an examination equivalent to it or an examination recognized
by the Licensing Authority as equivalent to it; or
(c) a person who has passed the Matriculation examination or an examination
recognized by the Licensing Authority as equivalent to it and has had not less than
four years practical experience in the manufacture, dispensing or repacking of
drugs.
1
71-B : Conditions for the grant of renewal of a licence in Form 25-A.- Before a licence in
form 25-A is granted or renewed, the applicant shall, while applying for a licence to manufacture
patent or proprietary medicines, furnish to the Licensing Authority evidence and date justifying
that the patent or proprietary medicines:
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as
determined in relation to the claims or conditions for which the medicines are
recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, recipients, additives and
pharmaceutical aids used in the formulations and under conditions in which the
formulations for administration and use are recommended;
(iii) are stable under the conditions of storage recommended; and
(iv)contain such ingredients and in such quantities for which there is therapeutic
justification.
______________________________________________________________________________
1
Ins.by G.O.I. Notification No. GSR 515 dt 10.4.1976.
110
1
72. Duration of licence.- An original licence or a renewed licence inform 25,2
[Form 25-B or
Form 25-F] unless sooner suspended or cancelled shall be 3
[valid for a period of five years on
and from the date on which] it is granted or renewed.
4
Provided that if the application for the renewal of a licence is made before its expiry, or if
the application is made within six months of its expiry, after payment of additional fee, the
licence shall continue to be in force until orders are passed on for its renewal is not made within
six months of its expiry.
2
[73. Certificate of renewal.- The certificate of renewal of a licence in Form 25 or Form 25-F
shall be issued in Form 26 or Form 26-F respectively].
5
73-A. A certificate of renewal of loan licence.- The certificate of renewal of a loan licence in
Form 25-A shall be issued in Form 26-A.
6
73-AA. Duration of loan licence.- An original loan licence in Form 25-A or a renewed loan
licence in Form 26-A, unless sooner suspended or cancelled, shall be 3
[valid for a period of five
years on and from the date on which] it is granted or renewed.
7
Provided that if the application for the renewal of a licence is made before its expiry, or if
the application is made within six months of its expiry, after payment of additional fee, the
licence shall continue to be in force until orders are passed on for its renewal is not made within
six months of its expiry.
8
73-B Certificate of renewal of licence in Form 25-B.- The certificate of renewal of a licence
in Form 25-B shall be issued in Form 26-B.
__________________________________________________________________________
1Amended by G.O.I. Notification No. F.1-10/62-D dt 10.4.1964.
2
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
3
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
4Amended by G.O.I. Notification No. S.O.2139 dt 12.8.1972.
5Amended by G.O.I. Notification No. F.1-10/62-D dt 10.4.1964
6Amended by G.O.I. Notification No. F.1-10/62-D dt 10.4.1964
7Amended by G.O.I. Notification No. S.O.2139 dt 12.8.1972.
8
Ins. by G.O.I. Notification No. F.1-22/59-D dt 9.4.1961.
111
1
74. Conditions of licence in Form 25.
____A licence in 2
[Form 25 and Form 25-F] shall be
subject to the conditions stated therein and to the following further conditions, namely :____
(a) the licensee shall provide and maintain staff, premises and the equipment as
specified in rule 71;
(b) the licensee shall comply with the provisions of the Act and of these Rules and with
such further requirements, if any, as may be specified in any rules subsequently
made under Chapter IV of the Act; provided that where such further requirements
are specified in the rules, these would come into force, four months after
publication in the official Gazette;
(c) the license shall either in his own laboratory or in any other laboratory approved by
the Licensing Authority under Part XV (A) of these rules test each batch or lot of
the raw material used by him for the manufacture of his products and also each
batch of the final product and shall maintain records or registers showing the
particulars in respect of such tests as specified in Schedule U. The records or
registers shall be retained for a period of 5 years from the date of manufacture;
(d) the licensee shall keep records of the details of manufacture as per particulars given
in Schedule U of each batch of the drugs manufactured by him and such records
shall be retained for a period of five years;
(e) the licensee shall allow an 3
Inspector appointed under the Act, to enter, with or
without prior notice, any premises and to inspect the plant and the process of
manufacture and the means employed in standardizing and testing the drugs;
(f) the licensee shall allow an 3
Inspector appointed under the Act to inspect all registers
and records maintained under these rules and to take samples of the manufactured
drugs and shall supply to such Inspector such information as he may require for the
purpose of ascertaining whether the provisions of the Act and the Rules thereunder
have been observed;
(g) the licensee shall, from time to time, report to the Licensing Authority any changes
in the expect staff responsible for the manufacture or testing of the drugs and any
material alterations in the premises or plant used for the purpose which have been
made since the date of the last inspection made on behalf of the licensing authority;
1 Amended by G.O.I. Notification No. F. 1-20/64-D, dated 26th October, 1968.
2. Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
3 Amended by G.O.I. Notification No. G.S.R. 444 dt. 28-4-1973.
112
1
(h) the licensee shall, on request, furnish to the Licensing Authority, the Controlling
Authority or to such authorities as the Licensing Authority or the Controlling
Authority may direct from every batch, or batches of drugs as the Licensing
Authority or the Controlling Authority may from time to time specify, a sample of
such quantity as may be considered adequate by such authority for any examination
and, if so required, also furnish full protocols of tests which have been applied;
(i) if the Licensing Authority or the Controlling Authority so directs and if requested
by the licensee who had also furnished prima facie reason for such directions, the
licensee shall not sell or offer for sale any batch in respect of which a sample is or
protocols are furnished under clause (h) until a certificate authorizing the sale of the
batch has been issued to him by or on behalf of the Licensing Authority or the
Controlling Authority;
(j) the licensee shall on being informed by the Licensing Authority or the Controlling
Authority that any part of any batch of the drug has been found by the Licensing
Authority or the Controlling Authority not to conform with the standards of
strength, quality or purity specified in these rules and on being directed so to do,
withdraw the remainder of the batch from sale, and, so far as may in the particular
circumstances of the case be practicable, recall all issues already from that batch;
(k) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed;
1
(l) the licensee shall maintain reference samples from each batch of the drugs
manufactured by him in a quantity which is at least twice the quantity of the drug
required to conduct all the tests performed on the batch. In case of drugs bearing an
expiry date on the label, the reference samples shall be maintained for a period of
three months beyond the date of expiry or potency. In case of drugs where no date
of expiry of potency is specified on the label, the reference samples shall be
maintained for a period of three years from the date of manufacture.
2
(m) The licensee, who has been granted a licence in Form 25-F, shall-
_____________________________________________________________________________
1Amended /Ins by G.O.I. Notification GSR No. 444 dt 23.4.1973.
2
Ins. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
113
(i) forward to the licensing authority of the concerned States of manufacture and
supply of the drug a statement of the sales effected to manufacturers, wholesalers,
retailers, hospitals, dispensaries and nursing-homes and Registered Medical
Practitioners every three months;
(ii) maintain accounts of all transactions giving details as indicated below in a register
bound and serially page numbered and such records shall be retained for a period of
five years or one year after the expiry of potency, whichever is later:-
A. Accounts of the drugs specified in Schedule X used for the manufacture:-
1. Date of issue
2. Name of the drug
3. Opening balance of stock on the production day.
4. Quantity received, if any, and source from where received.
5. Quantity used in manufacture.
6. Balance quantity on hand at the end of the production day.
7. Signature of the person in charge.
B. Accounts of production.:-
1. Date of manufacture,
2. Name of the drug,
3. Batch Number
4. Quantity of raw material used in manufacture.
5. Anticipated yield.
6. Actual yield,
7 Wastage,
8. Quantity of the manufactured goods transferred.
C. Accounts of the manufactured drugs:-
1. Date of manufacture,
2. Name of the drug,
3. Batch Number,
4. Opening Balance,
5. Quantity manufactured,
6. Quantity sold,
7. Name of the purchaser and his address,
8. Balance quantity at the end of the day,
9. Signature of the person in charge.
114
(n) The licensee shall store drugs specified in Schedule X in bulk from and when any
of such drug is required for manufacture in a place other than its place of storage it
shall be kept in a separate place under the direct custody of a responsible person.]
1
[(o) The licensee shall comply with the requirements of ‘Good Manufacturing
Practices’ as laid down in Schedule M.]
74-A. Conditions for licence in Form 25-B.
____A licence in Fom 25-B shall be subject to the
conditions stated therein and to the following conditions :____
(a) the repacking of drugs shall at all times be conducted under the personal
supervision of at least one person who is approved as a competent person by the
Licensing Authority;
(b) the licensee shall either provide and maintain adequate arrangements in his own
premises for carrying out tests of the strength, quality and purity of the drugs
repacked or make arrangements with some institution approved by the Licensing
Authority under Part XV (A) of these rules for such tests to be regularly carried out
on his behalf by the institution;
(c) the licensee shall make adequate arrangements for the storage of drugs;
2 (d) the licensee shall comply with the provisions of the Act and of these Rules and with
such further requirements, if any, as may be specified in any rules subsequently
made under Chapter IV of the Act;
Provided that where such further requirements are specified in the rules, these
would come into force four months after publication in the Official Gazette.
(e) the licensee shall allow any Inspector appointed under the Act to enter with or
without notice, any premises where the packing of drugs in respect of which the
licence is issued is carried on, to inspect the premises and to take samples of
repacked drugs;
2
(f) The licensee shall, either in his own laboratory or, in any other laboratory approved
by the Licensing Authority, test each batch or lot of raw material used by him for
repacking and also each batch of the product thus repacked and shall maintain
records or registers showing the particulars in respect of such tests as specified in
Schedule U. The records or registers shall be retained for a period
____________________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 735(E)dt 24.6.1988.
2 Amended by G.O.I. Notification No. F.1-20/64-D dt 26.10.1968
115
of five years from the date of repacking. The licensee shall allow the Inspector to
inspect all registers and records maintained under these rules and shall supply to the
Inspector such information as he may require for the purpose of ascertaining
whether the provisions of the Act and these Rules have been observed;
1
(g) the licensee shall maintain an Inspection Book, in Form 35, to enable an Inspector
to record his impressions and the defects noticed;
2
(h) the licensee shall maintain reference samples from each batch of the drugs
manufactured by him in a quantity which is at least twice the quantity of the drug
required to conduct all the tests performed on the batch. In case of drugs bearing an
expiry date on the label, the reference sample shall be maintained for a period of
three months beyond the date of expiry of potency. In case of drugs where no date
of expiry of potency is specified on the label, the reference samples shall be
maintained for a period of three years from the date of manufacture.
3
74B. Conditions of licence in Form 25-A.
____(1) The licence in Form 25-A shall be deemed
to be cancelled or suspended, if the licence owned by the licensee in Form 25, whose
manufacturing facilities have been availed of by the licensee, is cancelled or suspended, as the
case may be, under these rules.
(2)The licensee shall comply with the provisions of the Act and of these Rules and with such
further requirements if any, as may be specified in any rules subsequently made under Chapter
IV of the Act; provided that where such further requirements are specified in the rules, these
would come into force four months after publication in the Official Gazette.
(3)The licensee shall test each batch or lot of the raw material used by him for the
manufacture of his products and also each batch of the final product and shall maintain records
or registers showing the particulars in respect of such tests as specified in Schedule U. The
records or registers shall be retained for a period of five years from the date of manufacture. The
licensee shall allow an Inspector to inspect all registers and records maintained under these rules
and shall supply to the Inspector such information as he may require for the purpose of
ascertaining whether the provisions of the Act and these rules have been observed.
___________________________________________________________________________
1Added under G.O.I. Notification No. 1-14/68-D, dt 26-10-68.
2Added under G.O.I. Notification No.G.S.R. 444 dt. 28-4-1973 .
3Amended under G.O.I. Notification No. F. 1-20/64-D, dated the 26th October, 1968.
116
(4) The licensee shall either-
(i) provide and maintain to the satisfaction of the Licensing Authority adequate staff
and adequate laboratory facilities for carrying out test of the strength, quality and
purity of the substances manufactured by him or
(ii) make arrangements with some institution approved by the Licensing Authority
under Part XV (A) of these rules for such tests to be regularly carried out on his
behalf by the institution.
1
(5) The licensee shall maintain reference samples from each batch of the drugs
manufactured by him in a quantity which is at least twice the quantity of the drug required to
conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label
the reference samples shall be maintained for a period of three months beyond the date of expiry
of potency. In case of drugs where no date of expiry of potency is specified on the label, the
reference samples shall be maintained for a period of three years from the date of manufacture.
2 [(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.]
3 [75. Form of application for licence to manufacture for sale or distribution of drugs
specified in Schedules C and C(1) and X 4
[excluding those specified in Part XB] _ (1)
Applications for the grant or renewal of licence to manufacture for sale or distribution of drugs
specified in Schedules C and C(1) 4
[excluding those specified in Part X-B and Schedule X],
shall be made to the Licensing Authority in Form 27 and 5
[shall be made upto ten items for each
category of drugs catagorised in Schedule M and Schedule M-III and shall be accompanied by a
licence of rupees six thousand and an inspection of rupees one thousand and five hundred for
every inspection or for the purpose of renewal of licence.]
Provided that if the applicant applies for renewal of licence after its expiry but within six
months of such expiry, the fee payable for renewal of the licence shall be 5
[a licence fee of
rupees six thousand plus an additional fee of rupees one thousand per month or a part thereof in
addition to an inspection fee of rupees one thousand and five hundred.]
(2)Application for grant or renewal of licence to manufacture for sale or distribution of drugs
specified in Schedules C, C(1) and X shall be made to the licensing authority in Form 27-B, and
5
[shall be made up to ten items for each category of drugs categorized in Schedule M and
____________________________________________________________________________
1
Ins. by G.O.I. Notification NO. GSR. No. 444, dt. 28-4-1973.
2 Ins. by G.O.I. Notification No. GSR 31(E) dt 8.5.1984.
3 Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
4 Subs. by G.O.I. Notification No. GSR 28(E) dt 22.1.1993.
5 Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
117
Schedule M-III and shall be accompanied by a licence fee of rupees six thousand and an
inspection fee of rupees one thousand five hundred for every inspection or for the purpose of
renewal of licences:].
Provided that the applicant shall possess a licence in Form 28 to manufacture such drugs:
Provided further that if the application for renewal of a licence is made after its expiry but
within six months of such expiry, the fee payable for renewal of the licence 1
[shall be rupees six
thousand plus an additional fee of rupees one thousand per month or part thereof in additional to
an inspection fee of rupees one thousand five hundred.]
2
[(3) The application for grant or renewal of licence to manufacture for sale or for distribution
of drugs in ‘Large Volume Parenterals’ and ‘Sera and Vaccines’ shall be made to the licensing
authority appointed under this Part in Form 27-D and 1
[shall be made up to ten items for each
category of drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees
six thousand and an inspection fee of rupees one thousand five hundred for every inspection or
for the purposes of renewal of licences:]
Provided that if the application for renewal of a licence is made after its expiry but within six
months of such expiry, the fee payable for renewal of the licence 1
[shall be rupees six thousand
plus an additional fee of one thousand per month or a part thereof in addition to the inspection
fee of rupees one thousand and five hundred.]
1
[(4) A fee of rupees one thousand shall be paid for duplicate copy of the licence issued under
sub-rule (1), sub-rule (2) or sub-rule (3), as the case may be, if the original licence is defaced,
damaged or lost.
(5) If the licence applies for manufacture of more than ten items of each category of drugs,
the application shall be accompanied by an additional fee at the rate of rupees three hundred for
each additional item of drugs categorized in Schedule M and Schedule M-III.]
3
[(6) Where an application under this rule is for the manufacture of drug formulations falling
under the purview of new drugs as defined in rule 122-E, such application shall also be
accompanied with approval, in writing, in favour of the applicant, from the licensing authority
as defined in clause (b) of rule 21.]]
___________________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
2
Ins. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
3 Ins. by G.O.I. Notification No. GSR 311(E) dt 1.5.2002.
118
1
75-A. Loan licences.
____(1) Applications for the grant or renewal of loan 2
[licences for the
manufacture for sale or for distribution] of drugs specified in Schedules C and C(1) 3
[excluding
those specified in Part X-B and Schedule X] shall be made in Form 27-A to the licensing
authority and 4
[shall be made upto ten items for each category of drugs categorized in Schedule
M and Schedule M-III and shall be accompanied by a fee of rupees six thousand and an
inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of
renewal of licences.].
5
Provided that if the applicant applies for the renewal of a licence after its expiry but within
six months of such expiry the fee payable for renewal of the licence shall be 4
[rupees six
thousand and an inspection of fee of rupees one thousand five hundred plus an additional fee at
the rate of rupees one thousand] per month or a part thereof.
Explanation.
____For the purpose of this rule a loan licence means a licence which a licensing
authority may issue to an applicant who does not have his own arrangements for manufacture but
who intends to avail himself of the manufacturing facilities owned by another licensee in Form
28.
(2) The licensing authority, shall, before the grant of a loan licence, satisfy himself that the
manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for
testing to undertake the manufacture on behalf of the applicant for a loan licence.
4
[(3) Subject to the provisions of sub-rule (2), the application for manufacture of more than
ten items of each category of drugs on a loan license, shall be accompanied by an additional fee
at the rate of rupees three hundred for each additional item of drugs.
(4) If the licensing authority is satisfied that a loan licence is defaced, damaged or lot, he
may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan licence.]
75-B. [ Omitted as per G.O.I. Notification No. GSR 944(E) dt 21.9.1988.]
1
76. 6
[Forms of licence to manufacture drugs specified in Schedules C and C(1), [excluding
those specified in Part XB and Schedule X], or drugs specified in Schedules C, C(1) and X and
the conditions for the grant or renewal of such licences.-
7
[A licence to manufacture
____________________________________________________________________________
1
Ins. as per G.O.I. Notification No. F.1-16/57-D dt 15.6.1969.
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
3
Subs. by G.O.I. Notification No. GSR 28(E) dt 22.1.1993.
4
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
5Amended by G.O.I. Notification No. S.O.2139 dt 13.8.1972
6
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
7 Subs. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
119
for sale or for distribution of drugs specified in Schedules C and C(1) other than Large Volume
Parenterals, Sera and Vaccines, drugs specified in Part X-B and Schedule X shall be issued in
Form 28 and a licence to manufacture for sale or distribution of drugs specified under Schedules
C and C(1) (other than Large Volume Parenterals, Sera and Vaccines, drugs specified in Part XB) and Schedule X shall be issued in Form 28-B. A licence to manufacture for sale or for
distribution of Large Volume Parenterals, Sera and Vaccines shall be issued in Form 28-D.
before a licence in Form 28 or Form 28-B or Form 28-D is granted or renewed, the following
conditions shall be complied with by the applicant.]
(1) The manufacture will be conducted under the active direction and personal supervision
of competent technical staff consisting at least of one person who is a whole time employee and
who is____
(a) a graduate in Pharmacy or Pharmaceutical Chemistry of 1
[a University established
in India by law or has an equivalent qualification recognized and notified by the
Central Government for such purpose] of this rule and has had at least eighteen
months’ practical experience after the graduation in the manufacture of drugs to
which this licence applies; this period of experience may however be reduced by six
months if the person has undergone training in manufacture of drugs to which the
licence applies for a period of six months during his University course; or
(b) a graduate in Science of 1
[a University established in India by law or has an
equivalent qualification recognized and notified by the Central Government for
such purpose] of his degree has studied Chemistry or Microbiology as a principal
subject and has had at least three years’ practical experience in the manufacture of
drugs to which this licence applies after his graduation; or
(c) a graduate in Medicine of 1
[a University established in India by law or has an
equivalent qualification recognized and notified by the Central Government for
such purpose] with at least three years’ experience in the manufacture and
pharmacological testing of biological products after his graduation; or
2
(d) a graduate in Chemical Engineering of a University recognized by the Central
Government with at least three years’ practical experience in the manufacture of
drugs to which this licence applies after his graduation; or
(e) holding any foreign qualification the quality and content of training of which are
comparable with those prescribed in clause (a), clause (b), clause (c) or clause (d)
and is permitted to work as competent technical staff under this rule by the Central
Government.
______________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 71(E) dt 30.1.1987.
2Amended by G.O.I. Notification No. F.1-19/59-B dt 13.6.1961.
120
Provided that any person who was approved by the licensing authority as an expert
responsible for the manufacture of drugs for the purpose of rule 76 read with rule 78 as these
rules were in force immediately before the 29th June, 1957, shall be deemed to be qualified for
the purposes of this rule.
1
Provided further that for the drugs specified in Schedules C and C(1) meant for veterinary
use, the whole time employee under whose supervision the manufacture is conducted may be a
graduate in Veterinary Science or general science or medicine or pharmacy of a University,
recognized by the Central Government and who has had at least three years’ experience in the
manufacture of biological products.
2
[Provided further also that for the medical devices specified in Schedule C, the whole time
employee under whose supervision the manufacture is conducted may be a Graduate in Science
with Physics or Chemistry or Microbiology as one of the subjects; or graduate in Pharmacy; or
Degree/Diploma holder in Mechanical or chemical or Plastic Engineering of a University
recognized by the Central government for such purposes.]
(2) The factory premises shall comply with the conditions prescribed in Schedule M.2
[and
Schedule M-III in respect of medical devices].
(3) The applicant shall provide adequate space, plant and equipment for any or all the
manufacturing operations; the space, plant and equipment recommended for various operations
are given in Schedule M 2
[and Schedule M-III].
2
(4)The applicant shall provide and maintain adequate staff, premises and laboratory
equipment for carrying out such tests of the strength, quality and purity of the substances as may
be required to be carried out by him under the provisions of Part X of these rules including
proper housing for animals used for the purposes of such tests, the testing unit being separate
from the manufacturing unit and the head of the testing unit being independent of the head of the
manufacturing unit :
Provided that the manufacturing units which before the commencement of the Drugs and
Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by
the Licensing Authority for such tests to be carried out on their behalf may continue such
arrangements upto the 30th June, 1977 :
Provided further that for tests requiring sophisticated instrumentation techniques or
biological or microbiological methods other than sterility the Licensing Authority may permit
such tests to be conducted by institutions approved by it under Part XV (A) of these rules for this
purpose.
___________________________________________________________________________
1
Ins. by G.O.I. Notification No. F.1-6/62-D dt 2.7.1969
2
Ins. by G.O.I. Notification No. GSR 109(E) dt 22.2.1994.
121
1
[(4-A) The head of the testing unit referred to in condition (4) shall possess a degree in
Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for
this purpose and shall have experience in the testing of drugs, which in the opinion of the
Licensing authority is considered adequate.]
(5) The applicant shall make adequate arrangements for the storage of drugs manufactured by
him.
2
(6)The applicant shall furnish to the Licensing Authority, if required to do so, data on the
stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be
printed on the labels of such drugs on the basis of the data so furnished.
3
(7)The applicant shall, while applying for licence to manufacture patent or proprietary
medicines, furnish to the Licensing Authority evidence and data justifying that the patent or
proprietary medicines :____
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as
determined in relation to the claims or conditions for which the medicines are
recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and
pharmaceutical aids used in the formulations and under the conditions in which the
formulations for administration and use are recommended;
(iii) are stable under the conditions or storage recommended; and
(iv) contain such ingredients and in such quantities for which there is therapeutic
justification.
4
[(v) have the approval, in writing, in favour of the applicant to manufacture drug
formulations falling under the purview of new drug as defined in rule 122-E, from
the licensing authority as defined in clause (b) of rule 21.]
5
[(8) The licensee shall comply, with the requirements of “Good Manufacturing Practices” as
laid down in Schedule M.]
_____________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 681(E) dt 5.12.1980.
2
Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973.
3
Ins. byG.O.I. Notification No. GSR 515 dt 10.4.1976.
4 Ins. by G.O.I. Notification No. GSR 311(E) dt 1.5.2002.
5
Ins. by G.O.I. Notification No. GSR 735(E) dt 24.6.1988.
122
1
[Explanation.- For the purpose of this rule, “Large Volume Parenterals” shall mean the
sterile solutions intended for parenteral administration with a volume of 100 ml. or more (and
shall include anti-coagulant solutions) in one container of the finished dosage from intended for
single use.]
2
76-A : Form of loan licence to manufacture for sale 3
[or for distribution] drugs specified in
Schedules C and C(1) 4
[excluding the drugs specified in Schedule X] and conditions for the grant
or renewal of such licence :____A loan licence to manufacture for sale 3
[or for distribution] drugs
specified in Schedules C and C(1) 4
[excluding the drugs, specified in Schedule X] shall be issued
in Form 28-A, and the applicant shall, while applying for a licence to manufacture patent or
proprietary medicines, furnish to the Licensing Authority evidence and date justifying that the
patent or proprietary medicines;
(i) certain the constituent ingredients in therapeutic/prophylactic quantities as
determined in relation to the claims or conditions for which the medicines are
recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and
pharmaceutical aids used in the formulations, and under the conditions in which
the formulations for administration and use are recommended;
(iii) are stable under the conditions of storage recommended; and
(iv) contain such ingredients and in such quantities for which there is therapeutic
justifications.
5
77. Duration of licence.
____An original licence in 6
[Form 28, Form 28-B and form 28-D or
renewed licence informs 26, 26-F, and Form 26-H] or a renewed licence in Form 26, unless
sooner suspended or cancelled shall be 7
[valid for a period of five years on and from the date on
which] it is granted or renewed:
____________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
2
Ins. by G.O.I. Notification No. GSR 515 dt 10.4.1976
3
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
4
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
5Amended by G.O.I. Notification No. G.1-10/62-D dt 10.4.1964.
6
Subs. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
7
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
123
1
Provided that if the application for the renewal of a licence is made before its expiry, or if
the application is made within six months of its expiry after payment of additional fee, the
licence shall continue to be in force until orders are passed on the application and the licence
shall be deemed to have expired if the application for its renewal is not made within six months
of its expiry.
2
78. Conditions of licence.
____A licence in 3
[Form 28, Form 28-B or form 28-D] shall be
subject to the special conditions, if any, set out in Schedule F or Schedule F(1), as the case may
be, which relate to the substance in respect of which the licence is granted and to the following
general conditions____
(a) (i) The licence shall provided and maintain an adequate staff and adequate premises and
plant for the proper manufacture and storage of the substances in respect of which the licence is
issued;
(ii) Without prejudice to the generality of the foregoing requirement, every holder of a
licence who for any purpose engaged in the culture or manipulation of pathogenic spore-bearing
micro-organisms shall provide to the satisfaction of the Licensing Authority separate laboratories
and utensils and apparatus required for the culture or manipulation of such micro-organisms, the
laboratories, utensils and apparatus so provided not being used for the manufacture of any other
substance;
4
(b) The licensee shall provide and maintain staff, premises and equipment as specified in
rule 76;
5
(c) (i) The licensee shall maintain records of manufacture as per particulars given in
Schedule U.
(ii) The licensee shall either in his own laboratory or in any laboratory approved by the
Licensing Authority under Part XV (A) of these rules test each batch or lot of the raw material
used by him for the manufacture of his product and also each batch of the final product and shall
maintain records or registers showing the particulars in respect of such tests as specified in
Schedule U. The records or registers shall be retained in the case of a substance for which a
potency date is fixed for a period of two years from the expiry of such date, and in the case of
other substances for a period of five years from the date of manufacture.
____________________________________________________________________________
1Amended by G.O.I. Notification No. S.O. 2139 dt 12.8.1972.
2Amended by G.O.I. Notification No. F.1-6/62-B dt 2.6.1969.
3
Subs. by G.O.I. Notification No. GSR 119(E) dt 11.3.1976.
4Amended by G.O.I. Notification No. F.1-16/57-D dt 15.6.1957
5Amended by G.O.I. Notification No. F.1-20/64-D dt 26.10.1968.
124
(d) The licensee shall allow an 1
Inspector appointed under the Act to enter, with or without
prior notice, any premises where the manufacture is carried on and to inspect the premises, and
in the case of substances specified in Schedules C and C(1), to inspect the plant and the process
of manufacture and the means employed for standardizing and testing the substance;
(e) The licensee shall allow an 1
Inspector appointed under the Act, to inspect all registers and
records maintained under these rules and to take samples of the manufactured product and shall
supply to such Inspector such information as he may require for the purpose of ascertaining
whether the provisions of the Act and Rules thereunder have been observed;
(f) The licensee shall from time to time report to the Licensing Authority any changes in the
expert staff responsible for the manufacture or testing of the substance and any material
alterations in the premises or plant used for that purpose which have been made since the date of
the last inspection made on behalf of the Licensing Authority before the issue of the licence;
1
(g)the licensee shall on request furnish to the Licensing Authority, Controlling Authority or
to such authorities as the Licensing Authority or the Controlling Authority may direct, from
every batch of drug as the licensing authority or the Controlling Authority may from time to time
specify, a sample of such quantity as may be considered adequate by such Authority for any
examination and, if so required, also furnish, full protocols of the tests which have been applied.
(h) If the Licensing Authority or the Controlling Authority so directs, the licensee shall not
sell or offer for sale any batch in respect of which a sample is, or protocols are furnished under
the last preceding sub-paragraph until a certificate authorizing the sale of the batch has been
issued to him by or on behalf of the Licensing Authority or the Controlling Authority.
(i) The licensee shall on being informed by the Licensing Authority or the Controlling
Authority that any part of any batch of the substance has been found by the Licensing Authority
or the Controlling Authority not to conform with the standards of strength, quality or purity
specified in these Rules and on being directed so to do, withdraw the remainder of that batch
from sale and so far as may in the particular circumstances of the case be practicable recall all
issues already made from that batch;
(j) No drug manufactured under the licence shall be sold unless the precautions necessary
for preserving its properties have been observed throughout the period after manufacture;
(k) The licensee shall comply with the provisions of the Act and of these rules and with such
further requirements, if any, as may be specified in any rules subsequently made under Chapter
IV of the Act, provided that where such further requirements are specified in the rules, these
would come into force four months after publication in the Official Gazette.
____________________________________________________________________________
1Amended by G.O.I. Notification No. GSR 444 dt. 28.4.1973.
125
1
(l) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impression and defects noticed.
2
(m) The licensee shall maintain reference samples from each batch of the drugs
manufactured by him in a quantity which is at least twice the quantity of the drug required to
conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label,
the reference samples shall be maintained for a period of three months beyond the date of expiry
of potency. In case of drugs where no date of expiry is specified on the label the reference
samples shall be maintained for a period of three years from the date of manufacture.
3
[(n)The licensee, who has been granted a license in Form 28-B shall-
(i) forward to the licensing authority of the concerned States of
manufacture and supply of the drug a statement of the sales effected to
manufacturers, wholesalers, retailers, hospitals, dispensaries and nursinghomes and Registered Medical Practitioners every three months
(ii) maintain accounts of all transactions giving details as indicated below in a
register bound and serially page numbered and such records shall be
retained for a period of five years or one year after the expiry of potency,
whichever is later:-
A. Accounts of the drugs specified in Schedule X used for the manufacture:-
1. Date of issue
2. Name of the drug
3. Opening balance of stock on the production day.
4. Quantity received, if any, and source from where received.
5. Quantity used in manufacture.
6. Balance quantity on hand at the end of the production day.
7. Signature of the person in charge.
1Amended by G.O.I. Notification NO. F.1-14/68-B dt 26.10.1968.
2
Ins. by .GO.I. Notification No. GSR 444 dt 28.4.1973.
3
Ins. by .GO.I. Notification No. GSR 462(E) dt 22.6.1982.
126
B. Accounts of Production.:-
1. Date of manufacture,
2. Name of the drug,
3. Batch Number
4. Quantity of raw material used in manufacture.
5. Anticipated yield.
6. Actual yield,
7 Wastage,
8. Quantity of the manufactured goods transferred.
C. Accounts of the manufactured drugs:-
1. Date of manufacture,
2. Name of the drug,
3. Batch Number,
4. Opening Balance,
5. Quantity manufactured,
6. Quantity sold,
7. Name of the purchaser and his address,
8. Balance quantity at the end of the day,
(o) The licensee shall store drugs specified in Schedule X in bulk from and when any of such
drug is required for manufacture in a place other than its place of storage it shall be kept in a
separate place under the direct custody of a responsible person.]
1
[(p) The licensee shall comply with the requirements of ‘Good Manufacturing Practices’ as
laid down in Schedule M.]
2
78-A. Conditions of licence in Form 28-A.
____ (1) The licence in Form 28-A shall be deemed
to be cancelled or suspended, if the licence owned by the licensee in Form 28 whose
manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the
case may be, under these rules.
__________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 735(E) dt 24.6.1998.
2Amended by G.O.I. Notification No. F.1-14/68-D dt 26.10.1968.
127
(2) The licensee shall comply with the provisions of the Act, and of these rules and with such
further requirements if any, as may be specified in any rules subsequently made under Chapter
IV of the Act, provided that where such further requirements are specified in the rules, those
would come into force four months after publication in the official Gazette.
(3) The licensee shall test each batch or lot of the raw material used by him for the
manufacture of his products and also each batch of the final product and shall maintain records
or registers showing the particulars in respect of such tests as specified in Schedule U. Records
or registers shall be retained, in the case of a substance for which a potency date is fixed, for a
period of two years from the expiry of such date and in the case of other substances, for a period
of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all
registers and records maintained under these rules and shall supply to the Inspector such
information as he may require for the purpose of ascertaining whether the provisions of the Act
and these rules have been observed.
(4) The licensee shall either (i) provide and maintain to the satisfaction of the Licensing
Authority adequate staff and adequate laboratory facilities for carrying out tests of the strength,
quality and purity of the substances manufactured by him or (ii) make arrangements with some
institution approved by the Licensing Authority for such tests to be regularly carried out on his
behalf by the institution.
1
(5)The licensee shall furnish to the Licensing Authority, if required to do so, data on the
stability of drugs which are likely to deteriorate for fixing the date of expiry which would be
printed on the labels of such drugs on the basis of the data so furnished.
1
(6)The licensee shall maintain reference samples from each batch of the drug manufactured
by him in a quantity which is at least twice the quantity of the drug required to conduct all the
tests performed on the batch. In case of drugs bearing an expiry date on the labels, the reference
samples shall be maintained for a period of three months beyond the date of expiry of potency.
In case of drugs where no date of expiry of potency is specified on the label, the reference
samples shall be maintained for a period of three years from the date of manufacture.
2
[(7) The licensee shall maintain an Inspection Book in form 35 to enable an Inspector to
record his impressions and the defects noticed.]
3
[79. Inspection before grant or renewal of licence___Before a licence under this part is
_____________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973.
2
Ins. by G.O.I. Notification No. GSR 331(E) dt 8.5.1984.
3
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
128
granted or renewed the Licensing Authority or Central Licence Approving Authority, as the case
may be, shall cause the establishment in which the manufacture is proposed to be conducted or
being conducted to be inspected by one or more Inspectors appointed under this Act with or
without an expert in the concerned filed. The Inspector or Inspectors shall examine all portions
of the premises, plant and appliances and also inspect the process of manufacture intended to be
employed or being employed along with the means to be employed or being employed for
standardizing and testing the drugs to be manufactured or being manufactured and enquire into
the professional qualifications of the Technical Staff to be employed. He shall also examine and
verify the statements made in the application in regard to their correctness, and the capability of
the applicant to comply with the requirements of competent technical staff, manufacturing plants,
testing equipments and the ‘Requirements of Good Manufacturing Practices’ and the
‘Requirements of Plant and Equipment’ as laid down in Schedule M read with the Requirements
of Maintenance of Records as laid down in Schedule U.
80. Report by Inspector.
____The Inspector shall forward a detailed descriptive report giving
his findings on each aspect of inspection along with his recommendations after completion of his
inspection in accordance with the provisions of Rule 79, to the Licensing Authority or Central
Licence Approving Authority, as the case may be.]
81. Procedure of Licensing Authority.
____(1) If the Licensing Authority 1
[or Central Licence
Approving Authority, as the case may be,] after such further enquiry, if any, as he may consider
necessary, is satisfied that the requirements of the Rules under the Act have been complied with
and that the conditions of the licence and the Rules under the Act will be observed, he 2
[shall
issue a licence under this Part].
(2) If the Licensing Authority 1
[or Central Licence Approving Authority, as the case may
be,] is not so satisfied, he shall reject the application and shall inform the applicant of the reasons
for such rejection and of the conditions which must be satisfied before a licence can be granted
and shall supply the applicant with a copy of the inspection report.
3
82. Further application after rejection.
____If within a period of six months from the rejection
of an application for a licence the applicant informs the Licensing Authority 1
[or Central Licence
Approving Authority, as the case may be,) that the conditions laid down have been satisfied and
deposits an inspection 4
[fee of rupees two hundred and fifty] the Licensing Authority 1
[or Central
Licence Approving Authority, as the case may be,]may, if after causing a further inspection to be
_____________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
2
Subs. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
3
Ins. by G.O.I. Notification No. F.1-16/57-D dt 15.5.1959.
4
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
129
made, he is satisfied that the conditions for the grant of a licence have been complied with, 1
[in
respect of drugs notified under Rule 68-A] issue a licence in Form 28 2
[or Form 28-B].
83. Renewal.
____On application being made for renewal, the licensing authority may cause an
inspection to be made and, if satisfied that the condition of the licence and the Rules under the
Act are, and will continue to be observed, 3
[he shall prepare a report to that effect in respect of
those drugs which have been notified by the Central Government under Rule 68-A and forward it
along with the application to the Central Licence Approving Authority], and 4
[he shall issue a
certificate of renewal under this Part].
5
83-A. Certificate of a renewal of a loan licence.
____The certificate of renewal of a loan
licence in Form 28-A shall be issued in Form 26-A.
6
83-AA. Duration of loan licence.
____An original loan licence in Form 28-A or a renewed
loan licence in Form 26-A, unless sooner suspended or cancelled, shall be 7
[valid for a period of
five years on and from the date on which] it is granted or renewed.
6
Provided that if the application for the renewal of a licence is made before its expiry, or if
the application is made within six months of its expiry, after payment of the additional fee, the
licence shall continue to be in force until orders are passed on the application and the licence
shall be deemed to have expired if the application for its renewal is not made within six months
of its expiry.
84. The provisions of this Part shall apply to the manufacture of drugs for sale
notwithstanding that such drugs are manufactured for sale outside India.
3
[84-A.Provision for appeal to the State Government or Central Government by party whose
licence has not been granted or renewed.- Any person who is aggrieved by the order passed
by the Licensing Authority or the Central Licence Approving Authority, as the case may be,
refusing to 4
[grant or renew a licence under this Part], may within thirty days from the date of
receipt of such order, appeal to the State Government or Central Government, as the case may
be, and the State Government or the Central Government may, after such enquiry into the matte,
___________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
2
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982
3
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
4
Subs. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996..
5
Ins. by G.O.I. Notification No. F1-16/57-B dt 15.6.1959.
6Amended by G.O.I. Notification No. S.O.2139 dt 12.8.1972.
7
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001
130
as is considered necessary and after giving the said person an opportunity for representing his
views, may pass such order in relation thereto as it thinks fit.] .
84-AA Additional information to be furnished by an applicant for licence or a licensee to
the licensing authority.
____The applicant for the grant of a licence or any person granted a licence
under this Part s hall, on demand, furnish to the Licensing Authority before the grant of the
licence or during the period the licence is in force, as the case may be, documentary evidence in
respect of the ownership or occupation on rental or other basis of the premises, specified in the
application for licence or in the licence granted, constitution of the firm or any other relevant
matter which may be required for the purpose of verifying the correctness of the statements made
by the applicant or the licensee, while applying for or after obtaining the licence, as the case may
be.
1
84-B. Prohibition for the manufacture for sale of cyclamates and preparations containing
cyclamates.
____No person shall manufacture for sale cyclamates and preparations containing
cyclamates.
2
[85. Cancellation and suspension of licences.
____(1) The Central Licence Approving
Authority may, after giving the licensee an opportunity to show cause why such an order should
not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under
this Part, or suspend it for such period as he thinks fit either wholly or in respect of any of the
drugs to which it relates 3
[or direct the licensee to stop manufacture, sale or distribution of the
said drugs and an Inspector], if in his opinion, the licensee has failed to comply with any of the
conditions of the licencee or with any provisions of the Act or rules made thereunder.
(2) The Licensing Authority may, for such licences granted or renewed by him, after giving
the licensee an opportunity to show cause why such an order should not be passed, by an order in
writing stating the reason therefor, cancel a licence issued under this Part or suspend it for such
period as he thinks fit, either wholly or in respect of some of the substances to which it relates,
3
[or direct the licensee to stop manufacture, sale or distribution of the said drugs and an
Inspector] if, in his opinion, the licensee has failed to comply with any of the conditions of the
licence or with any provision of the Act or Rules thereunder.
4
[(3) A licensee whose lice has been suspended or cancelled by the Central Licence
Approving Authority or Licensing Authority under sub-rule (1) or sub-rule (2), as the case may
____________________________________________________________________________
1
Ins. by G.O.I. Notification No. S.O.2358 dt 26.8.1972.
2
Subs, by G..O.I. Notification No. GSR 923(E) dt 14.12.1992
3
Subs. by G.O.I. Notification No. GSR 20(E) dt 11.1.1996.
4
Ins. by G.O.I. Notification No. 615(E) dt 9.8.1994.
131
be, may within ninety days of the receipt of a copy of the order by him prefer an appeal to the
Central Government or the State Government, as the case may be, and the Central Government
or the State Government may after giving the licensee an opportunity of being head, confirm,
reverse or modify such order.]
1
PART VII-A
2
[MANUFACTURE FOR SALE OR FOR DISTRIBUTION] OF HOMOEOPATHIC MEDICINES
85-A. Manufacture on more than one set of premises.
____If Homoeopathic medicines are
manufactured in more than one set of premises a separate application shall be made and a
separate licence shall be obtained in respect of each such set of premises.
85-B. Application for licence to manufacture Homoeopathic medicines.
____(1) Application
for grant or renewal of licences to manufacture for sale 2
[or for distribution] of Homoeopathic
medicines shall be made to the Licensing Authority appointed by the State Government for the
purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) and shall be
made in Form 24-C.
3
(2) The application in Form 24-C shall be accompanied
(a) by a fee of 4
[rupees two hundred] for the manufacture of Homoeopathic mother
tinctures and potentised preparations and an inspection fee of 4
[rupees one
hundred] ten for the first inspection or 4
[rupees fifty] in case of inspection for
renewal of licence;
(b) by a fee of rupees two hundred for the manufacture of Homoeopathic potentised
preparations only, and an inspection fee of rupees one hundred for the first
inspection or rupees fifty e in case of inspection for renewal of licence;
(c) by a fee of rupees 4
[two hundred] for the manufacture of potentised preparation
from back potencies by pharmacies which are already licensed to sell
Homoeopathic medicines by retail and an inspection fee of rupees 4
[one hundred]
for the first inspection or 4
[rupees fifty] in case of inspection for renewal of
licence.
____________________________________________________________________
1Added under G.O.I.Notification No. F. 1-35/64-D, dtd 18.8.1964.
2
Ins. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985.
3 Amended G.O.I. Notification No. G.S.R. 245 dtd 11-2-1976.
4
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
132
1
(3)If a person applies for renewal of a licence after its expiry but within six months of such
expiry, the fee payable for the renewal of such a licence shall be____
(a) 2
[rupees two hundred] plus an additional fee at the rate of 2
[rupees one hundred]
per month or part thereof and an inspection fee of 2
[rupees fifty] for the
manufacture of Homoeopathic mother tinctures and potentised preparations;
(b) 2
[rupees two hundred] plus an additional fee at the rate of 2
[rupees one hundred]
per month or part thereof and an inspection fee of 2
[rupees fifty] for the
manufacture of Homoeopathic potentised preparations only;
(c) 2
[rupees two hundred] plus an additional fee at the rate of 2
[rupees one hundred]
per month or part thereof and an inspection fee of 2
[rupees fifty] for the
manufacture of Homoeopathic mother tinctures and potentised preparations from
back potencies by pharmacies who are already licensed to sell Homoeopathic
medicines by retail.]
(4) A fee of 2
[rupees fifty] shall be paid for a duplicate copy of the licence for the
manufacture of Homoeopathic mother tinctures and potentised preparations issued under subrule (1) if the original is defaced, damaged or lost. While the fee to be paid for such a duplicate
copy of the licence for the manufacture of Homoeopathic potentised preparations only shall be
[
2
rupees fifty].
3
[(5) Applications by licensee to manufacture additional items of Homoeopathic medicines
shall be made to the Licensing Authority and such applications shall be accompanied by a fee of
2
[rupees fifty] for each additional item.]
85C. Application to manufacture ‘New Homoeopathic medicines’____Subject to the other
provisions of these Rules____
(1) no ‘New Homoeopathic medicine’ shall be manufactured unless it is previously approved
by the Licensing Authority mentioned in rule 21;
(2) the manufacturer of ‘New Homoeopathic medicine’, when applying to the Licensing
Authority mentioned in sub-rule (1) shall produce such documentary and other evidence as may
be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine
including the minimum provings carried out with it.
__________________________________________________________________________
1 Amended by G.O.I Notification No. GSR 245 dt 11.2.1976.
2 Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
3
Ins. by G.O.I. Notification No. GSR 13(E) dt 7.1.1993.
133
(3) While applying for a licence to manufacture a ‘New Homoeopathic medicine’ an
applicant shall produce along with his application evidence that the ‘New Homoeopathic
medicine’ for the manufacture of which application is made has already been approved.
Explanation.
____The term ‘New Homoeopathic medicine’ in this rule shall have the same
meaning as in rule 30-AA.
1
85-D. Form of licence to manufacture Homoeopathic medicines.
____Licence for manufacture
of Homoeopathic medicines is a licence to manufacture potentised preparations from back
potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail and
shall be granted in Form 25-C.
85-E. Conditions for the grant or renewal of a licence in Form 25-C.
____Before a licence in
Form 25-C is granted or renewed the following conditions shall be complied with by the
applicant :____
(1)The manufacture of Homoeopathic medicines shall be conducted under the direction
and supervision of competent technical staff consisting at least of one person who is
a whole time employee 2
[and who is ____
a) a graduate in Science with Chemistry as one of the subjects with three years’
experience in manufacture of Homoeopathic Medicines; or
b) a graduate in Pharmacy with 18 months of experience in the manufacture of
Homoeopathic medicines; or
c) holds qualification as defined under sub-clause (g) of clause (1) of Section 2 of
Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of
experience in the manufacture of Homoeopathic medicines.
Provided that the persons who are already in employment with five years’ experience in
the manufacture of Homoeopathic medicines and whose name was accordingly entered
in any licence granted in Form 25-C for manufacture of different classes of
Homoeopathic medicines included in them shall be deemed to be qualified for the
purpose of this rule.]
3
[(2) The factory premises shall comply with the requirements and conditions specified
in Schedule M-I :
_____________________________________________________________________
1Amended by G.O.I.. Notification No.F.1-59/68-D dt 19.11.1969.
2
Subs. by G.O.I. Notification No. GSR 812(E) dt 14.11.1994.
3
Subs. by G.O.I. Notification No. GSR 570(E) dt 12.6.1987.
134
Provided that where the Licensing Authority considers it necessary or expedient so to
do, it may having regard to the nature and extent of manufacturing operations, relax or
suitably alter the said requirements or conditions in any particular case for reasons to be
recorded in writing.]
(3) The applicant for manufacture of Homoeopathic mother tinctures shall either (i)
provide and maintain adequate staff, premises and laboratory equipment for
identifying the raw materials and for testing the mother tinctures wherever
possible, or (ii) make arrangements with some institution approved by the
Licensing Authority under Part XV(A) of these rules for such tests, wherever
possible, to be regularly carried out on his behalf by that institution.
(4) The premises where Homoeopathic medicines are manufactured shall be distinct
and separate from the premises used for residential purposes.
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs
pertaining to other systems of medicine.
(6) The applicant shall make arrangements for proper storage of Homoeopathic
medicines manufactured by him.
1
Provided that in case potentised preparations are made in a Pharmacy holding licence in
Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the
satisfaction of the Licensing Authority that the products manufactured by it, conform to the
claims made on the label.]
2
[85-EA Inspection before grant or renewal of licence.- Before a licence under this Part is
granted or renewed in Form 25-C or Form 26-C, the Licensing Authority shall cause the
establishment, in which the manufacture is proposed, to be conducted or being conducted, to be
inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall
examine all portions of the premises, plant and appliances and also inspect the process of
manufacture intended to be employed or being employed along with the means to be employed
or being employed for standardizing and testing the substances to be manufactured and inquire
into the professional qualifications of the technical staff to be employed. He shall also examine
and verify the statements made in the application in regards to their correctness, and the
capability of the applicant to comply with the requirements of competent technical staff,
manufacturing plants, testing equipments and the requirements of plant and equipment as laid
down in Schedule M-I read with the requirements of maintenance of records as laid down in
Schedule U.
_____________________________________________________________________________
1 Amended by G.O.I. Notification No. F.1-59/68-D dt 19.11.1969.
2 Ins. by G.O.I. Notification No. GSR 493(E) dt 9.6.1995.
135
85-EB Report by Inspector.- The Inspector or Inspectors shall forward a detailed descriptive
report giving his or their findings on each aspect of inspection along with his or their
recommendations after completion of his or their inspection to the Licensing Authority.
85-EC.Grant or refusal of licence.- (1) If the Licensing Authority after such further enquiry,
if any, as he may consider necessary is satisfied that the requirements of the rules under the Act
have been complied with and that conditions of the licence and the rules under the Act shall be
observed, he shall grant or renew a licence in Form 25-C or Form 26-C.
(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall
inform the applicant of the reasons for such rejection and of the conditions which must be
satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of
inspection report.
85-ED. Further application after rejection.- If with a period of six months from the rejection
of an application for a licence, the applicant informs the Licensing Authority that the conditions
laid down have been fulfilled and deposits an inspection fee of 1
[rupees two hundred and fifty],
the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that
the conditions for the grant of licence have been complied with, issue a licence in Form 25-C or
Form 26-C.
85-EE Appeal to the State Government.- Any person who is aggrieved by the order passed
by the Licensing Authority refusing to grant or renew a licence under this Part may within ninety
days from the date of receipt of such order, appeal to the State Government and the State
Government may, after such enquiry into the matter as is considered necessary and after giving
the said person an opportunity for representing the case, pass such order as it thinks fit.]

85-F. Duration of licence.
____An original licence or a renewed licence unless it is sooner
suspended or cancelled shall be 1
[valid for a period of five years on and from the date on which]
it is granted or renewed:
2
Provided that if the application for renewal of a licence in force is made before its expiry or
if the application is made within six months of its expiry, after payment of additional fee, the
licence shall continue to be in force until orders are passed on the application and the licence
shall be deemed to have expired if application for its renewal is not made within six months of its
expiry.
1 Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
2Amended by G.O.I. Notification No. S.O.2139 dtd 12-8-1972. .
136
85-G.Certificate of renewal.
____The certificate of renewal of a licence in Form 25-C shall be
issued in Form 26-C.
85-H. Conditions of licence.
____A licence in Form 25-C shall be subject to the conditions
stated therein and to the following further conditions, namely :___
(a) the licensee shall provide and maintain staff and premises as specified in rule 85-E;
(b) the licensee shall allow an 1
Inspector appointed under the Act to enter, with or
without prior notice, any premises where the manufacture of a Homoeopathic
medicine in respect of which the licence is issued is carried on, to inspect the
premises and to take samples of the manufactured Homoeopathic medicines;
(c) the licensee shall allow an Inspector to inspect all registers and records maintained
under these rules and shall supply to the Inspector such information as he may
require for the purpose of ascertaining whether the provisions of the Act and the
Rules made thereunder have been observed;
2(d) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and defects noticed;
(e) the licensee shall comply with the following conditions in respect of mother
tinctures manufactured by him_
(i) the crude drug used in the manufacture of the mother tincture shall be identified
and records of such identification shall be kept 3
[for a period of five years].
(ii) the total solids in the mother tincture shall be determined and records of such
tests shall be kept 3
[for a period of five years].
(iii) the alcohol content in the mother tincture shall be determined and records of the
same shall be maintained 3
[for a period of five years].
(iv) the containers of mother tinctures shall preferably be of glass and shall be clean
and free from any sort of impurities or adhering matter. The glass shall be
neutral as far as possible.
(v) in the process of manufacture of mother tinctures hygienic conditions shall be
scrupulously observed by the licensee. Storage and handling conditions shall
also be properly observed by the licensee according to Homoeopathic principles.
_____________________________________________________________________________
1Amended by G.O.I. Notification No. G. S. R. 444 dtd 28-4-1973.
2Amended by G.O.I. Notification No. F-1-14/ 68-D, dated 26-10-68.
3
Ins. by .O.I. Notification No. GSR 13(E) dt 7.1.1983.
137
1
[(ea) no colour shall be added to any Homoeopathic medicines :
Provided that caramel may beaded to combination of Homoeopathic preparations
with syrup base;]
(f) records shall be maintained of Homoeopathic medicines containing alcohol and the
quantities sold together with names and addresses of parties to whom sold.2 [Such
records shall be maintained for a period of five years.]
3
85-HH Additional information to be furnished by an applicant for the licence or a licensee to
the Licensing Authority.-The applicant for the grant of licence or any other person granted a
licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of
the licence or during the period the licence is in force, as the case may be, documentary evidence
in respect of the ownership or occupation in rental or other basis of the premises, specified in the
application for licence or in the licence granted, constitution of the firm or any other relevant
matters which may be required for the purpose of verifying the correctness of the statements
made by the applicant or the licensee, while applying for or after obtaining the licence, as the
case may be.
85-I. Cancellation and suspension of licences.
_____(1) The Licensing Autority may, after
giving the licensee an opportunity to show cause why such an order should not be passed, by an
order in writing stating the reasons therefore, cancel a licence issued under this Part or suspend it
for such period as he thinks fit, either wholly or in respect of some of the substances to which it
relates if, in his opinion, the licensee has failed to comply with any of the conditions of the
licence or with any provisions of the Act or Rules made thereunder.
4
(2) A licensee whose licence has been suspended or cancelled may, within three months of
the date of the order under sub-rule (1), prefer an appeal against that order to the State
Government, which shall decide the same.
PART VIII___ MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS
86. Conditions relating to manufacture for examination, test or analysis____The provisions
of Section 18 of the Act shall not apply to the manufacture of any drug in small quantities for the
purpose of examination, test or analysis if the conditions prescribed in this Part are fulfilled.
___________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 680(E) dt 5.12.1980.
2
Ins. by G.O.I. Notification No. GSR 13(E) dt 7.1.1983.
3Added by G.O.I. Notification No. S. O. 2139 dtd 12-8-1972.
4Amended G.O.I. Notification No. G SR. 926 dtd 16-7-1977.
138
87.Labelling.
____Any drug manufactured for the purpose of examination, test or analysis
shall be kept in containers bearing labels indicating the purpose for which it has been
manufactured.
88.Labelling of drugs supplied to other persons.
____If any drug manufactured for the purpose
of examination, test or analysis is supplied by the manufacturer to any other person, the container
shall bear a label on which shall be stated the name and address of the manufacturer, the
accepted scientific name of the substance if known, or if not known a reference which will
enable the substance to the identified and the purpose for which it has been manufactured.
89.Licence.
____If the person proposing to manufacture a drugs for the purpose of examination,
test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall,
before commencing such manufacture, obtain a licence in Form 29.
1
Provided that in the case of a drug the composition of which is such that the drug is not
generally recognized among experts qualified by scientific training and experience to evaluate
the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant
produces a certificate from the “Licensing Authority” mentioned in rule 21, to the effect that
there would be no objection to such licence being granted.
90. Form of application.
____(1) An application for a licence in Form 29 shall be made to the
Licensing Authority appointed by the State Government for the purpose of this Part (hereafter in
this Part referred to as the Licensing Authority) in Form 30 and shall be made by or
countersigned by the head of the institution in which, or a director of the firm or company by
which, the substance will be manufactured.
2
(2) Every application in Form 29 shall be accompanied by a fee of 3
[rupees two hundred
fifty.].
91. Duration of licence.
____A licence in Form 29 shall, unless sooner cancelled, be in force
for a period of one year from the date of issue, and may thereafter be renewed for periods of one
year at a time.
92. Conditions of licence.
____A licence in Form 29 shall be subject to the following
conditions____
(a) the licensee shall use the drugs manufactured under the licence exclusively for
purpose of examination, test or analysis, and shall carry on the manufacture and
examination, test or analysis at the place specified in the licence;
____________________________________________________________________________
1Added under G.O.I. Notification No. F. 1-19/59-D, dtd 13-6-1961.
2Added by G.O.I. Notification No. S. O. 903 dtd 28-2-1976
3 Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001
139
(b) the licensee shall allow any 1
Inspector appointed under the Act to enter, with or
without notice, the premises where the drugs are manufactured and to satisfy
himself that only examination, test or analysis work is being conducted;
(c) the licensee shall keep a record of the quantity of drugs manufactured for
examination, test or analysis and of any person or persons to whom the drugs have
been supplied;
(d) the licensee shall comply with such further requirements, if any, applicable to the
holders of licences in Form 29 as may be specified in any Rules subsequently made
under the Act and of which the Licensing Authority has given him not less than one
month’s notice;
(e) the licensee shall maintain an Inspection Book to enable an Inspector to record his
impressions and defects noticed.
93. Cancellation of licences.
____(1) The Licensing Authority may after giving the licensee an
opportunity to show cause why such an order should not be passed, by an order in writing stating
the persons therefore, cancel a licence issued under this Part, either wholly or in respect of some
of the substances to which it relates, if, in his opinion, the licensee has failed to comply any of
the conditions of the licence or with any provisions of the Act or Rules thereunder.
1
(2) A licensee whose licence has been suspended or cancelled may appeal to the State
Government within three months of the date of the order.
PART IX
LABELLING AND PACKING OF DRUGS OTHER THAT
HOMOEOPATHIC MEDICINES
94. Exemption of certain drugs from certain provisions of this Part— (1) Labels on packages
or containers of drugs for export shall be adapted to meet the specific requirements of the law of
the country to which the drug is to be exported but the following particulars shall appear in a
conspicuous position on the innermost container in which the drug is packed and every other
covering in which that container is packed:
(a) name of the drug;
(b) the name, address of the manufacturer and the number of the licence under which
the drug has been manufactured;
(c) batch or lot number;
(d) date of expiry, if any.
___________________________________________________________________________
1 Amended by G.O.I. Notification No. F.1-10/68-D, dtd 17.6.1969.
140
1
[Provided that where a drug, not classified under Schedule F, Schedule F(1) and Schedule X,
blood products, Narcotic and Psychotropic Substances is required by the consignee to be not
labeled with the name and address of the manufacturer, the labels on packages or containers shall
bear a code number as approved by the Licensing Authority mentioned in rule 21.]
2
(2) The provisions of rules 96 to 101 inclusive, shall not apply to a medicine made up ready
for treatment, whether after or without dilution, which is supplied on the prescription of a
registered practitioner provided that:
(i) the medicine is labelled with the following particulars :—
(a) The name and address of the supplier;
(b) The name of the patient and the quantity of the medicine;
(c) The number representing serial number of the entry in the prescription register;
(d) The dose, if the medicine is for internal use;
3
[(e) The words ‘FOR EXTERNEL USE ONLY’ if the medicine is for external
application].
(ii) Condition (3) of the conditions in rule 65 is satisfied.
95. Prohibition of sale or distribution unless labelled.—Subject to the other provisions of
these Rules, no person shall sell or distribute any drug (including a patent or proprietary) unless
it is labelled in accordance with these Rules.
4
96. Manner of Labelling :— (1) Subject to the other provisions of these rules, the following
particulars shall be either printed or written in indelible ink and shall appear in a conspicuous
manner on the label of the innermost container of any drug and on every other covering which
the container is packed, namely : —
(i) The name of the drug
5
[(A) For this purpose, the proper name of the drug shall be printed or written in a
more conspicuous manner than the trade name, if any, which shall be shown
immediately after or under the proper name and shall be]—
(a) for drugs included in the Schedule F or Schedule F (1), the name given therein;
__________________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 676(E) dt 2.6.1988.
2Amended by G.O.I. Notification No. F.1-19/59-D, dtd 13-6-1961.
3
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982.
4Amended under G.O.I. Notification No. GSR19 dt 7-1-1978
5
Subs. by G.O.I. Notification No. GSR 27(E) dt 17.1.1981.
141
(b) for drugs included in the India Pharmacopoeia or the official pharmacopoeia and
official compendia of drug standards prescribed in the rule 124, the name or
synonym specified in the respective official pharmacopoeias and official
compendia of drug standards followed by the letters ‘I.P., or, as the case may be,
by the recognized abbreviations of the respective official pharmacopoeias and
official compendia of drug standards;
(c) for drugs included in the National Formulary of India, the name or synonym
specified therein followed by the letters ‘N.F.I.’;
(d) for other drugs, the international non-proprietary name, if any, published by the
World Health Organisation or where an international non-proprietary name is not
published, the name descriptive of the true nature or origin of the substance;
[ Clause B inserted by Notification No. GSR 27(E) dt 17.1.81 was deleted as per
G.O.I. Notification No. GSR 94(E) dt 8.2.2000.
(ii) A correct statement of the net content in terms of weight, measure, volume, number
of units of contents, number of units of activity, as the case may be, and the weight,
measure and volume shall be expressed in Metric system.
(iii) The content of active ingredients.
This shall be expressed—
(a) for oral liquid preparations in terms of the content per single dose being indicated
in 5 milliliters 1
[** *] :
Provided that where the dose is below 5 milliliters the contents of active
ingredients may be expressed in terms of one milliliter;2
[or fraction thereof.]

1
[Provided further that where the single dose is more than 5 milliliters, the content of active
ingredients shall be expressed in terms of minimum single dose as approved by the licensing
authority.]
(b) for liquid parenteral preparations ready for administration in terms of 1 milliliters
or percentage by volume or per dose in the case of single dose container :
_____________________________________________________________________________
1Amended/Inserted by G.O.I. Notification No. GSR 285(E) dt 16.7.1996.
2
Ins. by G.O.I. Notification No. GSR 681(E) dt 5.12.1980.
142
Provided that if the preparation is contained in an ampoule it will be enough
of the composition is shown on the label or wrapper affixed to any package
in which such ampoule is issued for sale;
(c) for drugs in solid form intended for parenteral administration, in terms of
units or weight per milligram or gram;
(d) For tablets, capsules, pills and the like, in terms of the content in each tablet,
capsule, pill or other unit, as the case may be;
(e) for other preparations, in terms of percentage by weight or volume or in
terms of unitage per gram or milliliter, as the case may be:
Provided that clause (iii) shall not apply to the pharmacopoeial preparations
where the composition of such preparation where the composition of such
preparation is specified in the respective pharmacopoeia and to a preparation
included in the National Formulary of India;
(iv) 1
[The name of the manufacturer and the address of the premises of the manufacturer
where the drug has been manufactured.]
Provided that of the drug is contained in an ampoule or a similar small container, it
shall be enough if only the name of the manufacturer and his principal place of
1
[manufacture] is shown;
(v) A distinctive batch number, that is to say, the number by reference to which details
of manufacture of the particular batch from which the substance in the container is
taken are recorded and are available for inspection, the figure representing the batch
number being preceded by the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’
or ‘Lot’;
NOTE
(1) In the case of drugs manufactured by a continuous process, like manufacture of
magnesium sulphate, pharmaceutical chemicals etc., the production resulting in one
homogenous mix of the finished products shall be considered as one “Batch”.
(2) In the case of powders, liquid orals, ointments etc., one “Batch Number” shall be
assigned to all the containers filled from one homogenous bulk.
__________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 491(E) dt 25.7.1991.
143
(3) In the case of tablets, capsules, lozenges, troches, etc., one “Batch Number” shall be
assigned to the products manufactured from one homogenous mix ready for
compression or filling.
(4) In the case of parenteral preparations sterilized by steam under pressure, one “Batch
Number” shall be assigned to all containers filled from one homogenous bulk
solution and sterilized in one sterilizer load.
(5) In the case of containers of parenteral preparations filled from one homogenous bulk
solution and sterilized in more than one sterilizer load, the “Batch Number” assigned
to the containers in the different sterilizer loads shall be the same “Batch Number” as
is assigned to the homogenous bulk solution, provided the samples taken from all the
sterilizer loads pass the sterility test, and are kept separate from one another until the
report of the sterility test is available.
EXPLANATION :— For the purpose of chemical and other tests, representative samples
from all containers filled from the homogenous bulk solution should be taken.
(6) In the case of parenteral and other sterile products filled aseptically, a “Batch
Number” shall be assigned to all containers filled from one homogenous mix during
one filling operation, the filling operation being completed in a period of not more
than a day and during which no schedule change in the filling assembly is made.
When containers are filled from one homogenous mix, in a number of filling operations, the
“Batch Number” assigned to the containers filled in individual filling operations shall be the
same “Batch Number” as is assigned to the homogenous mix, provided the samples taken from
all the different filling operations pass the sterility tests, and are kept separate from one another
until the report of the sterility test is available.
EXPLANATION : — For the purpose of chemical and other tests, representative samples
from all containers filled from the homogenous mix should be taken.
(7) In the case of medicinal gases produced by a continuous process of operation a
week’s production from one tank load shall be considered as a Batch :
(vi) Every drug manufactured in India shall bear on its label the number of the licence
under which the drug is manufactured, the figure representing the manufacturing
licence number being preceded by the words “Manufcaturing Licence Number” or
“Mfg. Lic. No.” or “M.L.”;
(vii) Drugs specified in Schedule P and their preparations including combinations with
other drugs shall bear on their labels the date of manufacture, and the date of expiry
of potency, and the period between the date of manufacture and the date of expiry
144
shall not exceed that laid down in the said Schedule 1
[under the conditions of
storage specified therein. 2
[Drugs and their preparations not included in Schedule
P], shall bear on their labels the date of their manufacture and also the date of their
expiry which shall not exceed sixty months from the date of manufacture]
Provided that this period may be extended by the Licensing Authority specified in
clause (b) of rule 21 in respect of any specified drug if satisfactory evidence is
produced by the manufacturer to justify such an extension.
(viii)Drugs specified in Schedule C (1) and their preparations including combinations
with other drugs shall bear on the labels (a) the date of manufacture, (b) date of
expiry of potency fixed by the manufacturer, and (c) where such drugs are
imported, also the number of licence under which the drug is imported, preceded by
the words “Import Licence”
1
[Provided that drugs in bulk form included in Schedule C(I) which are not ready
for use and not included in Schedule P need not bear on the label the date of expiry
of potency;]
2 [Provided further] that no reference shall be made to any other licence number
granted by any authority outside India on any label or container or in any covering
in which the container is packed or in any other matter or advertisement enclosed
herewith;
(ix) Every drug intended for distribution to the medical profession as a free sample
shall, while complying with the labelling provisions under clauses (i) to (viii),
further bear on the label of the container the words ‘Physician’s Sample—Not to be
sold’ which shall be overprinted.
3
[(x) If any preparation contains not less than 3 per cent by volume of alcohol the
quantity of alcohol shall be stated in terms of the average percentage by volume of
absolute alcohol in the finished products.]
4
[(xi)In addition to the other particulars which are required to be printed or written under
these rules, the label of innermost container of the following categories of drugs and
every other covering in which the container is packed shall bear a conspicuous red
vertical line on the left side running throughout the body of the label which should
not be less than 1mm in width and without disturbing the other conditions printed
____________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 487(E) dt 2.7.1984 &
Subs. by G.O.I. Notification No.GSR 813(E) dt 27.7.1998.
2 Ins. by G.O.I. Notification No. GSR 487(E) dt 2.7.1984
3 Ins. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982
4 Ins. by G.O.I. Notification No. GSR 597(E) dt 17.6.1992.
145
on the label under these rules, namely:-
Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones,
hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anticancer drugs and all other drugs falling under Schedules ‘G’, ‘H’, and ‘X’ whether
covered or not in the above list:
Provided that the provisions of this clause shall not apply to.-
(a) preparations intended for animal treatment;
(b) preparations intended for external use;
(c) Ophthalmic preparations and ear drops; and
(d) Sterile preparations such as sutures, surgical dressings and preparations intended
for parenteral use.]
(2) (i) The particulars to be printed or written on the label of a mechanical contraceptive
shall be as specified in Schedule R.
(ii) The following particulars, in addition to those specified under sub-rule (i) shall be
either printed or written in indelible ink and shall appear in a conspicuous manner
on the label of the innermost container and on every other covering in which the
container of a contraceptive, other than a mechanical contraceptive, is packed,
namely :—
(a) the date of manufacture;
(b) the date upto which the contraceptive is expected to retain its properties;
(c) the storage conditions necessary for preserving the properties of the
contraceptive upto the date indicated in sub-clause (b) :
Provided that for oral contraceptives it shall be sufficient to display on the label of the
container the date of manufacture only.
(3) (i) The particulars prescribed in sub-rule (1) shall be printed or written in indelible
ink either on the label borne by a container of vaccine lymph or on a label or
wrapper affixed to any package in which the container is issued for sale. The said
particulars shall be indelibly marked on the sealed container of surgical ligature or
suture or printed or written in indelible ink on a label enclosed therein.
(ii) Nothing in these rules shall be deemed to require the labelling of any transparent
cover or of any wrapper, case or other covering used solely for the purpose of
packing, transport or delivery.
(4) Where be any provision of these rules any particulars are required to be displayed on
a label on the container, such particulars may, instead of being displayed on a label,
be etched, painted or otherwise indelibly marked on the container :
146
Provided that, except where otherwise provided in these rules, the name of the drug or
any distinctive letters intended to refer to the drug shall not be etched, painted or
otherwise indelibly marked on any glass container other than ampoules.
Explanation :— For the purpose of this rule, the date of expiry shall be in terms of month and
year and it shall mean that the drug is recommended till the last day of the month. The date of
expiry shall be preceded by the words ‘Expiry date’.
97. Labelling of medicines—
1
[(1) The container of a medicine for internal use shall—
(a) if it contains a substance specified in Schedule G, be labeled with the words
‘Caution: it is dangerous to take this preparation except under medical
supervision’ – conspicuously printed and surrounded by a line within which there
shall be no other words;
(b) if it contains a substance specified in Schedule H be labelled with the symbol Rx
and conspicuously displayed on the left top corner of the label and be also labelled
with the following words:
Schedule H drug- Warning : To be sold by retail on the prescription of a
Registered Medical Practitioner only.’,
(c) If it contains a substance specified in Schedule H, and comes within the purview
of the [Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] be
labeled with the symbol NRx which shall be in red and conspicuously displayed
on the left top corner of the label, and be also labeled with the following words:
Schedule H drug -“Warning:– To be sold by retail on the prescription of a
Registered Medical Practitioner only.”
(d) If it contains a substance specified in Schedule X, be labeled with the symbol XRx
which shall be in red conspicuously displayed on the left top corner of the label
and be also labeled with the words : –
Schedule X drug -“Warning:– To be sold by retail on the prescription of a
Registered Medical Practitioner only.”
(2) The container of a embrocation, liniment, lotion, 2
[ointment, antiseptic cream,] liquid
antiseptic or other liquid medicine for external application shall be labeled with the word in
capital ‘For External use only.’]]
_____________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
2 Subs. by G.O.I. Notification No. GSR 850(E) dt 7.12.1984.
147
1
(3)The container of a medicine made up ready only for treatment of an animal shall be
labelled conspicuously with the words ‘Not for human use; for animal treatment only’ and shall
bear a symbol depicting the head of a domestic animal.
(4) [ * * *] Omitted as per G.O.I. Notification No. 462 (E) dt 22.6.1982..
2[(4) The container of a medicine prepared for treatment of human ailments shall if the
medicine contains industrial methylated spirit, indicate this fact on the label and be labelled with
the words : “For External Use only”.
(5) Substances specified in Schedule X in bulk form shall bear a label wherein they symbol
as specified in sub-rule (1) shall be given conspicuously in red letters.]
[* * * Rules 98, 99, 100 and 101 deleted as per G.O.I. Notification No. GSR 462(E)
dt 22.6.1982].
3
[102. Non-Sterile Surgical Ligature and Suture.- Every container of, and wrapper enclosing
surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale
as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible
red ink the words “Non-sterile surgical ligature (suture) – not be used for operations upon the
human body unless efficiently sterilized”.
103[* * * (1) Omitted as per G.O.I. Notification No. F.1-16/57-D dt 6.6.1957.]
(2) The name and address of the manufacturer shall be printed on the label of the container
of a patent or proprietary medicine.
4
(3)The true formula or list of the ingredients shall be printed or written in indelible ink on
the outer label of every package containing patent or proprietary medicine.
5
[104 Use of letter I.P. etc.-The letters ‘I.P’. and recognized abbreviations of pharmacopoeias
and official compendia of drug standards prescribed under these rules shall be entered on the
label of the drug only for the purpose of indicating that the drug is in accordance with standards
set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of
drug standards recognized under the Rules.]
_____________________________________________________________________________
1Amended by G.O.I. Notification No. F.1-6/62-D dt 2.7.1969
2
Sub Rule (5) re-numbered as No.(4) & new sub-rule (5) ins. as per G.O.I. Notification 462(E) dt 22.6.1982.
3Amended by G.O.I. Notification No. F.1-3/51-DS dt 15.10.1954.
4Amended as per G.O.I. Notification No. F.1-16/57-D dt 6.6.1957
148
1
[104-A. Prohibition against altering inscriptions on containers, labels or wrappers of
drug. – No person shall alter, obliterate or deface any inscription or mark made or recorded
by the manufacturer on the container, label or wrapper of any drug.
Provided that nothing in this rule shall apply to any alteration, any inscription or mark
made on the container, label or wrapper of any drug at the instance or direction or with the
permission of the Licensing Authority.]
2
[105. Packing of drugs.— (1) The pack sizes of drugs meant for retail sale shall be as
prescribed in Schedule P-1 to these rules.
(2) The pack sizes of drugs not covered by the Schedule P-1 shall be as given below:
Unless specified otherwise in Schedule P-1,
(i) The pack sizes for Tablets/Capsules shall beWhere the number of Tablets (coated or uncoated)/Capsules (hard or soft
gelatin) is less than 10, such packing shall be made by the integral number. For
numbers above 10, the pack size of Tablets/Capsules shall contain multiples of
5.
(ii) The pack sizes for liquid Oral preparations shall be 30ml (paediatric only) 60
ml/100 ml/200 ml/450 ml.
(iii)The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.
(iv)The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml.
(v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm.
Provided that the provisions of the pack sizes covered under this rule shall not apply
to:
1. Pack sizes or dosage forms not covered by the foregoing provisions of
this rule.
2. The imported formulations in finished form.
3. Preparations intended for Veterinary use.
4. Preparations intended for Export.
5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral
forms, Unit dose (including applicaps).
6. Pack sizes of dosage form meant for retail sale to Hospitals, Registered
Medic al practitioners, Nursing Homes.
7. Physician’s Samples.
8. Pack sizes of large volume intravenous fluids.
Provided also that pack sizes of any of the new drug as and when approved by the
Licensing Authority appointed under Rule 21 and if not covered under this rule, shall be
examined for the purpose of approval with the specific justification by the said Licensing
Authority.]
3
[Provided further that Oxytocin injection meant for sale shall be in single unit blister
pack only.]
_______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 1242(E) dt 17.9.1979
2
Ins. by G.O.I.Notification No. GSR 796(E) dt 1.10.1992.
3
Ins. by G.O.I. Notification No. GSR 242(E) dt 3.4.2001.
149
1
[105-A. Packings of drugs specified in Schedule X.- The drugs specified in Schedule
X shall be marketed in packings not exceeding-
(i) 100 unit doses in the case of tablets/capsules.
(ii) 300ml in the case of oral liquid preparations.
(iii)And 5 ml in the case of injections.
Provided that nothing in this rule shall apply to packing meant for use of a hospital or
a dispensary subject to the conditions that-
(i) such supplied are made by the manufacturers or distributors direct to the
hospital/dispensaries; and
(ii) hospital packs shall not be supplied to a retain dealer or to a Registered
Medical Practitioner.]
2
[106. Diseases which a drug may not purport to prevent or cure.—(1) No drug may
purport or claim to prevent or cure or may convey to the intending user thereof any idea
that it may prevent or cure one or more of the diseases or ailments specified in Schedule J.
(2) No drug may purport or claim to procure or assist to procure, or may convey to the
intending user thereof any idea that it may procure or assist to procure, miscarriage in
women.
[ * * * Omitted as per G.O.I. Notification No. GSR 462(E) dt 22.6.1982.]
3
[PART IX-A
LABELLING AND PACKING OR HOMOEOPATHIC MEDICINES
106-A. Manner of labelling of Homoeopathic medicines.—(A) The following
particulars shall be either printed or written in indelible ink and shall appear in a
conspicuous manner on the label of the innermost container of any Homoeopathic
medicine and on every other covering in which the container is packed—
(i) The words ‘Homoeopathic medicine’,
(ii) The name of the medicine—
4
[(a) For drugs included in the Homoeopathic Pharmacopoeias of India or
the United States of America or the United Kingdom, or the
German Homoeopathic Pharmacopoeia, the name specified in that
Pharmacopoeia.]
(b) For other drugs, the name descriptive of the true nature of the drug.
_______________________________________________________________________
1
Ins.by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
2 Amended by G.O.I. Notification No. F. 1-16/52-DC, dated 22-6-1954.
3
.Ins.by G.O.I. Notification No. F. 1-63/61-D, dated 17.7.1963.
4
Subs. by G.O.I. Notification No. GSR 680(E) dt 5.12.1980.
150

(iii) The potency of the Homoeopathic medicine—For this purpose the potency
shall be expressed either in decimal, centesimal or millisimal systems.
1
[(iii-A) In case of Homoeopathic medicine containing two or more ingredients the
name of each ingredient together with its potency and proportion
expressed in metric system shall be stated on the label.]
2
(iv) Name and address of the manufacturer when sold in original containers of the
manufacturer. In case a Homoeopathic medicine is sold in a container other
than that of the manufacturer—the name and address of the seller.
(v) In case the Homoeopathic medicine contains alcohol, the alcohol content in
percentage by volume in terms of ethyl alcohol shall be stated on the label.
3 [Provided that in case that the total quantity of the pharmacopoeial Homoeopathic
medicine in the container is 30 milliliter or less, it will not be necessary to state the content
of alcohol in the label.]
(B) In addition to the above particulars the labels of a Homoeopathic mother tincture
shall display the following particulars: —
(i) a distinctive batch number, that is to say, the number by reference to which
details of manufacture of the particular batch from which the substance in the
container is taken are recorded and are available for inspection, the figures
representing the batch number being preceded by the words “Batch No.” or
“Batch” or “Lot Number” or “Lot No.” or “Lot” or any distinguishing prefix.
(ii) Manufacturing licence number, the number being preceded by the words
“Manufacturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.
4
Explanation:– This clause shall not apply to a Homoeopathic mother tincture
manufactured outside India.
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary
name on its label.
________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 466(E) dt 17.5.1994.
2
Amended by G.O.I. Notification No. F.1-59/68-D dated 19-11-1969.
3 Subs. by G.O.I. Notification No. GSR 108(E) dt 22.2.1994.
4 Ins. by G.O.I. Notification S.O. No. 2139 dated 12-8-1972.
151
1
[106-B. Prohibition of quantity and percentage.- No Homoeopathic medicine
containing more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing
or bottles of more than 30 millilitres, except that it may be sold to hospital/dispensaries in
packings or bottles of not more than 100 millilitres.]
PART X—SPECIAL PROVISIONS RELATING TO BIOLOGICAL AND OTHER SPECIAL
PRODUCTS
2
107. Name of substance.—If any substance specified in Schedule C is advertised or
sold as a proprietary medicine or is contained in a medicine so advertised or sold, the
proper name of the substance shall appear on the label in the manner prescribed in this
Part.
3
Explanation :– For the purpose of this rule the expression “Proper name” means the
proper name stated in Schedule F or if no such name is stated, the name descriptive of the
true nature and origin of the substance. Provided that in the case of veterinary biological
product the expression “proper name” means the proper name stated in Schedule F (1) or
if no such name is stated, the name or synonym given in the current edition for the time
being of the 5
[British Pharmacopoea (Veterinary)] , or, if no such name is stated either in
Schedule F (1) or the 5
[British Pharmacopoea (Veterinary)], the name descriptive of the
true nature and origin of the substance approved by the Licensing Authority.
108. Container.—4
(1) No substance specified in Schedule C shall be sold or offered
for sale unless it has been sealed in a previously sterilized container made of glass or any
other suitable material approved for the purpose by the Licensing Authority appointed
under rule 21, in such manner as may, in the opinion of the Licensing Authority, suffice to
preclude the access of bacteria.
Provided that it shall not be necessary to use a previously sterilized container if the
filled and sealed container is to be sterilized after the sealing and such sterilizing
procedure would render the product sterile. However, the Licensing Authority may, for
any special reasons, direct the licensee to pre-sterile such containers.
(2) When any such substance is issued in liquid form in containers which are sealed in
such a manner that portions of the contents can be withdrawn for use on different
occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the
growth of any organisms which may be accidentally introduced in the process of removing
a portion of the contents of the container.
_______________________________________________________________________
1 Ins, by G.O.I. Notification No. GSR 108(E) dt 22.2.1994 w.e.f. 22.6.1994.
2Amended by G.O.I. Notification No. F. 1-5/47-D, dated 25-11-1949.
3Amended by G.O.I. Notification No. F. 1-6/62-D, dated 2-7-69.
4Amended by G.O.I. Notification G.S.R. No. 245 dated 21-2-1976..
Subs by G.O.I. Notification No. G.S.R.647(E) dt 28.10.1998
152
Provided that nothing in this sub-rule shall apply to a penicillin suspension in oil and
water.
1
(3) The container shall comply with such further requirements, if any, as are specified
in Schedule F or Schedule F (1) as the case may be, in that behalf.
1
(4) The Licensing Authority may in the case of any particular preparation of any such
substance dispense with any such substance dispense with any of the requirements of this
Rule or Schedule F or Schedule F (1) as the case may be, and may make such additional
requirements, as having regard to the nature of the preparation, they may deem necessary.
2
109-Labelling-(1) The following particulars and such further particulars, if any, as are
specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in
indelible ink on the label of every phial, ampoule or other container of a substance
specified in Schedule C and on every other covering in which such phial, ampoule or
container is packed—
(a) where a drug is imported, the number of licence under which it is imported,
preceded by the words ‘Import Licence’:
Provided that no reference shall be made to any other import licence number
granted by any authority outside India on any label or container or in any
covering in which the container is packed or in any other matter of
advertisement enclosed therein.
(b) Where a test for potency in units is required by these rules, a statement of the
potency in units defined in terms of relation to the standard preparation
specified in Schedule F or F (1), as the case may be :
Provided that this clause shall not apply in the case of vaccine lymph.
(c) where a test for potency or maximum toxicity is required the date upto which
the substance if kept under suitable conditions may be expected to retain a
potency not less than stated on the label of the container or not to acquire a
toxicity greater than that permitted by the test, as the case may be. The date of
expiry shall be in terms of month and year and it shall mean that the drug is
recommended for use till the last day of the month. The date of expiry shall be
preceded by the words ‘Expiry date’ :
Provided that nothing in these rules shall be deemed to require the labelling
of any transparent cover or any wrapper, case or other covering used solely for
the purpose of packing, transport or delivery.
1Amended by G.O.I. Notification No. F.1-6/62-D dated 2-7-1969.
2Amended by G.O.I. Notification No. G.S.R.19 dated 7/1/1978.
153

(2) The particulars prescribed in clause (a) of the preceding sub-rule shall be printed or
written in indelible ink either on the label borne by a container of vaccine lymph or on a
label or wrapper affixed to any package in which the container is issued for sale. The said
particulars shall be indelibly marked on the sealed container of surgical ligature or suture
or printed or written in indelible ink on a label enclosed therein.
(3) The following particulars, and such further particulars and such further particulars,
if any, as are specified in Schedule F or schedule F (1), as the case may be, shall be printed
or written in indelible ink either on the label borne by the container of any substance
specified in Schedule C or on a label or wrapper affixed to any package in which any such
container is issued for sale, namely :–
(a) the date on which the manufacture of the particular batch from which the
substance in the container is taken was completed as defined in Schedule F
or Schedule F (1), or if there is no definition in Schedule F or Schedule (1)
as hereafter defined in this rule and in the case of vaccine prepared from
concentrates, the date of completion of the final products and the bottling
for issue;
(b) where an antiseptic substance has been added, the nature and the
percentage proportion introduced;
(c) the perception necessary for preserving the properties of the contents up to
the date indicated in clause (c) of sub-rule (1).
(4) For the purpose of clause (a) of sub-rule (3), the date on which the manufacture of
a batch is completed shall be—
(a) in cases where a test for potency or toxicity is required by these rules or
not being so required, is accepted by the Licensing Authority as sufficient
for the purpose of fixing the date of completion of manufacture, the date
on which the substance was removed from cold storage after having been
kept at a temperature not exceeding 5°C continuously for a period not
exceeding two years from the time when the last test was completed.
(b) in cases where no such test is required or accepted;
(i) if the substance is a serum obtained from a living animal, the
earliest date on which any material contributing to the batch was
removed from the animal;
(ii) if the substance was obtained by the growth of organisms or
artificial media, the earliest date on which growth was terminated
in any of the material contributing to the batch:
154
Provided that if a batch of the substance (including all material
contributing to this batch) has for a period of not more than three years
been kept in cold storage at a temperature not exceeding 5°C
continuously from the earliest practicable date after that on which growth
was terminated in the material as the case may be, the date of removal
from cold storage shall be treated as the date on which the manufacture of
the batch is completed.
(c) in all other cases, the date on which the substance is filled in the container.
1
[109-A. Labelling of Medical Devices.- The labeling of Medical Devices shall
conform to the Indian Standards Specifications laid down from time to time by the Bureau
of Indian Standards in addition to any other requirement prescribed under the said rules.]
110. Prohibition of sale of substance after prescribed date—No person shall sell, or
exhibit for sale any substance specified in Schedule C after the date recorded on the
container, label or wrapper as the date upto which the substance may be expected to retain
a potency not less than, or not to acquire a toxicity greater than that required or permitted
by the prescribed test as the case may be.
110-A.[ * * * Omitted by G.O.I. Notification No. GSR 1242(E) dt 17.9.1979.
2
111.Standards—Every substance specified in Schedule C and C (1) intended for sale
shall confirm with the standards of strength, quality and purity specified in these Rules
and in Schedule F or F (1), as the case may be, and the tests for determining such
conformity shall be applied to samples taken from the final product after every
manufacturing process has been completed.
2
112. Tests for strength and quality—The tests, if any, required for determining the
strength and quality of each of the substances specified in Schedules C and C (1) shall be
those set out in Schedule F or Schedule F (1) 3
[or as specified]as the case may be.
[* * * Rules 113 and 114 Omitted as per G.O.I. Notification G.S.R. No.663(E) dt 3.7.1992.]
115. Application of tests for sterility—The tests shall be applied—
(a) to samples taken from each batch of the substance before the operation of
filling and sealing the containers in which it is to be issues has commenced
except preparations, which after being sealed in the containers are to be
sterilized by heat, in a manner satisfactory to the Licensing Authority; and
(b) to the contents of sample containers when ready for issue.
____________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 109(E) dt 22.2.1994.
2Amended by G.O.I. Notification No. F.1-6/62-D, dated 2-7-1969.
155
[* * * Rules 116, 117 and 118 Omitted as per G.O.I. Notification No. GSR 663(E) dt 3.7.1992.]
119. (1) If at this examination no growth of micro-organisms is found in any tube, the
sample may be treated as having passed the test.
(2) If at the examination of a growth of micro-organisms is visible, further samples
may be taken and the tests may be repeated on the further samples taken: but no container
the contents of which form part of the batch shall be issued until such further samples have
passed the test. The process of taking samples from the batch for a test may be repeated
twice :
Provided that if the same organism is visible in more than one test the batch shall be
treated as not sterile and the material contained in the batch shall not be issued or used as
part of a further batch unless and until it has been re-sterilized and has passed the tests.
120. Notwithstanding anything contained in the last preceding Rule in any case
where—
(a) a substance is required in an emergency by a registered medical practitioner,
but the licensee has no filled containers in stock; or
(b) a substance which in the opinion of the Licensing Authority is so unstable in
solution that the delay occasioned by the completing of the sterility test on
filled containers would render its issue in active form impossible, the licensee
may issue the substance from a batch which has already passed the tests for
sterility and freedom from abnormal toxicity, without completing the sterility
test on the filled containers, provided that he complies with the following
conditions—
(i) the licensee shall before the issue take samples in the required
proportion from the containers into which the batch is filled, and after
the required inoculation shall examine the tube every day for five
days;
(ii) if at any examination any growth is visible in any of the tubes, he shall
immediately notify the Licensing Authority;
(iii) he shall keep available for inspection a record of all issues made under
this Rule containing such particulars of the circumstances in which
the issue is made as the Licensing Authority may require.
1[121. Test for freedom from abnormal toxicity—The test for freedom from abnormal
toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the case
of each batch of the serum tested by the licensee or by an institution approved by the
licensing authority for the purpose of carrying out the test on its behalf.]
_______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 753(E) dt 4.11.1999.
156
1
121-A Test for pyrogens—Solution of substances intended for parenteral
administration in large volumes (10ml or more at a time) shall be pyrogen-free and tested
for pyrogens. If water or any other adequate solvent is supplied along with the substances
preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.
122. Substances specified in Schedule C (1)—The following provisions shall apply in
the case of a substance specified in Schedule C (1):–
2
(a) The container shall comply with the requirements, if any, specified in
Schedule F or Schedule F (1), 3
[or as specified] as the case may be.
(b) [* * * Deleted as per G.O.I. Notific ation No. GSR 19 dt 7.1.1978].
2
(c) The substance shall conform to the standards of strength, quality and purity
specified in Schedule F or Schedule F (1) 3
[or as specified], as the case may
be and the tests for determining the strength, quality and purity of the
substance shall be those specified in Schedules F or Schedule F (1) 3[or as
specified,] as the case may be.
2
(d) The tests for determining the strength, quality and purity of a substance
specified in Schedule F or Schedule F (1) 3
[or as specified] as the case may
be shall be applied to samples taken from the final product after each
manufacturing process has been completed.
(e) The substance should be stored in a cool place and away from light.
4
[PART XA
IMPORT OF MANUFACTURE OF NEW DRUG FOR CLINICAL
TRIALS OR MARKETING
122-A. Application for permission to import new drug.-
5
[(1) (a) No new drug shall be
imported, except under, and in accordance with, the permission granted by the Licensing
Authority as defined in clause (b) of rule 21.
(b) An application for the grant of permission to import a new drug shall be made in
Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees.
Provided further that where a subsequent application by the same applicant for that
drug, whether in modified dosage form or with new claims, is made, the fee to accompany
such application shall be fifteen thousand rupees.
________________________________________________________________________
1Added under G.O.I. Notification No. F.1-27/56-D, dated 18-12-1956
2Amended by G.O.I.Notification no. F.1-6/62-D, dated 2-7-1969
3
Subs. by G.O.I. Notification No. GSR 663(E) dt 3.7.1992.
4 Ins. by G.O.I. Notification No. GSR 944(E) dt 21.9.1988
5
Subs. by G.O.I. Notification No. GSR 900(E) dt 12.12.2001.
157
Provided further that any application received after one year of the grant of approval
for the import and sale of new drug, shall be accompanied a fee of fifteen thousand rupees
and such information and data as required by Appendix I or Appendix I-A of Schedule Y,
as the case may be].
(2) The importer of a new drug when applying for permission under sub-rule (1), shall
submit data as given in Appendix I to Schedule Y including the results of local clinical
trials carried out in accordance with the guidelines specified in that Schedule and submit
the report of such clinical trials in the format given n appendix II to the said Schedule.
Provided that the requirement of submitting the results of local clinical trials may not
be necessary if the drug is of such a nature that the Licensing Authority may, in public
interest decide to grant such permission on the basis of data available from other countries.
Provided further that the submission of requirements relating to Animal Toxicology,
Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and
Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed
for several years in other countries if he is satisfied that there is adequate published
evidence regarding the safety of the drug, subject to the other provisions of these rules.
1
[(3) the Licensing authority, after being satisfied that the drug if permitted to be
imported as raw material (bulk drug substance) or as finished formulation shall be
effective and safe for use in the country, may issue an import permission in Form 45
and/or Form 45-A, subject to the conditions stated therein.
Provided that the Licensing Authority shall, where the data provided or generated on
the drug is inadequate, intimate the applic ant in writing, and the conditions, which shall be
satisfied before permission could be considered.]
122-B. Application for approval to manufacture new drug other than the drugs
classifiable under Schedules C and C(1).-
1
[(1)(a) No new drug shall be manufactured for
sale unless it is approved by the Licensing Authority as defined in clause (b) of Rule 21.
(b) An application for the grant of approval to manufacture the new drug and its
formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b)
of Rule 21 and shall be accompanied by a fee of fifty thousand rupees.
Provided that where the application is for permission to import a new drug (bulk drug
substance) and grant of approval to manufacture its formulation/s, the fee to accompany
such application shall be fifty thousand rupees only.
_____________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 900(E) dt 12.12.2001
158
Provided further that where a subsequent application by same applicant for that drug,
whether in modified dosage form or with the new claims, is made, the fee to accompany
such subsequent application shall be fifteen thousand rupees.
Provided further also that any application received after one year of the gran t of
approval for the manufacture for sale of the new drug, shall be accompanied by a fee of
fifteen thousand rupees and such information and data as required by Appendix 1 or
Appendix 1-A of Schedule Y, as the case may be.]
(2) The manufacturer of a new drug under sub-rule (1) when applying for approval to
the Licensing Authority mentioned in the same sub-rule, shall submit data as given in
Appendix 1 to Schedule Y including the results of clinical trials carried out in the country
in accordance with the guideline specified in Schedule Y and submit the report of such
clinical trials in the same format given in Appendix II to the said Schedule.
1
[(2-A) The Licensing authority, as defined in clause (b) of Rule 21 after being
satisfied that the drug if approved to be manufactured as raw material (bulk drug
substance) or as finished formulation shall be effective and safe for use in the country,
shall issue approval in Form 46 and/or Form 46-A, as the case may be, subject to the
conditions stated therein.
Provided that the Licensing Authority shall, where the data provided or generated on
the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be
satisfied before permission could be considered.]
(3) When applying for approval to manufacture a new drug under sub-rule (1) or its
preparations, to the State Licensing Authority, an applicant shall produce along with his
application, evidence that the drug for the manufacture of which application is made has
already been approved by the Licensing Authority mentioned in Rule 21.
Provided that the requirement of submitting the results of local clinical trials may not
be necessary if the drug is of such nature that the Licensing Authority may, in public
interest decide to grant such permission on the basis of data available from other countries.
Provided further that the submission of requirements relating to Animal Toxicology,
Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and
Carnicogenicity may be modified or relaxed in case of new drugs approved and marketed
for several years in other countries if he is satisfied that there is adequate polished
evidence regarding the safety of the drug, subject to the other provisions of these rules.
122-C [*** Deleted as per G.O.I. Notification No. GSR 900(E) dt 12.12.2001.]
1
[122-D. Permission to import or manufacture fixed dose combination.- (1) An
application for permission to import or manufacture fixed dose combination of two or ore
________________________________________________________________________
1 Ins./Subs. by G.O.I. Notification No. GSR 900(E) dt 12.12.2001
159
drugs as defined in clause (c) of Rule 122-E shall be made to the Licensing Authority as
defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of fifteen thousand
rupees and shall be accompanied by such information and data as is required in Appendix
VI of Schedule Y.
(2) The Licensing Authority after being satisfied that the fixed dose combination if
approved to be imported or manufactured as finished formulation shall be effective and
safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may
be, subject to the conditions stated therein.
Provided that the Licensing authority shall where the data provided or generated on the
fixed dose combination is inadequate, intimate the applicant in writing, and the conditions
which shall be satisfied before grant of approval/permission could be considered.
122-DA. Application for permission to conduct clinical trials for New
Drug/Investigational New Drug.- (1) No clinical trial for a new drug, whether for clinical
investigation or any clinical experiment by any institution, shall be conducted except
under, and in accordance with, the permission, in writing, of the Licensing Authority
defined in clause (b) of Rule 21.
(2) An application for grant of permission to conduct.-
(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing
Authority in Form 44 accompanied by a fee of fifty thousand rupees and
such information and data as required under Schedule Y.
(b) exploratory clinical trials (Phase-II) on a new drug shall be made on the
basis of data emerging from Phase I trial, accompanied by a fee of twentyfive thousand rupees;
(c) confirmatory clinical trials (Phase-III) on a new drug shall be made on the
basis of the data emerging from Phase-II and where necessary, data
emerging from Phase-I also, and shall be accompanied by a fee of twentyfive thousand rupees,
Provided that no separate fee shall be required to be paid along with application for
import/manufacture of a new drug based on successful completion of phases clinical trials
by the applicant.
Provided further that no fee shall be required to be paid along with the application by
Central Government or State Government Institutes involved in clinical research for
conducting trials for academic or research purposes.
(3) The Licensing Authority after being satisfied with the clinical trials, shall grant
permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be,
subject to the conditions stated therein.
160
Provided that the Licensing Authority shall, where the data provided on the clinical
trials is inadequate, intimate the applicant in writing, within six months from the date of
such intimation or such extended period, not exceeding a further period of six months, as
the Licensing Authority may, for reasons to be recorded in writing, permit, intimating the
conditions which shall be satisfied before permission could be considered.
Explanation.- For the purpose of these rules Investigational New Drug means a new
chemical entity or a product having therapeutic indication but which have never been
earlier tested on human beings.
122-DB. Suspension or cancellation of Permission/Approval.- If the improper or
manufacturer under this Part fails to comply with any of the conditions of the permission
or approval, the Licensing Authority may, after giving an opportunity to show cause why
such an order should not be passed, by an order in writing stating the reasons therefore,
suspend or cancel it.
122-DC. Appeal.- Any person aggrieved by an order passed by the Licensing
Authority under this Part, may within sixty days from the date of such order, appeal to the
Central Government, and the Central Government may, after such enquiry into the matter
as is considered necessary, pass such an order in relation thereto as it thinks fit.]
122-E. Definition of new drug.- For the purpose of this part, new drug shall mean and
include.-
1
[(a) A drug, as defined in the Act including bulk drug substance which has not
been used in the country to any significant extent under the conditions
prescribed, recommended or suggested in the labeling thereof and has not
been recognized as effec tive and safe by the licensing authority mentioned
under Rule 21 for the proposed claims.
Provided that the limited use, if any, has been with the permission of the licensing
authority.]
(b) A new drug already approved by the Licensing Authority mentioned in
Rule 21 for certain claims, which is now proposed to be marketed with
modified or new claims, namely, indications, dosage, dosage form
(including sustained release dosage form) and route of administration.
(c) A fixed dose combination of two or more drugs, individually approved
earlier for certain claims, which are now proposed to be combined for the
first time in a fixed ratio, or if the ratio of ingredients in an already
marketed combination is proposed to be changed, with certain claims, viz.
indic ations, dosage, dosage form (including sustained release dosage form)
and route of administration. (See items (b) and (c) of Appendix VI to
Schedule Y.)
________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 591(E) dt 17.8.1999.
161
Explanation.- For the purpose of this rule.-
(i) all vaccines shall be new drugs unless certified otherwise by the Licensing
Authority under Rule 21;
(ii) a new drug shall continue to be considered as new drug for a period of four
years from the date of its first approval or its inclusion in the Indian
Pharmacopoeia, whichever is earlier.]
1
[PART XB
REQUIREMENTS FOR THE COLLECTION, STORAGE,
PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD,
HUMAN BLOOD COMPONENTS BY BLOOD BANKS AND
MANUFACTURE OF BLOOD PRODUCTS.
2
[122-EA. Definitions.- (1) In this Part and in the Forms contained in Schedule A and
in Part XII-B and Part XII-C of Schedule F, unless there is anything repugnant in the
subject or context.-
(a) “apheresis” means the process by which blood drawn from a donor, after
separating plasma or platelets or leucocytes, is re-transfused
simultaneously into the said donor;
(b) “autologous blood” means the blood drawn from the patient for retransfusion into himself later on;
(c) ‘blood” means a place or organization or unit or institution or other
arrangements made by such organization, unit or institution for carrying
out all or any of the operations for collection, apheresis, storage,
processing and distribution of blood drawn from donors and/or for
preparation, storage and distribution of blood components.
(d) “blood bank” means a place or organization or unit or institution or other
arrangements made by such organization, unit or institution for carrying
out all or any of the operations for collection, apheresis, storage,
processing and distribution of blood drawn from donors and/or for
preparation, storage and distribution of blood components;
(e) “blood component” means a drug prepared, obtained, derived or separated
from a unit of blood drawn from a donor;
(f) “blood product” means a drug manufactured or obtained from pooled
plasma of blood by fractionation, drawn from donors;
________________________________________________________________________
1
Ins. By G.O.I. Notification No. GSR 28(E) dtd 22.1.1993.
2
Ins. by G.O.I. Notification No.245(E) dt 5.4.1999.
162
(g) “donor” means a person who voluntarily donates blood after he has been
declared fit after a medical examination, for donating blood, on fulfilling
the criteria given hereinafter, without accepting in return any
consideration
Explanation.- For the purposes of this clause, benefits or incentives like pins,
plaques, badges, medals, commendation certificates, time-off from work,
membership of blood assurance programme, gifts of little or intrinsic monetary
value shall not be construed as consideration.
(h) “leucapheresis” means the process by which the blood drawn from a
donor, after leucocyte concentrates have been separated is re-transfused
simultaneously into the said donor,
(i) “plasmapheresis” means the process by which the blood drawn from a
donor, after plasma has been separated, is re-transfused during the same
sitting into the said donor;
(j) “plateletpheresis” means the process by which the blood drawn from a
donor, after platelet concentrates have been separated, is re-transfused
simultaneously into the said donor.
(k) “professional donor” means a person who donates blood for a valuable
consideration, in cash or kind, for any source, on behalf of the recipientpatient and includes a paid donor or a commercial donor,
(l) “replacement donor” means a donor who is a family friend or a relative of
the patient-recipient.]
122-F. Form of application for licence for operation of Blood Bank/processing of
whole human blood for components/manufacture of blood products for sale or
distribution.- (1) Application for the grant and/or renewal of licence for the operation of a
Blood Bank/processing of human blood for components/manufacture of blood products
shall be made to the Licensing Authority appointed under Part VII in 1
[Form 27-C or
Form 27-E,as the case may be], and shall be accompanied by 2
[licence fee of rupees six
thousand and an inspection fee of rupees one thousand and five hundred for every
inspection thereof or for the purpose of renewal of licence].
Provided that if the applicant applies for renewal of licence after its expiry but within
six months of such expiry the fee payable for the renewal of the licence 2
[shall be rupees
six thousand and inspection fee of rupees one thousand five hundred plus an additional fee
at the rate of rupees one thousand per month or a part thereof in addition to the inspection
fee].
Provided further that a licensee holding a licence in 1
[Form 28-C or Form 28-E,as the
case may be,] for operation of Blood Bank/processing of whole human blood for
_____________________________________________________________________
1
Ins. by G.O.I. Notification No.245(E) dt 5.4.1999.
2 Subs, by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
163
components/manufacture of blood products shall apply for grant of licence under subrule(1) before the expiry of the said licence on 1
[Form 27-C or Form 28E, as the case may
be,] and he shall continue to operate the same till the orders on his application are
communicated to him.
2
[Explanation.- For the purpose of this rule, “Blood Bank” means a place or
organizational unit or an institution or other arrangement made by such organizational unit
or institution for carrying our all or any of the operations of manufacture of human blood
components, or blood products or whole human blood for its collection, storage,
processing, distribution from selected human donors.]
(2) A fee of 3
[rupees one thousand] shall be paid for a duplicate copy of a licence
issued under this rule, if the original is defaced, damaged or lost.
(3) Application by a licensee to manufacture additional drugs listed in the application
shall be accompanied by a 3
[fee of rupees three hundred] for each drug listed in the
application.
(4) On receipt of the application for the grant or renewal of such licence, the Licensing
Authority shall,-
(i) verify the statements made in the application form
(ii) cause the manufacturing the testing establishment to be inspected in
accordance with the provision of Rule 122-I and
(iii) in case the application is for renewal of licence, call for information of past
performance of the licence.
(5) If the Licensing Authority is satisfied that the applicant is in a position to fulfil the
requirements laid down in the rules, he shall prepare a report to that effect and forward it
2
[along with the application and the licence (in triplicate) to be granted or renewed, duly
completed] to the Central Licence Approving Authority.
Provided that if the Licensing Authority is of the opinion that the applicant is not in a
position to fulfil the requirements laid down in these rules, he may, by order, for reasons to
be recorded in writing, refuse to grant or renew the licence, as the case may be.
(6) If, on receipt of the application and report of the Licensing Authority referred to in
sub-rule (5) and after taking such measures including inspection of the premises, by the
Inspector, appointed by the Central Government under Section 21 of the Act, and/or along
with the Expert in the field concerned if deemed necessary, the Central Licence approving
authority is satisfied that the applicant is in a position to fulfil the requirements laid down
in these rules, he may grant or renew the licence, as the case may be.
_______________________________________________________________________
1
Ins. by G.O.I. Notification No.245(E) dt 5.4.1999.
2
Subs. by G.O.I. Notification No. GSR 89(E) dt 14.2.1996.
3
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001
164
Provided that if the Central Licence approving Authority is of the opinion that the
applicant is not in a position to fulfil the requirements laid down in these rules he may,
notwithstanding the report of the Licensing Authority, by order, for reasons to be recorded
in writing, reject the application for grant or renewal of licence, as the case may be, and
shall supply the applicant with a copy of the inspection report.
122-G. Form of Licence for the operation of a Blood Bank/processing of whole human
blood for components and manufacture of blood products and the conditions for the grant
or renewal of such licence.- A licence for the operation of a Blood Bank or for processing
whole human blood for components and manufacture of blood products shall be issued in
1
[Form 28-C or Form 28-E or Form 26-G or Form 26-I, as the case may be]. Before a
licence in 1
[Form 28-C or Form 28-E or Form 26-G or Form 26-I, as the case may be] is
granted or renewed the following conditions shall be complied with by the applicant:-
1
[(i) The operation of Blood Bank and/or processing of whole human blood for
components shall be conducted under the active direction and personal supervision of
competent technical staff consisting of at least one person who is whole-time employee
and who is Medical Officer, and possessing-
(a) Postgraduate degree in Medicine – M.D (Pathology/Transfusion Medicines);
or
(b) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion
Medicines having adequate knowledge in blood group serology, blood group
methodology and medical principles involved in the procurement of blood
and/or preparation of its components; or
(c) Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one
year during regular service and also has adequate knowledge and experience
in blood group serology, blood group methodology and medical principles
involved in the procurement of blood and/or preparation of its components.
the degree or diploma being from a University recognized by the Central Government.
Explanation.- For the purposes of this conditions, the experience in Blood Bank for
one year shall not apply in the case of persons who are approved by the Licensing
Authority and/or Central Licence Approving Authority prior to the commencement
of the Drugs and Cosmetics (Second Amendment) Rules, 1999].
(ii) The applicant shall provide adequate space, plant and equipment for any or
all the operations of blood collection or blood processing. The space, plant
and equipment required for various operation is given in Schedule ‘F’, Part
XII-B and/or XII-C.
________________________________________________________________________
1
Ins. by G.O.I. Notification No.245(E) dt 5.4.1999.
165
(iii) The applicant shall provide and maintain adequate technical staff as
specified in Schedule F, Part XII-B and/or XII-C.
(iv) The applicant shall provide adequate arrangements for storage of whole
human blood, human blood components and blood products.
(v) The applicant shall furnish to the Licensing Authority, if required to do so,
data on the stability of whole human blood, its components or blood
products which are likely to deteriorate, for fixing the date of expiry which
shall be printed on the labels of such products on the basis of the data so
furnished.
122-H. Duration of licence.- An original licence in 1
[Form 28-C or Form 28-E or a
renewed licence in Form 26-G or Form 26-I] unless sooner suspended or cancelled shall
be 2
[valid for a period of five years on and from the date on which] it is granted or
renewed.
122-I. Inspection before grant or renewal of licence for operation of Blood Bank,
processing of whole human blood for components and manufacture of blood products.-
Before a licence in 1
[Form 28-C or Form 28-E is granted or a renewal of licence inform
26-G or Form 26-I is made, as the case may be,] the Licensing Authority or the Central
Licence Approving authority, as the case may be, shall cause the establishment in which
Blood Bank is proposed to be operated/whole human blood for components is processed/
blood products are manufactured to be inspected by one or more Inspectors, appointed
under the Act and/or along with the Expert in the field concerned. The Inspector or
Inspectors shall examine all portions of the premises and appliance/equipments and
inspect the process of manufacture intend to be employed or being employed along with
the means to be employed or being employed for operation of blood bank/processing of
whole human blood for components/manufacture of blood products together with their
testing facilities and also enquire into the professional qualification of the expert staff and
other technical staff to be employed.
122-J. Report by Inspector.- The Inspector or Inspectors shall forward a detailed
descriptive report giving his findings on each aspect of inspection along with his
recommendation in accordance with the provisions of Rule 122-I to the Licensing
Authority or to the Central Licence Approving Authority.
122-K. Further application after rejection.- If within a period of six months from the
rejection of application of a licence the applicant informs the Licensing Authority that the
conditions laid down have been satisfied and deposits an inspection 2
[fee of rupees two
hundred and fifty] the Licensing Authority may, if after causing further inspection to be
made is satisfied that the conditions for the 1
[grant or renewal of a licence have been
complied with, shall grant or renew the licence in Form 28-C or Form 28-E.
_______________________________________________________________________
1
Ins. by G.O.I. Notification No.245(E) dt 5.4.1999
2
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001
166
Provided that in the case of a drug notified by the Central Government under rule 68-
A, the application, together with the inspection report and the Form of licence (in triplicate
to be granted or renewed), duly completed shall be sent, to the Central Licence approving
Authority, who may approve the same and return it to the Licensing Authority for issue of
the licence.]
122-L. Delegation of powers by the Central Licence Approving Authority.- The
Central Licence Approving Authority may, with the approval of the Central Government,
by notification delegate his powers of signing licences and any other power under rules to
persons under his control having same qualifications as prescribed for Controlling
Authority under rule 50-A, for such areas and for such period as may be specified.
122-M. Provision for appeal to the State Government by a party whose licence has not
been granted or renewed.- Any person who is aggrieved by the order passed by the
Licensing Authority or Central Licence Approving Authority, as the case may be, may
within thirty days from the date of receipt of such order, appeal to the State Government or
Central Government, as the case may be, after such enquiry into the matter as it considers
necessary and after giving the said person an opportunity for representing his view in the
matter may pass such order in relation thereto as it thinks fit.
122-N. Additional information to be furnished by an applicant for licence or by a
licensee to the Licensing Authority.- the applicant for the grant of licence or any person
granted a licence under the Part shall, on demand furnish to the Licensing Authority,
before the grant of the licence or during the period the licence is in force, as the case may
be, documentary evidence in respect of the ownership or occupation, rental or other basis
of the premises, specified in the application for licence or in the licence granted,
constitution of the firm or any other relevant matter, which may be required for the
purpose of verifying the correctness obtaining the licence, as the case may be.
122-O. Cancellation and suspension of licences.- (1) The Licensing Authority or
Central Licence Approving Authority may for such licences granted or renewed by him
after giving the licensee an opportunity to show cause why such an order should not be
passed by an order in writing stating the reason thereof, cancel a licence issued under this
part or suspend it for such period as he thinks fit, either wholly or in respect of some of the
substances to which it relates 1
[or direct the licensee to stop collection, storage,
processing, manufacture and distribution of the said substances and 2
[thereupon order the
destruction of substances and] stocks thereof in the presence of an Inspector], if in his
opinion, the licensee has failed to comply with any of the conditions of the licence or with
any provision of the Act or Rules thereunder.
(2) A licensee whose licence has been suspended or cancelled may, within three
months of the date of the order under sub-rule(1) prefer an appeal against the order to the
State Government or Central government, which shall decide the same.
_______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 20(E) dt 11.1.1996.
2
Subs. by G.O.I. Notification No. GSR 514(E) dt 5.11.1996.
167
122-P. Conditions of licence.-
1
[A licence in Form 28-C, Form 28-E, Form 26-G or
Form 26-I shall be subject to the special conditions set out in Schedule F, Part XII-B and
Part XII-C, as the case may be, which relate to the substance in respect of which the
licence is granted or renewed and to the following general conditions, namely:-]
(i) (a) The licensee shall provide and maintain adequate staff, plant and premises
for the proper operation of a Blood Bank for processing whole human
blood, its components and/or manufacture of blood products.
(b) The licensee shall maintain staff, premises and equipment as specified in
Rule 122-G. the licensee shall maintain necessary records and registers as
specified in Schedule F, Parts XII-B and XII-C.
(c) The licensee shall test in his own laboratory whole human blood, its
components and blood products and maintain records and registers in
respect of such tests as specified in Schedule F, Parts XII-B and XII-C.
The records and register shall be maintained for a period of five years
from the date of manufacture.
(d) The licensee shall maintain/preserve reference sample and supply to
collect the Inspector the reference sample of the whole human blood
collected by him in an adequate quantity to conduct all the prescribed
tests. The licensee shall supply to the Inspector the reference sample for
the purpose of testing.
(ii) The licensee shall allow an Inspector appointed under the Act to enter, with or
without prior notice, any premises where the activities of the Blood Bank and
are being carried out for the processing of Whole Human Blood and/or Blood
Products, to inspect the premises and plant and the process of manufacture and
the means employed for standardizing and testing the substance.
(iii) The licensee shall allow an Inspector appointed under the Act to inspect all
registers and records maintained under these rules and to take samples of the
manufactured product and shall supply to the Inspector such information as he
may require for the purpose of ascertaining whether the provisions of the Act
and rules thereunder have been observed.
(iv) The licensee shall from time to time report to the Licensing Authority any
changes in the expert staff responsible for the operation of a Blood
Bank/processing of whole human blood for components and/or manufacture of
blood products and any material alterations in the premises or plant used for
that purpose which have been made since the date of last inspection made on
behalf of the Licensing Authority before the grant of the licence.
(v) The licensee shall on request furnish to the Licensing Authority, or Central
Licence Approving Authority or to such Authority as the Licensing Authority,
or the Central Licence Approving Authority may direct, from any batch unit or
drugs as the Licensing Authority or Central Licence Approving Authority may
from time to time specify, sample of such quantity as may be considered
adequate by such Authority for any examination and, if so required, also furnish
full protocols of the test which have been applied.
168
(vi) If the Licensing Authority of the Central Licence Approving Authority so
directs, the licensee shall not sell or offer for sale any batch/unit in respect of
which a sample is, or protocols are furnished under the last preceding subparagraph until a certificate authorizing the sales of batch/unit has been
issued to him by or on behalf of the Licensing Authority or the Central
Licence approving Authority.
(vii) The licensee shall on being informed by the Licensing Authority or the
Controlling Authority that any part of any batch/unit of the substance has
been found by the Licensing Authority or the Central Licence Approving
Authority not to conform with the standards of strength, quality or purity
specified in these Rules and on being directed so to do, withdraw, from sales
and so far as may in the particular circumstances of the case be practicable
recall all issues already made from that batch/unit.
(viii) No drug manufactured under the licence shall be sold unless the precautions
necessary for preserving its properties have been observed throughout the
period after manufacture. Further no batch/unit manufactured under this
licence shall be supplied/distributed to any person without prescription of a
Registered Medical Practitioner.
(ix) The licensee shall comply with the provisions of the Act and of these Rules
and with such further requirements, if any, as may be specified in any Rules
subsequently made under Chapter IV of the Act, provided that where such
further requirements are specified in the Rules, these would come in force
four months after publication in the Official Gazette.
(x) The licensee shall maintain an Inspection Book in Form 35 to enable an
Inspector to record his impression and defects noticed.
(xi) The licensee shall destroy the stock of batch/unit which does not comply with
standard tests in such way that it would not spread any disease/infection by
way of proper disinfection method.
1
[(xii) All bio -medical waste shall be treated, disposed of or destroyed as per the
provisions of the Bio -Medical Wastes (Management and Handling) Rules,
1996.
(xii) The licensee shall neither collect blood from any professional donor or paid
donor nor shall he prepare blood components and/or manufacture blood
products from the blood drawn from such a donor.]
PART XI-EXEMPTION
123. The drugs specified in schedule K shall be exempted from the provisions of
Chapter IV of the Act and the Rules made thereunder to the extent and subject to the
conditions specified in that Schedule.
_______________________________________________________________
1
Ins. by G.O.I. Notification No.245(E) dt 5.4.1999
169
PART XII
STANDARDS
1
124—Standards of drugs:–
(1) Drugs included in the Indian Pharmacopoeia–
(a) The standards for identity, purity and strength shall be those as may be
specified in the edition of the Indian Pharmacopoeia for the time being in
force.
(b) In case the standards for identity, purity and strength for drugs are not
specified in the edition of the Indian Pharmacopoeia for the time being in
force but are specified in the edition of the Indian Pharmacopoeia
immediately preceding, the standards for identity, purity and strength shall
be those occurring in such immediately preceding edition of the Indian
Pharmacopoeia.
(2) For other drugs–
(a) The standards for identity, purity and strength shall be those as may be
specified in the edition of the official pharmacopoeia, for the time being in
force, of any country to which the drug claims to comply with,
(b) In case the standards for identity, purity and strength for drugs are not
specified in the edition of such official pharmacopoeia for the time being in
force, but are expected in the edition immediately preceding, the standards
for identity, purity and strength shall be those occurring in such immediately
preceding edition of such official pharmacopoeia to which the drug claims to
comply with.
(c) For drugs for which standards are not included in the edition of the official
pharmacopoeia, for the time being in force, of any country or in edition
immediately preceding, but included in the official compendia of drug
standards, namely, the British Pharmaceutical Codex or the National
Formulary of the United States, for the time being in force, to which the drug
claims to comply with.
2
124A.Standards for veterinary drugs—For drugs intended for veterinary use, the
standards shall be those given in the current edition for the time being in force of the
3
[British Pharmacopoeia (Veterinary)].
4
124-B Standards for patent or proprietary medicines: — The standards for patent or
proprietary medicines shall be those laid down in Schedule V and such medicines shall
also comply with the standards laid down in the Second Schedule to the Act.
________________________________________________________________________
1Amended by G.O.I. Notification No. GSR 19 dt 7.1.978.
2Amended by G.O.I. Notification No. F. 1-6/62-D dt 2.7.1969.
3
Subs. by G.O.I. Notification No. GSR 647(E) dt 28.10.1998.
4
Ins. by G.O.I. Notification No. GSR 665 dt 28.5.1977.
170
1
[124-C. Standards for Surgical Dressings. – The standards for Surgical Dressing shall
be such as are laid down in Schedule F (II).]
2
[124-D. Standards for Sterilised Umbilical tapes.- The standards for Sterilised
Umbilical tapes shall be as laid down in Schedule F(III).]
3
125. Standards for substances (other than food) intended to affect the structure or any
function of human body—contraceptives—(1) The standards for mechanical
contraceptives shall be such as are laid down in Schedule R.
(2) The standards which other contraceptives will have to comply with shall be in
conformity with the formulae approved as safe and efficacious by the Central
Government. Such formula shall be displayed on the label of every container of such
contraceptive.
4
[125-A. Standards for Medical Devices.- the standards for the Medical Devices shall
be such as are laid down in Schedule R-1.]
5
126. Standards for substances intended to be used for the destruction of vermin or
insects which cause disease in human beings or animals.
Disinfectants.
The standards of disinfectants shall be such as are laid down in Schedule O.
6
126-A Standards for ophthalmic preparations7
[including Homoeopathic
ophthalmic preparations] —The standards for ophthalmic preparations 7
[including
Homoeopathic ophthalmic preparations]shall be those laid down in Schedule FF., and
such preparations shall also comply with the standards set out in the Second Schedule to
the Act.
________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 318(E0 dt 1.5.1984.
2 Ins. by G.O.I. Notification No. GSR 1115(E) dt 13.9.1986.
3 Amended by G.O.I. Notification No. F-1-28/65D dt 8.3.1966
4 Ins. by G.O.I. Notification No. GSR 109(E) dt 22.2.1994.
5
Amended by G.O.I. Notification No. F.1-20/60-D dt 24.1.1964.
6 Ins. by G.O.I. Notification No. 1-113/60-D dt 23.12.1969
7
Subs. by G.O.I. Notification No. GSR 245(E) dt 17.6.1996.
171
1
127. List of colours permitted to be used in drugs—(1) No drug shall contain a colour
other than specified below : —
(1) Natural Colours
Annatto
Carotene
Chlorophyll
Cochineal
Curcumin
Red Oxide of Iron
Yellow Oxide of Iron

4
Titanium Dioxide

2
[Black Oxide of iron]
(2) Artificial Colours
Caramel
3
[Riboflavin]
(3) Coal Tar Colours
Common name of the
colour
Colour Index
Number
Chemical Name
1 2 3
GREEN
Quinazarine Green S.S. 61565 1, 4-bis (p-Toluino) anthra-quinone
Alizarin Cyanine Green F. 61570 Disodium salt of 1, 4-bis (O-sulfo-pToluino) anthra-quinone
4
Fast Green F.C.F. 42053 Disodium salt of 4-{[4-(N-ethylpsulfobenzylamino)-phenyl-]-(4-
hydroxy-2- sulfoniumphenyl)-
methylene]
[1-(N-ethyl-N-p-sulfobenzyl]?
2, 5-cyclohexadienimine]-
[* * * Green S- Omitted by G.O.I. Notification No.GSR 753(E) dt 4.11.1999.]
YELLOW
Tartrazine 19140 Trisodium salt of 3-carboxy-5-
Hydroxyl-1-p-sulfophenyl-4-p
Sulfophenylazopyrazole
Sunset Yellow FCF 15985 Disodium salt of 1-p-sulfophenyl Azo2-naphthol-6-sulfonic acid.
________________________________________________________________________
1Amended by G.O.I. Notification S.O.No. 289 dt 3.2.1973
2
Ins. by G.O.I. Notification No. GSR 370(E) dt 7.4.1994.
3
Ins. by G.O.I. Notification No. GSR 681(E) dt 6.6.1988.
4
Ins. by G.O.I. Notification No. X.11013/3/76-DM.S dt 19.8.1978.
172
1
[Quinoline Yellow WS 47005 Disodium salt of disulfonic acid of 12-(2-
quinolyl)-1, 3-indandione.
RED
[* * * ‘Amaranth’-Omitted by G.O.I. Notification No.GSR 753(E) dt 4.11.1999.]

Erythrosine 45430 Disodium salt of 9-0-carboxypheny l6-
hydroxy 2,4-5,7-tetriodo-3-isoxanthone
Eosin YS or Eosine G 45380 Disodium of salt of 2,4,5, 7-Tetrabromo 9-
p-carboxyphenyl-6-hydroxy 3-isoxanthone.
Toney Red or Sudan III 26100 1-p-phenylazophenylazo-2-naphthol.
Ponceau 4 R 16255 Trisodium salt of 1-(4-sulpho-1-1-
Napthylazo)-2 napthol-6 : 8-disulphonic
acid.
Carmoisine 14720 Disodium salt of 2-(4-sulpho-1-napThylazo)-1 napthol-4 sulphonic acid
[* * * ‘Fast Red’- Omitted by G.O.I. Notification No.GSR 753(E) dt 4.11.1999.]
BLUE
Indigo Carmine
73015 Disodium salt of indigotin-5 : -5 Disu
lphonic Acid
1Brilliant Blue FCF 42090 Disodium salt of 4-[ {4-(N-ethyl-psulfobenzylamino)-phenyl }-](2- sulfo -nium
phenyl)-methylene)-1-(N- ethyl-N-psulfobenyl)- ? 2, 5-cyclohexadienimine
ORANGE
Orange G 16230 Disodium salt of 1-phenylaze-2- naphthol-6,
8-disulfonic acid.
BROWN
Resorcin Brown 20170 Monosodium salt of 4-p- sulfophenylazo-2-
(2, 4-xylylazo)-1, 3 resorcinol.
BLACK
Naphthol Blue Balck 20470 Disodium salt of 8-amino-7-p-nitrophenylazo-2-phenylazo-1-naphthol-3, 6-
disulfonic acid.
______________________________________________________________________
1
Ins. by G.O.I. Notification No. X.11013/3/76-DM.S dt 19.8.1978.
173
(4) LAKES
The Aluminum or calcium salts (lakes) of any of the water-soluble
colours listed above.
(2) The label on the container of a drug containing a permitted colour shall indicate the
common name of the colour.
128. The following rules are hereby repealed except as respect things done or omitted
to be done under these rules, namely :—
Andhra Pradesh Drugs Rules, 1945.
Assam Drugs Rules, 1945.
Bihar Drugs Rules, 1945.
Bombay Drugs Rules, 1946.
East Punjab Drugs Rules, 1945.
C.P. & Berar Drugs Rules, 1945.
Madras Drugs Rules, 1945.
Orissa Drugs Rules, 1945.
Saurashtra Drugs Rules, 1953.
Travancore-Cohin Drugs Rules, 1953.
United Provinces Drugs Rules, 1945.
West Bengal Drugs Rules, 1946.
Mysore Drugs Rules, 1954.
1
PART XIII-IMPORT OF COSMETICS
129. Statement to accompany imported cosmetics—All consignments of cosmetics
sought to be imported shall be accompanied by an invoice or statement showing the name
and quantities of each article of cosmetic included in the consignment and the name and
address of the manufacturer.
130. Documents to be supplied to the Collector of Customs—Before any cosmetics are
imported, a declaration signed by or on behalf of the manufacturer or by on behalf of the
importer that the cosmetics comply with the provisions of Chapter III of the Act, and the
Rules made there under, shall be supplied to the Collector of Customs.
131. Procedure for the import of cosmetics. – If the officer appointed at the post of
entry by the Central Government has reason to believe that any cosmetic contravenes any
of the provisions of the Act or the rules made thereunder he may take sample of the
cosmetic from the consignment for inspection. If on examination of the sample defects are
noticed the officer shall advise the Collector of customs for further action to be taken.
______________________________________________________________________
1Added under G.O.I. Notification No. F. 1-36/64-D, dated 17-8-1961.
174
If the suspected contravention of the provisions of the Act or the Rules is such as may
have to be determined by test, the officer shall send the sample to the laboratory
established for the purpose for performing such that the test report on such sample is
received from the Director of the said laboratory or any other officer of the laboratory
empowered by him in this behalf with the approval of the Central Government.
Provided that if the importer gives an undertaking in writing not to dispose of the
cosmetic without the consent of the Collector of Customs and to return the consignment or
such portion thereof, he shall return the consignment or such portion thereof as may be
required, the Collector of Customs shall make over the consignment to the importer.
(2) If the importer who has given an undertaking under the proviso to sub-rule (1) is
required by the Collector of Customs to return the consignment or portion thereof, he shall
return the consignment or portion thereof within ten days of receipt of the notice.
Further procedure on receipt of the report of analysis
(3) If the Direc tor of the Laboratory established for the purpose by the Central
Government or any other officer of the laboratory empowered by him in this behalf with
the approval of the Central Government, reports to the Collector of Customs or to the
officer mentioned in sub-rule (1) above that the sample of any cosmetic in a consignment
contravenes the provisions of Chapter III of the Act or the Rules made there under and that
the contravention is such that it cannot be remedied by the importer, the Collector of
Customs shall communicate the report forthwith to the importer who shall within two
months of receiving such a communication either send back all cosmetic of that
description to the country in which it was manufactured or to the country from which it
was imported or hand it over to the Central Government which shall cause it to be
destroyed.
Provided that the importer may within thirty days of receipt of the report make a
representation against the report to the Collector of Customs who shall forward the
representation with a fresh sample of the cosmetic to the Drugs Controller, India, who
after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory
shall pass orders thereon which shall be final.
(4) If the Drugs Controller or any other empowered by him in this behalf with the
approval of Central Government reports to the Collector of Customs after the inspection of
the sample of cosmetic and if necessary, after obtaining a test report thereon that the
sample of the said cosmetic contravenes in any respect the provisions of Chapter III of the
Act or the Rules made thereunder but that the contravention is such that it can be remedied
by the importer, the Collector of Customs shall communicate the report forthwith to the
importer and permit him to import the cosmetic on his giving an undertaking in writing
not to dispose of the cosmetic without the permission of the officer authorised in this
behalf by the Central Government.
175
132. Exemption of cosmetics—Cosmetics as may be specified in Schedule D shall be
exempted from the provisions of Chapter III of the Act and the Rules made thereunder to
the extent and subject to the conditions specified in that Schedule.
133. Import through points of entry—No cosmetic shall be imported into India except
through the points of entry specified in rule 43A.
1
[134. Cosmetic to contain Dyes, Colours and Pigments.- No Cosmetic shall contain
Dyes, Colours and Pigments other than those specified by the Bureau of Indian Standards
(IS:4707 Part 1 as amended) and Schedule Q.
The permitted Synthetic Organic Colours and Natural Organic Colours used in the
Cosmetic shall not contain more than:-
(i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii)100 parts per million of heavy metals other than lead calculated as
the total of the respective metals.]
2
134-A Prohibition of import of cosmetic containing Hexachlorophene— No
cosmetic containing hexachlorophene shall be imported.
135. Import of cosmetic Lead or Arsenic compound prohibited—No cosmetic shall be
imported in which a Lead or Arsenic compound has been used for purposes of colouring.
3
135-A. Import of cosmetics containing mercury compounds prohibited. No cosmetic
shall be imported which contains mercury compounds.
136. Import of cosmetic for personal use—Small quantities of cosmetics the import of
which is otherwise prohibited under section 10 of the Act, may be imported for personal
use subject to the following conditions: —
(j) The cosmetics shall form part of a passenger’s baggage and shall be the
property of and intended for, the bonafide use of the passenger; and
(ii) The cosmetics shall be declared to the Customs authorities, if they so
direct.
4
[PART XIV—MANUFACTURE OF COSMETIC FOR
SALE OR FOR DISTRIBUTION]
________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 811(E) dt 14.11.1994.
2Added by G.O.I. Notification No. G.S.R. 116 dated 25-1-1975.
3 Ins. by G.O.I. Notification No. X.11013/76-D & MS dt 19.8.1978.
4 Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
176
137. Manufacture on more than one set of premises—If cosmetics are manufactured
on more than one premises, a separate application for each such premises shall be made
and a separate licence obtained for each such premises.
138. Application for licence to manufacture cosmetics—(1) Application for grant or
renewal of licence to manufacture any cosmetic for sale 1
[shall be made up to ten items of
each category of cosmetics categorized in Schedule M-II to the Licensing Authority
appointed by the State Government for the purpose of this Part (hereafter’ in this Part
referred to as the Licensing Authority) in Form 31 and shall be accompanied by a fee of
rupees two thousand and five hundred and an inspection fee of rupees one thousand for
every inspection thereof or for the purpose of renewal of licence.]
[* * * Omitted as per G.O.I. Notification No. GSR 331-E dt 8.5.1984]
.
(2) If a person applies for the renewal of licence after expiry but within six months of
such expiry, the fee payable for the renewal of such licence shall be 1
[rupees two thousand
five hundred plus an additional fee at the rate of rupees four hundred per month or part
thereof in additional to an inspection fee of rupees one thousand.]
[* * * Omitted as per G.O.I. Notification No. GSR 331-E dt 8.5.1984]
(3) Application by a licensee to manufacturer additional items of cosmetics shall be
accompanied by a fee of 1
[rupees one hundred for each item subject to a maximum of
rupees three thousand for each application.]
[* * * Omitted as per G.O.I. Notification No. GSR 331-E dt 8.5.1984]
(4) A fee of 1
[rupees two hundred and fifty] shall be paid for a duplicate copy of a
licence under sub-rule (1) and the proviso to sub-rule (1) respectively if the original is
defaced, damaged or lost.
2
138-A Application for loan licence to manufacture cosmetics .-
(1) Application for grant or renewal of a loan licence for the manufac ture for sale of
cosmetics 1
[shall be made up to ten items of each category of cosmetics
categorized in Schedule M-II in Form 31-A to the Licensing Authority and shall
be accompanied by a licence fee of rupees two thousand and five hundred and an
inspectio n fee of rupees one thousand foe every inspection thereof].
Explanation—For the purpose of this rule a ‘loan licence’ means a licence, which a
Licensing Authority may issue to an applicant who does not have his own
arrangements to manufacture but who intends to avail himself of the manufacturing
facilities owned by a licensee in Form 32.
______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
2 Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973.
177
(2) If a person applies for the renewal of a loan licence after the expiry but within six
months of such expiry, the fee payable for the renewal of such a licence 1
[shall
be rupees two thousand and five hundred plus an additional fee at the rate of
rupees four hundred for each month or part thereof.]
(3) The Licensing Authority shall before the grant of a loan licence satisfy himself
that the manufacturing unit has adequate equipments, staff, capacity for
manufacture and facilities to undertake the manufacture on behalf of the
applicant for a loan licence.
(4) The loan licence shall be granted by the Licensing Authority to only such
applicants who propose to avail of the facilities of manufacture of cosmetics in
the premises of a manufacturer located in the same State where the applicant is
located. In case the manufacture of cosmetic involves any special process of
manufacture or use of equipments which are not available in the State where the
applicant is located, the Licensing Authority after consulting the Licensing
Authority where the manufacturing unit is located, may grant the loan licence.
(5) Subject to the provisions of sub-rule (2), application for manufacture of
additional items on a loan licence shall be accompanied by fee of 1
[rupees one
hundred for each item subject to a maximum of rupees three thousand per
application.]
(6) A fee of 1
[rupees two hundred and fifty] shall be paid for a duplicate copy of a
licence issued under sub-rule (1) if the original is defaced, damaged or lost;
139. Conditions for the grant or renewal of a licence in Form 32—Before a licence in
Form 32 is granted or renewed, the following conditions shall be compiled with by
applicant:
(1) The manufacture shall be conducted under the direction and personal supervision
of a competent technical staff consisting of at least one person who is a whole time
employee and who possesses any one of the following qualifications:
(a) holds a Diploma in Pharmacy approved by the Pharmacy Council of India
under the Pharmacy Act, 1948 (8 of 1948), or .
(b) is registered under the Pharmacy Act, 1948 (8 of 1948), or
(c) has passed the Intermediate Examination with Chemistry as one of the
subjects or an examination recognized by the Licensing Authority as
equivalent to it.
[* * * Omitted as per G.O.I. Notification No. GSR 331-E dt 8.5.1984]
[* * * Omitted as per G.O.I. Notification No. GSR 331-E dt 8.5.1984]
______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
178
.
1
[(2) The factory premises shall comply with the requirements and conditions specified
in Schedule M-II.
[* * * Omitted as per G.O.I. Notification No. GSR 723-E dt 11.8.1982.]
[* * * Omitted as per G.O.I. Notification No. GSR 723-E dt 11.8.1982.]
(5) The applicant shall either–
(i) provide and maintain adequate staff, premises and laboratory equipment for
testing the cosmetic manufactured, and the raw materials used in the
manufacture; or
(ii) make arrangements with some institution appro ved by the Licensing
Authority under Part XV (A) of these rules for such tests to be regularly
carried out in this behalf by the institution.
2
139-A Form of 3
[ licence to manufacture cosmetics for sale or for distribution]—A
3
[licence to manufacture cosmetic for sale or for distribution] against application in Form
31, shall be granted in Form 32.
4
[139AA.Inspection before grant or renewal of licence.- Before a licence under this
part is granted or renewed in Form 32, Form 32-A or Form 3, the Licensing Authority
shall cause the establishment, in which the manufacture is proposed to be conducted or
being conducted, to be inspected by one or more Inspectors appointed under the Act. The
Inspector or Inspectors shall examine all portions of the premises, plant and appliances
and also inspect the process of manufacture intended to be employed or being employed
along with the means to be employed or being employed for standardizing and testing the
substances to be manufactured and enquire into the professional qualifications of the
technical staff to be employed. He shall also examine and verify the statements made in
the application in regard to their correctness, and the capability of the applicant to comply
with the requirements of competent technical staff, manufacturing plant, testing
equipments and the requirements of plant and equipments as laid down in Schedule M-II
read with requirements of maintenance of records as laid down in Schedule U-1.

139AB. Report by Inspector.- The Inspector or Inspectors shall forward a detailed
descriptive report giving his or their findings on each aspect of inspection along with his
or their recommendations after completion of his or their inspection to the Licensing
Authority.
________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 723(E) dt 11.8.1992.
2
Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973.
3
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
4
Ins. by G.O.I. Notification No.493(E) dt 9.6.1995.
179
139AC. Grant or refusal of licence.- (1) If the Licensing Authority after such further
enquiry, if any as he may consider necessary is satisfied that the requirements of the rules
under the Act have been complied with and that the conditions of the licence and the rules
under Act shall be observed, he shall grant or renew a licence inform 32, Form 32-A or
Form 33.
(2) If the Licensing Authority is not so satisfied, he shall reject the application and
shall inform the applicant of the reasons for such rejection and of the conditions which
must be satisfied before a licence can be granted or renewed and shall supply the applicant
with a copy of inspection report.
130AD. Further application after rejection.- If within a period of six months from the
rejection of an application for a licence, the applicant informs the Licensing Authority that
the conditions laid down have been fulfilled and deposits an inspection 1
[a fee of rupees
two hundred and fifty], the Licensing Authority may, if, after causing further inspection to
be made, he is satisfied that the conditions for the grant of licence have been complied,
with issue a licence in Form 32, Form 32-A or Form 33.
139AE. Appeal to the State Government.- Any person who is aggrieved by the order
passed by the Licensing Authority refusing to grant or renew a licence under this Part
may, within ninety days from the date of receipt of such order, appeal to the State
Government and the State Government may, after such enquiry into the matter as is
considered necessary and after giving the said person an opportunity for representing the
case, pass such order as it thinks fit.]
2
139-B Form of loan 3
[licence to manufacture cosmetics for sale or for
distribution]—A loan 3
[licence to manufacture cosmetics for sale or for distribution]
against application in Form 31-A shall be granted in Form 32-A.
140 Duration of licence.- An original licence or a renewal licence shall unless sooner
suspended or cancelled be 1
[valid for a period of five years and on from the date on which]
it is granted or renewed.
4
Provided that if the application for renewal of a licence in force is made before its
expiry or if the applications is made within six months of its expiry, after payment of
additional fee, the licence shall continue to be in force until orders are passed on the
application for its renewal is not made within six months of its expiry.
141. Certificate of renewal—The certificate of renewal of a licence in Form 32 shall
be issued in Form 33.
______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 723(E) dt 11.8.1992.
2
Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973.
3
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
4 Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
180
1
141-A Certificate of renewal of a loan licence—The certificate of renewal of a
licence in Form 32-A shall be issued in Form 330A.
1
141-AA Duration of a loan licence—An original loan licence in Form 32-A or a
renewed loan licence in Form 33-A, unless sooner suspended or cancelled, shall be 2
[valid
for a period of five years on and from the date on which] it is granted or renewed.
Provided that if the application for the renewal of a licence is made before its expiry,
or if the applic ation is made within six months of its expiry, after payments of the
additional fee, the licence shall continue to be in force and orders are passed on the
application. The licence shall be deemed to have expired if the application for its renewal
is not made within six months of expiry.
142. Conditions of licence—A licence in Form 32 shall be subject to the conditions
stated therein and to the following other conditions, namely:—
(a) the licensee shall provide and maintain staff, premises and equipment as
specified in rule 139.
(b) The licensee shall comply with the provisions of the Act and the Rules
made thereunder and with such further requirements, if any, as may be
specified in any rules to be made hereafter under Chapter IV of the Act.
3
(b-1) the licensee shall keep records of the details of each batch of cosmetic
manufactured by him and of raw materials used therein as per particulars
specified in Schedule U(1) and such records shall be retained for a period
of three years.
(c) The licensee shall test eac h batch or lot of the raw materials used by him
for the cosmetics and also each batch of the final product and shall maintain
records or registers showing the particulars in respect of such tests. The
records or registers shall be retained for a period of three years from the
date of manufacture.
(d) The licensee shall allow any Inspectors appointed under the Act to enter
with or without prior notice any premises where the manufacture of a
substance in respect of which the licence is issued is carried on, to inspect
the premises and to take samples of the manufactured products under a
receipt.
_______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973
2
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
3
Ins. by G.O.I. Notification No. GSR 1594 dt 13.11.9176.
181
(e) The licensee shall allow an Inspector to inspect all registers and
records maintained under these rules and shall supply to the Inspector
such information as he may require for the purpose of ascertaining
whether the provisions of the Act and the Rules made thereunder have
been complied.
1
(f) The licensee shall maintain an Inspection Book in Form 35 to
enable an Inspector to record his impression and the defects
noticed.
2
[Provided that clauses (b -1) and (c) shall not apply to the manufacture of soap and the
procedure for testing of raw materials and the records to be maintained by the
manufacturer of soap shall be such as are approved by the Licensing Authority.]
3
142-A Additional information to be furnished by an applicant for licence or a
licensee to the Licensing Authority.—The applicant for the grant of a licence or any person
granted a licence under this Part shall, on demand; furnish to the Licensing Authority,
before the grant of the licence or during the period of licence is in force, as the case may
be, documentary evidence in respect of the ownership or occupation on rental or other
basis of the premises specified in the application for licence or in the licence granted,
constitution of the firm, or any other relevant matter, which may be required for the
purpose of verifying the correctness of the statements made by the applicant or the
licensee, while applying for or after obtaining the licence as the case may be.
1
142-B Conditions of licence in Form 32-A.-
(a) A licence in Form 32-A shall be deemed to be cancelled or suspended, if the
licence owned by the licensee, in Form 32, whose manufacturing facilities are
cancelled or suspended, as the case may be under these Rules.
(b) The licensee shall comply with the provisions of the Act and these rules and
with each further requirements, if any, as may be specified from time to time in
Chapter IV of the Act, provided that where such further requirements are
specified in the rules, these would come into force four months after
publication in the Official Gazette.
5
(b-1)the licensee shall keep records of the details of each batch of cosmetic
manufactured by him and of raw materials used therein as per particulars
specified in Schedule U (1) and such records shall be retained for a period of
three years.
(c) The licensee shall test each batch or lot of the raw materials used by him for the
manufacture of the cosmetics and also each batch of the final product and shall
______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 444 dt 28.4.1973
2
Ins. by G.O.I. Notification No. GSR 681(E) dt 6.6.1988.
3 Ins. by G.O.I. Notification No. S.O.2139 dt 12.8.1972.
4
Ins. by G.O.I. Notification No. GSR 1594 dt 13.11.9176.
182
maintain records of registration showing the particulars in respect of such tests.
The records or registers shall be retained for a period of three years from the
date of manufacture.
(d) The licensee shall allow an Inspector appointed under the Act to enter with or
without prior notice any premises where the manufacture of a substance in
respect of which licence is issued is carried on, to inspect the premises and to
take samples of the manufactured products under a receipt.
(e) The licensee shall allow an Inspector to inspect all registers and records
maintained under these rules and shall supply to the Inspector such information
as he may require for the purpose of ascertaining whether the provisions of the
Act, and the rules made thereunder have been compiled.
(f)The licensee shall maintain an Inspection Book in Form 35 to enable an
Inspector to record his impressions and the defects noticed.
143. Cancellation and suspension of licence.—(1) The Licensing Authority may, after
giving the licensee an opportunity to show cause why such an order should not be passed,
by an order in writing stating the reasons therefore, cancel a licence issued under this Part
or suspend it for such period as he thinks fit, either wholly or in respect of some of the
substances to which it relates, if in his opinion, the licensee has failed to comply with any
of the conditions of the licence or with any provisions of the Act or the rules made
thereunder.
(2) A licensee whose license has been suspended or cancelled may appeal with in a
period of three months from the date of the order to the State Government which shall
after considering the appeal, pass orders, and such orders shall be final.
1
[144. Prohibition of manufacture of cosmetics containing colours other than those
prescribed.- No Cosmetic shall be manufactured which contains Dyes, Colours and
Pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part I
as amended) and Schedule Q.
The permitted Synthetic Organic colours and Natural Organic colours used in the
Cosmetic shall not contain more than :
(i) 2 parts per million of arsenic calculated as arsenic trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii) 100 parts per million of heavy metals other than lead calculated as
the total of the respective metals.]
2
144-A. Prohibition of manufacture of cosmetics containing Hexachlorophene.—No
cosmetic contain ing Hexachlorophene shall be manufactured.
_______________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 811(E) dt 14.11.1994.
2 Ins. by G.O.I. Notification No. GSR 116 dt 25.1.1975.
183
1
[Provided that in the case of soaps hexachlorophene may be used in concentrations
not exceeding one per cent weight by weight.
Provided further that the following cautionary note shall be printed and shall appear in
a conspicuous manner on the wrapper of package of each soap, namely:-
“Contains hexachlorophene – not to be used on babies”.]
145. Use of Lead and Arsenic compounds for the purpose of colouring cosmetics
prohibited.—The use of Lead and Arsenic compounds for the purpose of colouring
cosmetics is prohibited.
2
145-A. Form of intimation for purpose of taking samples of cosmetics.—Where an
Inspector takes a sample of a cosmetic for the purpose of test or analysis, he shall intimate
such purpose in writing in Form 17 to the person from whom he takes it.
3
[145-AA. Form of receipt of samples of cosmetics where fair price tendered is
refused.- Where the fair price, for the samples of Cosmetics taken for the purpose of test
or analysis, tendered under sub-section (1) of Section 23 has been refused, the Inspector
shall tender a receipt therefore to the person from whom the said samples have been taken
as specified in Form 17-A.]
145-B. Form of receipt for seized cosmetics.—A receipt by an Inspector for the stock
of any cosmetic seized under clause (c) of sub-section (1) of section 22 of the Act, shall be
in Form 15.
4
[145-BA Manner of certifying copies of seized documents.- The Drugs Inspector
shall return the documents, seized by him under clause (cc) or produced before him under
clause (cca) of sub-section (1) of Sectio n 22 of the Act, within a period of twenty days of
the date of such seize or production, to the person from whom they were seized or, as the
case may be, the person who produced them, after copies thereof or extracts therefrom
have been signed by the Drugs Inspector concerned and the person from whom they were
seized, or, as the case may be, who produced such records.]
5
145-C Form of order not to dispose of stocks of cosmetics—An order in writing by an
Inspector under clause (c) of sub-section (1) of Section 22 of the Act requiring a person
not to dispose of any stock of cosmetics in his possession shall be in Form 15.
______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 1049(E) dt 29.8.1986.
2
Added by G.O.I. Notification No. S.O. 2139 dtd 12.8.1972.
3 Ins. by G.O.I. Notification No. GSR 292(E) dt 29.5.1997
4
Ins. by G.O.I. Notification No. GSR 89(E) dt 16.2.1985.
5
Ins. by G.O.I. Notification No. GSR 1594 dt 13.11.9176.
184
1
145-D Prohibition of manufacture of cosmetics containing mercury compounds—No
cosmetics containing mercury compounds shall be manufactured.
PART XV—LABELLING, PACKING AND STANDARDS OF COSMETICS
146. Prohibition of sale or distribution—Subject to other provisions of these rules, no
person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin is
manufactured by a licensed manufacturer and labelled and packed in accordance with
these rules.
2
[147. Exemption of cosmetics not manufactured for consumption or sale in India
from the provisions of this Part.- Labels on packages or containers of cosmetics not
manufactured for consumption or sale in India shall be adapted to meet the specific
requirements, if any, of the consignee.
Provided that where a cosmetic is required by the consignee to be not labeled with the
name and address of the manufacturer, the labels on packages or containers shall bear a
code number as approved by the Licensing Authority mentioned in Rule 21.]
148. Manner of labelling—Subject to other provisions of the rules, a cosmetic shall
carry.-
(1) On both the inner and outer labels;
(a) The name of the cosmetic,
3
[(b) The name of the manufacturer and complete address of the
premises of the manufacturer where the cosmetic has been
manufactured.
Provided that if the cosmetic is contained a very small size container where
the address of the manufacturer cannot be given, the name of the
manufacturer and his principal place of manufacture shall be given along with
pin code.]
(2) On the outer labelA declaration of the net contents expressed in terms of weight for solids, fluid
measure for liquids, weight for semi solids, combined with numerical court if
the content is sub-divided:
________________________________________________________________________
1 Ins. by G.O.I. Notification No. X.11013/3/76-D&MS dt 19.8.1978.
2
Subs. by G.O.I. Notification No. GSR 682(E) dt 5.12.1980
3
Subs. by G.O.I. Notification No. GSR 352(E) dt 26.4.2000.
185
Provided that this statement need not appear in case of a package of perfume, toilet
water or the like the net content of which does not exceed 60ml or any package of solid or
semi-solid cosmetic the net content of which does not exceed 30 grams.
(3) On the inner label, where a hazard exists—
(a) Adequate direction for safe use.
(b) Any warning, caution or special direction required to be observed by
the consumer,
(c) A statement of the names and quantities of the ingredients that are
hazardous or poisonous.
1
(4) A distinctive batch number, that is to say, the number by reference to which
details of manufacture of the particular batch from which the substance in the container is
taken are recorded and are available for inspection, the figures representing the batch
number being preceded by the letter “B”, provided that this clause shall not apply to any
cosmetic containing 10grams or less if the cosmetic is in solid or semi-solid state, and 25
milliliters or less if the cosmetic is in a liquid state.
2
[Provided further that in the case of soaps, instead of the batc h number, the month and
year of manufacture of soap shall be given on the label.]
3
(5) manufacturing licence number, the number being preceded by the letter ‘M’.
(6) Where a package of a cosmetic has only one label, such label shall contain all the
information required to be shown on both the inner and the outer labels, under these Rules.
4
[148-A. Prohibition against altering inscriptions on containers, labels or wrappers of
cosmetics.- No person shall alter, obliterate or deface any inscription or mark made or
recorded by the manufacturer on the container, label or wrapper of any cosmetic.
Provided that nothing in this rule shall apply to any alteration, inscription or mark
made on the container, label or wrapper of any cosmetic at the instance or direction or
with the permission of the licensing authority.]
149. 5
[Labelling of Hair dyes containing Dyes, Colours and Pigments.—Hair dyes
containing Para-Phenylenediamine or other Dyes, Colours and Pigments] shall be labelled
with the following legend in English and local languages and these shall appear on both
the inner and the outer labels.
________________________________________________________________________
1Amended by G.O.I. Notification No. GSR 245 dt 21.2.1976.
2
Ins. by G.O.I. Notification No. 681(E) dt 6.8.1988.
3Amended by G.O.I. Notification No. GSR 245 dt 21.2.1976
4
Ins. by G.O.I. Notification No.GSR 351(E) dt 26.4.2000.
5
Subs. by G.O.I. Notification No.GSR 811(E) dt 14.11.1994.
186
“Caution—This product contains ingredients which may cause skin irritation in
certain cases and so a preliminary test according to the accompanying direction
should first be made. This product should not be used for dyeing the eye-lashes or
eye-brows; as such a use may cause blindness”.
Each package shall also contain instructions in English and local languages on the
following lines for carrying out the test:
“This preparation may cause serious inflammation of the skin in some cases and so a
preliminary test should always be carried out to determine whether or not special
sensitivity exists. To make the test, cleanse a small area of skin behind the ear or
upon the inner surface of the forearm, using either soap and water or alcohol. Apply
a small quantity of the hair dye as prepared for use to the area and allow it to dry.
After twenty-four hours, wash the area gently with soap and water. If no irritation or
inflammation is apparent, it may be assumed that no hypersensitivity to the dye
exists. The test should, however, be carried out before each and every applic ation.
This preparation should on no account be used for dyeing eye-brows or eye-lashes as
severe inflammation of the eye or even blindness may result”.
1
[149-A. Special provisions relating to toothpaste containing fluoride.-
(i) Fluoride content in toothpaste shall not be more than 1000 ppm and the
content of fluoride in terms of ppm shall be mentioned on the tube and
carton.
(ii) Date of expiry should be mentioned on tube and carton.]
150. Report of result of test or analysis of cosmetics—Test reports on samples of
cosmetics taken for test or analysis under these Rules shall be supplied in Form 34.
2
[150-A. Standard for cosmetics.- Subject to the provisions of these rules, the
standards for cosmetics shall be such as may be prescribed in Schedule S.]
3PART XV (A)
APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON
DRUGS, COSMETICS AND RAW MATERIALS USED IN THEIR
MANUFACTURE ON BEHALF OF LICENSEES FOR
MANUFACTURE FOR SALE OF DRUGS / COSMETICS.
150-B. Application for grant for testing drugs / cosmetics—
__________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 223(E) dt 19.4.1991.
2
Ins. by G.O.I. Notification No. GSR 510(E) dt 26.7.1982..
3
Ins. by G.O.I. Notification No. X.1104/7/76-D&M dt 23.8.1977.
187
(1) Application for grant or renewal of approval for carrying out tests for identity,
purity, quality and strength on drugs or cosmetics or the raw materials used in
the manufacture thereof on behalf of licensees for manufacture for sale of
drugs or cosmetics, shall be made in Form 36 to the Licensing Authority
appointed by the State Government for the purposes of Part VII, VII (A) or
XIV of these Rules, as the case may be and referred to as the “approving
authority” under this Part and shall be accompanied by an inspection fee of
1
[rupees six thousand] in the case of testing of drugs specified in Schedules C
and C (1) and 1
[rupees one thousand five hundred] in the case of testing of
drugs other than those specified in Schedule C and C (1), homoeopathic drugs
and cosmetics.
Provided that the applicant shall furnish to the approving authority such
additional information as may be required by him in connection with the
application in Form 36;
1
[Provided further that if the applicant applied for renewal of approval after its
expiry but within six months of such expiry, the inspection fee payable shall be
rupees six thousand in the case of testing of drugs specified in Schedule C and
C (1) and rupees one thousand five hundred in the case of testing of drugs other
than those specified in Schedule C and C (1), Homoeopathic medicines and
cosmetics plus an additional fee at the rate of rupees one thousand per month.]
(2) A separate application shall be made for grant of approval for carrying out tests
on additional categories of drugs or items of cosmetics and shall be
accompanied by an inspection fee of rupees one thousand five hundred in the
case of drugs specified in Schedule C and Schedule C(1) and rupees one
thousand each in case of drugs other than those specified in Schedule C and
Schedule C(1), homeopathic medicines and cosmetics.
Explanation—For the purpose of this Part, the words ‘drugs’ and ‘cosmetics’ shall
also mean and include the raw materials used in the manufacture of drugs including
Homoeopathic drugs or cosmetics, as the case may be.]
150-C. Form on which approval to be granted for carrying out tests on drugs /
cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for
grant or renewal of such approval—
(1) Approval for carrying out such tests of identity, purity, quality and strength
of drugs or cosmetics as may be required under the provisions of these rules,
ob behalf of licensee for manufacture of drugs or cosmetics shall be granted
in Form 37.
(2) Before ap proval in Form 37 is granted or renewed, the following conditions
shall be compiled with by the applicant—
______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
188
(1) The premises where the tests are being carried out shall be well lighted
and properly ventilated except where the nature of tests of any drug or
cosmetic warrants otherwise. Wherever necessary, the premises shall
be air conditioned so as to maintain the accuracy and functioning of
laboratory instruments or to enable the performance of special tests
such as sterility tests, microbiological tests etc.
2) The applicant shall provide adequate space having regard to the nature
and number of samples of drugs or cosmetics proposed to be tested;
Provided that the approving authority shall determine from time to
time whether the space provided continues to be adequate.
3) If it is intended to carry out tests requiring the use of animals, the
applicant shall provide for an animal house and comply with the
following requirements.
(a) The animal house shall be adequate in area, well lighted and
properly ventilated and the animals undergoing tests shall be
kept in air conditioned area.
(b) The animals shall be suitably housed in hygienic surroundings
and necessary provisions made for removal of excreta and foul
smell.
(c) The applicant shall provide for suitable arrangements for
preparation of animal feed.
(d) The applicant shall provide for suitable arrangements for
quarantining of all animals immediately on their receipt in the
institution.
(e) The animals shall be periodically examined for their physical
fitness
(f) The applicant shall provide for isolation of sick animals as well
as animals under test.
(g) The applicant shall ensure compliance with the requirements of
the Prevention of Cruelty to Animal Act, 1960 (59 of 1960).
(h) The applicant shall make proper arrangements for the disposal of
the carcasses of animals in a manner as not to cause to public
health.
(4) The applicant shall provide and maintain suitable equipment having
regard to the nature and number of samples of drugs or cosmetics
intended to be tested which shall be adequate in the opinion of the
approving authority.
(5) The testing of drugs or cosmetics, as the case may be shall be under
the active direction of a person whose qualifications and experience
are considered adequate in the opinion of the approving authority and
who shall be held responsible for the reports of test or analysis issued
by the applicant.
189
(6)
The testing of drugs or cosmetics, as the case may be, for identity,
purity, quality and strength shall be carried out by persons whose
qualifications and experience of testing are adequate in the opinion
of the approving authority.
(7) The applicant shall provide books of standard recognized under the
provisions of the Act and the Rules made thereunder and such books
of reference as may be required in connection with the testing or
analysis of the products for the testing of which ap proval is applied
for.
150-D: Duration of approval: An approval granted in Form 37 or renewed in Form 38,
unless sooner suspended or withdrawn, shall be 1
[valid for a period of five years on and
from the date on which] it is granted or renewed:
Provided that if an application for the renewal of an approval in Form 37 is made
before its expiry or if the application is made within six months of its expiry after the
payment of the additional fee, the approval shall continue to be in force until orders are
passed on the applications and the approval within six months of its expiry.
150E: Conditions of approval: An approval in Form 37 shall be subject to the
following general conditions: —
(a) The institution granted approval under this Part (hereinafter referred to as the
approved institution) shall provide and maintain an adequate staff and adequate
premises and equipment as specified in rule 150-C.
(b) The approved institution shall provide proper facilities for storage so as to
preserve the properties of the samples of the samples to be tested by it.
(c) The approved institution shall maintain records of tests for identity, purity,
quality and strength carried out on all samples of drugs or cosmetics and the
results thereof together with the protocols of tests showing the readings and
calculation in such form as to be available for inspection and such records shall
be retained in the case of substances for which an expiry date is assigned for a
period of two years from the expiry of such date and in the case of other
substances for a period of six years.
(d) The approved institution shall allow the Inspector appointed under this Act to
enter with or without prior notice the premises where the testing is carried on
and to inspect the premises and the equipment used for test and the testing
procedures employed. The institution shall allow the Inspectors to inspect the
registers and records maintained under these Rules and shall supply to such
______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
190
Inspectors such information as they may require for the purpose of ascertaining
whether the provisions of the Act and Rules made thereunder have been
observed.
(e) The approved institution shall from time to time report to the approving
authority any changes in the person-in-charge of testing of drugs or cosmetics
or in the expert staff responsible for testing as the case may be and any material
alteration in the premises or changes in the equipment used for the purposes of
testing which have been made since the date of last inspection made on behalf
of the approving authority before the grant or renewal of approval.
(f) The approved institution shall furnish reports of the results of test or analysis in
Form 39.
(g) In case any sample of a drug or a cosmetic is found on test to be not of standard
quality, the approved institution shall furnish the approving authority 1
[and the
licensing authority of the State where the manufacturer and/or sender of the
drug or cosmetic is located] with copy of the test report on the sample with the
protocols of tests applied.
(h) The approved institution shall comply with the provisions of the Act and Rules
made thereunder and with each further requirements, if any, may be specified
in the rules subsequently made under Chapter IV of the Act of which the
approving authority has given the approved institution not less than four
months notice.
(i) The approved institution shall maintain an Inspection Book to enable the
Inspectors to record his impression or defects noticed.
150-F:Inspection before grant of approval: Before an approval in Form 37 is granted,
the approved authority shall cause the institution at which the testing of drugs or
cosmetics, as the case may be, is proposed to be carried out to be inspected jointly by the
Drugs Inspectors of the Central Drugs Standard Control Organisation and the State Drugs
Control Organisation who shall examine the premises and the equipment intended to be
used for testing of drugs or cosmetics and inquire into the professional qualifications of
the expert staff to be employed.
150-G: Report of Inspection: The Drug Inspector mentioned in rule 150-F shall
forward to the appointing authority a detailed report of the result of the inspection.
______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 93(E) dt 24.2.1995.
191
150-H: Procedure of approving authority: (1) If the approving authority after such
further enquiry, if any, as he may consider necessary, is satisfied that the requirements of
the rules made under the Act have been compiled with and that the conditions of the
approval and the Rules made under the Act will be observed, he shall grant an approval in
Form 37.
(2) If the appointing authority is not so satisfied, he shall reject the application and
shall inform the applicant of the reasons for such rejections and of the conditions, which
must be satisfied before an approval could be granted.
150-I: Further application after rejection: If within a period of six months from the
rejection for approval, the applicant informs the approving authority that the conditions
laid down have been satisfied and deposits inspection fee of 1
[rupees two hundred and
fifty], the approving authority mat, if, after causing a further inspection to be made,
satisfied that the conditions for grant of approval have been compiled with, grant the
approval in Form 37.
150-J: Renewal: On an application being made for renewal the approving authority
may cause an inspection to be made and if satisfied that the conditions of the approval and
the Rules made under the Act are and shall continue to be observed shall issue a certificate
of renewal in Form 38.
150-K: Withdrawal and suspension of approvals: (1) The approving authority may,
after the approved institution an opportunity to show cause why such an order should not
be passed, by an order in writing stating the reasons therefore, withdraw an approval
granted under this Part or suspend it for such period as he th inks fit either wholly or in
respect of some of the categories of drugs or items of cosmetics to which it relates, if in his
opinion the approved institution has failed to comply with any of the conditions of the
approval or with any provisions of the Act or the Rules made thereunder.
(2) Any approved institution whose approval has been suspended or withdrawn may
within three months of the date of the order, appeal to the State Government which shall
dispose of the appeal in consultation with a panel of competent persons appointed by it in
this behalf and notified in the Official Gazette.
2PART XVI—MANUFACTURE FORSALE OF AYURVEDIC (INCLUDING SIDDHA) OR UNANI
DRUGS.
151. manufacture on more than one set of premises—If Ayurvedic (including Siddha)
or Unani drugs are manufactured are manufactured on more than one set of premises, a
separate applications shall be made and a separate licence shall be obtained in respect of
each such set of premises.
______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 601(E) dt 24.8.2001.
2 Added under G.O.I.Notification No. 1-23/67-D dated the 2-2-1970.
192
152. Licensing Authorities—Fore the purpose of this Part the State Government shall
appoint such Licensing Authorities and for such areas as may be specified in this behalf by
notification in the Official Gazette.
153. Application for licence to manufacture Ayurvedic (including Siddha) or Unani
drugs.—(1) An application for the grant or renewal of a licence to manufacture for sale
any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the
Licensing Authority alongwith a fee of rupees sixty.
Provided that in the case of renewal the applicant may apply for the renewal of the
licence before its expiry or within one month of such expiry:
Provided further that the applicant may apply for renewal after the expiry of one
month but within three months of such expiry in which case the fee payable for renewal of
such licence shall be rupees thirty.
(ii) A fee of rupees fifteen shall be payable for a duplicate copy of a licence issued
under this rule, if the original licence is defaced, damaged or lost.
1
153-A. Loan Licence.—(i) An application for the grant of renewal of a loan licence to
manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in
Form 25-E to the Licensing Authority along with a fee of rupees thirty.
Explanation—For the purpose of this rule, a loan licence means a licence which a
Licensing Authority may issue to an applicant who does not have his own arrangements
for manufacture but intends to avail himself of the manufacturing facilities owned by a
licence in Form 25-D:
Provided that in the case of renewal the applicant may apply for the renewal of the
licence before its expiry or within one month of such expiry:
Provided further that the applicant may apply for renewal after the expiry of one
month, but within three months of such expiry in which case the fee payable for renewal
of such licence shall be rupees thirty plus an additional fee of rupees fifteen.
(ii) A fee of rupees seven and paise fifty shall be payable for a duplicate copy of a
licence issued under this rule, if the original licence is defaced , damaged or lost.
154. Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs:
(1) Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale
any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The
licence shall be issued within a period of three months from the date of receipt of the
application.
_______________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 376(E)dt 20.7.1978.
193
(2) A licence under this rule shall be granted by the licensing authority after consulting
such expert in Ayurvedic (including Siddha) or Unani Systems of medicine as the case
may be, which the State Government may approve in this behalf.
1
154-A Form of loan licence to manufacture for sale of Ayurvedic (including Siddha)
or Unani drugs:—
A loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani
drugs shall be issued in Form 25E.
(2) A licence under this rule shall be granted by the Licensing Authority after
consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as
the case may be, which the State Government may approve in this behalf.
(3) The Licensing Authority shall, before the grant of a loan licence, satisfy himself
that the manufacturing unit has adequate equipment, staff, capacity for manufacture and
facilities for testing, to undertake the manufacture on behalf of the applicant for a loan
licence.
155. Certificate of renewal—The certificate of renewal of a licence in Form 25-D
shall be issued in Form 26-D.
1
155-A. Certificate of renewal of a loan licence.—The certificate of renewal of a loan
licence in Form 25-E shall be issued in Form 26-E.
2
[155-B. Certificate of award of G.M.P. of Ayurveda, Siddha and Unani Drugs.- The
certificate of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha or
Unani drugs shall be issued to licensees who comply with the requirements of Good
Manufacturing Practice of Ayurveda, Siddha and Unani drugs as laid down in Schedule
T.]
156. Duration of licence—An original licence in Form 25-D or a renewed in Form 26-
D, unless sooner suspended or cancelled shall be valid upto the 31st December of the year
following the year in which it is granted or renewed.
Provided that if the application for the renewal of a licence is made before its expiry or
within one month of its expiry after payment of the additional fee of rupees thirty, the
licence shall continue to be in force until orders are passed on the application. The licence
shall be deemed to have expired, if the application for its renewal is not made within three
months of its expiry.
______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 376(E)dt 20.7.1978
2
Ins. by G.O.I. Notification No. GSR 561(E)dt 23.6.2000.
194
1
156-A. Duration of loan licence—An original loan licence in Form 25-E or a
renewed loan licence in Form 26-E, unless sooner suspended or cancelled, shall be valid
up to the 31st December of the year following the year in which it is granted or renewed.
Provided that if the application for the renewal of a loan licence is made in accordance
with rule 153-A, the loan licence shall continue to be in force until orders are passed on
the application. The licence shall be deemed to have expired, if the application for its
renewal is not made within three months of its expiry.
157. Conditions for the grant or renewal of a licence in Form 25-D—Before a licence
in Form 25-D is granted or renewed in Form 26-D the following conditions shall be
compiled with by the applicant, namely: — (1) The manufacture of Ayurvedic (including
Siddha) or Unani drugs shall be carried out in such premises and under such hygienic
conditions as are specified in Schedule T.
2
[1-A for getting a certificate of ‘Good Manufacturing Practices’of Ayurveda SiddhaUnani drugs, the applicant shall made application on plain paper, providing the
information on existing infrastructure of the manufacturing unit, and the licensing
authority shall after verification of the requirements as per Schedule ‘T’ issue the
certificate within a period of 3 months in form 26-E-I]..
(2) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be
conducted under the direction and supervision of competent tec hnical staff consisting at
least one person, who is a whole time employee and who possesses the following
qualifications, namely—
(a) A degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of
medicine, as the case may be, conferred by a University, a State Government or Statutory
Faculties, Councils and Boards of Indian Systems of medicines recognized by the Central
Government or a State Government for this purpose, or
(b) A diploma in Ayurveda, Siddha or Unani system of medicine granted by a State
Government for this purpose, or
(c) A graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a
University recognized by the Central Government with experience of at least two years in
the manufacture of drugs pertaining to the Ayurvedic or Siddha or Unani systems of
medicines, or
(d) A Vaid or Hakim registered in a State Register of Practitioners of indigenous
systems of medicines having experience of at least four years in the manufacture of
Ayurvedic or Siddha or Unani drugs, or
______________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 376(E)dt 20.7.1978
2
Ins. by G.O.I. Notification No. GSR 561(E)dt 23.6.2000.
195
(e) A qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems of
medicines, possessing experience of not less than eight years in the manufacture of
Ayurvedic or Siddha or Unani drugs as may be recognized by the Central Government.
(3) The competent technical staff to direct and supervise the manufacture of
Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff to
direct and supervise the manufacture if Siddha drugs and Unani drugs shall have
qualification in Siddha or Unani, as the case may be.
158. Conditions of licence.—A licence in Form 25-D shall be subject to the conditions
stated therein and to the following further conditions, namely—
(a) The licensee shall maintain proper records of the details of manufacture and of the
tests, if any, carried out by him, or by any other person on his behalf, of the raw material
and finished products.
(b) The licensee shall allow an Inspector appointed under the Act to enter any
premises where the manufacture of a substance in respect of which the licence is issued is
carried on, to inspect the premises, to take samples of the raw material as well as finished
products, and to inspect the records maintained under these rules.
1
[(c) The licensee shall maintain an Inspection Book in form 35 to enable an Inspector
to record his impressions and the defects noticed.]
2
158-A Conditions of loan licence.—A licence in Form 25-E shall be subject to the
conditions stated therein and to the following conditions, namely—
(a) The licence in Form 25-E shall be deemed to be cancelled or
suspended, if the licence owned by the licensee in Form 25-D whose
manufacturing facilities have been availed of by the licensee is
cancelled or suspended, as the case may be, under these rules.
(b) The licensee shall comply with the provisions of the Act and of the
Rules and with such further requirements if any, as may be specified in
any Rules subsequently made under Chapter IV-A of the Act, provided
that where such further, requirements are specified in the Rules; these
would come into force four months after publication in the Official
Gazette.
(c) The licensee shall maintain proper records of the details of manufacture
and of the tests, if any, carried out by him, or any other person on his
behalf, of the raw materials and finished products.
____________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 376(E)dt 20.7.1978
2
Ins. by G.O.I. Notification No. GSR 561(E)dt 23.6.2000.
196
(d) The licensee shall allow an Inspector appointed under the Act to
inspect all registers and records maintained under these rules and shall
supply to the Inspector such information as he may require for the
purpose of ascertaining whether the provisions of the Act and the Rules
have been observed.
1
[(e) The licensee shall maintain an Inspection Book in form 35 to enable an
Inspector to record his impressions and the defects noticed.
159. Cancellation and suspension of licences—(1) The Licensing Authority may,
after giving an opportunity to show cause within a period which shall not be less than
fifteen days from the date of receipt of such notice, why such an order should not be
passed, by an order in writing stating the reasons therefore, cancel a licence issued under
this Part or suspend it for such period as he thinks fit, either wholly or in respect of some
of the drugs to which it relates, if in his opinion, the licensee has failed to comply with any
of the conditions of the licence or with any provisions of the Act and the Rules made
thereunder.
(2) A licensee whose licence has been suspended or cancelled may appeal to the State
Government within a period of three months from the date of receipt of the order which
shall, after considering the appeal, decide the same.
160. Identification of raw materials—Raw materials used in the preparation of
Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever test
are available for their genuineness, and records of such tests as are carried out for the
purpose and the methods thereof shall be maintained.
2
[PART XVI-A
APPROVAL OF INSTITUTIONS FOR CARRYING
OUT TESTS ON AYURVEDIC, SIDDHA AND UNANI DRUGS
AND RAW MATERIALS USED IN THEIR MANUFACTURE ON
BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE OF
AYURVEDIC, SIDDHA AND UNANI DRUGS.
160-A. Application for grant of approval for testing Ayurvedic, Siddha and Unani
drugs. – Application for grant or renewal of approval for carrying out tests for identity,
purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials
used in the manufacture thereof on behalf of licensees for manufacture for sale of the said
Ayurvedic, Siddha and Unani drugs, shall be made in Form 47 to the Licensing Authority
______________________________________________________________________
1
Ins. by G.O.I. Notification No.GSR 331(E) dt 8.5.1984.
2
Ins. by G.O.I. Notification No. GSR 701(E) dt 27.7.2001 and sub. By G.S.R.73(E) dt.31.01.2003.
197
appointed by the State Government for the purposes of Part XVI, XVII or XVIII of these
rules, as the case may be, and referred to as the ‘approving authority’ under this Part and
shall be accompanied by an inspection fee of six thousand rupees in respect of the drugs
specified in First Schedule to the Act.
Provided that the applicant shall furnish to the approving authority such additional
information as may be required by it in connection with the application in Form 47.
Provided further that if the applicant applies for renewal of approval after is expiry but
within six months of such expiry, the inspection fee payable shall be six thousand rupees
plus an additional inspection fee at the rate of one thousand rupees per month in the case
of testing of Ayurvedic, Siddha and Unani drugs specified in First Schedule to the Act.
Explanation. – For the purpose of this Part, the words “Ayurvedic, Siddha and Unani
drugs” shall also mean and include the raw materials used in the manufacture of
Ayurvedic, Siddha and Unani drugs, as the case may be.
160-B. Form in which approval to be granted for carrying out tests on Ayurvedic,
Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and
Unani drugs and conditions for grant or renewal of such approval. – (1) Approval for
carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and
Unani drugs as may be required under the provisions of these rules, on behalf of licensee
for manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48.
(2) Before approval in Form 41 is granted or renewed, the following conditions shall
be complied with by the applicants, namely: –
(i) The premises where the tests are carried out shall be well lighted and
properly ventilated except where the nature of tests of any Ayurvedic,
Siddha and Unani drug warrants otherwise. Wherever necessary, the
premises shall be air-conditioned so as to maintain the accuracy and
functioning of laboratory instruments or to enable the performance of
special tests such as sterility tests and microbiological tests.
(ii) (a) The applicant shall provide adequate space having regard to the nature and
number of samples of drugs proposed to be tested:
Provided that the approving authority shall determine from time to time
whether the space provided continues to be adequate.Provided further that
separate section shall be provided for (i) Chemistry, (ii) Pharmacognosy,
(iii) Ayurveda, Siddha and Unani, (iv) Microbiology, (v) Sample Room,
(vi) Office-cum-Record Room with proper partitions and minimum
required area is 800 sq. ft.
198
(b) The applicant shall provide a list of persons who may be employed with
him as experts, such as Chemist, Botanist and expert in
Ayurveda/Siddha/Unani or Pharmacist who shall possess a degree in
Chemistry, Botany, Ayurveda/Siddha/Unani/Bachelor in Pharmacy from a
recognized University or equivalent, with experience for 2 years for
carrying out tests or analysis as per the Ayurvedic, Siddha and Unani
Pharmacopoeias.
(c) The applicant shall provide adequate equipments essesntial for carrying
out tests for identity, purity, quality and strength of Ayurvedic, Siddha and
Unani drugs as per pharmacopoeial standards or other available standards.
· List of equipment recommended is given below:
Chemistry section.
1. Alcohol determination apparatus complete set.
2. volatile oil determination apparatus.
3. Boiling point determination apparatus
4. Melting point determination apparatus.
5. Refractometer.
6. Polarimeter.
7. Viscometer (Ostwalds, Red Viscometer.)
8. Tablet disintegration apparatus.
9. Moisture determination apparatus (IC filtrator.).
10. U.V.Spectro-photometer.
11. Muffle furnace.
12. Electronic Balance.
13. Hot air oven(s) different range of temperature/vacuum oven.
14. Refrigerator.
15. Glass distillation apparatus/plant.
16. Water supply demineralised exchange equipment/distillation equipment.
17. Air conditioner.
18. LPG Gas cylinder with burners.
19. Water bath(temperature controlled.)
20. Heating mantle(4) as required.
21. TLC apparatus with all accessories.
22. Sieves 10 to 120 wqith sieve shaker.
23. Centrifuge machine.
24. Dehumidifier.
25. pH meter.
26. G.L.C. with F.I.detector.
27. Silica crucible.
28. Tablet friability tester.
29. Tablet dissolution tester.
30. Other related equipment, reagents, glasswares etc.
Pharmacognosy Section.
1. Microscope binocular.
2. Dissecting Microscope.
199
3. Microtome.
4. Chemical balance.
5. Microslide cabinet.
6. Aluminium slide trays.
7. Hot air oven.
8. Occular Micrometer.
9. Stage Micrometer.
10. Camera Lucida Prism type and mirror type.
11. Hot plates.
12. Refrigerator.
13. LPG Cylinder with burners.
14. Other related equipments,reagents, glasswares etc.
Note: Instuments like HPLC, HPTLC, atomic absorption Spectrophotometer
could be arranged by tie up with other laboratories.
Microbiology section.
1. Laminar air flow bench(L.A.F.)
2. B.O.D. Incubator.
3. Plain Incubator.
4. Serological water bath.
5. Oven.
6. Autoclave/sterilizer.
7. Microscope (high power).
8. Colony counter.
9. Other related equipment and reagents.
(3). The applicant shall provide and maintain suitable equipment having regard to the
nature and number of samples of Ayurvedic, Siddha and Unani drugs intended to be tested
which shall be adequate in the opinion of the approving authority.
(4) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity,
purity, quality and strength shall be carried out under the active direction of one of the
experts stated in clause (b) of sub-rule (2) who shall be the person-in-charge of testing and
shall be held responsible for the reports of test issued by the applicant.
(5) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity,
purity, quality and strength shall be carried out by persons whose qualifications and
experience of testing are adequate as stated in clause (b) of sub-rule (2).
(6) The applicant shall provide books of standard recognized under the provisions of
the act and the rules made there under and such books of reference as may be required in
connection with the testing of analysis of the products for the testing of which approval is
applied for.
(7) The applicant shall provide list of standard Ayurvedic, Siddha and Unani drugs
(Reference samples) recognized under the provisions of the Act and rules made thereunder
and such reference samples kept in the laboratory may be required in connection with the
testing or analysis of the products of which approval is applied for.
200
160-C. Duration of approval. – An approval granted in Form 47 or renewed in Form
49 unless sooner suspended or withdrawn, shall be valid for a period of three years from
the date on which it is granted or renewed.
Provided that if an application for the renewal of an approval in form 47 is made
before its expiry or if the application is made within six months of its expiry after the
payment of the additional inspection fee, the approval shall continue to be in force until
orders to the contrary are passed on the application and approval shall be deemed to have
expired if the application for renewal is not made within six months of expiry.
160-D. Conditions of approval. – An approval in Form 41 shall be subject to the
following conditions, namely: –
I. The Institution granted approved under this Part (hereinafter referred to as the
approved laboratory) shall provide and maintain adequate staff and adequate premises and
equipment as specified in Rule 160-B.
II. The approved laboratory shall provide proper facilities for storage so as to preserve
the properties of the samples to be tested by it.
III. The approved laboratory shall maintain records of tests for identity, purity, quality
and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs and the
results thereof together with the protocols of tests showing the readings and calculation in
such form as to be available for inspection and such records shall be retained in the case of
substances for which date of expiry is assigned; for a period of two years from such date
of expiry and in the case of other substances, for a period of three years.
IV. The approved laboratory shall allow the Inspector appointed under the Act to enter
with or without prior notice the premises where testing is carried out and to inspect the
premises and the equipment used for test and the testing procedures employed. The
laboratory shall allow the Inspectors to inspect the registers and records maintained under
these rules and shall supply to such Inspectors such information as they may require for
the purpose of ascertaining whether the provisions of the Act and rules made thereunder
have been observed.
V. The approved laboratory shall from time to time report to the approving authority
any changes in the person-in-charge of testing of Ayurvedic, Siddha and Unani drugs or
the expert staff responsible for testing, as the case may be, and any material alterations in
the premises or changes in the equipment used for the purposes of testing which have been
made since the date of last inspection made on behalf of the approving authority before the
grant or renewal of approval.
VI. The approved laboratory shall furnish reports of the results of tests or analysis in
Form 50.
VII. In case any sample of Ayurvedic, Siddha and Unani drug is found on test to be
not of standard quality, the approved laboratory shall furnish to the approving authority
201
and the licensing authority of the State where the manufacturer and/or sender of the
Ayurvedic, Siddha and Unani drugs is located, a copy of the test report of the sample with
the protocols of tests applied.
VIII. The approved laboratory shall comply with the provisions of the Act and rules
made thereunder and with such further requirements, if any, as may be specified in the
rules made from time to time under Chapter IV-A of the Act of which the approving
authority has given the approved laboratory not less than four months’ notice.
IX. The approved laboratory shall maintain an inspection book to enable the Inspector
to record his impression or defects noticed.
160-E. Inspection before grant of approval. – Before an approval in form 48 is
granted, the approving authority shall cause the laboratory at which the testing of
Ayurvedic, Siddha and Unani drugs as the case may be, is proposed to be carried out to be
inspected jointly by the Inspectors appointed or designated by the Central Government and
State Government for this purpose, who shall examine the premises and the equipment
intended to be used for testing of drugs and verify into the professional qualifications of
the expert staff who are or may be employed by the laboratory.
160-F. Report of inspection. – The Inspectors appointed by the Central Government as
stated in Rule 160-E shall forward to the approving authority a detailed report of the
results of the inspection.
160-G. Procedure of approving authority. – (1) If the approving authority after such
further enquiry, if any, as it may consider necessary, is satisfied that the requirements of
the rules made under the Act have been complied with and that the conditions of the
approval and the rules made under the Act have been observed, it shall grant appro val in
Form 48.
(2) If the approving authority is not satisfied, it shall reject the application and shall
inform the applicant of the reasons for such rejection and of the conditions which shall be
satisfied before approval could be granted.
160-H. Application after rejection. – If within a period of six months from the
rejection of an application for approval, the applicant informs the approving authority that
the conditions laid down have been satisfied and deposits inspection fee of two thousand
rupees, the approving authority may, if, after causing a further inspection to be made and
after being satisfied that the conditions for grant of approval have been complied, with
grant the approval in Form 48.
160-I. Renewal. – On an application being made for renewal, the approving authority
shall, after causing an inspection to be made and if satisfied that the conditions of the
approval and the rules made under the Act have been complied with, shall issue a
certificate of renewal in form 49.
202
160-J. Withdrawal and suspension of approvals. – (1) The approving authority may,
after giving the approved laboratory an opportunity to show cause why such an order
should not be passed, by an order in writing stating the reasons therefore, withdraw an
approval granted under this Part or suspend it for such period as it thinks fit either wholly
or in respect of testing of some of the categories of Ayurvedic, Siddha and Unani drugs to
which it relates, if in his opinion the approved laboratory had failed to comply with any of
the conditions of the approval or with any provision of the Act or the rules made
thereunder.
(2) Any approved laboratory, whose approval has been suspended or withdrawn, may,
within three months of the date of the order of suspension or withdrawal, appeal to the
State Government which shall dispose of the appeal in consultation with a panel of
competent persons appointed by the Department of Indian Systems of Medicine &
Homoeopathy, Government of India in this behalf and notified in the Offic ial Gazette.]
PART XVII—1
[LABELLING, PACKING AND LIMIT OF ALCOHOL IN] AYURVEDIC
(INCLUDING SIDDHA) OR UNANI DRUGS
1
[161. Labelling, packing and limit of alcohol.]—(1) There shall be considerably
displayed on the label of the container or package of an Ayurvedic (including Siddha) or
Unani drug, the true list of all the ingredients used in the manufacture of the preparation
together with quantity of each of the ingredients incorporated therein and a reference to
the method of preparation thereof as detailed in the standard text and Adikarana, as are
prescribed in the authoritative books specified in the First Schedule to the Act:
Provided that if the list of ingredients contained in the medicine is large and cannot be
accommodated on the label, the same may be printed separately and enclosed with
packing and reference be made to this effect on the label.
(2) The container of a medicine for internal use made up ready for the treatment of
human ailments shall, if it is made up from a substance specified in Schedule E (1), be
labelled conspicuously with the words ‘Caution: To be taken under medical supervision’
both in English and Hindi language.
(3) Subject to the other provisions of these rules, the following particulars shall be
either printed or written in indelible ink and shall appear in a conspicuous manner on the
label of the innermost container of any Ayurvedic (including Siddha) or Unani drug and
on any other covering in which the container is packed namely–
(i) The name of the drug. For this purpose the name shall be the same as
mentioned in the authoritative books included in the Firs Schedule of the
Act.
________________________________________________________________________
1
Ins. By G.O.I. Notification No. GSR 904(E) dt 2.11.1992.
203
(ii) A correct statement of the net content in terms of weight, measure or
number as the case may be. The weight and volume shall be expressed in
metric system.
(iii) The name and address of the manufacturer.
(iv) The number of the licence under which the drug is manufactured, the
figure representing the manufacturing licence number being preceded by
the words ‘Manufacturing Licence Number’ or ‘Mfg. Lic. No.’ or ‘M.L.’.
(v) A distinctive batch number, that is to say, the number by reference to
which details of manufacture of the particular batch from which the
substance in the container is taken are recorded and are available for
inspection, the figure representing the batch number being preceded by
the words “Batch No.” or “Batch” or “Lot Number” or “Lot No.” or “Lot
No.” or “Lot” or any distinguishing prefix.
(vi) The date of manufacture. For this purpose the date of manufacture shall be
the date of completion of the final products, or the date of bottling or
packing for issue.
(vii) The words “Ayurvedic medicine” or “Siddha medicine” or “Unani
medicine” as the case may be.
(viii) The words “FOR EXTERNAL USE ONLY” if the medicine is for
external application.
(ix) Every drug intended for distribution to the medical profession, as a free
sample shall, while complying with the labelling provisions under clauses
(i) to (viii), further bear on the label of the container the words
“Physicians sample. Not to be sold” which shall be over-printed.
1
[ix (a) Preparation (Asavas) with high content of alcohol as base
Name of the drug Maximum size of packing
(i) Karpur Asava 15 ml
(ii) Ahiphensava 15 ml
(iii) Mrgamadasava 15 ml
(ix (b) Preparations containing self-generated alcohol
Name of the drug Maximum content of alcohol
(Ethyl alcohol v/v)
Maximum
size of
packing
(i) Mritsanjivani Sura
(ii) Mahadrakshasava
16 per cent
16 per cent
30 ml.
120 ml.]
_______________________________________________________________________
1
Ins. By G.O.I. Notification No. GSR 904(E) dt 2.11.1992.
204
(4) Nothing in these rules shall be deemed to require the labelling of any transparent
cover or of any wrapper case or other covering used solely for the purpose of packing,
transport or delivery.
1
[161-A. Exemption in labeling and packing, provisions for export of Ayurvedic
(including Siddha) and Unani drugs.- (1) Labels and packages or containers of
Ayurvedic, Siddha and Unani drugs for export may be adapted to meet the specific
requirements of the law of the country to which the said drug is to be exported, but the
following particulars shall appear in conspicuous position on the container in which drug
is packed and on every other covering in which that container is packed, namely :
(a) Name of the Ayurvedic, Siddha and Unani drug (Single or compound
formulations;
(b) the name, address of the manufacturer and the number of licence under
which the drug has been manufactured;
(c) batch or lot number;
(d) date of manufacture, along with the date for “Best for use before”;
(e) main ingredients, if required by the import country;
(f) for export;
Provided that where Ayurvedic, Siddha and Unani Single or compound drug not
classified under First Schedule or Schedule E-(I), is required by the consignee to be not
labeled with the name and address of the manufacturer, the labels on packages or
containers shall bear a code number as approved by the Licensing Authority menti9oned
in Rule 152.
(2) the provisions of Rule 161 shall not apply to a medicine made up “ready for
treatment”, whether after, or without, alteration, which is supplied on the prescription of a
registered medical practitioner if the medicine is labeled with the following particulars,
namely:-
(a) the name and address of the suppliers;
(b) the words “For External Use Only”, if the medicine is for external application.]
PART XVIII-GOVERNMENT ANALYSIS AND INSPECTORS FOR AYURVEDIC (INCLUDING
SIDDHA) OR UNANI DRUGS
162. Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic
(including Siddha) or Unani drugs—Subject to the instructions of the controlling
authority, it shall be the duty of an Inspector authorised to inspect the manufacture of
Ayurvedic (including Siddha) or Unani drugs—
________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 787(E) dt 17.10.2000
205
(i) to inspect not less than twice a tear, all premises licensed for manufacture of
Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy
himself that the conditions of the licence and the provisions of the Act and the Rules made
thereunder are being observed;
(iii) to take samples of the drugs manufactured on the premises and send them for test
or analysis in accordance with these Rules;
(iv) to institute prosecutions in respect of violation of the Act and the Rules made
thereunder.
1
[162A-Qualification of the State Drug Licensing Authority for Licensing of
Ayurvdeda,Siddha and Unani drugs:
(a) The Ayurvedic/ siddha/ Unani qualifications as per Schedule II of CCIM Act
1970/ B Pharma (Ayurveda0 of a recognized University.
(b) At least 5 years experience in the Ayurveda/ Siddha/ Unani drug manufacturing
or testing of Ayurvedic, siddha and Unani drugs or enforcement of provisions
of Chapter IVA of the Drugs and Cosmetics Act,1940 and Rules made there
under or teaching/ research on clinical practice of Ayurveda/ siddha/ Unani
System.]
163. Procedure for despatch of sample to Government Analyst and to receipt by the
Government Analyst—(1) Sample for test or analysis shall be sent to the Government
Analyst by registered post or by hand in a sealed package, enclosed together with a
memorandum in Form 18-A in an outer addressed to the Government Analyst.
(2) The package as well as the outer cover shall be marked with a distinguishing
number.
(3) A copy of the memorandum and a specimen impression of the seal used to seal the
package shall be sent by registered post or by hand to the Government Analyst.
(4) On the receipt of the package from an Inspecto r, the Government Analyst or an
Officer authorised by him in writing in his behalf shall open the package and shall also
record the conditions of the seals on the package.
(5) After the test or analysis has been completed, one copy of the results of the test or
analysis shall be supplied forthwith to the sender in Form 13-A shall also be sent
simultaneously to the Controlling Authority and to the Drugs Controller, India.
164. Method of test or analysis to be employed in relation to Ayurvedic (including
Siddha) or Unani drugs.—The method of test or analysis to be employed in relation to an
Ayurvedic (including Siddha) or Unani drug shall be such as may be specified in the
Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such pharmacopoeias,
________________________________________________________________________
Ins. by G.O.I.Notification No G.S.R.76(E) dt03.02.2003.
206
such tests as the Government Analyst may employ, such tests being scientifically
established to determine whether the drug contains the ingredients as stated on the label.
165. Qualifications of Government Analyst. —A person who is appointed a
Government Analyst under section 33 F of the Act shall be a person possessing the
qualifications prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani System, as
the case may be, conferred by a University, a State Government or Statitory Faculties,
Councils and Boards of Indian Systems of Medicine recognized by the Central or State
Government, as the case may be, for this purpose and has had not less than three years’
post graduate experience in the analysis of drugs in a laboratory under the control of (i) a
Government Analyst appointed under the Act, or (ii) a Chemical Examiner to
Government, or (iii) the Head of an institution specially approved for the purpose by the
appointing authority.
166. Duties of Government Analyst—(1) The Government Analyst shall analyze or test
or cause to be analyzed or tested such samples of Ayurvedic (including Siddha) or Unani
drugs as may be sent to him by Inspectors or any other persons or authority authorised by
the Central Government or State Government under the provisions of Chapter IV A of the
Act and shall furnish reports of the results of test or analysis in accordance with these
rules.
(2) A Government Analyst appointed under Section 33F shall from time to time
forward to the Government reports giving the result of analytical work and research with a
view to their publications at the discretion of the Government.
1
167. Qualifications of Inspector—A person who is appointed an Inspector under
section 33G shall be a person who—
(a) has the qualifications laid down under rule 49 and shall have undergone
practical training in the manufacture of Ayurvedic (including Siddha) or
Unani drug, as the case may be; or
(b) has a degree in Ayurvedic or Siddha or Unani System or a degree in
Ayurveda Pharmacy, as the case may be, conferred by a University or State
Government or a Statutory Faculty, Council or Board of Indian Systems of
Medicine recognized by the Central Government or the State Government for
this purpose; or
(c) has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be,
granted by a State Government or an Institution recognized by the Central
Government or a State Government for this purpose.
________________________________________________________________________
1 Amended by G.O.I. Notification No. GSR 376 dt 27.7.1978.
207
1
[PART XIX
STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS
168. Standards to be complied with in manufacture for sale or for distribution of
Ayurvedic, Siddha and Unani Drugs.-
Class of Drugs Standards to be complied with
1.
2.
Single drugs included in
Ayurvedic Pharmacopoeia.
Asavas and Arishtas
The standards for identity, purity and
strength as given in the editions of
Ayurvedic Pharmacopoeia of India for the
time being in force.
The upper limit of alcohol as self generated
alcohol should not exceed 12% v/v
excepting those that are otherwise notified
by the Central government from time to
time.]
_______________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 519(E) dt 26.6.1995.
208
SCHEDULE A
FORM 1
[See Rule 4]
Memorandum to the Central Drugs Laboratory
Serial Number……………………..
To the Director, Central Drugs Laboratory………………………………….
From………………………..
I send herewith, under the provisions of Section 25 (4) of the Drugs and Cosmetics Act,
1940, sample(s) of a drug purporting to be……………for test or analysis and request that a
report that a report of the result of the test or analysis may be supplied to this Court.
1. The distinguishing number on the packet is ………………………………
2. Particulars of offence alleged…………………………………………….
3. Matter on which opinion is required……………………………
4. A fee of Rs……………..has been deposited in Court.
Date……………. …………………
Magistrate
_________________
FORM 2
[See Rule 6]
Certificate of test or analysis by the Central Drugs Laboratory
Certified that the sample bearing number…………………………..
Purporting to be a separate to be a sample of. ……………received on…………… with
memorandum No. …………………………………….dated……………………… from
………………………………has been tested / analysed and that the result of such test /
analysis is as stated below.
2. The conditions of the seals on the packet on receipt was as follows: —

*
3. In the opinion of the undersigned the sample is of standard quality as defined in the
is not of standard quality as defined in
Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given below:
the Drugs and Cosmetics Act, 1940, and Rules thereunder
209

Date…………… Director
Central Drugs Laboratory or other authorised officer
Details of results of test or analysis with protocols of test applied
Date………….. Director
Central Drugs Laboratory or other authorised officer
* If opinion is required on any other matter, the paragraph should be suitably amended.
_____________________
1
Form 3 to 7
______________________
2
FORM 8
(See Rule 24)
Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs
and Cosmetics Rules 1945.
I/We* ………………………………………….. (full address with telephone number, fax
number and e-mail address) hereby apply for a licence to import drugs specified below
manufactured by M/s ………………………………(full address with telephone no, fax and email no.).
2. Names of the drugs to be imported:
(1)
(2)
(3)
3. I/We* …………………………………. enclose herewith an undertaking in Form 9
dated………. signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics
Rules, 1945.
4. I/We …………………………………. enclose herewith a copy of Registration
Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules,
vide Registration Certificate No. …………dated ………….. issued through M/s.
.………………….(name and full address)……………………valid up to …………………..
210
5. I/We*
……………………………….. hold a valid wholesale licence for sale or
distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and
rules made thereunder. A copy of the said licence is enclosed.
6. A fee of ………….. has been credited to Government under the Head of Account “0210
– Medical and Public Health, 04-Public Health, 104-Fees and Fines” under the Drugs and
Cosmetics Rules 1945 – Central vide Challan No. ……………… dated ……….. (attached in
original)
Signature ………………..
Name ………………..
Designation …………
Seal/Stamp of Manufacturer’s agent in India
Place ……..
Date ………..
___________________________________________________________________________
1Omitted under Government of India Notification No. F. 1-16/57-D, dated 15-6-1957.
2
Subs. by G.O.I. Notification No. GSR 604(E) dt 24.8.2001.
*delete whichever is not applicable.

FORM 8-A
[See rule 24)
Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetic
Rules 1945.
I/We* ……………………………(full address with telephone number, fax number and e-mail
address) hereby apply for a licence to import drugs specified below manufactured by
M/s………………………… (full address with telephone No, fax and e-mail No.).
2. Name of the drugs to be imported.
(1)
(2)
(3)
3. I/We* ………………………… enclose herewith an undertaking in Form 9 dated
………… signed by the manufacturer as required by rule 24 of the Drugs and
Cosmetics Rules, 1945.
4. I/We* ………………………….. enclose herewith a copy of Registration Certificate
concerning the drugs to be imported in India, issued under Form 41 of the rules, vide
Registration Certificate No. …………. dated ………………. issued through M/s.
……………………….(name and full address) ………..……….. valid upto
…………………
211
5 I/We* ………………. Hold a valid wholesale licence for sale or distribution of drugs
or licence to manufacture drugs, under the provisions of the Act and rules made
thereunder. A copy of the said licence is enclosed.
6. A fee of ……………….. has been credited to Government under the Head of Account
“0210 – Medical and Public Health, 04- Public Health, 104- Fees and Fines” under the
Drugs and Cosmetics Rules 1945 – Central vide Challan No. ……. dated ……….. (
attached in original).
Signature ………………..
Name ………………..
Designation …………
Seal/Stamp of Manufacturer’s agent in India
Place ……..
Date ………..
FORM 9
[See Rule 24]
Form of undertaking to accompany an application for an import licence
Whereas …………………… of ………………… intends to apply for a licence under the
Drugs & Cosmetics Rules, 1945, for the import into India, of the drugs specified below
manufactured by us, we ………………… of …………………. hereby give this undertaking
that for the duration of the said licence—
(1) the said applicant shall be our agent for the import of drugs into India;
(2) we shall comply with the conditions imposed on a licence by 1
[Rules 74 and 78]of the
Drugs & Cosmetics Rules, 1945;
(3) we declare that we are carrying on the manufacture of the drugs mentioned in this
undertaking at the premises specified below, and we shall from time to time report any
change of premises on which manufacture will be carried on and in cases where
manufacture is carried on in more than one factory any change in the distribution of
functions between the factories;
(4) we shall comply with the provisions of Part IX of the Drugs & Cosmetics Rules, 1945;
___________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
* delete whichever is not applicable.
212
(5) every drug, manufactured by us for import under licence into India shall as regards
strength, quality and purity conform with the provisions of Chapter III of the Drugs &
Cosmetics Act, 1940, and the Drugs & Cosmetics Rules, 1945;
(6) we shall comply with such further requirements, if any, as may be specified by Rules,
by the Central Government under the Act and of which the licensing authority has
given to the licensee not less than four months’ notice.
Names of drugs and classes of drugs
Particulars of premises where manufacture is carried on.
Date………….. 1
[Signature, Name, Designation Seal/Stamp
of manufacturer or on behalf of the manufacturer]
1[FORM 10
[See rules 23 and 27]
Licence to import drugs (excluding hose specified in Schedule X) to the Drugs and
Cosmetic Rules, 1945.
Licence Number ………………. Date ……………
………………………………………………………… (Name and full address of the Importer)
is hereby licensed to import into India during the period for which the licence is in force, the
drugs specified below, manufactured by M/s. ……………………………. (name and full
address) and any other drugs manufactured the said manufacturer as may from time to time be
endorsed on this licence.
2. This licence shall be valid in force from …………. to ……… unless it is sooner
suspended or cancelled under the said rules.
3. Names of drugs to be imported.
Place :
Date : LICENSING AUTHORITY
Seal/Stamp
* Delete whichever is not applicable.
____________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 604(E) dt 24.8.2001.
213
Conditions of Licence.
1. A photocopy of licence shall be displayed in a prominent place in a part of the
premises, and the original licence shall be produced, whenever required.
2. Each batch of drug imported into India shall be accompanied with a detailed batch
test report and a batch release certificate, duly signed and authenticated by the
manufacturer with date of testing, date of release and the date of forwarding such
reports. The imported batch of each drug shall be subjected to examination and
testing as the licensing authority deems fit prior to its marketing.
3. The licensee shall be responsible for the business activities of the manufacturer in
India along with the registration holder and his authorized agent.
4. The licensee shall inform the licensing authority forthwith in writing in the event of
any change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be deemed
to be valid for a maximum period of three months from the date on which the change
takes place unless, in the meantime, a fresh licence has been taken from the licensing
authority in the name of the firm with the changed constitution.
.
FORM 10-A
(See rule 23 and 27)
Licence to import drugs specified in Schedule X to the Drugs and Cosmetic Rules, 1945.
Licence Number ……………………….. Date ………………….
……………………………………………………………………….. (Name and full address of
the importer) is hereby licenced to import into India during the period for which the licence is
in force, the drugs specified below, manufactured by M/s. ……………………… (name and
full address) and any other drugs manufactured by the said manufacturer as may from time to
time be endorsed on this licence.
2. This licence shall be in force from ………………… to ………………. unless it is
sooner suspended or cancelled under the said rules.
3. Names of drugs to be imported.
Place: …………
Date : …………
LICENSING AUTHORITY
Seal/Stamp.
* Delete whichever is not applicable.
214
Conditions of Licence.
1. A photocopy of licence shall be displayed in a prominent place in a part of the
premises, and the original licence shall be produced, whenever required.
2. Each batch of drug imported into India shall be accompanied with a detailed batch
test report and a batch release certificate, duly signed and authenticated by the
manufacturer with date of testing, date of release and the date of forwarding such
reports. The imported batch of each drug shall be subjected to examination and
testing as the licensing authority deems fit prior to its marketing.
3. The licencee shall be responsible for the business activities of the manufacturer in
India along with the registration holder and his authorized agent.
4. The licencee shall inform the licensing authority forthwith in writing in the event of
any change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be deemed
to be valid for a maximum period of three months from the date on which the change
takes place unless, in the meantime, a fresh licence has been taken from the licensing
authority in the name of the firm with the changed constitution.]

FORM 11
[See Rule 33]
Licence to import drugs for the purposes of examination, test or analysis
I…………………….of……………….is hereby licensed to import from……………………the
drugs specified below for the purposes of examination, test or analysis at
……………………or in such other places as the licensing authority may from time to time
authorize.
2. This licence is subject to the conditions prescribed in the Rule under the Drugs & Cosmetics
Act, 1940.
3. This licence shall, unless previously suspended or revoked, be in force for a period of one
year from the date specified below—
Names of drugs Quantity which may be imported
Date…………………. Licensing Authority
215
____________________
1
[FORM 11 – A
(See rule 33-A)
Licence to import drugs by a Government Hospital or Autonomous Medical Institution for the
treatment of patients.
Licence No. ……………… Date ………….
Dr. ……………………………………. Designation ……………………………………. of
………………………………….(Name of College/Hospital/Autonomous Institution) is hereby
licenced to import from M/s. …………………………..(name and full address) the drugs
specified below for the purpose of treatment of patients for the disease (name of the disease)
……………. at ………………… or in such other places as the licensing authority may from
time to time authorize.
2. This licence shall, unless previously suspended or revoked, be in force for a period of one
year form the date of issue specified above.
3. Name of drugs to be imported:
Names of drugs Quantity which may be imported
Place :………..
Date : ………. Licensing Authority
Seal / Stamp
_______________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 604(E) dt 24.8.2001
216
Conditions of Licence
1. The licence shall be displayed in the Office of the Medical Superintendent of government
Hospital / Head of Institution of Autonomous Medical Institution.
2. The licensee shall store the drugs imported under this licence under proper storage
conditions.
3. The drugs imported under this licence shall be exclusively used for the treatment of
patients, and a record shall be maintained in this regard, by a registered pharmacist
giving the full name(s) and address(es) of the patients, diagnosis, dosage schedule, total
quantity of drugs imported and issued, and shall be countersigned by the Medical
Superintendent of the Government Hospital or Head of the Autonomous Medical
Institution which shall be produced, on demand by an Inspector appointed under the
Act.]
FORM 12
[See Rule 34]
Application for licence to import drugs for purpose of examination, test or analysis
I ………………………………..resident of …………………………………by
occupation ……………….hereby apply for a licence to import the drugs specified below for
the purposes of examination, test or analysis at………………….from………………..and I
undertake to comply with the conditions applicable to the licence.
1
[A fee of rupees…………… has been credited to Government under the head of
Account ‘0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines under the
Drugs and Cosmetics Rules, 1945—Central vide Challan No……. dated…… (attached in
original).]
Names of drugs and classes of drugs Quantities
Date……………
Signature…………………
__________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 604(E) dt 24.8.2001
217
1
FORM 12-A
[See Rule 36, second proviso]
Application for the issue of a permit to import small quantities of drugs for personal use
I ………………………..resident of ……………………………………….by
occupation……………………………….hereby apply for a permit to import the drugs
specified below for personal use from……………………………………………
I attach a prescription from a registered medical practitioner in regard to the need for
the said drugs.
Names of drugs Quantities
Date…………………… Signature…………………
2 [FORM 12-AA
(See rule 34A)
Application for licence to import small quantities of new drugs by a Government Hospital or
Autonomous Medical Institution for the treatment of patients.
I, ………………… (name and designation) ………………………………….. of …………
…………… (name of the Hospital/Autonomous Medical Institution) hereby apply for a
licence to import small quantities of new drugs specified below for the purpose of treatment of
patients for the disease ………………. (name of the disease) at ……………….. (name and
place of the hospital) and I undertake to comply with the conditions applicable to the licence
and other provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder
from time to time.
A fee of rupees ……………………… has been credited to Government under the Head of
Account “0210-Medical and Public Health, 04- Medical and Public Health, 10- Fees and
Fines” under the Drugs and Cosmetics Rules, 1945 – Central vide Challan No……….. dated
………… (attached in original).
2. Name of new drugs to be imported:
_____________________________________________________________________
1Added under Government of India Notification No. F. 1-36/54-DS, dated 3-3-1955.
2
Subs. by G.O.I. Notification No. GSR 604(E) dt 24.8.2001
218
Names of drugs Quantity which may be imported
Place: …………
Date : …………
Signature ……………………….
Name ………………………….
Seal / Stamp ………………….
CERTIFICATE
Certified that the drugs specified above for import are urgently required for the treatment of
patients suffering from………………………….. and that the said drug(s) is/are not available
in India.
Signature ………………….
Place : ……….. Medical Superintendent of the Government of Hospital / Head of
Date: ………… Autonomous Medical Institution
Seal / Stamp
FORM 12-B
[See Rule 36, second proviso]
Permit for the import of small quantities of drugs for personal use
……………………………….of ………………………….is hereby permitted to
import from………………………….the drugs specified below for personal use.
2. This permit is subject to the conditions prescribed in the Rules under the Drugs and
Cosmetics Act, 1940.
3. This permit shall, unless previously suspended or revoked, be in force for a period of
six months from date specified below.
Names of drugs Quantities, which may be imported.
Date……………………… Licensing Authority
________________
219
FORM 13
[See Rule 46]
Certificate of test or analysis by Government Analyst under Section 25 (1) of the Drugs and
Cosmetics act, 1940
1. Name of Inspector from whom received……………
2. Serial No. and date of Inspector’s memorandum ………..
3. Number of sample…………………………
4. Date of receipt ………………
5. Name of drugs purporting to be contained in the sample ……….
6. Condition of seals on the 1
[packet or on portion of sample or container] ……….
7. Result of test or analysis with protocols of test or analysis applied …………
In the opinion of the undersigned the sample referred to above
is of standard quality as defined in the Drugs and Cosmetics Act, 1940. and Rules thereunder
is not of standard quality as defined in the Drugs and Cosmetics Act 1940 and Rules thereunder
for the reasons given below:-
Date…………… Government Analyst…………..
_______________
2
FORM 13-A
[See Rule 163 (5)]
Certificates of tests or analyst by Government Analyst under Section 33H of the Drugs and
Cosmetics Act, 1940
1. Names of Inspector from whom received………………………..
2. Serial No. and date of Inspector’s memorandum…………………..
3. Number of sample…………………………………………………
4. Date of receipt………………………………….
5. Names of drugs purporting to be contained in the sample…………….
6.Condition of seals on the package……………………………………..
7.Result of test or analysis with protocols of test or analysis applied
…………………………………………………….
Date…………… Government Analyst…………..
____________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 59(E) dt 7.2.1995.
2Added under G.O.I. Notification No. F 1-23/67-D, dated 2-2-1970.
220
FORM 14-A
[See Rule 47]
Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and
Cosmetics Act, 1940
1. Full name and address of the applicant……………………………………….
2. Occupation…………………………………….
3. Name of drug purporting to be contained in the sample………………………
4. Name and full address of the pharmacy or concern where the drug was purchased .
5. Date on which purchased……………………………………………..
6. Reasons why the drug is being submitted for test or analysis
.…..…………………………………………………………………………
1
7. A fee of rupees …………………………………..vide Schedule B of the Drugs and
Cosmetics Rules, 1945, has been credited to Government under the head of account “080—
Medical—Miscellaneous—Fees under the Drugs and Cosmetics Rules, 1945—
Central/State”—vide treasury receipt attached.
I hereby declare that the drug being submitted for test was purchased by or for me. I further
declare that the sample of the drug being sent for test or analysis is exactly as it was purchased
and has not been tampered with in any way to reduce its potency.
Date………………….. Signed…………
______________
FORM 14-B
[See Rule 47]
Certificate of test or analysis by Government Analyst under Section 26 of the Drugs and
Cosmetics Act, 1940
1. Name of person from whom sample received……………………….
2. Date of receipt………………………………………………………
3. Name of drug purporting to be contained in the sample…………………..
____________________________________________________________________
1Added under Government of India Notification No. F. 1-3/51-D.S., dated 15-10-1954.
221
4. Opinion of the Government Analyst—The sample referred to above is / is not of
standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules hereunder.
Date…………… Government Analyst…………..
_______________
1
FORM 15
[See Rule 54 and 145 C]
Order under Section 22 (1)(c) of the Drugs and Cosmetics Act, 1940 requiring a person not to
dispose of stock in this possession
Whereas, I have reasons to believe that the stocks of drugs / cosmetics in your
possession, detailed below contravene the provisions of section 18 of the Drugs and Cosmetic s
Act, 1940;
Now, therefore, I hereby require you under clause (c) of sub-section (1) of section 22 of
the said Act not to dispose of the said stock for a period of ………….days from the date of this
order.
Date……………. Inspector……………….
Details of stock of drugs/ cosmetics
Date………………… Inspector……………….
——————————
2
FORM 16
[See Rule 55 and 145-B]
Receipt for stock of drugs or cosmetics or for record, register documents or material object
seized under section 22 (1) (c) or (cc) of the Drugs and Cosmetics Act, 1940.
The stock of drugs or cosmetics or records, registers, documents or material objects
detailed below has / have this day been seized by me under the provisions of clause (c) or
clause (cc) of sub-section (1) of section 22 of the Drugs and Cosmetics Act. 1940 (23 of 1940)
from the premises of ……………………………situated at …………………………..
Date………………. Inspector……………….
Details of drugs, cosmetics, records, registers, documents or material object seized
Date………………… Inspector…………………
___________________________________________________________________
1Amended by G.O.I. Notification No. G.S.R.1594, dtd 13-11-1976.
2Amended by G.O.I. Notification No. G.S.R. 926 dtd 16-07-1977.
222
1
FORM 17
[See Rules 56 and 145-A]
Intimation to person from whom sample is taken
To…………………..
I have this day taken from the premises of ……………………..situated
at……………………………samples of the drugs / cosmetics specified below for the purpose
of test or analysis.
Date………………. Inspector……………….
Details of samples taken
Date………………. Inspector………………..
______________
2
[FORM 17-A
I[See Rules 56-A and 145-AA]
Receipt for samples of drugs or cosmetics taken where fair price tendered thereof under subsection (I) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused.
To ……………………..
……………………..
Whereas I, this ……… day of …….19 …….. have taken, from the premises of situated
at …………… samples of drugs/cosmetics as specified below:-
Details of Samples …………..
And where I had offered to pay you rupees……………….. as the fair price of the
samples of drugs/cosmetics taken:
And whereas, you have refused to accept the fair price tendered thereof.
Now, therefore, I give you the receipt as the fair price tendered for the samples of the
drugs/cosmetics taken by me.
Date: ……………. Inspector …………….]
__________________________________________________________________________
1Added under G.O.I.Notification No. F 1-23/67-D, dated 2-2-1970.
2 Ins. by G.O.I. Notification No. GSR 292(E) dt 29.5.1977.
223
FORM 18
[See Rule 57]
Memorandum to Government Analyst
Serial No. of Memorandum…………………………………………………
From
To
The Government Analyst
The portion of sample / container described below is sent herewith for test or analysis
under the provisions of clause (i) of sub-section (4) of Section 23 of the Drugs and Cosmetics
Act, 1940.
The portion of sample / container has been marked by me with the following mark.
Details of portion of sample or container with 1
[name of drug/cosmetic] which it
purports to contain—
Date……………. Inspector……….…….
________________
2 FORM 18-A
[See Rule 163 (1)]
Memorandum to Government Analyst
Serial No.
From
To
The Government Analyst
The portion of sample / container described below is sent herewith for test or analysis
under the provisions of Section 33H of the Drugs and Cosmetics Act. 1940.
The portion of sample / container has been marked by me with the following mark.
Details of portion of sample or container with name of ingredients from which it is
claimed to be made.
Date………………. Inspector………………..
____________________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 370(E) dt 7.4.1994.
2Amended by G.O.I. Notification No. S.O. 2139 dt 12-8-1972.
224
1
FORM 19
[See Rule 59 (2)]
Application for grant or renewal of a2
[licence to sell, stock or exhibit or offer for sale, or
distribute] drugs other than those specified in Schedule X.
1. I / We ……………………hereby apply for licence to sell by wholsesale/retail drugs
specified in Schedules C and C(1) excluding those specified in Schedule X *and/or drugs
other than those specified in Schedules C, C(1) and X to the Drugs and Cosmetics Rules, 1945
*and also to operate a pharmacy on the premises situated at ………………………………….
2. ? The sale and dispensing of drugs will be made under the personal supervision of
the qualified persons namely:-
……………………………… (Name) …………………….. (Qualification)
……………………………… (Name) …………………….. (Qualification)
3. Categories of drugs to be sold……………………………………………..
4.O Particulars of special storage accommodation …………………………………..
5. A fee of rupees………………….has been credited to Government under the head of
account………………………………………………
Date………………………… Signature………………..]
* Delete whichever is not applicable.
? To be deleted if drugs will be sold only by wholesale.
O Required only if products requiring special storage are to be sold.
______________
FORM 19-A
[See Rule 59 (2)]
Application for the grant or renewal of a restricted 2
[licence to sell, stock or exhibit for sale,
or offer for sale or distribute] drugs by retail by3
[* * *] dealers who do not engage the
services of a qualified person
1. I / We ………………………….of………………………………..hereby
Drugs other than those specified
apply for a licence to sell by retail (i) in Schedule C, C1 and X_______

3
[* * * ]
on the premises situated at……………………………………
_____________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982.
2
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985.
3Omitted by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
.
225
or (ii) 1
[Drugs specified in Schedule C(1)] on the premises situated
[Drugs specified in Schedule C(1)] as vendor in the
at………………………………………
__________________________________
area……………………………………….
2. Sales shall be restricted to such drugs as can be sold without the supervision of a
qualified person under the Drugs and Cosmetics Rules.
3. Names or classes of drugs proposed to be sold……………………………..
*4. Particulars of the storage accommodation for the storage of 1
[Schedules C(1)] on the
premises referred to above.
**5. The drugs for sale will be purchased from the following dealers and such other
dealers as may be endorsed on the licence by the Licensing Authority from time to time.
Name of dealers………………………………….Licence No. ……………………..
2
[* * *]
6. A fee of rupees ___________has been credited to Government under the
twenty
head of account……………………………………………………………………..
Date…………………… Signature……………….
*Delete whichever is not required.
**Applies only to an itinerant vendor.
3
FORM 19-AA
[See Rule 62C]
Application for grant or renewal of a4
[ licence to sell, stock or exhibit or offer for sale by
wholesale or to distribute] drugs from a motor vehicle
1. I / We __________________________________of _________________hereby
apply for 4
[licence to sell, stock or exhibit or offer for sale by wholesale or to distribute]
drugs specified in Schedule C and C (1) and /or drugs other than those specified in Schedule C
and C (1) from the vehicle bearing registration no._______________ assigned under the Motor
Vehicles Act, 1939.
2. Categories of drugs to b e sold / distributed_________________________
___________________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 487(E) dt 2.7.1984.
2Omitted by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
3
Ins. by G.O.I. Notification No.X.11013/7/76-D&MS dt 25.1.1979.
4
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985.
226
3. A fee of rupees________________________ has been credited to Government under
the head of account_________________________________
*4. Particulars of the storage accommodation for the storage of drugs specified in
Schedules C and C (1) on the vehicle referred to above.
Date______________________ Signature_____________
——————-
FORM 19-B
[See Rule 67-A]
Application for 1
[licence to sell, stock or exhibit for sale, or offer for sale or distribute]
Homoeopathic medicines
1. I / We ………………………of…………………….hereby apply for a licence to sell by
*[wholesale / retail] Homoeopathic medicines on the premises situated at……………………..
**2. The sale and dispensing of Homoeopathic medicines shall be made under the personal
supervision of the following competent person in -charge.
Name………………………
3. A fee of rupees ………………has been credited to Government under the head of
account…………………………………..
Date………………. Signature………………
*Delete whichever is not required.
** To be deleted if Homoeopathic medicines will be sold by wholesale.
———–
2
[FORM 19-C
[See Rule 59(2)]
Application for grant or renewal of a1
[licence to sell, stock, exhibit or
offer for sale, or distribute] drugs specified in Schedule X.
1. I/We …………………………. of ………………….. hereby apply for a licence to
sell by *wholesale/retail drugs specified in Schedule X to the Drugs and Cosmetics Rules,
1945. We operate a pharmacy on the premises, situated at …………….
__________________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
2 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
227
2. ** The sale and dispensing of drugs will be made under the personal supervision of
the qualified persons mentioned below:-
……………………………… (Name) …………………….. (Qualification)
……………………………… (Name) …………………….. (Qualification)
3. Names of drugs to be sold.
4. # Particulars of storage accommodation.
5. A fee of rupees ……………………….. has been credited to Government account
under the head of account………………………
Date…………. Signature …………………..]
* Delete whichever is not applicable.
** To be deleted if drugs will be sold only by whole.
# Required only if products requiring special storage are to be sold.
—————
FORM 20
[See rule 61 (1)]
1
[Licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail other than
those specified in 2
[Schedules C, C(1) and X].
I ……………………………….is hereby 1
[licensed to sell, stock or exhibit or offer for
sale or distribute] by retail drugs other than those specified in 2
[Schedules C,C (1) and X]
of the Drugs and Cosmetics Rules 1945, *and to operate a pharmacy on the premises situated
at………………..subject to the conditions specified below and to provisions of the Drugs and
Cosmetics Act, 1940 and the Rules thereunder.
1. The licence shall be in force from……………………..to…………………
2. Name (s) of qualified person (s) in charge………………………………….
3. Categories of drugs……………………………
Date……………………… Licensing Authority……………..
* Delete whichever is applicable
Conditions of Licence
1. This licence shall be displayed in a prominent place in a part of the premises open to
the public.
2. The licence shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and
the Rules thereunder for the time being in force.
_____________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
2 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
228
3. The licence shall report to the Licensing Authority any change in the qualified staff
in-charge within one month of such change.
4. No drug shall be sold unless such drug is purchased under cash or credit memo from
a duly licensed dealer or a duly licensed manufacturer.
5. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm taken place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the firm with the changed constitution.
________________
FORM 20-A
[See Rule 61 (1)]
Restricted 1
[Licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail
other than those specified in2
[Schedules C, C (1) and X] for3
[* **] dealers who do not engage
the services of a qualified person.
I ………………………..is hereby 1
[licensed to sell, stock or exhibit or offer for sale or
distribute] on the premises situated at 3
[* * *]…………….the following drugs being drugs
other than those specified in 2
[Schedules C,C (1) and X] of the Drugs and Cosmetics Rules,
1945, subject to the conditions specified below and to the provisions of the Drugs and
Cosmetics Act, 1940 and the Rules made thereunder.
1. The licence shall be in force from……………………to………………..
2. The licensee can deal only in such drugs as can be sold without the supervision of
qualified person under the Drugs and Cosmetics Rules, 1945.
3. The licence, if he be an itinerant vendor, shall buy drugs only from the following
dealers and such other dealers as may be endorsed on the licence by Licensing
Authority from time to time.
4. [ * * * Omitted as per G.O.I. Notification No. GSR 504(E) dt 18.7.2002.]
____________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
2
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
3Omitted by G.O.I. Notification No. GSR 231(E) dt 4.6.1996
229
Name of the dealer…………………………. Licence No………………….
Date………………. Licensing Authority
Conditions of Licence
1. This licence shall be displayed in a prominent place in a part of the premises open to
the public. [* * * Omitted by G.O.I. Notification No. GSR 231(E) dt 4.6.1996].
2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act,
1940 and the Rules thereunder for the time being in force.
3. No drug shall be sold unless such drug is purchased under a cash or credit memo
from a duly licensed dealer or a duly licensed manufacturer.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the operating under the licence. Where any change in
the constitution of the firm takes place, the current licence shall be deemed to be
valid for a maximum period of three months from the date on which the change
takes place unless, in the meantime, a fresh licence has been taken from the
Licensing Authority in the name of the firm with the changed constitution.
—————–
FORM 20-B
[See Rule 61 (1)]
1
[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other than
specified in2
[Schedules C, C(I) and X]
1. …………………………… hereby 1
[licensed to sell, stock or exhibit or offer for sale
or distribute] by wholesale drugs other than those specified in 2
[Schedule C,C(1) and X] on the
premises situated at……………………subject to the conditions specified below and to the
provisions of the Drugs and Cosmetics Act, 1940, and the Rules thereunder.
2. The licence shall be in force from ……………….. to…………………..
3
[3. The sale shall be made under the personal supervision of a competent person
(Name of the competent person.)]
_______________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
2
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
3 Ins. by G.O.I. Notification No. GSR 681(E) dt 6.6.1988.
230
Date…………………… Licence No…………………
Licensing Authority
Conditions of Licence
1. This licence shall be d isplayed in a prominent place in part of the premises open to
the public
2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act,
1940 and the Rules thereunder for the time being in force.
1
3.(i) No drug shall be sold unless such drug is purchased under a cash or credit
memo from a duly licensed dealer or a duly licensed manufacturer.
(ii) No sale of any drug shall be made to a person not holding the requisite licence to
sell, stock or exhibit for sale or distribute the drug. Provided that this condition
shall not apply to the sale of any drug to–
(a) an officer or authority purchasing on behalf of Government or
(b) a hospital, medical, educational or research institution or a registered medical
practitioner for the purpose of supply to his patients, or
(c) a manufacturer of beverages, confectional biscuits and other nonmedicinal products, where such drugs are required for processing these
products;
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm taken place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the changes takes place unless, in the meantime, a fresh licence has been taken
from the Licensing Authority in the name of the firm with the changed
constitution.
____________________________________________________________________________
1 Amended by G.O.I. Notification No. F.1/63/61-D, dtd 17.7.1963.

231
1
[FORM 20-BB
[See Rule 62-D]
2
[Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute] drugs other than
those specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from
a motor vehicle.
1.__________________________is hereby 2
[licensed to sell, stock or exhibit or offer
for sale by wholesale, or distribute] to sell by wholesale, or to distribute drugs other than those
specified in Schedule C and Schedule C (1) from the vehicle bearing registration
no._________________________ assigned under Motor Vehicle Act, 1939, subject to the
conditions specified below and to the provisions of the Drugs and Cosmetics Act, 1940 and the
Rules made thereunder.
2. The licence shall be in force from__________________ to______________
3. Categories of drugs…………………………………
Date _______________________ Licence No.__________________
Licensing Authority
Conditions of Licence
1. This licence shall be displayed in prominent place on the vehicle.
2. The licence shall comply with the provisions of the Drugs and Cosmetics Act, 1940
and the Rules made thereunder for the time being in force.
3(i)No drugs shall be sold by wholesale or distributed unless such drug is purchased
under a cash or credit memo from a duly licensed dealer or a duly licensed
manufacturer.
(ii) No sale by wholesale or distribution of any drug shall be made to a person not
holding the requisite licence to sell, stock, or exhibit for sale or distribute the drug:
Provided that this condition shall not apply to the sale of any drug to—
a) an officer or authority purchasing on behalf of the Government, or
b) a hospital, medical, educational or research institution or a registered
medical practitioner for the purpose of supply to his patients, or
c) a manufacturer of beverages, confectionary, biscuits and other non-medical
products where such drugs are required for processing these products.
___________________________________________________________________
1 Added by G.O.I. Notification No. X. 11013/7/76-D&MS, dtd 25.1.1979.
2 Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
232
4. The licensee shall inform the Licensing Authority in writing in the event of change in the
constitution of the firm operating under the licence. Where any change in the constitution
of the firm takes place, the current licence shall deemed to be valid for a maximum period
of three months from the date on which the change takes place unless, in the meantime, a
fresh licence has been taken from the Licensing Authority in the name of the firm with the
changed constitution.
5. The licensee shall inform the Licensing Authority in writing in the event of any change in
ownership of the vehicle specified in this licence within seven days of such change.
___________________
1
FORM 20-C
[See Rule 67-C]
2
[Licence to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines by
retail
1. …………………………..is hereby licensed to sell, stock or exhibit for sale or
distribute by retail Homoeopathic medicines on the premises situated
at…………………….subject to the conditions specified below and to the provisions of the
Drugs and Cosmetics Act, 1940 and the Rules made thereunder.
2. The licence shall be in force from…………………..to………………
3. Name of the competent person-in-charge.
Date…………………….. Licensing Authority
Conditions of Licence
1. The licence shall be displayed in a prominent place in a part of the premises open to
the public.
2. The licensee shall comply with the provisions applicable to homoeopathic
medicines under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder
for the time being in force.
3. The licensee shall report to the Licensing Authority any change in the competent
staff within one month of such change.
3
4. This licence authorises the sale of Homoeopathic medicines made from one earlier
potency up to a quantity of 30ml at a time.
_____________________________________________________________________
1Added under G.O.I. Notification No. F. 1-35/64-D dtd 18.8.1964.
2 Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
3 Added under G.O.I.Notification No. F. 1-59/68-D, dtd 19.11.1969.
233
1
5. Where any change in the constitution of the firm takes place, a licensee shall inform the
Licensing Authority in writing about the same and the current licence shall be valid
only for a period of three months from the date on which the change takes place
unless, in the meantime, name of the form with the changed constitution.
_______________
2
FORM 20-D
[See Rule 67-C]
3
[Licence to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines by
wholesale.
1. …………………………….is hereby 3
[licensed to sell, stock or exhibit or offer for
sale or distribute] by wholesale Homoeopathic medicines on the premises situated
at…………………………………….subject to the conditions specified below and to the
provisions of the Drugs and Cosmetics Act. 1940 and the Rules made thereunder.
2. The licence shall be in force from…………………………..
Date…………………. Licensing Authority
Conditions of Licence
1. This licence shall be displayed in a prominent place on the premises.
2. The licence shall comply with the provisions as applicable to Homoeopathic
medicines under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder
for the time being in force.
3. No sale of any drug shall be made to a person not holding the requisite licence to
sell, stock or exhibit for sale or distribute the drug. Provided that this condition
shall not apply to the sale of any drug to (a) an authority purchasing on behalf of
Government, or (b) a hospital, medical, educational or research institute or a
Homoeopathic medical practitioner for the purpose of supply to his patients.
1
4 The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence and the current
licence shall be valid only for a period of three months from the date on which the
change takes place unless, in the meantime, a fresh licence has been taken from the
Licensing Authority in the name of the firm with the changed constitution.
_____________________________________________________________________
1Added under G.O.I. Notification No. G.S.R. 665, dtd 28-5-1977..
2Added under G.O. Notification No. F.1-35/64-D, dtd 18.8.1964.
3
Subs. by G.O.I. Notification No.GSR 788(E) dt 10.10.1985
234
1
FORM 20-E
[See Rule 67-EE]
Certificate of renewal of 2
[Licence to sell, stock or exhibit or offer for sale or distribute]
Homoeopathic medicines.
1. Number of licence and date of issue……………………………….certified that
licence no………………….in Form 20-C / 20D granted on the …………….to………….for
sale of Homoeopathic medicines at the premises situated at…………..has been renewed for a
period from……..to………………….
2. Name of competent persons in-charge.

Date………………… Licensing Authority
________________
3
[FORM 20-F
[See Rule 61(3)]
Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X
1. …….is hereby licensed to sell, stock or exhibit for sale or distribute by retail drugs
specified in Schedule X to the Drugs and Cosmetics Rules, 1945 on the premises situated at
………………………………….
2. Name of drugs
3. This licence shall be in force from ……………. to …………………
4. Name(s) of qualified person-in-charge.
5. the licence is subject to the conditions stated below and the provisions of the Drugs and
Cosmetics Act, 1940 and the Rules, made thereunder.
Date: …………….
Licence No. ………..
Licensing Authrotity.
Conditions of the licence.
1. This licence shall be displayed in a prominent place in a part of the premises open to
the public.
_________________________________________________________________________
1
Ins. by G.O.I. Notification No. F.1-14/67-D dt 3.2.1969.
2
Subs, by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
3 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
235
2. The licencee shall report to the licensing authority any change in the qualified staff
incharge within one month of such change.
3. No drug shall be stocked or sold unless such drug has been purchased under cash/credit
memo from a duly licensed dealer or a duly licensed manufacturer.
4. The licensee shall inform the licensing authority in writing in the event of any change
in the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
maximum period of three months from the date on which the change takes place unless
in the meantime, a fresh licence has been taken from the licensing authority in the name
of the firm with the changed constitution.
——————
FORM 20-G
[See Rule 61(3)]
1
[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale
drugs specified in Schedule X.
1. …….is hereby licensed to sell, stock or exhibit for sale or distribute by retail drugs
specified in Schedule X to the Drugs and Cosmetics Rules, 1945 on the premises situated at
………………………………….
2. Name of drugs
3. This licence shall be in force from ……………. to …………………
4. The licence is subject to the conditions stated below and the provisions of the Drugs
and Cosmetics Act, 1940 and the Rules, made thereunder.
Conditions of the licence.
1. This licence shall be displayed in a prominent place in a part of the premises open to
the public.
2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940
and the rules made thereunder.
3. No drug shall be stocked or sold unless such drug has been purchased under a cash or
credit memo from a duly licensed dealer or a duly licensed manufacturer.
4. The licensee shall forward to the licensing authority copies of the invoices of sales
made to the retail dealers.
5. No sale of any drug by wholesale shall be made to a person not possessing the requisite
licence to sell, stock or exhibit for sale or distribute drugs specified in Schedule X :
____________________________________________________________________
1
Subs, by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
236
Provided that this condition shall not apply to the sale of any drug to –
(a) an officer or authority purchasing on behalf of Government;
(b) a hospital, medical, educational or research institution, nursing home, Registered
Medical Practitioner for the purpose of supply to its/his patients or manufacturer
holding a licence in Form 25-E or 28-B to manufacture the drugs containing drug
included in Schedule X.]
1
[The licensee shall inform the licensing authority in writing in the event of any change
in the constitution of the firm operating under the licence, where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
maximum period of three months from the date on which the change takes place unless in
the meantime, a fresh licence has been taken from the licensing authority in the name of the
firm with the changed constitution.]
_________________
FORM 21
[See Rule 61 (2)]
1
[Licence to sell, stock or exhibit or offer for sale distribute] by retail drugs specified in
Schedules C and C (1) 2
[excluding those specified in Schedule X.]
3
1. …………………..is hereby 1
[licensed to sell, stock or exhibit or offer for sale or
distribute] by retail the following categories of drugs specified in Schedules C and C (1)
2
[excluding those specified in Schedule X.] to the Drugs and Cosmetics Rules, 1945*
and to
operate a pharmacy on the premises situated at……………..subject to the conditions specified
below and to the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder.
2. The licence shall be in force from………….to………………
3. Name(s) of qualified persons in charge………………………….

3
4. Categories of drugs…………………………………………..
Date………………………… Licensing Authority
Licence No…………………………
*Delete if not applicable.
________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
2 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
3 Amended by G.O.I. Notification No. S.O. 2139 dt 12-8-1972.
237
Conditions of Licence
1. This licence shall be displayed in a prominent place in a part of the premises open
to the public.
2. The licensee shall report to the Licensing Authority any change in the qualified
staff in charge within one month of such change.
3. [ * * * Omitted by G.O.I.Notification No. GSR 17(E) dt 7.1.1986.]
4. If the licensee wants to sell, stock or exhibit for sale or distribute, during the
currency of the licence, additional categories of drugs listed in Schedules C and C
(1) 2
[excluding those specified in Schedule X.]but not included in this licence, he
should apply to the Licensing Authority for the necessary permission. This licence
will be deemed to extend to the categories of drugs in respect of which such
permission is given. This permission shall be endorsed on the licence by the
Licensing Authority.
1
5 No drug shall be sold unless such drug is purchased under a cash or credit
memo from a duly licensed dealer or a duly licensed manufacturer.
6. The licence shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place, unless in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the firm with the changed constitution.
__________________
FORM 21-A
[See Rule 61 (2)]
3
Licence to sell, stock or exhibit or offer for sale distribute] by retail drugs specified in
5
[Schedules C (1)] 4
[* * *] dealers who do not engage the services of a qualified person.
1. …………………………..is hereby [licensed to sell, stock or exhibit or offer for sale
or distribute] by retail on the premises situated at /4
[* * *] …………………the following rugs
being drugs specified in 5
[Schedule C (1)] to the Drugs and Cosmetics Rules, 1945, subject to
the conditions specified below and to the provisions of the Drugs and Cosmetics Act, 1940 and
the Rules thereunder.
____________________________________________________________________________
1 Ins. by G.O.I. Notification No. F. 1-63/61-D dtd 17.7.1963.
2 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
3 Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
4Omitted by G.O.I. Notification No. GSR 231(E) dt 4.6.1996
5 Subs. by G.O.I. Notification No. GSR 487(E) dt 2.7.1984.
238
2. The licence will be in force from……………..to…………………..
3. Particulars of 1
[Schedule C (1)] drugs to be sold…………………….
4. [ * * * Omitted as per G.O.I. Notification No. GSR 504(E) dt 18.7.2002.]
Date…………………. Licensing Authority……
Conditions of Licence
1. This licence shall be displayed in a prominent and conspicuous place in a part of the
premises open to public or shall be kept on the process of the vendor who shall
produce it on demand by an Inspector or an officer authorised by the State
Government in this behalf.
2. [ * * * Omitted as per G.O.I. Notification No. GSR 17(E) dt 7.1.1986.]
3. The licensee shall deal only in such drugs as can be sold without the supervision of
a “qualified person” as defined in the Explanation to sub -rule (15) of rule 65 of the
Drugs and Cosmetics Rules, 1945.
4. No drug shall be sold unless such drug is purchased under cash or credit memo
from duly licensed manufacturer.
5. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the firm with the changed constitution.
FORM 21-B
[See Rule 61 (2)]
2
[Licence to sell, stock or exhibitor offer for sale or distribute] by wholesale drugs specified in
Schedules C and C (1) 3
[excluding those specified in Schedule X].
1…………………….is hereby licensed to sell, stock or exhibit for sale or distribute by
wholesale on the premises situated at……………..the following categories of drugs specified
in Schedule C and C (1) 3
[excluding those specified in Schedule X] to the Drugs and
Cosmetics Rules, 1945.
__________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 487(E) dt 2.7.1984.
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
3
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
239
Categories of drugs
2. This licence shall be in force from……………to…………………
1
[2-A. The sale shall be made under the person supervision of a competent person.
(Name of the competent person.)].
3. This lic ence is subject to the conditions stated below and to the provisions of the
Drugs and Cosmetics Act, 1940 and the Rules thereunder.
Licence No……………
Date…………………. Licensing Authority……
Conditions of Licence
1. This licence shall be displayed in a prominent place in a part of the premises open
to the public.
2. [ * * * Deleted by G.O.I. Notification No. GSR 17(E) dt 7.1.1986.]
3. If the licensee wants to sell, stock or exhibit for sale or distribute during the
currency of the licence additional categories of drugs listed in Schedule C and C (1)
2
[excluding those specified in Schedule X] but not included in this licence. He
should apply to the Licensing Authority for the necessary permission. This licence
will be deemed to extend to the categories of drugs in respect of which such
permission is given. This permission shall be endorsed on the licence by the
Licensing Authority.
3
4. (i) No drug shall be sold unless such drug is purchased under a cash or credit
memo from a duly licensed dealer or a duly licensed manufacturer.
(ii) No sale of any drug shall be made for purposes of resale to a person not holding
the requisite licence to sell, stock or exhibit for sale or distribute the drug.
Provided that this condition shall not apply to the sale of any drug to—
(a) an officer or authority purchasing on behalf of Government, or
(b) a hospital, medical, educational or research institute or a registered medical
practitioner for the purpose of supply to his patients, or
4
(c) a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other
non-medicinal products, where such drugs are required for processing these
products

____________________________________________________________________________
1
Ins. by G.O.I. Notification No.GSR 681(E) dt 6.6.1988.
2
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
3Added under G.O.I. Notification No. F. 1-63/61-D, dtd 17.7.1963.
4Added under G.O.I. Notification No. F. 1-113/69-D, dtd 23.12.1969.
240
5. The licence shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any change in
the constitution of the firm takes place, the current licence shall be deemed to be valid
for a maximum period of three months from the date on which the change takes place
unless, in the meantime, a fresh licence has been taken from Licensing Authority in the
name of the firm with the changed constitution.
————————
FORM 21-BB
[See Rule 62-D]
Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedules C (1)
to the Drugs and Cosmetics Rules, 1945 from a motor vehicle.
1 ……………………is hereby licensed to sell by wholesale, or to distribute drugs
specified in Schedule C and Schedule C (1) from the vehicle bearing registration no.
………………………..assigned under Motor Vehicles Act, 1939, subject to the conditions
specified below and to the provisions of the Drugs and Cosmetics Act, 1940 and the Rules
made thereunder.
2. The licence shall be in force from …………….. to……………..
3. Categories of drugs………………………………………..
Date …………… Licence No. ……………………..
Licensing Authority
Conditions of licence
1. This licence shall be displayed in a prominent place on the vehicle.
2. No drugs to which this licence applies shall be sold by the Licensing Authority
from time to time in the Official Gazette have been observed throughout the period
during which it has been in the possession of the licensee.
3. If the licensee wants to sell by wholesale or distribute during the currency of the
licence, additional categories of drugs listed in Schedule C and C (1) not included
in this licence, he shall apply to the Licensing Authority for necessary permission.
This licence shall be deemed to extend to the categories of drugs in respect of
which such permission is given. This shall be endorsed on the licence by the
Licensing Authority.
241
4. (i) No drugs shall be sold by wholesale or distributed unless such drug is purchased
under a cash or credit memo from a duly licensed manufacturer.
(ii) No sale for wholesale or distribution of any drug shall be made for the purpose
of resale to a person, not holding the requisite licence to sell, stock or exhibit for
sale or distribute the drug:
Provided that this condition shall not apply to the sale of any drug to.—
(a) an officer or authority purchasing on behalf of the Government.
(b) a hospital, medical, educational or research institution or a registered medical
practitioner for the purpose of supply to his patients, or
(c) a manufactures of hydrogenated vegetable oils, beverages, confectionary and
other non-medical products, where such drugs are required for processing their
products.
5. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the firm with the changed constitution.
6. The licensee shall inform the Licensing Authority in writing in the event of any
change in the ownership of the vehicle specified in this licence within seven days of
such change.
_____________
FORM 21 – C
[See Rule 63-A]
Certificate of renewal of 1
[licence to sell, stock or exhibit or offer for sale
or distribute] drugs
1. Certified that licence No……………….in 2
[Form 20, 20A, 20-B, 20-F, 20-G, 21,
21-A, 21-B], granted on the…………….to………….for sale of the following drugs at the
premises situated at……………has been renewed for a period from…………………to……….
2. Categories or particulars of drugs……………………………….
3. Name (s) of qualified person (s) in-charge……………………..
Date………………………. Licensing Authority
_________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
2
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
242
FORM 21-CC
[See Rule 63-B]
Certificate of renewal of 1
[licence to sell, to stock or exhibit or offer for sale by wholesale or
distribute] drugs from a motor vehicle.
Number of licence and date of issue_________________________________
1. Certified that licence no. _________ in Form 20-BB or Form 21-BB granted on the
__________________________ to ________________________ for sale by wholesale or
distribution of the following drugs from the vehicle having registration No.
____________________________ assigned under the Motor Vehicle Act, 1939 has been
renewed for a period from _________________ to ____________________________
2. Categories of the drugs:
______________________ ________________________
______________________ ________________________
Date ___________________ Licensing Authority

FORM 24
[See Rule 69]
Application for the grant of or renewal of a 1
[ licence to manufacture for sale or for
distribution of] drugs other than those specified in Schedules C and C (1).
1. I / We …………………………..of………………………… hereby apply for the
grant / renewal of a licence to manufacture on the premises situated at ……………….. the
following drugs being drugs other than those specified in Schedules C and C (1) of the Drugs
and Cosmetics Rules, 1945.
2. Names of drugs categorized according to Schedule M.
……………………………… .
3. Names, qualifications and experience of technical staff employed for manufacture
and testing.
4. A fee of rupees ………………………………. has been credited to Government
under the head of account……………………………………………..
Date……………………… Signature…………….
NOTE.—The application should be accompanied by a plan of the premises.
___________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
243
FORM 24-A
[See Rule 69-A]
Application for grant or renewal of a loan 1
[licence to manufacture for sale or for distribution
of] drugs other than those specified in Schedule C and C (1).
1. I / We*…………………………………off …………………………..hereby apply
for the grant / renewal of a loan licence to manufac ture on the premises situated
at…………………………………………..C /o§ ………………………… the undermentioned drugs, other than those specifies in Schedule C and C (1) to the Drugs and
Cosmetics Rules.
Names of drugs (each substance to be separately specified).
2. The names, qualifications and experience of the expert staff actually connected with
the manufacture and testing of the specified products in manufacturing premises.
4. I / We enclose
(a) A true copy of a letter from me / us to the manufacturing concern whose
manufacturing capacity is intended to be utilized by me / us.
(b) A true copy of a letter from the manufacturing concern that they agree to lend the
services of their expert staff, equipment and premises for manufacture of each item
required by me / us and that they will analyze every batch of finished product and
maintain the registers of raw materials, finished products and reports of analysis
separatly in this behalf.
(c) Specimens of labels, cartons of the products proposed to be manufactured.
4, A fee of rupees ……………………………………….has been credited to
Government under the head of account ……………………………………
Date …………………………. Signature…………………….
* Enter here the name of the proprietor, partners of Managing Director as the case may be.
f .Enter here the name of the applicant form and the address of the principal place of business.
§ Enter here the name and address of the manufacturing concern where the manufacture will be actually
carried out and also the Licence number under which the latter operates.
___________________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
244
FORM 24-B
[See Rule 69]
Application for grant or renewal of licence to repack for sale or distribution of drugs, being
drugs other than those specified in Schedules C and C (1) 1
[excluding those specified in
Schedule X]
1. I / We ………………………..of ……………………………..hereby apply for grant
/ renewal of a licence to repack the following drugs at the premises situated
at………………………………………………
2. Names of the drugs to be repacked……………………………………..
3. Name, qualification and experience of competent staff……………………
4. A fee of rupees forty has been credited to Government under the head of
account……………………………………..
Date………………………….. Signature of applicant…………
NOTE :—The applications shall be accompanied by a plan of the premises.
___________________
1
FORM 24-C
[See Rule 85-B]
Application for the grant or renewal of a2
[licence to manufacture for sale or for distribution
of]Homoeopathic medicines or a licence to manufacture potentised preparations from back
potencies by licensees holding licence in Form 20-C
3
[1. I / We ………………………….. of ……………………….. holder of licence
no……………………………………in Form 20-C hereby apply for the grant / renewal of
licence to manufacture the under mentioned Homoeopathic mother tinctures / potentised
preparations on the premises situated at…………………….
Name of the Homoeopathic preparations………………………. (Each item to be
separately specified)].
2. Names, qualifications and experience of technical staff employed for manufacture
and testing of Homoeopathic medicines.
___________________________________________________________________________
1Amended by G.O.I. Notification No. F. 1-598-D, dtd 19.11.1969
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
3
Subs. by G.O.I. Notification No. GSR 13(E) dt 7.1.1983.
245
3. A fee of rupees……………………….has been credited to Government under head
of account…………………………………………………………………………
Date………………………. Signature…………………..
NOTE 1. Delete whichever portion is not applicable.
2. The application should be accompanied by a plan of the premises.
_________________
1
FORM 24-D
[See Rule 153]
Application for the grant / renewal of a licence to manufacture for sale of Ayurvedic / Siddha
or Unani drugs
1. I / We ……………………….. of ………………………………..hereby apply for the
grant / renewal of a licence to manufacture Ayurvedic (including Siddha) or Unani drugs on
the premises situated at…………………………………….
2. Names of drugs to be manufactured (with details)
3. Names, qualification and experience of technical staff employed for manufacture and
testing of Ayurvedic (including Siddha) or Unani drugs ………………………………..
4. A fee of rupees………………..has been credited to the Government under the head
of account……………………….and the relevant Treasury Challan is enclosed herewith.
Date…………………………… Signature………………………..
(applicant)
NOTE—The application should be accompanied by a Plan of the premises.
____________________
2
FORM 24-E
[See Rule 154-A]
Application for grant or renewal of a loan licence to manufacture or sale Ayurvedic (including
Siddha) or Unani Drugs
1. I / We*……………………………………………..of**……………………hereby
apply for the grant / renewal of a loan licence to manufacture Ayurvedic (including Siddha) or
Unani Drugs…………………………………..on the premises situated
at……………………………………………………………………………………..
C/o ***………………………………………………..
____________________________________________________________________________
1
Ins. by G.O.I. Notification No.1-23/67-D dt 2.2.1970.
2 Added by G.O.I. Notification No.GSR 376 (E) dtd 20.7.1978.
246
2. Names of drugs to be manufactured (with details).
3. The names, qualifications and experience of technical staff actually connected with
the manufacture and testing of Ayurvedic (including Siddha) or Unani drugs in the
manufacturing premises.
4. I / We enclose,
a) A true copy of a letter from me / us to the manufacture concern whose
manufacturing capacity is intended to be utilized by me / us.
b) A true copy of a letter from the manufacturing concern that they agree to
lend the services of their competent technical staff, equipment and premises
for the manufacture of each item required by me / us and that they shall
maintain the registers of raw materials and finished products separatly in
this behalf.
c) Specimen of labels, cartons of the drugs proposed to be manufactured.
4. A fee of Rs…………………………………..has been credited to Government under
the head of account……………………….and the relevant Treasury Challan is enclosed
herewith.
Date………………… Signature………………]
(applicant)
____________________________________________________________________
* Enter here the name of the proprietor, partners or Managing Director as the case may be.
** . Enter here the name of the applicant firm and the address of the principal place of
business.
*** Enter here the name and address of the manufacturing concern where the manufacture will
be actually carried out and also the licence number under which the letter operates.
________________
1
[FORM 24-F
[See Rule 69]
Application for grant or renewal of a 2
[licence to manufacture for sale or for distribution of]
drugs specified in Schedule X and not specified in Schedules C and C(1).
1. I/We……………………. of …………………….. hereby apply for the grant/renewal
of licence to manufacture on premises situated at …………………the undermentioned drugs,
specified in Schedule X to the Drugs and Cosmetics Rules, 1945.
_________________________________________________________________________
1 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
247
2. Name of drugs.
3. Names, qualifications and experience of technical staff employed for manufacture and
testing.
4. A fee of rupees………….. has been credited to Government account under the head of
account…………………………………
Signature……………
Date: …….. Designation ………..]
____________
FORM -25
[See Rule 70]
1
[Licence to manufacture for sale or for distribution of] drugs other than those specified in
Schedules C and C(1).
Number of Licence and date of issue…………………………………………
1…………………………………………….is hereby to manufacture the following
categories of drugs being drugs other than those specified in Schedules C and C (1) to the
Drugs and Cosmetics Rules, 1945, on the premises situated
at………………………………………………………………under the direction and
supervision of the following 2
[competent technical staff]
a) 2
[competent technical staff]
b) Names of Drug (each item to be separately specified)…………………………
2. The licence authorizes the sale by way of wholesale dealing and storage for sale by
the licensee of the drugs manufactured under the licence, subject to the conditions applicable to
licence for sale.
3. The licence shall be in force from…………………………..to……………
__________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
2 Subs. by G.O.I. Notification No. GSR 5(E) dt 6.1.1997.
248
4. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs & Cosmetics Act,
1940.
Date………………………… Signature………………………
Designation…………………….
1
[*Licensing Authority
*Central Licence Appoving Authority.]
*Delete whichever is not applicable.
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
3. If the licensee wants to manufacture for sale additional items of drugs not included
above he should apply to the Licensing Authority for the necessary endorsement as
provided in Rule 69 (5). This licence will be deemed to extend to the categories so
endorsed.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the form with th e changed constitution.
_________________
FORM 25-A
[See Rule 70-A]
Loan 2
[licence to manufacture for sale or for distribution of] drugs other than those specified
in Schedules C and C (1)
1. Number of licence and date of issue………………………………………
2. ……………………………….of……………………..is hereby granted a loan
licence to manufacture the following drugs other than those specified in Schedules
C and C (1) to the
______________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
249
Drugs and Cosmetics Rules, 1945, on the premises situated
at………………………………C/o……………………………………under the direction and
supervision of the following 1
[competent technical staff]
a) 1
[competent technical staff]
b) Name of drugs……………………………
3. The licence authorizes the sale by way of wholesale dealing and storage for sale by
the licensee of the drugs manufactured under the licence subject to the conditions applicable to
licences for sale.
4. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs & Cosmetics Act,
1940.
Date…………………… Signature……………………
Designation……………………
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
3. If the licensee wants to undertake during the currency of the licence the
manufacture for sale additional drugs he should apply to the Licensing Authority
for the necessary endorsement to the licence as provided in Rule 69-A. This licence
will be deemed to extend to the drugs so endorsed.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the form with the changed constitution.
______________________________________________________________________
1 Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
250
1
FORM 25-B
[See Rule 70]
Licence to repack for sale or distribution of drugs being drugs other than those specified in
Schedules C and C (1) 2
[excluding those specified in Schedule X]
Number of licence and date of issue……………………………………….
1……………………………of……………………….is hereby granted a licence to
repack the following drugs for sale or distribution on the premises situated
at…………………….under the supervision of the following competent staff.
a) Names of drugs to be repacked.
b) Names of competent staff.
2. The licence shall be in force from……………………..to…………………
3. The licence authorizes the sale by way of wholesale dealing by the licensee and
storage for sale by the licensee of the drugs repacked under the licence subject to conditions
applicable to licences for sale.
4. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act,
1940.
Date……………………….. Signature……………………..
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
3. If the licensee wants to repack for sale or distribution additional items he should
apply to the Licensing Authority for the necessary endorsement to this licence.
This licence will be deemed to extend to only those items so endorsed.
____________________________________________________________________________
1
Added under G.O.I.Notification No. F. 1-22/59-D, dtd 9-4-1960.
2 Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
251
4. The drugs repacked under this licence shall bear on their label, apart from other
particulars required by these Rules, the name and address of the licensee and the
number of the licence under which the drug is repacked proceeded by the words
“Rpg. Lic. No.”.
5. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the form with the changed constitution.
________________
1
FORM 25-C
[See Rule 85-D]
2
[Licence to manufacture for sale or for distribution of] Homoeopathic medicines
Number of Licence and date of issue…………………………………….
3
[1,…………………………………who holds a licence in Form 20-C is hereby
licensed to manufacture Homoeopathic mother tinctures / potentised and other preparations on
the premises situated at…………………………….under the direction and supervision of the
following technical staff :
Name of the Homoeopathic preparations (Each item to be separately specified).
Names of the Technical Staff …………………………]
2. The licence shall be in force from…………………………….to……………
3. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act,
1940.
Date……………………….. Signature………………………
Designation…………………….
_______________________________________________________________________
1
Added under G.O.I. Notification No. F.1-36/64-D, dated 18th August 1964.
2 Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
3 Subs. by G.O.I. Notification No. GSR 13(E) dt 7.1.1983.
252
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
1
3. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the form with the changed constitution.
______________
2
FORM 25-D
[See Rule 154]
Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs
No. of Licence…………………………..
1……………………………is / are hereby licensed to manufacture the following
Ayurvedic (including Siddha) or Unani drugs on the premises situated
at……………………………………………………………….under the direction and
supervision of the following technical staff: —
a) Technical staff (Name)
b) Names of drugs (each item to be separatly specified).
2. The licence shall be in force from…………………………..to……………
_____________________________________________________________________
1 Added by G.O.I. Notification No.S.O. 903 dtd 28-2-1976.
2 Added under G.O.I. Notification No. 1-23/67-D, dtd 2-2-1970
253
3. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act,
1940.
Date……………………………… Signature………………
Designation……………
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
3. This licence shall be deemed to extend to such additional items as the licensee may
intimate to the Licensing Authority from time to time, and as may be endorsed by
the Licensing Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the form with the changed constitution.
______________
1
FORM 25-E
[See Rule 154-A]
Loan Licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs
1. Number of Licence………………………………….
2…………………………………..of……………………………is hereby granted a
loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani drugs, on the
premises situated at…………………………………C/o…………………………………under
the direction and supervision of the following expert technical staff.
a) Technical staff
b) Names of drugs (each item to be separately specified)
_________________________________________________________________________
1
Added by G.O.I. Notification No. GSR 376 (E), dtd 20.7.1978
254
3. The licence shall be in force from………………….to………………………
4. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act,
1940.
Date of Issue……………………………….
Signature………………….
Designation………………..
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
3. This licence shall be deemed to extend to such additional items as the licensee may
intimate to the Licensing Authority from time to time, and as may be endorsed by
the Licensing Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any
change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which
the change takes place unless, in the meantime, a fresh licence has been taken from
the Licensing Authority in the name of the form with the changed constitution.
______________
1
[FORM 25-F
[See Rule 70]
2
[Licence to manufacture for sale or for distribution of] drugs specified in
Schedule X and not specified in Schedules C and C(I).
1. ………………………….. of ……………. is hereby licensed to manufacture at
the premises situated at …………… the following drugs specified in Schedule
X to the Drugs and Cosmetics Rules, 1945.
2. Name of drugs.
3. Names of approved 1
[competent technical staff]
____________________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
255
4. The licence authorizes the sale by way of wholesale dealing and storage for sale
by the licensee of the drugs manufactured under the licence subject to the
onditions applicable to licence for sale.
5. The licence shall be in force ……….. to ……………………..
6. The licence is subject to conditions stated below and to other conditions as may
be specified in the rules for the time being in force under the Drugs and
Cosmetics Act, 1940.
Date of issue …………. Signature …………………..
Licence No. …………… Designation………………..

2
[*Licensing Authority
*Central Licence Approving Authority.
Conditions of Licence
1. The licence and any certificate of renewal in force shall be kept on the licensed
premises and shall be produced at the request of an Inspector appointed under the Drugs and
Cosmetics Act, 1940.
2. If the licensee wishes to undertake during the currency of the licence the
manufacture of any drug specified in Schedule X not included above, he should apply to the
Licensing Authority for the necessary endorsement of this licence. This licence shall be
deemed to extend to only those items so endorsed.
3. Any change in the 1
[competent technical staff] shall be forthwith reported to the
Licensing Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
maximum period of three months from the date on which the change takes place unless, in the
meantime, a fresh licence has been taken from the Licensing Authority in the name of the form
with the changed constitution.
5. The licensee shall furnish to the Licensing Authority copies of the invoices of
sales made to dealers.
6. The licensee shall not manufacture drugs covered by this licence for use as
‘Physician’s Samples’.]
_________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
2
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.2.1992.
256
1
[FORM 26
[See Rules 73 and 83]
Certificate of renewal of licence to manufacture for sale of drugs other than those specified in
Schedule X
1. Certified that licence no……………………………………………granted on
the…………..to………………for the manufacture of the following categories of drugs being
*drugs other than those specified in Schedules C and C (1) and X
*drugs covered by Schedules C and C (1) excluding those specified in Schedule X
to the Drugs and Cosmetics Rules, 1945, at the premises situated at …………….
……………………….has been renewed from………………to ……………
2. Name (s) of 2
[competent technical staff]………………..
3
[3 Name of the drugs (each item to be separately specified) …………..]
Signature…………………..
Date ……… Designation……………
*Delete whatever portion is not required.
___________________
1
FORM 26-A
[See Rules 73-A and 83-A]
Certificate of renewal of loan licence to manufacture for sale of drugs other than those
specified in Schedule X
1. Certified that loan licence No………………………………………..granted on
the……………………………..to……………………………for the manufacture of the under
mentioned drugs being
*drugs other than those than drugs in Schedule C, C (1) and X
drugs specified in Schedules C and C (1) excluding those specified in Schedule X.
to the Drugs and Cosmetics Rules, 1945, at the premises situated
at…………………..C/o……………….has been renewed from………………..to……………
2. Names of the drugs (each substance to be separately specified).
___________________________________________________________________________
1 Subs.by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
2 Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996
3 Ins. by G.O.I. Notification No. GSR 370(E) dt 7.4.1994.
257
3. Name of the 1
[competent technical staff]
Signature……………….
Designation……………..
Date…………………….
* Delete whichever is not applicable.
______________
2
FORM 26-B
[See Rule 73-B]
Certificate of renewal of licence to repack for sale or distribution of drugs
being drugs other than those specified in Schedules C and C (1) 3
[excluding those specified in
Schedule X]
1. Certified that licence No…………………………granted on
the………………to……………………….for the repacking of the following drugs at the
premises situated at………………………….has been renewed from…………….
to…………………………………………
Names of drugs to be repacked……………………………….
2. Names of competent staff…………………………
Date : …… Signature …………….
Designation ………………
4
[*Licensing Authority.
* Central Licence Approving Authority.
* Delete whichever is not applicable.
_________________
FORM 26-C
[See Rule 85-G]
Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines
1. Certified that licence No………………..granted on the ………….to……………for
the manufacture for sale of the Homoeopathic mother tinctures / potentised preparation at the
premises situated at……………………..has been renewed for a period from
the…………………..to……………………….
_________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996
2Added under G.O.I. Notification No. F.1-22/59-D, dtd 9.4.1964
3
Subs.by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
4
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.2.1992.
258
2. Name of the technical staff……………………………………..
1
[3. Names of the drugs (each item to be separately specified) …………]
Signature……………………..
Designation………………………
Date……………………………….
________________
2
FORM 26-D
[See Rule 155]
Certificate of renewal of licence to manufacture for sale of Ayurvedic / Siddha or Unani drugs
1. Certified that licence No…………………………….granted on
the…………………………………………to Shri/ Messers…………………………..for the
manufacture of Ayurvedic/Siddha/Unani drugs at the premises situated at………………..has
been renewed from………………………….to………………………….
2. Name of technical staff………………………………………….

3
3. Names of drugs (each item to be separately specified).]
Signature……………….
Designation…………….
Date………………………
———————-
3
FORM 26-E
[See Rule 155-A]
Certificate of renewal of loan licence to manufacture for sale of
Ayurvedic / Siddha or Unani Drugs
1. Certified that Loan Licence No…………………..granted on
the………………………………………to…………………………….for the manufacture of
Ayurvedic / Siddha or Unani drugs at the premises situated
at……………………………………………….C/o………………………..has been renewed
from……………………………………….to………………………………….
__________________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 370(E) dt 7.4.1994.
2
Ins. by G.O.I. Notification No. 1-23/67-D, dtd 2-2-1970.
3
Ins. by G.O.I. Notification No. GSR 376 (E), dtd 20.7.1978
259
2. Name of technical staff……………………………………………….
Date………………………….
Signature…………………..
Designation………………..
_______________
1
[FORM 26-E-1
(See Rule 157 155-B)
(Certificate of Good Manufacturing Practices (GMP) to manufacture of
Ayurveda, Siddha or Unani drugs):
Certified that manufacturing unit licensee, namely ……………situated at …………
State ………….. Licence No. ……………… comply with the requirements of Good
Manufacturing Practices of Ayurveda-Siddha-Unani drugs as laid down in Schedule T of the
Drugs and Cosmetic Rules, 1945.
This certificate is valid for a period of three years.
Dated :….. Signature ………….
Place : …. Designation ………..
Licensing Authority for Ayurveda/
Siddha/ Unani Drugs.]
______________
2
[FORM 26-F
[See Rules 73 and 83]
Certificate of renewal of licence to manufacture for sale of
drugs specified in Schedule X
1. Certified that licence No. ……………….. granted on the ……….. to ……….
For the manufacture of drugs specified in Schedule X to the Drugs and
Cosmetics Rules, 1945, at the premises situated at ………………… has been
renewed from ………… to ………….
2. Names of drugs (each substance to be separately specified).
_________________________________________________________________________
1
Ins. by G.O.I. Notification No.GSR561(E) dt 23.6.2000 and subs. By G.O.I.Notification No.G.S.R.198(E)
dt.07.03.2003.
2 Ins. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
260
3. Names of the 1
[competent technical staff].
Signature …………….
Designation ………………
2
[*Licensing Authority.
* Central Licence Approving Authority.
* Delete whichever is not applicable.
Date of issue ………………………..
____________________
3
[FORM 26-G
[See Rule 122-F]
Certificate of renewal of licence to operate f Blood Bank for processing of whole human blood
and/or* for preparation for sale or distribution of its components.
1. Certified that Licence No………….. granted on ……………… to M/s.
……………… for the operation of a Blood Bank for processing of whole human blood and/or
for preparation of its components at the premises situated…………………….. is hereby
renewed with effect from …………….. to ……………..
2. Name(s) of items :
1.
2.
3.
3. Name(s) of competent Technical Staff:
1.
2.
3.
4.
5.
Date ……….. Signature ………………
Name and Designation ………
Licensing Authority.
Central Licence Approving Authority.
* Delete whichever is not applicable.]
________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
2
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
3
Subs. by G.O.I. Notification No. GSR 244(E) dt 5.4.1999.
261
1
[FORM 26-H
[See Rules 68-A, 76, 78]
Certificate of renewal of licence to manufacture for sale of Large Volume
Parenterals/Sera and Vaccines specified in Schedules C and C(I)
excluding those specified in Schedule X.
1. Certified that Licence No. …………. granted on the ………… to……… for
the manufacture of following Large Volume Parenterals/Sera and Vaccines at the premises
situated at …………….has been renewed from …………… to …………….
2. Name(s) of drug(s) ………………………(each item to be separately specified).
3. Name(s) of competent technical staff:
(a) responsible for manufacturing (b) responsible for testing
a) 1.
b) 2.
c) 3.
d) 4.
Signature ………………
Designation ………………….
Licensing Authority
Central Licence Approving Authority
Date ……………………..]
___________________
2
[FORM 26-I
[See Rules 122-I]
Certificate of renewal of licence for manufacture of blood products.
1. Certified that Licence No. …………. granted on the ………… to……… for
the manufacture of blood products at the premises situated at …………….has been renewed
from …………… to …………….
2. Name(s) of item (s).
1.
2.
3.
_________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
2
Ins. by G.O.I. Notification No. GSR 245(E) dt 5.4.1999.
262
3.Name(s) of competent technical staff:
(a) responsible for manufacturing (b) responsible for testing
1. 1.
2. 2.
3. 3.
4. 4.
Signature ………………
Designation ………………….
Licensing Authority
Central Licence Approving Authority
Date ……………………..]
___________________
FORM -27
Application for grant or renewal of a 1
[licence to manufacture for sale or for
distribution of] drugs specified in Schedules C and C (1) 2
[excluding those
specified in Schedule X]
1. I / We ……………………………………hereby apply for the grant / renewal of a
licence to manufacture on the premises situated at…………………………..the under
mentioned drugs, being drugs specified in Schedule C and C (1) 2
[excluding those specified in
Schedule X] to the Drugs and Cosmetics Rules, 1945.
Names of drugs
(each item to be separately specified).
2. The names, qualifications and experience of the expert staff responsible for the
manufacture and testing of the above mentioned drugs.
a) Name (s) of staff responsible for test………………………
b) Name (s) of staff responsible for manufacture……………….
3. The premises and plan are ready for inspection
will be ready for inspection on
4. A fee of rupees ……………………. ……………and an inspection fee of rupees
___________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
2
Subs. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
263
has been credited to Government under the head of account.
Date…………………………. Signature…………………
Designation……………………
FORM 27-A
[See Rule 75-A]
Application for grant or renewal of a loan 1
[licence to manufacture for sale or for distribution
of] drugs specified in Schedules C and C (1)
1. I / We*……………………….of**………………………………..hereby apply for
the grant / renewal of Loan Licence to manufacture on the premises situated
at……………………………………………C/o***…………………………………… the
undermentioned drugs, being drugs specified in Schedules C and C (1) to the Drugs and
Cosmetics Rules.
Names of drugs (each substance to be separately specified).
2. The names, qualifications and experience of the expert staff actually connected with
the manufacture and testing of the specified products in the manufacturing premises.
a) Name (s) of expert staff responsible for manufacture……………….
b) Name (s) of the expert staff responsible for testing…………………….
3. I /We enclose
(a) A true copy of a letter from me / us to manufacturing concern whose
manufacturing capacity is intended to be utilized by me / us.
(b) A true copy of a letter from the manufacturing concern that they agree to
lend the services of their competent technical staff, equipment and premises
for the manufacture of each item required by me / us and that they shall
maintain the registers of raw materials, finished products and reports of
analysis separately on this behalf.
(c) Specimens of labels, cartons of the drugs proposed to be manufactured.
* Enter here name of the proprietor, partners or Managing Director, as the case may be.
** Enter here name of the applicant firm and the address of the principal place of business.
*** Enter here the name and address of the manufacturing concern where the manufacture will
be actually carried out and also the licence number under which the latter operates.
_________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
264
4. A fee of Rs…………………………………..has been credited to Government under
the head of account………………………………………………..
Date………………………… Signature………………..
Designation……………………..
___________________
1
[FORM 27-B
Application for grant or renewal of a 2
[licence to manufacture for sale or for distribution of]
drugs specified in Schedule C, C(I) and X
1. I/We ………………. of ………………..hereby apply for the grant/renewal of a licence
to manufacture on the premises situated at …………………….the under-mentioned drugs,
specified in Schedule C, C(I) and X to the Drugs and Cosmetics Rules, 1945.
2. Name of drugs.
3. The names, qualifications and experience of the expert staff responsible for the
manufacture and testing of the above-mentioned drugs:
(a) Name(s) of staff responsible for testing
(b) Name(s) of staff responsible for manufacture.
4. The premises and plant* are ready for inspection/will be ready for inspection on ………
5. A fee of rupees ……………………………….and an inspection fee of rupees…….has
been credited to the Government under the head of account………………….
Date ………….. Signature …………..
The application shall be accompanied by a plan of the premises.]
* Delete whichever is not applicable.
________________
3
[FORM 27-C
[See Rule 122-F]
Application for grant/renewal* of licence for the operation of a Blood Bank for processing of
whole blood and/or* preparation of Blood Components.
1. I/We…………………….of M/s………………………………….hereby apply for the
grant of licence/renewal of licence number………..dated………..to operate a Blood Bank, for
processing of whole blood and/or* for preparation of its components on the premises situated
at……………………..
2. Name(s) of the item(s)
265
1.
2.
__________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 462(E) dt 22.6.1982.
2 Ins. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
3 Subs. by G.O.I. Notification No.GSR 245(E) dt 5.4.1999.
3.
3. The name(s), qualification and experience of competent Technical Staff are as under:
(a) Name(s) of Medical Officer,
(b) Name(s) of Technical Supervisor
(c) Name(s) of Registered Nurse.
(d) Name(s) of Blood Bank Technician.
4. The premises and plant are ready for inspection/will be ready for inspection on……..
5. A licence fee of rupees ……………….and an inspection fee of rupees…………..has
been credited to the Government under the Head of Account………………(receipt enclosed).
Signature………………..
Dated………… Name and Designation………….
* Delete whichever is not applicable.
Note :
1. The application shall be accompanied by a plan of the premises, list of machinery and
equipment for collection, processing, storage and testing of whole blood and its
components, memorandum of association/constitution of the firm, copies of
certificate relating to educational qualifications and experience of the competent
technical staff and documents relating to ownership or tenancy of the premises.
2. A copy of the application together with the relevant enclosures shall also be sent to
the Central Licence Approving Authority and to the Zonal/Sub-Zonal Officers
concerned of the Central Drugs Standard Control Organization].
______________
1
[FORM 27-D
[See Rule 75]
Application for grant or renewal of a licence to manufacture for sale or for
distribution of Large Volume Parenterals/Sera and Vaccines excluding those
specified in Schedule X.
_________________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR119(E) dt 11.3.1996.
266
1. I/We………………………of……………………..hereby apply for grant/renewal of a
licence to manufacture for sale or distribution on the premises situated at………………….the
under-mentioned Large Volume Parenteral/Sera and Vaccines, specified in Schedules C and
C(1) to the Drugs and Cosmetics Rules, 1945.
2. Name(s) of drug(s)……………………………(each item to be separately specified).
3. The name(s), qualification and experience of the competent technical staff responsible
for the manufacture of the above mentioned drugs.
(a) Name(s) of staff responsible for testing……………………
(c) Name(s) of staff responsible for manufacturing………………..
4. The premises and plant are ready for inspection/will be ready for inspection on………
5. A fee of rupees………………………and an inspection fee of rupees……….has been
credited to the Government under the Head of Account……………….
Date: ……….. Signature……………………..
Designation…………………
* Delete whichever is not applicable.
Note :
1. The application is to be accompanied by a plan of the premises, list of machinery and
equipment to be employed for manufacture and testing, memorandum of
association/constitution of the firm, copies of certificate relating to educational
qualifications and experience of the competent technical staff and documents relating
to ownership or tenancy of the premises.
2. A copy of the application together with the relevant enclosures shall also be sent
each to the Central Licence Approving Authority and concerned Zonal/Sub-Zonal
Officers of the Central Drugs Standard Control Organization].
_______
1
[FORM 27-E
[See Rule 122-F]
Application for grant/renewal* of licence to manufacture blood products
for sale or distribution..
1. I/We…………………….of M/s………………………………….hereby apply for the
grant of licence/renewal of licence number………..dated………..to manufacture Blood
products on the premises situated at ………………………
__________________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 245(E) dt 5.4.1994.
267
2. Name(s) of the item(s)
1.
2.
3.
3. The name(s), qualification and experience of competent Technical Staff are as under:
(a) responsible for manufacturing (b) responsible for testing
1. 1.
2. 2.
3. 3.
4. The premises and plant are ready for inspection/will be ready for inspection on……..
5. A licence fee of rupees ……………….and an inspection fee of rupees…………..has
been credited to the Government under the Head of Account………………(receipt enclosed)
Signature………………..
Dated………… Name and Designation………….
* Delete whichever is not applicable.
Note :
1. The application shall be accompanied by a plan of the premises, list of machinery and
equipment for manufacture of blood products, memorandum of
association/constitution of the firm, copies of certificate relating to educational
qualifications and experience of the competent technical staff and documents relating
to ownership or tenancy of the said premises.
2. A copy of the application together with the relevant enclo sures shall also be sent to
the Central Licence Approving Authority and to the Zonal/Sub-Zonal Officers
concerned of the Central Drugs Standard Control Organization].
______________
FORM 28
[See Rule 76]
1
[Licence to manufacture for sale or for distribution of] drugs specified
in Schedules C and C (1)
Number of Licence and date of issue………………………………….
1…………………………………….is hereby licensed to manufacture at the premises
situated at the…………………………………………………..the following drugs, being drugs
specified in Schedules C and C (1) to the Drugs and Cosmetics Rules, 1945.
__________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
268
Names of drugs……………………………………………
2. Names of approved 1
[competent technical staff]……………….
3. The licence authorises the sale by way of wholesale dealing and storage for sale by
the licensee of the drugs manufactured under the licence subject to the conditions applicable to
licences for sale.
4. The licence will be in force from………………………….to………………
5. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act,
1940.
Date of Issue……………………………. Signature………………..
Designation ………………
2
[*Licensing Authority.
* Central Licence Approving Authority.
* Delete whichever is not applicable.
Conditions of Licence
1 This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the Drugs
and Cosmetics Act, 1940.
2. If the licensee wants to undertake during the currency of the licence the manufacture for
any drug specified in Schedules C and C (1) not in cluded above, he should apply to the
Licensing Authority for the necessary endorsement to the licence as provided in Rule 75
(3). This licence will be deemed to extend to the items so endorsed.
3. Any change in the expert staff named in the licence shall be forthwith reported to the
Licensing Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any change in
the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
maximum period of three months from the date on which the change takes place unless,
in the meantime, a fresh licence has been taken from the Licensing Authority in the name
of the form with the changed constitution.
____________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
2
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.12.1992.
269
FORM 28-A
[See Rule 76-A]
Loan1
[Licence to manufacture for sale or for distribution of] drugs specified in Schedules C
and C (1)
1. Number of licence and date of issue…………………………………….
2………………………………………..of…………………………is hereby granted a
loan licence to manufacture on the premises situated
at…………………….C/o………………………the following drugs being drugs specified in
Schedules C and C (1) to the Drugs and Cosmetics Rules, 1945.
Names of Drugs…………………………………
3. Names of 2
[competent technical staff.]………………………………
3
3 A The licence shall be in force from…………………………to……………
4. The licence authorizes the sale by way of wholesale dealing by the licensee and
storage for sale by the licensee of the drugs manufactured under the licence subject to the
conditions applicable to licence for sale.
5. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act,
1940.
Date of Issue…………………………. Signature……………….
Designation……………..
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. If the licensee wishes to undertake during the currency of the licence the manufacture
for any drug specified in Schedules C and C (1) not included above, he should apply to
the Licensing Authority for the necessary endorsement to the licence as provided in
Rule 75 (3). This licence will be deemed to extend to the items so endorsed.
3. Any change in the expert staff named in the licence shall be forthwith reported to the
Licensing Authority.
_____________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985
2 Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
3 Ins. by G.O.I. Notification No. F.1-10/62-D, dtd 11.4.1964
270
4. The licensee shall inform the Licensing Authority in writing in the event of any change
in the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
maximum period of three months from the date on which the change takes place unless,
in the meantime, a fresh licence has been taken from the Licensing Authority in the
name of the form with the changed constitution.
______________
1
[FORM 28-B
[See Rule 76]
2
[Licence to manufacture for sale or for distribution of] drugs
specified in Schedules C, CI and X.
No. of Licence…………………
1. ……………………….……………. is hereby licensed to manufacture at the
premises situated at …………… the following drugs specified in Schedule C, CI and X to the
Drugs and Cosmetics Rules, 1945.
Name of drugs.
2. Names of 3
[competent technical staff]
3. The licence authorizes the sale by way of wholesale dealing and storage for sale
by the licensee of the drugs manufactured under the licence subject to the onditions applicable
to licence for sale.
4. The licence shall be in force ……….. to ……………………..
5. The licence is subject to conditions stated below and to other conditions as may
be specified in the rules for the time being in force under the Drugs and Cosmetics Act, 1940.
Date of issue …………. Signature …………………..
Licence No. …………… Designation………………..

4
[*Licensing Authority
*Central Licence Approving Authority.
Conditions of Licence
1. The licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the Drugs and
Cosmetics Act, 1940.
____________________________________________________________________________
1
Subs. by G.O.I. Notification No.GSR 462(E) dt 22.6.1982
2
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
3
Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
4
Subs. by G.O.I. Notification No. GSR 923(E) dt 14.2.1992.
271
2. If the licensee wishes to undertake during the currency of the licence the
manufacture of any drug specified in Schedule X not included above, he should apply to the
Licensing Authority for the necessary endorsement as provide in Rule 75(4). This licence will
be deemed to be applicable to the items so endorsed.
3. Any change in the 1
[competent technical staff] shall be forthwith reported to the
Licensing Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any change in the
constitution of the firm takes place, the current licence shall be deemed to be valid for a
maximum period of three months from the date on which the change takes place unless, in the
meantime, a fresh licence has been taken from the Licensing Authority in the name of the form
with the changed constitution.
5. The licensee shall furnish to the Licensing Authority copies of the invoices of
sales made to dealers.
6. The licensee shall not manufacture drugs covered by this licence for use as
‘Physician’s Samples’.]
—————
2
[FORM 28-C
[See Rule 122-G]
Licence to operate a Blood Bank for collection, storage and processing of whole human blood
and/or* its components for sale or distribution
1.Number of licence………………..date of issue……………………at the premises situated
at……………..
2. M/s…………………………..is hereby licensed to collect, store, process and distribute
while blood and/or its components.
3. Name(s) of the item(s) :
1.
2.
3.
4. Name(s) of the competent Technical Staff :
1.
2.
3.
_________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 923(E)dt 14.12.1992
2 Ins. by G.O.I. Notification GSR 245(E) dt 5.4.1999.
272
5. The licence authorises licensee to collect, store, distribute and processing of whole
blood and/or blood components subject to the conditions applicable to this licence.
6. The licence shall be in force from…………….to………………
7. The licence shall be subject to the conditions stated below and to such other conditions
as may be specified from time to time in the Rules made under Drugs and Cosmetics Act,
1940.
Dated :……… Signature……………….
Name and Designation…………
Licensing Authority
Central Licence Approving Authority
* Delete whichever is not applicable.
Conditions of Licence
1. The licensee shall neither collect blood from any professional donor or paid
donor nor shall be prepare blood components from the blood collected from
such donor.
2. The licence and any certificate of renewal in force shall be displayed on the
approved premises and the original shall be produced at the request of an
Inspector appointed under the Drugs and Cosmetics Act, 1940.
3. any cnange in the technical staff shall be forthwith reported to the Licensing
Authority and/or Central Licence Approving Authority.
4. The licensee shall inform the Licensing Authority and/or Central Licence
approving Authority in writing in the event of any change in the constitution of
the firm operating under the licence, where any change in the constitution of the
firm takes places, the current licence shall be deemed to be valid for maximum
period of three months from the date on which the change has been taken place
unless, in the meantime, a fresh licence has been taken from the Licensing
Authority and/or Central Licence approving Authority in the name of the firm
with the changed constitution.]
___________
1
[FORM 28-D
[See Rules 76]
Licence to manufacture for sale of Large Volume
Parenterals/Sera and Vaccines specified in Schedules C and C(I)
excluding those specified in Schedule X.
Number of licence………………………and date of issue…………………
___________________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 119(E) dt 11.3.1996.
273
1. …………………is hereby licensed to manufacture at the premises situated
at…………………..the following Large Volume Parenterals/Sera and Vaccines specified in
Schedules C and C(1) excluding those specified in Schedule X to the Drugs and Cosmetics
Rules, 1945.
2. Name(s) of drug(s) ………………………(each item to be separately specified).
3. Name(s) of competent technical staff:
(a) responsible for manufacturing (b) responsible for testing
1. 1.
2 2
3 3
4. The license authorizes the sale by way of wholesale dealing and storage for sale
by the licensee of the drugs manufactured under the licence, subject o the conditions applicable
to licence for sale.
5. The licence shall be in force from………………………….to……………..
6. The licence shall be subject to the conditions stated below and to such other
conditions as shall be specified in the rules for the time being in force under the Drugs and
Cosmetics Act, 1940.
Signature ………………
Designation ………………….
Licensing Authority
Central Licence Approving Authority
Date ……………………..]
Conditions of Licence
1. The licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under
the Drugs and Cosmetics Act, 1940.
2. If the licensee wishes to undertake during the currency of the licence the
manufacture of any drug specified in Schedule X not included above, he should
apply to the Licensing Authority for the necessary endorsement as provided in
Rule 75(4). This licence will be deemed to be applicable to the items so
endorsed.
3. Any change in the competent technical staff shall be forthwith reported to the
Licensing Authority.
(c) The licensee shall inform the licensing authority and/or Central Licence
Approving Authority in writing in the event of any change in the
constitution of the firm operating under the licence, where any change in the
constitution of the firm takes place, the current licnece shall be deemed to
be valid for a maximum period of three months from the date on which the
change takes place unless, in the meantime, a fresh licence has been applied
274
for along with prescribed fee and necessary documents to the Licensing
Authority and/or Central Licence Approving Authority in the name of the
firm with the changed constitution.]
_____________
1
[FORM 28-E
[See Rule 122-G]
Licence to manufacture and store blood products for sale or distribtion.
1.Number of licence………………..date of issue……………………at the premises situated
at……………..
2. M/s…………………………..is hereby licensed to manufacture, store, sell or distribute
the following blood products:-
3. Name(s) of the item(s) :
1.
2.
3.
4. Name(s) of the competent Technical Staff :
a) responsib le for manufacturing b) responsible for testing
1. 1.
2. 2.
3. 3.
5. The licence authorises licensee to manufacture, sore, sell or distribute the blood
products, subject to conditions applicable to this licence.
6. The licence shall be in force from…………….to………………
7. The licence shall be subject to the conditions stated below and to such other conditions
as may be specified from time to time in the Rules made under Drugs and Cosmetics Act,
1940.
Dated :……… Signature……………….
Name and Designation…………
Licensing Authority
Central Licence Approving Authority
* Delete whichever is not applicable.
_________________________________________________________________________
1Ins. by G.O.I. Notification GSR 245(E) dt 5.4.1999.
275
Conditions of Licence
1. The licensee shall not manufacture blood products from the blood drawn from
any professional donor or paid donor.
2. The licence and any certificate of renewal in force shall be displayed on the
approved premises and the original shall be produced at the request of an
Inspector appointed under the Drugs and Cosmetics Act, 1940.
3. Any cnange in the technical staff shall be forthwith reported to the Licensing
Authority and/or Central Licence Approving Authority.
4. The licensee shall inform the Licensing Authority and/or Central Licence
approving Authority in writing in any change in the constitution of the firm
operating under the licence. In the event of any change in the constitution of
the firm, the licence shall be deemed to be valid for maximum period of three
months from the date on which the change takes place unless, in the meantime,
a fresh licence has been taken from the Licensing Authority and/or Central
Licence approving Authority in the name of the firm with the changed
constitution.]
___________
FORM 29
[See Rule 89]
Licence to manufacture drugs for purposes of examination, test or analysis
1.……………………………….of………………………..is hereby licensed to
manufacture the drugs specified below for purposes of examination, test or analysis
at………………………………………………………………………………
2. This licence is subject to the conditions prescribed in Part VII of the Drugs and
Cosmetics Rules, 1945.
3. This licence shall be in force from one year from date specified below.
Names of drugs
Date………………………………. Licensing Authority……..
______________
FORM 30
[See Rule 90]
Application for licence to manufacture drugs for purposes of examination, test or analysis
I……………………………………………of……………………by occupation………….
………………hereby apply for licence to manufacture the drugs specified below for purposes
of examination test or analysis at……………………………… and I undertake to comply with
the conditions applicable to the licence.
276
Names of Drugs
Date…………………………. Signature……………………….
________________
FORM 31
[See Rule 139]
Application for grant or renewal of a1
[licence to manufacture cosmetics for sale for
distribution.]
1. I / We …………………………of……………….hereby apply for grant / renewal of
a licence to manufacture on the premises situated at…………………………..the following
cosmetics:-
2. Name of Cosmetics……………………………………………..
3. Names, qualifications and experience of technical staff employed for manufacture
and testing……………………………………..
4. A fee of rupees ………………………….has been credited to Government under
head of account………………………………………………
Date……………………….. Signature…………………….
Note:—The application should be accompanied by plan of the premises.
2
[FORM 31-A
[See Rule 138-A]
Application for grant or renewal of loan1
[ licence to manufacture cosmetics for sale or for
distribution]
1. I / We ……………………………..of…………………..hereby apply for grant /
renewal of a loan licence to manufacture cosmetics for sale on the premises situated
at…………………………………….C/o……………………………………….…….the following
cosmetics:–
2. Names of Cosmetics……………………………………….
3. The names, qualifications and experience of the expert shall actually connected with
the manufacture and testing of the specified products in the manufacturing premises.
_________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 788(E) dt 10.10.1985.
2 Ins. by G.O.I. Notification No. GSR 444 dtd 28-4-1973.
277
4. I /We enclose
a) A true copy of a letter from me / us to the manufacture concern whose
manufacturing capacity is intended to be utilized by me / us.
b) A true copy of a letter from the 2manufacturing concern that they agree to lend
the services of their competent technical staff, equipment and premises for the
manufacture of each item required by me / us and that they shall maintain the
registers of raw materials and finished products separately in this behalf.
c) Specimen of labels, cartons of the drugs proposed to be manufactured.
5. A fee of Rs…………………………………..has been credited to Government under
the head of account………………………………………………..
Date………………………… Signature………………………
______________
FORM 32
[See Rule 140]
1
[Licence to manufacture cosmetics for sale or for distribution]
Number of Licence and date of issue…………………………….
1…………………..is hereby licensed to manufacture on the premises situated
at……………………..the following cosmetics under the supervision of the following technical
staff:–
a) Names of cosmetics.
b) Names of technical staff
2. Enter here the name and address of the manufacturing concern where the
manufacture will be actually carried out and also their licence number.
2. The licence shall be in force from…………………………….to…………………….
3. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Drugs and Cosmetics Rules, 1945.
Date………………………….. Signature……………….
Designation……………..
_____________________________________________________________________
1
Ins. by G.O.I. Notification No. GSR 788 (E) 10.10.1985.
278
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the expert staff named in the licence shall be forthwith reported to
the Licensing Authority.
3. If the licensee wants to manufacture for sale of additional items he should apply to
the Licensing Authority for necessary endorsement to the licence as provided in
rule 138 (3). This licence shall be deemed to extend to the cosmetics so endorsed.
1
4.The licensee shall inform the Licensing Authority in writing in the event of any
change in the constitution of the firm operating under the licence. Where any change
in the constitution of the firm takes place, the current licence shall be deemed to be
valid for a maximum period of three months from the date on which the change takes
place unless, in the meantime, a fresh licence has been taken from the Licensing
Authority in the name of the form with the changed constitution.
_________________
2
FORM 32-A
[See Rule 139-B]
Loan 3
[Licence to manufacture cosmetics for sale or for distribution]
1. Number of Licence and date of issue
2………………………………..of……………………………..is hereby granted a loan
licence to manufacture the following cosmetics on the premises situated
at…………………….C/o……………………………………under the direction and personal
supervision of the following technical staff: –
a) Names of technical staff.
b) Names of cosmetics.
3. The licence shall remain in force from…………………to…………..
4. The licence is subject to the conditions stated below and to such other conditions as
are specified in the rules for the time being in force under the Drugs and Cosmetics Act, 1940.
Date……………………… Signature……………
Designation………..
_____________________________________________________________________ 1.
1
Ins.by G.O.I. Notification No. S.O. 903 dtd 28-2-1976.
2
Ins. by G.O.I. Notification No.GSR 444 dtd 28-4-1973.
3
Ins. by G.O.I. Notification No. GSR 788 (E) 10.10.1985.
279
Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved
premises and shall be produced at the request of an Inspector appointed under the
Drugs and Cosmetics Act, 1940.
2. Any change in the technical staff shall be forthwith reported to the Licensing
Authority.
3. If the licensee wants to manufacture for sale additional items he should apply to the
Licensing Authority for the necessary endorsement to the licence as provided in
rule 138-A (5). This licence shall be deemed to extend to the cosmetics so
endorsed.
_____________________
FORM 33
[See Rule 141]
Certificate of renewal of loan licence to manufacture Cosmetics for sale
1. Certified that licence no………………granted on the
…………………………to…………………for the manufacture for sale of the following
cosmetics at the premises situated at………………has been renewed
from…………………..and shall expire on…………………………..
1. Names of cosmetics
2. Names of technical staff
Date………………………… Signature……………………..
Designation…………………..
_________________
1
FORM 33-A
[See Rule 141-A]
Certificate of renewal of loan licence to manufacture Cosmetic for sale
1. Certified that loan licence No………………granted on the
………………to…………………………for the manufacture for sale of the following
cosmetics at the premises situated at C/o…………………………………has been renewed
from……………………….to………………….
1. Names of cosmetics.
2. Names of technical staff.
Date………………………… Signature…………………..
Designation………………..
_____________________________________________________________________
1
Ins. by G.O.I. Notification No.GSR 444 dtd 28-4-1973.
280
FORM 34
[See Rules 131 and 150]
Certificate of test or analysis of cosmetic by the Central Drugs Laboratory or
the Government Analyst
1. Name of the officer or Inspector from whom received……………………..
2. Serial number and date of the Officer’s / Inspector’s
memorandum…………………………………………
3. Number of sample……………………………..
4. Date of receipt………………………………..
5. Name of the Cosmetic purporting to be contained in the
sample……………………………………………………………..
6. Condition of seals on the 1
[packet or on portion of sample or container]
7. Results of test or analysis:–
The sample of cosmetics—
(a) contains a prescribed colour only
does not contain a prescribed colour.
(b) does not contain harmful ingredients
contains harmful ingredients
(c) conforms to claims made on the label as
to the nature and quality of the cosmetic
does not conform to claims made on the label as to the nature
nature and quality of the cosmetic
2
[d) contains not more than……………………………….parts per
million of Lead and………………………………….parts per
million of Arsenic…………………………………………..
_______________________________________
contains more than……………………………….. parts per
million of Lead and ……………………………….. parts per
million of Arsenic.].
Date………………………… Director,
Central Drugs Laboratory / Government Analyst
_________________
__________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 59(E) dt 7.2.1995.
2
Subs. by G.O.I. Notification No. GSR 510(E) dt 26.7.1982.
281
1
FORM 35
2
[See Rule 65, 67-G, 74, 74A, 74B, 78A, 85H, 142 and 142-A, 158 and 158A]
Form in which the Inspection Book shall be maintained
(A) The cover of the Inspection Book shall contain the following particulars, namely:–
1. The name and address of the Licensee…………………………………
2. Licence number and the date upto which the licence is valid……………………….
(B) (i) The pages of the Inspection Book shall be serially numbered and duly stamped
by the Licensing Authority. The pages, other than the first and the last pages, shall
have the following particulars:–
Name and designation of the Inspector who inspects the premises of the Licensee:-
Date of Inspection…………….
Observations of the Inspector…………….
Signature of the Inspector
(ii) The first and last pages of the Inspection Book shall be endorsed by the Licensing
Authority with the following words, namely:–
Inspection Book maintained by M/s……………………………
Situated at……………………..for license number…………………………….
In Form…………………………………….under the Drugs and Cosmetics
Rules.
Seal and Signature of the Licensing Authority
Notes : (i) Printed copy of the Inspection Book may be obtained by the licensee from
the Licensing Authority on payment.
(ii) The Inspection Book shall be maintained at the premises of the Licensee.
(iii) The observations made by the Drug Inspector shall be in triplicate. The
original copy shall be retained in the Inspection Book to be maintained in the
premises of the Licence. The duplicate copy shall be sent to the Licensing
Authority. The triplicate copy shall be taken as record by the Inspector.
___________________________________________________________________________
1
Ins. by G.O.I. Notification No.F.1-14/68-D, dtd 26.10.1968.
2 Subs. by G.O.I. Notification No. GSR 331(E) dt 8.5.1984.
282
1
FORM 36
[See Rule 150-B]
Application for grant or renewal of approval for carrying out tests
on drugs / cosmetics or raw materials used in the manufacture thereof
on behalf of licensees for manufacture for sale of drugs / cosmetics
(1) I / We ………………………………….of………………………………hereby,
apply for the grant or renewal of approval for carrying out tests hereby, apply for the grant or
renewal of approval for carrying out tests of identity, purity, quality and strength on the
following categories of drugs / items of cosmetics or raw materials used in the manufacture
thereof on behalf of licensees for manufacture for sale of drugs / cosmetics.
(2) *Categories of drugs, items of cosmetics:–
(a) Drugs other than those specified in Schedule C and C (1) and also excluding
Homoeopathic Drugs:–
1. Crude vegetable drugs.
2. Mechanical contraceptives
3. Surgical dressings
4. Drugs requiring the use of ultravoilet / Infra Red Spectrophotometer
or Chromatography.
5. Disinfectants
6. Other drugs
(b) Drugs specified in Schedule C and C (1):—
1. Sera, Vaccines, Antigens, Toxins, Antitoxins, Toxoids,
Bacteriophages and similar Immunological Products.
2. Antibiotics.
3. Vitamins.
4. Parenteral preparations.
5. Sterilized surgical ligature / suture.
6. Drugs requiring the use of animals for their test.
7. Drugs requiring the use of Ultravoilet/ Infra Red/ Spectrophotometer
or Chromatography.
8. Other drugs.
(c) Homoeopathic drugs.
(d) Cosmetics
(3) Name, qualifications and experience of expert staff employed for testing and the
person-in-charge of testing.
* Delete whichever is not applicable
_____________________________________________________________________
1 Ins.by G.O.I. Notification No.X. 11014/7/76-D&MS, dtd 23-8-1977.
.
283
(4) List of testing equipments provided.
(5) I / We enclose a plan of the testing premises showing the location and area of the
different sections thereof.
(6) An inspection fee of rupees………………………………….has been credited to
Government under Head of Account……………………………
Date……………….. Signature………………
_________________
FORM 37
[See Rule 150-C]
Approval for carrying out tests on drugs / cosmetics and raw materials used in their
manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
Number of approval and date of issue:
(1) Approval is hereby granted to……………………………………..for carrying out
tests for identity, purity, quality and strength on the folowing categories of drugs/items of
cosmetics and the raw materials used in the manufacture thereof on the premises
situated……………………………………………..
Categories of drugs / items of cosmetics
…………………………………………
…………………………………………
…………………………………………
(2) Names of 1
[competent technical staff] employed for testing and the person-incharge of testing.
(3) The approval shall be in force from……………………….to………………
(4) The approval is subject to the conditions stated below and such other conditions as
may be specified in the rules for the time being in force under the Act.
Date………………………. Signature………………………
Designation…………………….
_________________________________________________________________________
1
Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996.
284
Conditions of Approval
(1) This approval and any certificate of renewal in Form 38 shall be kept in the approved
premises and shall be produced at the request of the Inspectors appointed under the
Act.
(2) If the approved institution wishes to undertake during the currency of the approval
the testing of any other category of drugs or items of cosmetics it should apply to the
approving authority for necessary endorsement meant as provided in rule 150-B.
This approval will be deemed to extend to the item so endorsed.
(3) Any change in the analytical staff or in the person-in-charge of the testing shall be
forthwith to the approving authority.
1
[(4) The approved institution shall inform the approving authority in writing in the event
of any change of the constitution of the institution operating under this Form. Where
any change in the constitution of the institution takes place, the current approval shall
be deemed to be valid for a maximum period of three months from the date on which
the change takes place unless in the meantime, a fresh approval has been taken from
the approving authority in the name of the institution with the changed constitution.]
__________________
FORM 38
[See Rule 150-J]
Certificate of renewal of approval for carrying out tests on drugs / cosmetics and raw
materials used un the manufacture thereof on behalf of licensees for manufacture for sale of
drugs / cosmetics
(1) Certified that approval number…………………..granted on the
…………………………………for carrying out tests of identity, purity, quality and strength
on the following categories of drugs / items of cosmetics and the raw materials used in the
manufacture thereof at the premises situated at…………………………………………..has
been renewed from………………………..to…………………………………………..
Categories of drugs / items of cosmetics
………………………………………..
……………………………………….
(2) Names of 2
[competent technical staff] and person-in-charge of testing.
………………………………….
………………………………….
_____________________________________________________________________
1 Ins. by G.O.I. Notification No. GSR 681(E) dt 5.12.1980.
2 Subs. by G.O.I. Notification No. GSR 231(E) dt 4.6.1996
285
Date…………………… Signature………………..
Designation……………..
——————–
FORM 39
[See Rule 150-E (f)]
Report of test or analysis by approved institution
(1) Name of the manufacturer from whom sample received together with his
manufacturing licence number under the Act and under the Rules made thereunder.
(2) Reference number and date of the letter from the manufacturer under which the
sample was forwarded.
(3) Date of receipt of the sample.
(4) Name of drug / cosmetics / raw material / final product in bulk / final product (in
finished pack)* as obtained from the manufacturer.
(a) Original manufacturer’s name (in the case of raw materials and drugs repacked).
(b) Batch number.
1
[(c)Batch size as represented by sample.].
(d) Date of manufacture, if any.
(e) Date of expiry, if any.
(6) Results of test or analysis with protocols of test or analysis applied.
In the opinion of the undersigned, the sample referred to above is *of standard
quality/is not of standard quality as defined in the Act and the Rules made thereunder for the
reasons given below.
Date…………………….. …………………………………..
Signature of Person-in-charge of testing
Note:- Final product includes repacked material.
*Delete whichever is not applicable
_____________________________________________________________________
.
1 Subs. by G.O.I. Notification No.GSR 681(E) dt 6.6.1988.
286
*Form 40
[See rule 24-A]
Application for issue of Registration Certification for import of drugs into India under the
Drugs and Cosmetics Rules 1945.
I/We_______________________________________________________________
___________________________ (Name and full address) hereby apply for the grant of
Registration Certificate for the manufacturer, M/s. ___________________ (full address
with telephone, fax and E-mail address of the foreign manufacturer) for his premises, and
manufactured drugs meant for import into India.
1. Names of drugs for registration.
(1)
(2)
(3)
2. I/We enclose herewith the information and undertakings specified in Schedule
D (1) and Schedule D (II) duly signed by the manufacturer for grant of
Registration Certificate for the premises stated below.
3. A fee of _______________ for registration of premises, the particulars of
which are given below, of the manufacturer has been credited to the
Government under the Head of Account “0210-Medical and Public Health,
04-Public Health, 104-Fees and Fines under Drugs and Cosmetics Rules, 1945
– Central vide Challan No. ________ dated, (attached in original).
4. A fee of __________________ for registration of the drugs for import as
specified at Serial No.2 above has been credited to the Government under the
Head of Account “0210-Medical and Public Health, 04-Public Health, 104-
Fees and Fines” under the Drugs and Cosmetics Rules, 1945 – Central vide
Challan No. _______, dated ___________. (attached original).
5. Particulars of premises to be registered where manufacture is carried on:
___________________________________________________________________
* Ins. by G.O.I. Notification G.S.R. No.604(E) dt. 24-8-2001 w.e.f. 1-1-2003.
287
Address (es) ___________________________________________
Telephone No. __________________________________________
Fax __________________________________________
E-mail __________________________________________
I/We undertake to comply with all terms and conditions required to obtain Registration
Certificate and to keep it valid during its validity period.
PLACE
DATE
Signature __________________
Name ______________________
Designation _________________
Seal/Stamp of manufacturer or his authorized
Agent in India.
(Note: – In case the applicant is an authorised agent of the manufacturer in India, the Power of Attorney is
to be enclosed).
*Form No. 41
[See rule 27-A]
Registration Certificate
Registration Certificate to be issued for import of drugs into India under Drugs and
Cosmetics Rules, 1945.
Registration Certificate No. ____________ Date _____________
M/s ___________________________________ (Name and full address of registered
office) ________________________________________________having factory
premises at ___________________________________________(full address) has been
registered under rule 27-A as a manufacturer and is hereby issued this Registration
Certificate.
2. Name (s) of drugs which many be imported under this Registration Certificate:
(1)
(2)
(3)
____________________________________________________________________
* Ins. by G.O.I. Notification G.S.R. No.604(E) dt. 24-8-2001 w.e.f. 1-1-2003
288
3. This Registration Certificate shall be in force from __________ to
____________ unless it is sooner suspended or cancelled under the rules.
4. This Registration Certificate is issued through the office of the manufacturer
or his authorized agent in India M/s ……………………………… (name and
full address) who will be responsible for the business activities of the
manufacturer, in India in all respects.
5. This Registration Certificate is subject to the conditions, stated below and to
such other conditions as may be specified in the Act and the rules, from time
to time.
Place: _________
Date: _________ LICENSING AUTHORITY
Seal / Stamp
Conditions of the Registration Certificate.

1. The Registration Certificate shall be displayed at a prominent place by the
authorized agent.
2. No drug shall be registered unless it has a free sale approval in the country of
origin, and/or in other major countries.
3. The manufacturer or his authorized agent in India shall comply with the
conditions of the import licence issued under the Drugs and Cosmetics Rules,
1945.
4. The manufacturer or his authorised agent in India shall inform the licensing
authority forthwith in the event of any administrative ac tion taken due to
adverse reaction, viz. market withdrawal, regulatory restrictions, or
cancellation of authorization, and/or not of standard quality report of any drug
pertaining to this Registration Certificate declared by the Regulatory Authority
of the country or origin or by any Regulatory Authority of any other country,
where the drug is marketed/sold or distributed.
The dispatch and marketing of the drug in such cases shall be stopped
immediately, and the licensing authority shall be informed immediately.
Further action in respect of such stopped marketing of drug shall be followed
as per the direction of the licensing authority. In such cases, action equivalent
to that taken with reference to the concerned drug in the country of origin or in
the country of marketing shall be followed in India also, in consultation with
the licensing authority. The licensing authority may, however, direct any
289
further modification to this course of action, including the withdrawal of the
drug from Indian market within 48 hours time period.
5. The manufacturer or his authorized agent in India shall inform the licensing
authority within 30 days in writing in the vent of any change in manufacturing
process, or in packaging, or in labeling or in testing, or in documentation of
any of the drug pertaining to this Registration Certificate.
In such cases, where there shall be any major change/modification in
manufacturing or in processing or in testing, or in documentation as the case
may be, at the discretion of the licensing authority, the manufacturer or his
authorized agent in India shall obtain necessary approval within 30 days by
submitting a separate application along with the registration fee, as specified
in clause (ii) of sub rule (3) of rule 24-A.
6. The manufacturer or his authorized agent in India shall inform the licensing
authority immediately in writing in the event or any change in the constitution
of the firm and / or address of the registered office / factory premises operating
under this Registration Certificate. Where any such change in the constitution
of the firm and/or address takes place, the current Registration Certificate shall
be deemed to be valid for a maximum period of three months from the date on
which the change has taken place unless, in the meantime, a fresh Registration
Certificate has been taken from the licensing authority in the name of the firm
with the changed constitution of the firm and/or changed address of the
registered office or factory premises.
( Forms 40 to 43 pertaining to Ayurveda, Siddha and Unani drugs replaced by Forms
Nos.47 to 50.)
**FORM 44
[See rules 122A, 122B, 122D and 122 DA]
Application for grant of permission to import or manufacture a New Drug or to
undertake clinical trial.
I/We …………………………………………………………of M/s.
……………………………….… (address) hereby apply for grant of permission for
import and/or clinical trial or for approval to manufacture a new drug or fixed dose
combination or subsequent permission for already approved new drug. The necessary
information / date is given below :
___________________________________________________________________
**Forms 44 to 46 A inserted as per G.O.I. Notification No.G.S.R.900 (E) dt. 12.12.2001.
290
1. Particulars of New Drug :
(1) Name of the drug :
(2) Dosage Form :
(3) Composition of the formulation :
(4) Test specification :
(i) active ingredients :
(ii)inactive ingredients :
(5) Pharmacological classification of the drug :
(6) Indications for which proposed to be used :
(7) Manufacturer of the raw material (bulk drug substances)
(8) Patent status of the drug.
2. Data submitted along with the application (as per Schedule Y with indexing and page
numbers:)
A. Permission to market a new drug :-
(1) Chemical and Pharmaceutical information
(2) Animal Pharmacology
(3) Animal Toxicology
(4) Human / Clinical Pharmacology (Phase I)
(5) Exploratory Clinical Trials (Phase II)
(6) Confirmatory Clinical Trials (Phase III) (including published review articles)
(7) Bio-availability, dissolution and stability study Data
(8) Regulatory status in other countries
(9) Marketing information :
(a) Proposed product monograph
(b) Drafts of labels and cartons
(10) Application for test license
B. Subsequent approval / permission for manufacture of already approved new drug :
(a) Formulation:
(1) Bio-availability / bio-equivalence protocol
(2) Name of the investigator/center
(3) Source of raw material (bulk drug substances) and stability study data.
(b)Raw material (bulk drug substances)
(1) Manufacturing method
(2) Quality control parameters and/or analytical specification, stability report.
(3) Animal toxicity data.
C. Approval / Permission for fixed dose combination:
(1) Therapeutic Justification.
(authentic literature in pre-reviewed journals/text books)
(2) Data on pharmacokinetics / pharmacodynamics combination.
291
(3) Any other data generated by the applicant on the safety and efficacy of the
combination.
D. Subsequent Approval or approval for new indication – new dosage form
(1) Number and date of Approval / permission already granted.
(2) Therapeutic justification for new claim / modified dosage form
(3) Data generated on safety, efficacy and quality parameters.
A total fee of rupees…………………………….(in words)………………….) has been
credited to the Government under the Head of Account ………………….(Photocopy of
receipt is enclosed).
Dated :….. Signature …………………….
Designation ………….
FORM 45
[See rules 122 A, 122 D and 122 DA]
Permission to import Finished Formulation of the New Drug.
Number of the permission and date of issue
………………………………………………..
M/s. …………………………………………. .of
………………………………………………
(address) is hereby permitted to import the following new drug formulation under rule
122 A / 122 D/ 122 DA of the Drugs and Cosmetics Rules 1945.
(1) Name of the New Drug :
(2) Dosage form :
(3) Composition :
(4) Indications :
Dated ………….. Signature …………………
Name and designation
of Licensing Authority …………
Conditions for Grant of Approval / Permission.
(1) The formulation shall conform to the specifications approved by the Licensing
Authority.
(2) The proper name of the drug shall be printed or written in indelible ink and shall
appear in a more conspicuous manner than the trade name, if any, which shall be
shown immediately after or under the proper name on the label of the innermost
container of the drug or every other covering in which the container is packed.
292
(3) The label of the innermost container of the drug and every other covering in which
the container is packed shall bear a conspicuous red vertical line on the left side
running throughout the body of the label which shall not be less than 1 mm in width
and without disturbing the other conditions printed on the label to depict it is
prescription drug.
(4) The label on the immediate container of the drug as well as the packing in which the
container is enclosed should contain the following warning:
“WARNING : To be sold by retail on the prescription of a …………… Only.”
(5) Post marketing surveillance study shall be conducted during initial period of two
years of marketing of the new drug formulation, after getting the protocol and the
names of the investigator duly approved by the Licensing Authority.
(6) All reported adverse reactions related to the drug shall be intimated to the Drugs
Controller, India and Licensing Authority and regulatory action resulting from their
review should be complied with.
(7) No claims except those mentioned above shall be made for the drug without the prior
approval of the Licensing Authority.
(8) Specimen of the carton, labels, package insert that will be adopted for marketing the
drug in the country shall be got approved from the Licensing Authority before the
drugs is marketed.
(9) Each consignment of imported drug shall be accompanied by a test/analysis report.
FORM 45 A
[See rules 122 A and 122 DA]
Permission to import raw material (new bulk drug substance)

Number of the permission and date of issue ……………………………………………….

M/s.…………………………………………………….of ……………………….(address)
is hereby permitted to import the following raw material (new bulk drug substances)
under rule 122 A / 122DA of the Drugs and Cosmetics Rules, 1945, namely :-
Name of the raw material (new bulk drug substances) :
(1)……………………………
(2) ……………………………
(3)……………………………
Dated ………….. Signature ……………………………..
Name and Designation of the Licensing
Authority.
293
Conditions for Grant of Approval / Permission
(1) The raw material (new bulk drug substance) shall conform to the test specifications
as approved by the Licensing Authority.
(2) For manufacture of raw material (new bulk drug substance) or its formulation in the
country, separate approval under rule 122-B shall be obtained from the Licensing
Authority.
(3) The permission to import shall not be used to convey or imply that the raw material
(new bulk drug) is categorized as “life saving or essential drug.”
FORM 46
[See Rules 122 B, 122 D and 122 DA]
Permission / Approval for manufacture of new drug formulation.

Number of permission and date of issue ………………M/s…………………………… of
…………………………………… (address) is hereby granted Permission / Approval to
manufacture following new drug formulation under rule 122 B / 122 D / 122 DA of the
Drugs and Cosmetics Rules, 1945, namely :-
(1) Name of the formulation:
(2) Dosage form:
(3) Composition:
(4) Indications:
Signature ………………………
Date : …………….. Name and designation of Licensing Authority
Conditions for Grant of Approval / Permission.
(1) The formulation shall conform to the specifications approved by the Licensing
Authority.
(2) The proper name of the drug shall be printed or written in indelible ink and shall
appear in a more conspicuous manner than the trade name, if any, which shall be
shown immediately after or under the proper name on the label of he innermost
container of the drug or every other covering in which the container is packed.
(3) The label of the innermost container of the drug and every other covering in which
the container is packed shall bear a conspicuous red vertical line on the left side
running throughout the body of the label which shall not be less than 1 mm in width
and without disturbing the other conditions printed on the label to depict it is
prescription drug.
(4) The label on the immediate container of the drug as well s the packing in which the
container is enclosed should contain the following warning:
“WARNING : To be sold by retail on the prescription of a ……………. only”
294
(5) Post marketing surveillance study shall be conducted during initial period of two
years of marketing of the new drug formulation, after getting the protocol and the
names of the investigator duly approved by the Licensing Authority.
(6) All reported adverse reactions related to the drug shall be intimated to the Drugs
Controller, India and Licensing Authority and regulatory action resulting from their
review should be complied with.
(7) No claims except those mentioned above shall be made for the drug without the prior
approval of the Licensing Authority.
(8) Specimen of the carton, labels, package insert that will be adopted for marketing the
drug in the country shall be got approved from the Licensing Authority before the
drug is marketed.

FORM 46 A
[See rules 122 B and 122 DA)
Name of the permission / approval and date of issue ………………………………
Permission / Approval for manufacture of raw material (new bulk drug substance)
M/s. …………………………of…………………………..(address) is hereby granted
Permission / Approval to manufacture the following raw material (new bulk drug
substance) under rule 122 B / 122 DA of the Drugs and Cosmetics Rules, 1945.
Name of the raw material (new bulk drug substance)
(1) ………………………………………………
(2) ……………………………………………..
(3) …………………………………………….
Dated ……………………. Signature …………………………
Name and designation of Licensing
Authority
………………………….
Conditions for Grant of Permission / Approval
(1) The raw material (new bulk drug substance) shall conform to the specifications
approved by the Licensing Authority.
(2) The raw material (new bulk drug substance) can be sold to only those manufacturers
who have permission, in writing, from Licensing Authority, either to use the
drug for development purpose/clinical trial-b io-equivalence study or to manufacture
the formulation.
(3) For manufacture of the formulation in the country, separate approval under rule 122-
B shall be obtained from the Licensing Authority.
295
[**FORM 47
[See rule 160 A]
Application for grant or renewal of approval for carrying out tests on Ayurvedic, Siddha
and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees
for manufacture for sale of Ayurv edic, Siddha and Unani drugs.
(1) *I/We ………………………… of …………………….. hereby apply for the
grant / renewal of approval for carrying out tests of identity, purity, quality and strength
on the following categories of Ayurvedic Siddha and Unani drugs or raw materials used
in the manufacture thereof on behalf of licensee for manufacture for sale of Ayurvedic,
Siddha and Unani drugs.
(2)*Categories of Ayurvedic, Siddha and Unani drugs other than those specified
in the First schedule to this Act for which testing will be carried out :
AYURVEDA AND SIDDHA UNANI
1. Asava and Arista 1. Nabeez, Khal (Sirka)
2. Arka-Tinir 2. Majoon and its sub-categories
Itrifal, Jawarish, Khameera,
Laooq, Halwa
3. Avaleha and Paka-Ilakam 3. Sufoof, Zuroor, Sunoon.
4. Kavatha Curna-Kutinir Curanam 4. Namak, Khar
5. Guggulu . 5. Raughan
6. Ghrita-Ney 6. Zimad
7 Churna-Curanam 7. Habb (Pill)
8. Taila-Tailam 8. Shiyaf
9. Dravaka-Tiravakam 9. Qutoor (drops)
10. Lavana-Uppu 10. Kohal (Surma), Kajal
11. Kshara-Saram 11. Satt, Usara
12. Lepa-Pacai 12. Kushta
13. Vati, Gutika-Kulikai 13. Joshanda (Single drugs)
14. Varti 14. Sharbat Sikanjabeen
15. Netrabindu (Aschyotan) 15. Sayyal, Arq (Distillates)
16. Anjana-Kanmai 16. Qurs (Tablet)
17. Sattva-Sattu 17. Marham, Qairooti
18. Kupipakva Rasayana-Kuppi Centuram 18. Humool, Furzaja
19. Parpati 19. Bakhoor
20. Pishti 20. Nabati Advia
21. Bhasma-Parpam 21. Maadni Advia
22. Mandura-Atai kutinir 22. Asjad Advia
________________________________________________________________________
**Ins. by G.O.I. Notification G.S.R. No.701(E) dt. 27-9-2001 and subs.by G.O.I. Notification
No.G.S.R.73(E) dt31.01.2003.
296
23. Rasayoga-Centuram 23. Haiwani Advia
24. Lauha 24. Jauhar
25. Ghana Sattva 25. Natool
26. Kvath Pravahi- Kutinir 26. Nashooq,Naswar
27. Panak (Syrup)-Manappaku 27. Shamoom
28. Tablet-Mattirai 28. Saoot (Nasal drops)
29. Capsule 29. Mazoogh
30. Ointment-Kalimapu 30. Tila
31. Phalavarti 31. Lashooq
32. Dhoomravarti/Doopan 32. Gulqand
33. Kshar Sutra/Kshar Varti 33. Fateela
34. Single drugs:
(a) Plant based
(b) Mineral based
(c) Metal based
(d) Animal based
(e) Synthetic
(f) Any other Ayurvedic, Siddha,
Unani formulation
34. Ghaza, Utban, Sabagh
35. Pushp (Phool) 35. Capsule
36. Nasya 36. Huqna
37. Swarasa (Fresh juice) 37. Naurah
38. Karna Bindu (Ear drops) 38. Latook
39. Any other dosage of patent and
Proprietary and Ayurvedic, Siddha,
Unani Drug
39. Vajoor (Throat paint)
40. Mazmazah (Mouth washer)
(3) Names, qualifications experience of experts employed for testing and the personin-charge of testing.
(4) List of testing equipment provided.
(5) *I/We enclose a plan of the testing premises showing the location and area of the
different sections thereof.
(6) An inspection fee of rupees ……………………has been credited to Government
under the head of account………………………………………………
Dated …………
Signature …………………..
Full address of the Applicant
*Delete whichever is not applicable.
297
[**FORM 48
(See Rule 160 B)
Approval for carrying out tests or analysis on Ayurvedic, Siddha and Unani drugs
or raw materials used in the manufacture thereof on behalf of licensees for manufacture
for sale of Ayurvedic, Siddha and Unani drugs.
Number of approval and date of issue:
(1)Approval is hereby granted to ……………………………………….. for carrying out
tests in identity, purity, quality and strength on the following categories of Ayurvedic,
Siddha or Unani drugs and the raw materials used in the manufacture thereof on the
premises situated at …………………………………………………
Categories of Ayurvedic, Siddha and Unani drugs.
……………………………………………………….
……………………………………………………….
……………………………………………………….
……………………………………………………….
(2) Name of experts employed for testing and the person-in-charge of testing ……..
……………………………………………(experts) and …………… (person in charge).
(3)The approval shall be in force from ………………….. to ……………………..
(4)The approval is subject to the conditions stated below and such other conditions as
may be specified in the rules for the time being in force under the Act.
Date ………………… Signature …………………….
Place ……………….. Designation ………………….
Seal of State Licensing Authority
Conditions of Approval
(1) The approval and any certificate of renewal in Form 42 shall be displayed in the
approved premises and shall be produced in the request of the Inspectors
appointed under the Act.
(2) If the applicant wishes to undertake during the currency of the approval the testing
of any other category of Ayurvedic, Siddha or Unani drugs it should apply to the
approving authority for necessary endorsement as provided in Rule 160A, this
approval will be deemed to extend to the items so endorsed.
(3) Any change in the experts or in the person in-charge of the testing shall be
forthwith reported to the approving authority.
____________________________________________________________________
** Ins. by G.O.I. Notification G.S.R. No.702(E) dt. 27-9-2001 and subs.by G.O.I. Notification
No.G.S.R.73(E) dt31.01.2003.
298
(4) The applicant shall inform the approving authority in writing in the event of any
change of the constitution of the laboratory operating under this Form. Where any
change in the constitution of the laboratory takes place, the current approval shall
be deemed to be valid for a maximum period of three months from the date on
which the change takes place unless in the meantime, a fresh approval has been
taken from the approving authority in the name of the laboratory with the changed
constitution.]
[**Form 49
(See rule 160 I)
Certified of renewal for carrying out tests of analysis on Ayurvedic Siddha or Unani
drugs of raw materials used in the manufacture thereof on behalf of licensees for
manufacture for sale of Ayurvedic, Siddha or Unani drugs.
(1) Certified that approval number …………………..granted on the ……… day
of…………..2001 for carrying out tests of identity, purity, quality and strength on the
following categories of Ayurvedic, Siddha or Unani, dugs and the raw materials used in
the manufacture thereof at the premises situated at …………………….. has been
renewed from ……………….. to ……………….. (Date).
Catagories of Ayurvedic, Siddha or Unani drugs
………………………………………………………
………………………………………………………
(2) Names of experts and the person-in-charge of testing ………….(experts) and
………………………………….. (person-in-charge).
Date: …………….. Signature …………………..
Place : …………… Designation ………………
Seal of State Licensing Authority ]
[**FORM 50
(See Rule 160 D(f))
Report of test analysis by approved Laboratory
____________________________________________________________________
** Ins. by G.O.I. Notification G.S.R. No.701(E) dt. 27-9-2001 and subs.by G.O.I. Notification
No.G.S.R.73(E) dt31.01.2003.
.
299
(1) Name of manufacturer from which sample received together with his
manufacturing license number under the Act or the rules made thereunder,
………………………………………………………………………………………………
(2) Reference number and date of the letter from the manufacturer under which the
same was forwarded.
……….……………………………………………………………………………………
(3) Date of receipt of the sample
……………………………………………………………………………………………
(4) Name of Ayurvedic, Siddha and Unani drug of raw material purporting to be
contained in the sample.
…………………………………………………………………………………………
(5) Details of raw material of final product (in bulk finished pack)* as obtained
from the manufacturer:
(a) Original manufacturer’s name in the case of raw materials and drugs packed
…………………………………………………………………….
(b) Batch number ………………………………………………….
(c) Batch size as represented by sample…………………………….
(d) Date of manufacture, if any …………………………………….
(6)Results of test or analysis with protocols of test or analysis applied or as per
Ayurvedic, Siddha or Unani Pharmacopocial standards.
(7) Other specific tests for identity, purity, quality and strength of Patent and
Proprietary drugs.
In the opinion of the undersigned, the sample referred
to above is of standard *quality / is not standards quality
as defined in the Act or the rules made thereunder for the
reasons given below
…………………………………………………………
……………………………………
Date : (F.No. ……………………………)
Place : Name & Designation & Seal …………………………
Name & Address of the Laboratory ……………………..
Licence No. ………………………………..
Note : Final product includes repacked material.
* Delete whichever is not applicable.]
300
*“SCHEDULE B”
[See rules 7 & 48)
Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories :
1. Fees for test and assay of Drugs requiring use of animals –

Rupees
Adrenocorticotrophic hormone assay 1000
Gonadotrophic hormone for LH activity 1000
FSH Activity 1000
Posterior pituitary extract or its synthetic substitute for oxytocin
activity
400
Vasopressor activity 400
Insulin and insulin in combination for hypoglycaemic activity 2000
Hyaluronidase 500
Glucagon 2000
Heparin for anticoagulant activity 600
Protamine sulphate 300
Depressor or Histamine like substane 300
Pyrogen test 500
Antigenecity or foreign protein test 300
Abnormal or undue toxicity or safety test 200
Determination of Lethal doses, LD10 or LD 50 in mice 800
Skin sensitivity/eye irrigation 250
Implantation test 2000
2. Microbiological tests and assays –
Bioassay of Antibiotic 400
Microbiological assay of vitamins 300
Phenol coefficient 300
Preservatives – Microbial challenge test 2000
Sterility test – Parenteral preparations 100
Surgical dressings 200
Syringes and needles 300
Transfusion and infusion sets of assemblies
Other sterile devices
400

3. Identification tests –
(a) Chemical Methods 50
________________________________________________________________________
* Subs. by G.O.I. Notification G.S.R. No.478(E) dt. 7-8-1998.
301
(b) Microscopical 50
(c) IR Spectroscopy 150
(d)
(e)
UV Spectroscopy
Chromotography
100
(i) Paper
(ii) Thin layer
(iii) Column
(iv) GLC
(v) HPCL
(vi) Gel Filtration
100
150
100
250
500
300
(f) Electrophoresis
(i) Paper and Cellulose acetate 200
(ii) Polyacrylamide Gel, starch gel, agar gel 300 each
4. Physical tests –
(a) Optical rotation, specific gravity, refractive index,
weight per ml, fluorescence.
75 each
(b) Viscocity 100
(c) pH, Solubility, loss on drying, net content, ash, sulphated
ash etc.
20 each
(d) Absorbancy, wt/unit area (surgical), foreign matter,
extractive value, thread count etc.
30 each
(e) Uniformity of weight
(i) Tablets 15
(i) Capsules 20
(f) Acid value, iodine value, peroxide value,
Soponification value, acetyl value.
100 each
(g) Disintegration tests –
(i) Ordinary tablets
(ii) Capsule
(iii) Sugar Coated tablets
(iv) Enteric coated tablets
20
30
50
100
(h) Dissolution test 250
(i) Uniformity of content. 500
(j) Wt. per unit area (powder), particle size, count, methoxy
value.
200 each
(k) Limit test for impurities 100 each
(l) Related substances
(i) T LC method
(A) Without reference standard
(B) With reference standard
150
250
302
(ii) Gas Liquid Chromatography
(A) Without reference standard
(B) With reference standard
(iii)High pressure Liquid Chromatography
(A)Without reference standards
(B)With reference standards

250
350
500
500
(m) Water (Karl Fisher) 200
(5) Assays –
(a) General chemical methods
100 for
each
ingredient
(b) Non-aqueous/instrumental
200 for
each
ingredient
(c) Chromatography
(i) TLC
(ii) Column
(iii) GLC
(iv) HPCL
(v) Gel filtration
250
200
350
500
400
(d) Nitrogen determination 200
(e) Medicinal gases 400

(6)
Polymorph test –
(Content of polymorph A in chloramphenicol palmitate)
Surgical sutures (Depending on number of test to be
carried).. …. 200-500
Other miscellaneous tests 100-500
II Fees for Sera and Vaccine –
Sterility test 100
Abnormal toxicity test 400
Specific toxicity test 800
Inactivation test (Rabies) 200
Potency testing of rabies vaccine 2025
Potency testing of pertussis fraction of DPT vaccine 2025
Potency testing of tetanus fraction of DPT/DT/TT
vaccine
2500
Potency testing of diphtheria Fraction of DPT/DT
vaccine.
2700
Testing of antisera for the specific titre 1000
Potency testing measles/Mumps/Rubella vaccine 760 each
Testing of Oral Polio Vaccine (OPV) –
303
Potency
Identity
Stability
4550
1000
800
Potency testing of Japanese Encephalitis Vaccine 3900
Potency testing of Snake
Venom serum
400
for each venom
Identity testing for vaccines/sera
Cell culture (Other than OPV)

400
Other than cell culture 100
Estimation of volume/PH/total solids/No. of
organisms/Physical checking.
50 each
Estimation of total proteins/aluminium
content/phenol/formaldehyde/thiomersal/moisture.

200 each
Pyrogen testing 500
Stability test for vaccines other than Oral Polio Vaccine 4550
III Cosmetics 400 – 1500
(The exact amount of the fee shall be determined by the
Director of Laboratory or the Government Analyst, as the
case may be).
IV Rubber Condoms 1000
V Homoeopathic medicines:
1. Identification test for raw material of botanical origin
(other than assay of constituents).
125
2. Identification test for raw material of chemical origin
(other than assay)
100
3. Limit test for drugs of chemical origin 150
4. Assay of total alkaloids or of drugs of chemical origin 100
5. Identification test for drugs of animal origins or
microbiological.
100
6. Fees for testing of Mother tincture, lower potencies upto
3xor equivalent.
100
7. Determination of Biochemic drug through atomic
absorbance spectrophotometer.
75
Note:-1For tests not listed in the Schedule, charges will be determined by the Director or the Government
Analyst of the laboratory / institute as the case may be.
2.For the tests relating to Ayurvedic, Unani and Siddha medicines, charges will be determined by the
Adviser (Indigenous System of Medicine), Director or Government Analyst of the Laboratory /
Institute, as the case may be.
304
1
SCHEDULE C
[See Rules 23, 61 and 76 and Part X)
Biological and Special Products
1. Sera.
2. Solution of serum proteins intended for injection.

2
3. Vaccines for parenteral injections.
4. Toxins.
5. Antigen.
6. Antitoxins.
7. Neo-arsphenamine and analogous substances used for the specific treatment of
infective diseases.
8. Insulin.
9. Putuitary (Posterior Lobe) Extract.
10. Adrenaline and Solutions of Salts of Adrenaline.
3
[11. Antibiotics and preparations thereof in a form to be administered parenterally.]
4[12 Any other preparation which is meant for parenteral administration as such or
after being made up with a solvent or medium or any other sterile product and
whicha) requires to be stored in a refrigerator; or
b) does not require to be stored in a refrigerator.]
13. Sterilized surgical ligature and sterilized surgical suture.
14. Bacteriophages.
5
[15 Ophthalmic preparations.]
6[16 Sterile Disposable Devices for single use only.]
1. Amended by G.O.I. Notification No. F. 1-30/47-A, dated 5-1-1950
2. Amended by G.O.I. Notification No. F. 1-8/60-D, dated 31-8-1960
3. Subs. by G.O.I. Notification No. G.S.R. 487(E) dt 2.7.1984.
4. Amended by G.O.I. Notification No. F. 1-14/68-D, dated 26-10-1968
5. Ins. by G.O.I. Notification No. G.S.R. 1242(E) dt 17.9.1979
6. Ins. by G.O.I. Notification No. G.S.R. 109(E) dt 22.2.1994.
305
1
SCHEDULE C (1)
[See Rule 23, 61 and 76]
Other Special Products
1 Drugs belonging to the Digitalis groups and preparations containing drugs belonging to
the Digitalis group not in a form to be administered parentally.
2 Ergot and preparations containing Ergot not in a form to be administered parentally.
3 Adrenaline and preparations containing Adrenaline not in a form to be administered
parenterally.
4 Fish Liver Oil and preparations containing Fish Liver Oil.
5 Vitamins and preparations containing any vitamins not in a form to be administered
parenterally.
6 Liver extract and preparations containing liver extract not in a form to be administered
parenterally.
7 Hormones and preparations containing Hormones not in a form to be administered
parenterally.
8 Vaccine not in a form to be administered parenterally.
2
[9 Antibiotics and preparations thereof not in a form to be administered parenterally.]
5
[10 In-vitro Blood Grouping Sera.
11 In-vitro diagnostic Devices for HIV, HbsAg and HCV.]
SCHEDULE D
[See Rule 43]
Class of drugs Extent and conditions of exemption
1. Substances not intended for
medicinal use
All provisions of Chapter III of the Act and
Rules thereunder subject to the conditions that if
the substance is imported in bulk, the importer
shall certify that the substance is imported for
non-medicinal uses, and if imported otherwise
than in bulk, each container shall bear a label
indicating that the substance is not intended for
medicinal use or is intended for some purposes
other than medicinal use or is intended for some
purposes other than medicinal use or is of
commercial quality.
2. 3
[* * *]
3. 3
[* * *]
4. 4
[* * *]
1Amended under G.O.I. Notification No. F. 1-22/59-D, dated 9-4-1960
2
Subs. by G.O.I. Notification No.G.S.R.487(E) dt 2-7-1984.
3
Entry 2 and 3 of Schedule D omitted by G.O.I. Notification No. F.1-6/62-D dt 2-7-1969
4
Entry 4 of Schedule D omitted as per GOI Notification No.604 (E) dt 24-8-2001
5 Ins by G.O.I. Notification No G,S,R, 600(E) dt 27.08.2002.
306
Class of drugs Extent and conditions of exemption
5. The following substances, which
are used both as articles of food
as well as drugs: —
All provisions of Chapter III of the Act
and Rules there under.
i)
ii)
iii)
iv)
All condensed or powered milk
whether pure, skimmed or
malted, fortified with vitamins
and minerals.
Farex, Oats, Lactose and all
other similar cereal preparations
whether fortified with vitamins or
otherwise excepting those for
parenteral use.
Virol, Bovril, Chicken essence
and all other similar predigested
food.
Ginger, Pepper, Cumin, Cinnamon
and all other similar spices and
condiments unless they are
specifically labelled as conform –
ing to the standards in the Indian
Pharmacopoeia or the official
pharmacopoeias and the official
compendia of the drug standards
prescribed under the Act and
Rules made thereunder.
**SCHEDULE D (I).
[See rule 21 (d) and rule 24 A]
Information and undertaking required to be submitted by the manufacturer or his
authorized agent with the Application Form for Registration Certificate. The format shall
be properly filled in for each application in Form 40. The detailed information, secret in
nature, may be furnished on a Computer Floppy.
1. Particulars of the manufacturer and manufacturing premises
1.1 Name and address f the manufacturing premises (Telephone No.,
Fax No.,E- mail address) to be registered.
1.2 Name (s) and address (es) of the Proprietor /ProprietorS /Partners / Directors.
1.3 Name and address of the authorized Agent in India, responsible for
the business of the manufacturer.
** Ins. by G.O.I. Notification G.S.R. No.604(E) dt 24-8-2001 w.e.f. 1-1-2003,
307
1.4 A brief profile of the manufacturer’s business activity, in domestic as
well as global market.
1.5 A copy of Plant Master File (duly notarised)
1.6 A copy of Plant Registration / approval Certificate issued by the
Ministry of Health/National Regulatory Authority of the foreign
country concerned (duly notarised)
1.7 A brief profile of the manufacturer’s research activity.
2. Particulars of the manufactured drugs to be registered under Registration
Certificate.
a. Name of drugs (Bulk/Formulations/Special product) to be registered meant
for import into and use in India.
b. A copy of the approved list showing the bulk drugs/formulations/special
products mentioned in 2.1 above are permitted for manufacturing /
marketing in the country of origin, (duly notarized)
c. A copy of Good Manufacturing Practice (GMP) certificate, as per WHOGMP guidelines, or Certificate of Pharmaceutical Products (CPP), issued by
the National Regulatory Authority of the foreign country concerned, in
relation to the bulk drugs or formulations or special products, meant for
import into India.
d. The domestic prices of the drugs to be registered in India, in the currency of
the country of origin.
e. The name(s) of the drugs which are original research products of the
manufacturer.
3.Undertaking to declare that: –
3.1. We shall comply with all the conditions imposed on the Registration
Certificate, read with rules 74 and 78 of the Drugs and Cosmetics rules, 1945.
3.2 We declare that we are carrying on the manufacture of the drugs mentioned in
this Schedule, at the premises specified above, and we shall from time to time
report any change of premises on which manufacture will be carried on and in
the cases where manufacture is carried on in more than one factory any change
in the distribution of functions between the factories.
308
3.3 We shall comply with the provisions of Part IX of the Drugs and Cosmetics
Rules, 1945.
3.4 Every drug manufactured by us for import under the Registration Certificate
into India shall be as regard strength, quality and purity conforms with the
provisions of Chapter III of Drugs and Cosmetics Act, 1940 and Part IV of the
Drugs and Cosmetics Rules 1945, and their amendments from time to time.
3.5 We shall from time to time report for any change or manufacturing process, or
in packaging, or in labeling, or in testing, or in documentation of any of the
drugs, pertaining to the Registration Certificate, to be granted to us. Where
any change in respect of any of the drugs under the Registration Certificate
has taken place in respect of any of the above matters, we shall inform the
same to the licensing authority in writing within 30 days from the date of such
changes. In such cases, where there will be any major change/modification in
manufacturing or in processing or in testing, or in documentation, as the case
may be, at the discretion of the licensing authority, we shall obtain necessary
approval within 30 days by submitting a separate applic ation, alongwith the
registration fee as specified in clause (ii) of sub rule (3) of rule 24-A.
3.6 We shall from time to time report for any administrative action taken due to
adverse reaction, viz. market withdrawal regulatory restriction, or cancellation
of authorization and/or “not of standard quality report” of any drug pertaining
to the Registration Certificate declared by any Regulatory Authority of any
country where the drug is marketed/sold or distributed. The despatch and
marketing of the drug in such cases, shall be stopped immediately and the
licensing authority shall be informed immediately. Further action in respect of
stop marketing of drug shall be taken as per the directions of the licensing
authority. In such cases, action equivalent to that taken with reference to the
concerned drug(s) in the country of origin or in the country of marketing will
be followed in India also, in consultation with the licensing authority. The
licensing authority may direct any further modification to this course of action,
including the withdrawal of the drug from Indian market within 48 hours time
period.
3.7 We shall comply with such further requirements, if any, as may be specified,
by the Government of India, under the Act and the rules made there under.
3.8 We shall allow the licensing authority and/or any person authorized by him in
that behalf to enter and inspect the manufacturing premises and to examine the
process/procedure and documents in respect of any drug manufactured by us
for which the application for Registration Certificate has been made.
3.9 We shall allow the licensing authority or any person authorized by him in that
behalf to take samples of the drugs concerned for test, analysis or examination,
if considered necessary by the licensing authority.
309
Place:
Date:
Signature of the manufacturer
Seal / Stamp
**SCHEDULE D (II)
(See rule 21 (d) and rule 24 A)
Information required to be submitted by the manufacturer or his authorized agent with the
Application Form for the registration of a bulk drug/formulation/special product for its import
into India. The format shall be properly filled in and the detailed information, secret in nature,
may be furnished on a Computer Floppy.
1. GENERAL
1.1. Name of the drug/formulation/special product, a brief description and the
therapeutic class to which it belongs.
1.2. Regulatory status of the drug. Free Sale Certificate and/or Certificate of
Pharmaceutical Products (CPP) issued by the Regulatory Authority of the
country of origin. Free sale approval issued by the Regulatory Authorities of
other major countries.
1.3. Drugs Master File (DMF) for the drug to be registered (duly notarised).
1.4. GMP Certificate in WHO formats or Certificate of Pharmaceutical Products
(CPP) issued by National Regulatory Authority of the country of origin
(duly notarised).
1.5. List of countries where marketing authorization or import permission for the
said drug is granted with date (respective authorisation shall be enclosed).
1.6. List of countries where marketing authorisation or import permission for the
said drug is cancelled/withdrawn with date.
1.7. List of countries where marketing authorisation or import permission for the
said drug is pending since (date).
1.8. Domestic price of the drug in the currency followed in the country of origin.
1.9. List of countries where the said drug is patented.
_________________________________________________________
** Ins. by G.O.I. Notification G.S.R. No.604(E) dt 24-8-2001 w.e.f. 1-1-2003,
310
2. CHEMICAL AND PHARMACEUTICAL INFORMATION OF DRUGS.
2.1 Chemical name.
Code name or number, if any
Non-proprietory or generic name, if any
Structure
Physico-chemical properties.
2.2 Dosage form and its composition.
Qualitative and Quantitative composition in terms of the active
substances(s) and excipient(s)
List of active substance(s) separately from the constituent(s) of
excipients.
2.3 Specifications of active and inactive ingredient (s) including pharmacopoeal
references.
2.4 Source of active ingredient(s), name and address.
2.5 Tests for identification of the active ingredient(s),
Method of its assays and tests for impurity profile with reference standards
for the impurities (Protocol to be submitted alongwith reference standards for
the impurities / relative substances).
2.6 Outline method and flow chart of manufacture of the bulk drug or finished
formulation or special product.
2.7 Detailed test protocol for the drug with pharmacopoeal reference or in- house
specification as approved by the registration authority, in the country of
origin.
2.8 Stability data including accelerated stability and real time stability analysis.
2.9 Documentation on pack size.
2.10 Numerical expression on EAN bar code on the labels and cartons,
2.11 Safety documents on containers and closures.
2.12 Documentation on storage conditions.
2.13 Three samples of medicinal product/drug and outlet packing are to be
submitted with batch certificates. Additional samples as well as reference
substances with batch certificates including date of manufacture, shelf life,
and storage conditions of reference substance may be required both during
311
registration procedure and during validity of registration decision.
2.14 Batch test reports/certificate of five consecutive production batches in details
of the medicinal product are to be submitted for every site of manufacturing
premises.
2.15 Manner of labeling as per rule 96 of the Drugs and Cosmetics Rules 1945.
2.16 Package insert.
2.17 Details of safety handling procedure of the drug.
2.18 Details of PMS study report for marketing period not exceeding five years
.
3. BIOLOGICAL AND BIOPHARMACEUTICAL INFORMATION OF DRUGS.
3.1 Biological control tests applied on the starting material, if applicable.
3.2 Biological control tests applied on the intermediate products, if applicable.
3.3 Biological control tests applied on the finished medical products, if
applicable.
3.4 Stability of the finished products in terms of biological potency of the drug,
if applicable.
3.5 Sterility tests, if applicable, specification and protocol therein.
3.6 Pyrogen tests, if applicable, specification and protocol therein.
3.7 Acute and sub-acute toxicity tests, if applicable specification and protocol
therein.
3.8 Bio-availability studies and bio-equivalence data, if applicable.
3.9 Data relating to the environmental risk assessment for r-DNA products.
3.10 Other information relevant under the section.
312
4. PHARMACOLOGICAL AND TOXICOLOGICAL INFORMATION OF DRUGS.
Executive summary of the product is to be submitted mentioning the specific and
general pharmacological actions of the drug and pharmacokinetic studies on
absorption, metabolism, distribution and excretion. A separate note is to be given on
acute and sub-acute toxicity studies and long term toxicity studies. Specific studies
on reproductive toxicity, local toxicity and carcinogenic activity of the drug is to be
elaborated, as far as possible.
5 CLINICAL DOCUMENTATION
A new drug as defined under rule 122-E of the Drugs and Cosmetics Rules, 1945 is
required to be permitted separately by the licensing authority under rule 122-A of the
said rules prior to its registration. Such a new drug requires a brief summary and
clinical documentation, alongwith permission under 122-A of the said rules for its
Registration Certificate.
6. LABELLING AND PACKAGING INFORMATION OF DRUGS.
6.1 Labels should conform as per the specifications under the Drugs and
Cosmetics Rules 1945.
6.2 Package insert should be in English and shall indic ate the following
therapeutic indications: –
Posology and method of administration
.
Contra-indications.
Special warnings and special precautions for use, if any.
Interaction with other medicaments and other forms of interaction.
Pregnancy and lac tation, if contra-indicated.
Effects on ability to drive and use machines, if contra-indicated.
Undesirable effects/side effects.
Antidote for overdosing.
6.3 Package insert should indicate the following pharmaceutical information: –
List of excipients
Incompatibilities
Shelf life in the medical product as packaged for sale.
Shelf life after dilution or reconstitution according to direction.
Shelf life after first opening the container.
Special precautions for storage.
Nature and specification of the container.
Instructions for use/handling.
313
7 SPECIFIC INFORMATION REQUIRED FOR THE SPECIAL PRODUCTS (to be
supplied, separately in annexure, as ‘A’, ‘B’ and ‘C’)
The information submitted above is true to the best of my knowledge and belief.
Place
Date Signature of the manufacturer
Seal/Stamp

NB: 1. Any change in the process of manufacture, method of testing, labeling,
packing, designing of the sale pack, medical literature and documentation is
to be intimated to the licensing authority forthwith and permission to be
obtained from him within 30 days time period.
2. Information relating to Serial No.4 and Serial No.5 are not applicable for
drugs figuring in Indian Pharmacopoeia and also for the drugs figuring
in United States of Pharmacopoeia, European Pharmacopoeia, and British
Pharmacopoeia provided such drugs have already been approved for
marketing in India for the applicant under rules 122A, 122B, 122C or
122D of the Drugs and Cosmetics Rules 1945.
ANNEXURE-A
(See Schedule D-II, item No.7)
INFORMATION TO BE SUBMITTED IN SCHEDULE D-II
SPECIFIC INFORMATION REQUIRED FOR THE BLOOD PRODUCTS.
A product dossier showing the: –
1. Details of source Plasma, its viral screening, storage and transport from Collection
Centres to Fractionation Centre. Regulatory status of Collection Centres.
2. Details of Fractionation Centre, Regulatory Status, Method of Fractionation and
Control Processes.
3. Details of viral inactivation process for enveloped and non-enveloped virus(es) and
viral validation studies to assess the viral load of the product. Testing of viral
screening at any stage is to be high lighted with the details of the kits used with their
respective sensitivity and specificity.
4. Bulk filtration prior to pharmaceutical packing giving the full details of Microfiltration or nanofiltration followed.
5. Complete details of pharmaceutical processing and utilization.
314
6. Test protocol of the product showing the specification and pharmacopoeia method
followed for various testing parameters.
Specific batch test report for at least 3 batches showing the specifications of each
testing parameter.
7. Pack size and labeling.
8. Product insert.
9
.
Specimen Batch Release Certificate issued by the National Regulatory Authority of
the country of origin.
Specific processings like safe handling, material control, area control, pasteurization,
stability studies, storage at quarantine stage and finished stage and packaging should
be highlighted in the product dossier.
The information submitted above is true to the best of my knowledge and belief.
Place:
Date: Signature of the manufacturer
Seal / Stamp
NB: 1. Any change in the process of manufacture, method of testing, labeling,
packing, designing of the sale pack, medical literature and documentation is to
be intimated to the licensing authority forthwith and permission to be obtained
from him within 30 days time period.

ANNEXURE-B
(See Schedule D-II, item No.7)
INFORMATION TO BE SUBMITTED IN SCHEDULE D-II
SPECIFIC INFORMATION REQUIRED FOR THE DIAGNOSTIC KITS.
A product dossier showing the :-
1. The details of source antigen or antibody as the case may be and characterization
of the same. Process control of coating of antigen or antibody on the base
material like Nitrocellulose paper, strips or cards or ELISA wells etc.
Details of composition of the kit and manufacturing flow chart process of the kit
showing the specific flow diagram of individual components or source of the
individual components.
2. Test protocol of the kit showing the specifications and method of testing.
315
In house evaluation report of sensitivity, specific ity and stability studies carried
out by the manufacturer.
3. The report of evaluation in details conducted by the National Control Authority
of country of origin.
Specimen batch test report for at least consecutive 3 batches showing
specification of each testing parameter.
4. The detailed test report of all the components used/packed in the finished kit.
5. Pack size and labeling.
6. Product insert.
Specific evaluation report, if done by any laboratory in India, showing the
sensitivity and specificity of the kit.
Specific processing like safe handling, material control, area control, process
control, stability studies, storage at quarantine stage and finished stage,
packaging should be highlighted in the product dossier.
The information submitted above is true to the best of my knowledge and belief.
Place:
Date: Signature of the manufacturer
Seal / Stamp
NB: 1. Any change in the process of manufacture, method of testing, labeling,
packaging, designing of the sale pack, medical literature and documentation
is to be intimated to the licensing authority forthwith and permission to be
obtained from him within 30 days time period.
ANNEXURE-C
(See Schedule D-II, item No.7)
INFORMATION TO BE SUBMITTED IN SCHEDULE D-II
SPECIFIC INFORMATION REQUIRED FOR VACCINES.
A product dossier showing the: –
1. History, source, date of receipt, storage, identity and characterization of the seed
strain.
316
2. Detailed flow chart of manufacturing process showing al the details of inprocess
control on toxicity, potency study and stability data of the final bulk and the final
finished product including the storage temperature.
3. Complete details of chemical and pharmaceutical data for the product.
Composition and dosage form – method of manufacture with detailed flow chart
– control of starting material – control tests on intermediate and finished
products – certificate of analysis of finished products – validation of critical
manufacturing steps.
4. Test protocol of the vaccines showing the specification and method of testing
including pharmacopoeal specification.
5. Specimen batch test report for at least consecutive three batches showing the
specification of each testing parameter.
6. The detailed test reports of all the components used / packed in the finished
vaccine.
7. Pack-size and labelling.
8. Product insert
9. Specimen batch release certificates issued by the National Regulatory Authority
of the country of origin.
10. Summary of pre-clinical and clinical data including :
(a)Prescribing information.
(b) Pharmacological and toxicological data pertaining to tests on animals
Characterisation of immune response and safety study in human use, in
specific conditions.
Specific information on source of seed strain, its characterization, inactivation,
etc. and processings like safe handling, material control area control, process
control, stability studies, storage at quarantine stage and finished state, packing
should be highlighted in the product dossier.
Specimen production and quality control protocols for at least three consecutive
lots showing the specifications for each quality control parameter including
pharmacopoeial requirement shall be submitted for study.
The information submitted above is true to the best of my knowledge and belief.
Place Signature of the manufacturer
Date: Seal / Stamp
317
NB: 1. Any change in the process of manufacture, method of testing, labelling,
packaging, designing of the sale pack, medical literature and documentation is
to be intimated to the licensing authority forthwith and permission to be
obtained from him within 30 days time period.
2. All vaccines shall be new drugs unless certified otherwise by the liencesing
authority approved under Rule 21 of the Drugs and Cosmetic Rules, 1945. A
copy of approval of the vaccine issued by the said licensing authority is to be
enclosed, prior to issue of Registration Certificate of the said vaccines.

SCHEDULE E
[Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982]
*[SCHEDULE E (1)
[See Rule 161 (2)]
List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems
of Medicine
A. AYURVEDIC SYSTEM
I Drugs of vegetable origin
Ahipena Papaver somniferum Linn.
Arka Calotropis gigantea (linn.)R. Br. ex. Ait.
Bhallataka Semecarpus anacardium Linn. F
Bhanga Cannabia eativa Linn.
Danti Baliospermum monatanum Mull. Arg
Dhattura Datura metal Linn..
Gunj Abrus precatirius Linn.
Jaipala (Jayapala) Croton tiglium Linn
Karaveera Rerium indicum Mill
Langali Gloriosa superba Linn
Parasika Yavani Hyoseyamus inibar Linn
Snuhi Euphorbia neriifolia Linn
Vatsanabha Acontium Chasmanthum StapfexHolm
Vishamushti Strychnox nuxvomica Linn.
Shringivisha Acontium chasmanthum Stapfex Holm.
II Drugs of Animal Origin .
Sarpa Visha Snake poison
III Drugs of Mineral Origin
Gauripashana Arsenic
Hartala Arseno sulphide
Manahashila Arseno sulphide
Parada Mercury
Rasa Karpura Hydrargyri subchloridum
Tuttha Copper sulphate
Hingula Cinnabar
________________________________________________________________
* Added under G.O.I. Notification No. 1-23/67-D dated 2-2-1970
318
Sindura Red oxide of lead
Girisindura Red oxide of mercury
B. SIDDHA SYSTEM
Abini Papaver Somniferum Linn.
Alari Nerium indicum Mill.
Azhavanam Lawsonia inermis Linn.
Attru thummatti Citrullis colocynthis Scharad.
Anai Kunri Adanathera pavonina Linn.
Rattha Polam Aloe barbadensis Mill.
Ilaikalli Euphorbia neriifolia Linn.
Eezhaththalari Plumeria acuminota Ait.
Gomatthai Datrua stramonium Linn.
Etti Strychnos nuxvomica Linn.
Ganja Cannabis sativa Linn.
Kalappaik Kizhangu Gloriosa superba Linn.
Kodikkalli Euphorbia tiruqalli Linn.
Chadurakkalli Euphorbia antiquorium Linn.
Karia polam Aloe sp.
Kattamanakku Jatropha glandulifera Roxb.
Kattu thumatti Cucmis trigonus Roxb.
Kunri Abrus precotorusu Linn.
Cheran Kottai Semicorpus anacardium Linn.
Thillai Exoecoria agallocha Linn.
Nabi Aconitum ferox Wall.
Nervalam Croton tiglium Linn.
Pugai Elai Nicotiana tobucum Linn.
Marukkarai Randia dumetorum Lam.
Mansevikkalli Euphorbia sp.
C. UNANI SYSTEM
I Drugs of vegetable origin
Afiyun Papaver somniferum Linn.
Bazrul-banj Hyoscyamus niger Linn
Bish Aconitum chasmanthum Strapfex Holmes
Bhang Cannabis sativa Linn.
Charas Canabis sativa Linn
Dhatura seeds Datura metal Linn (seeds)
Kuchla Strychnos nuxvomica Linn
Shokran Conium maculatum Linn
II Drugs of Animal origin
Sanp (head) Snake (head)
319
Telni makkhi Mylabris cichori Linn
Mylabaris pustulata Thund
Mylabris macilenta
III Drugs of Mineral origin
Darchikna Hydrargryi perchloridum
Hira Diamond
Ras Kapoor Hydrargryi Subchloridum (calomel)
Shingruf Hydrargryi bisulphuratum
Zangar Cupri subacetas
Sammul-Far (Abyaz, Asfar, Aswad
and Ahmar)
Arsenic (white, yellow, black and red)
Tootiya Copper Sulphate
Para Hydrargyrum
Hartal Arsenic trisulphide (yellow)
_________________________
SCHEDULE F
Part I – Omitted as per G.O.I. Notification GSR 663(E) dt 3-7-1992 and corrected as per
GOI Notification No. GSR 27 (E) dt 22-1-1993.
Part II, Part III, Part IV, Part V, Part VI, Part VII, Part VIII, Part IX, Part X, Part X, Part
XI, Part XII and Part XII-A omitted as per G.O.I. Notification No. GSR 663(E) dt 3-7-
1992.
____________________________________________
320
1
PART XII B
REQUIREMENTS FOR THE FUNCTIONING AND OPERATION OF A BLOOD BANK
AND / OR FOR PREPARATION OF BLOOD COMPONENTS.
BLOOD BANKS / BLOOD COMPONENTS.
A. GENERAL
1. Location and Surroundings : The blood bank shall be located at a place which
shall be away from open sewage, drain, public lavatory or similar unhygienic
surroundings.
2. Building : The building (s) used for operation of a blood bank and/or preparation
of blood components shall be constructed in such a manner so as to permit the
operation of the blood bank and preparation of blood components under hygienic
conditions and shall avoid the entry of insects, rodents and flies. It shall be well
lighted, ventilated and screened (mesh), wherever necessary. The walls and
floors of the rooms, where collection of blood or preparation of blood
components or blood products is carried out shall be smooth, washable and
capable of being kept clean. Drains shall be adequate size and where connected
directly to a sewer, shall be equipped with traps to prevent back siphonage.
3. Health, clothing and sanitation of staff: The employees shall be free from
contagious or infectious diseases. They shall be provided with clean overalls,
headgears, foot-wears and gloves, wherever required. There shall be adequate,
clean and convenient hand washing and toilet facilities.
B. ACCOMMODATION FOR A BLOOD BANK.
A blood bank shall have an area of 100 square meters for its operations and an
additional area of 50 square meters for preparation of blood components. It shall be
consisting of a room each for –
(1) Registration and medical examination with adequate furniture and facilities for
registration and selection of donors;
(2) Blood collection (air-conditioned);
(3) Blood component preparation. (This shall be air-conditioned to maintain
temperature between 20 degree centigrade to 25 degree centigrade);
___________________________________________________________________

1
Schedule “M” substituted by G.O.I. Notification G.S.R. No.245(E) dtd 05.04.1999.
(4) Laboratory for blood group serology. (air-conditioned);
321
(5) Laboratory for blood transmissible diseases like Hepatitis, Syphilis, Malaria,
HIV-antibodies (air-conditioned);
(6) Sterilization-cum-washing;
(7) Refreshment-cum-rest room (air-conditioned);
(8) Store-cum-records.
NOTES :
(1) The above requirements as to accommodation and area may be relaxed, in respect of
testing laboratories and sterilization-cum-washing room, for reasons to be recorded
in writing by the Licensing Authority and/or the Central Licence Approving
Authority, in respect of blood banks operating in hospitals, provided the hospital
concerned has a pathological laboratory and a sterilization-cum-washing room
common with other departments in the said hospital.
(2) Refreshments to the donor after phlebotomy shall be served so that he is kept under
observation in the Blood Bank.
C PERSONNEL
Every blood bank shall have following categories of whole time component
technical staff:-
(a) Medical Officer, possessing the qualification specified in condition (i) of rule
122-G.
(b) Blood Bank Technician(s) possessing –
(i) Degree in Medical Laboratory Technology (M.L.T) with six months
experience in the testing of blood and/or its components; or
(ii) Diploma in Medical Laboratory Technology (M.L.T) with one year’s
experience in the testing of blood and / or its components.
the degree or diploma being from a University / Institution recognized by the
Central Government or State Government.
(c) Registered Nurse(s);
(d) Technical supervisor (where blood components are manufactured), possessing-
(i) Degree in Medical Laboratory Technology (M.L.T) with six month’s
experience in the preparation of blood components; or
(ii) Diploma in Medical Laboratory Technology (M.L.T) with one year’s
experience in the preparation of blood components the degree or diploma being
from a University / Institution recognized by the Central Government or State
Government.
.
322
NOTES :
(1) The requirements of qualification and experience in respect of Technical
Supervisor and Blood Bank Technician shall ap ply in the cases of persons who
are approved by the Licensing Authority and / or Central Licence Approving
Authority after the commencement of the Drugs and Cosmetics (Amendment)
Rules, 1999.
(2) As regards the number of whole time competent technical personnel, the blood
bank shall comply with the requirements laid down in the Directorate General
of Health Services Manual.
3) It shall be the responsibility of the licensee to ensure through maintenance of
records and other latest techniques used in blo od banking system that the
personnel involved in blood banking activities for collection, storage, testing
and distribution are adequately trained in the current Good Manufacturing
Practices/Standard Operating Procedures for the tasks undertaken by each
personnel. The personnel shall be made aware of the principles of Good
Manufacturing Practices / Standard Operating Procedures that affect them and
receive initial and continuing training relevant to their needs.
D. MAINTENANCE
The premises shall be main tained in a clean and proper manner to ensure adequate
cleaning and maintenance of proper operations, the facilities shall include:-
(1) Privacy and thorough examination of individuals to determine their suitability
as donors.
(2) Collection of blood from donors with minimal risk of contamination of
exposure to activities and equipment unrelated to blood collection.
(3) Storage of blood or blood components pending completion of tests.
(4) Provision for quarantine, storage of blood and blood components in a
designated location, pending repetition of those tests that initially give
questionable serological results.
(5) Provision for quarantine, storage, handling and disposal of products and
regarding not suitable for use.
(6) Storage of finished products prior to distribution or issue.
(7) Proper collection, processing, compatibility testing, storage and distribution of
blood and blood components to prevent contamination.
(8) Adequate and proper performance of all procedures relating to plasmapheresis,
plateletpheresis and leucapheresis.
(9) Proper conduct of all packaging, labeling and other finishing operations.
(10) Provision for sale and sanitary disposal of :
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(i) Blood and/or blood components not suitable for use, distribution or sale.
(ii) Trash and items used during the collection, processing and compatibility
testing of blood and / or blood components.
E. EQUIPMENT.

Equipment used in the collection, processing, testing, storage and sale/distribution of
blood and is components shall be maintained in a clean and proper manner and so
placed as to facilitate cleaning and maintenance. The equipment shall be observed,
standardized and calibrated on a regularly scheduled basis as described in the Standard
Operating Procedures Manual and shall operate in the manner for which it was
designed so as to ensure compliance with the official requirements (the equipments) as
stated below for blood and its components.
Equipment that shall be observed, standardized and calibrated with at least the
following frequencies:
EQUIPMENT PERFORMANCE FREQUENCY FREQUENCY OF
CALIBRATION
1. Temperature
Recorder
Compare against
thermometer
Daily As often as
necessary
2 Refrigerated
centrifuge
Observe speed and
temperature
Each day of
use
As often as
necessary
3 Hematocrit
centrifuge
— — Standardise before
initial use, after
repair or
adjustments and
annually.
4, General lab. — — Tachometer, every 6
months.
5. Automated Blood
typing,
Observe controls for
correct results
Each day of
use

6. Haemoglobinometer Standardize against
cyanamethemoglobulin
standard
Each day of
use.

7. Refractiometer or
Urinometer
Standardize against
distilled water
— ditto — —
8. Blood container Standardize against — ditto — As often as
324
weighing device container of known
weight.
necessary
9 Water Bath Observe temperature — ditto — — d itto–
10 Rh view box
(wherever
necessary)
— ditto — — ditto — — d itto —
11 Autoclave — d itto– Each time of
use.
— d itto–
12 Serologic rotators Observe controls for
correct results
Each day of
use
Speed as often as
necessary.
13 Laboratory
thermometers

— —
Before initial use
14 Electronic
thermometers

— Monthly —
15 Blood agitator Observe weight of the
first container of blood
filled for correct results
Each day of
use
Standardize with
container of known
mass or value
before initial use,
and after repairs or
adjustments.
F. SUPPLIES AND REAGENTS:
All supplies and reagents used in the collection, processing, compatibility, testing,
storage and distribution of blood and blood components shall be stored at proper
temperature in a safe and hygienic place, in a proper manner and in particular –
(a) all supplies coming in contact with blood and blood components intended for transfusion
shall be sterile, pyrogen-free, and shall not interact with the product in such a manner as
to have an adverse effect upon the safety, purity, potency or effectiveness of the product.
(b) supplies and reagents that do not bear an expiry date shall be stored in a manner that the
oldest is used first.
(c) supplies and reagents shall be used in a manner consistent with instructions provided by
the manufacturer.
(d) all final containers and closures for blood and blood components not intended for
transfusion shall be clean and free of surface solids and other contaminants.
(e) each blood collecting container and its satellite container(s), if any, shall be examined
325
visually for damage or evidence of contamination prior to its use and immediately after
filling. Such examination shall include inspection for breakage of seals, when indicated,
and abnormal discoloration. Where any defect is observed, the container shall not be
used, or if detected after filling, shall be properly discarded.
(f) representative samples of each lot of the following reagents and/or solutions shall be
tested regularly on a scheduled basis by methods described in the Standard Operating
Procedures Manual to determine their capacity to perform as required,
Reagents and solutions Frequency of testing along with controls
Anti-human serum Each day of use
Blood grouping serums Each day of use
Lectin Each day of use
Antibody screening and reverse
grouping cells
Each day of use
Hepatitis test reagents Each run
Syphilis serology reagents Each run
Enzymes Each day of use
HIV I and II reagents Each run
Normal saline (LISS and PBS) Each day of use
Bovine Albumin Each day of use.
G. GOOD MANUFACTURING PRACTICES (GMPs) /STANDARD OPERATING
PROCEDURES (SOPs):
Written Standard Operating Procedures shall be maintained and shall include all steps to be
followed in the collection, processing, compatibility testing, storage and sale or distribution of
blood and/or preparation of blood components for homologous transfusion, autologous
transfusion and further manufacturing purposes. Such procedures shall be available to the
personnel for use in concerned areas. The Standard Operating Procedures shall inter alia
include:
1.(a) criteria used to determine donor suitability.
(b)
(c)
methods of performing donor qualifying tests and measurements including minimum
and maximum values for a test or procedure, when a factor in determining
acceptability;
solutions and methods used to prepare the site of phlebotomy so as to give maximum
assurance of a sterile container of blood;
326
(q) procedures of plasmapheresis, plateletphersis and leucapheresis if performed,
including precautions to be taken to ensure re-infusion of donor’s own cells;
(r) procedures for preparing recovered (salvaged) plasma if performed, including details
of separation, pooling, labelling, storage and distribution;
(s) All records pertinent to the lot or unit maintained pursuant to these regulations shall be
reviewed before the release or distribution of a lot or unit of final product. The review
or portions of the review may be performed at appropriate periods during or after
blood collection, processing, testing and storage. A thorough investigation, including
the conclusions and follow-up, if any unexplained discrepancy or the failure of a lot or
unit to meet any of its specification shall be made and recorded.
2. A licensee may utilise current Standard Operating Procedures, such as the Manuals of
the following organizations, so long as such specific procedures are consistent with,
and at least as stringent as, the requirements contained in this Part, namely :-
(d) method of accurately relating the product (s) to the donor;
(e) blood collection procedure, including in-process precautions taken to measure
accurately the quality of blood drawn from the donor;
(f) methods of component preparation including, any time restrictions for specific steps in
processing;
(g) all tests and repeat test performed on blood and blood components during processing;
(h) pre-transfusion testing, wherever applicable, including precautions to be taken to
identify accurately the recipient blood components during processing;
(i) procedures of managing adverse reactions in donor and recipient reactions:
(j) storage temperatures and methods of controlling storage temperatures for blood and its
components and reagents;
(k) length of expiry dates, if any assigned for all final products;
(l) criteria for determining whether returned blood is suitable for re-issue;
(m) procedures used for relating a unit of blood or blood components from the donor to its
final disposal;
(n) quality control procedures for supplies and reagents employed in blood collection,
processing and re-transfusion testing;
(o) schedules and procedures for equipment maintenance and calibration;
(p) labelling procedures to safe guard its mix-ups, receipt, issue, rejected and in-hand;
327
(i) Directorate General of Health Services Manual,
(ii) Other Organisations’ or individual blood bank’s manuals, subject to the approval of
State Licensing Authority and Central Licence Approving Authority.
H. CRITERIA FOR BLOOD DONATION:
Conditions for donation of blood:
(1) General – No person shall donate blood and no blood bank shall draw blood from a
person, more than once in three months. The donor shall be in good health, mentally alert and
physically fit and shall not be inmates of jail, persons having multiple sex partners and drugaddicts. The donors shall fulfill the following requirements, namely: –
(a) the donor shall be in the age group of 18 to 60 years.
(b) the donor shall not be less than 45 kilograms;
( c) temperature and pulse of the donor shall be normal;
(d) the systolic and diastolic blood pressure and are within normal limits without
medication;
(e) haemoglobin which shall not less than 12.5 grams;
(f) the donor shall be free from acute respiratory diseases;
(g) the donor shall be free from any skin diseases at the site of phlebotomy;
(h) the donor shall be free from any disease transmissible by blood transfusion,
insofar as can be determined by history and examination indicated above;
(i) the arms and forearms of the donor shall be free from skin punctures or scars
indicative of professional blood donors or addiction of self injected narcotics.
(2) Additional qualifications of donor – No person shall donate blood, and no blood bank
shall draw blood from a donor, in the conditions mentioned in column (1) of the Table
given below before the expiry of the period of deferment mentioned in the column (2)
of the said Table.
Table: Deferment of blood donation

CONDITIONS
(1)
PERIOD OF DEFERMENT
(2)
(a) Abortions 6 months
(b) History of Blood transfusion 6 months
(c) Surgery 12 months
(d) Typhoid 12 months after recovery
(e) History of Malaria and duly
treated
3 months (endemic)
3 years (non endemic area)
(f) Tattoo 6 months
(h) Breast feeding 12 months after delivery
328
(i) Immunization (Cholera,
Typhoid, Diphtheria, Tetanus,
Plague, Gammaglobulin)
15 days
(j) Rabies vaccination 1 year after vaccination
(k) History of Hepatitis in family or
close contact.
12 months
(l) Immunoglobulin 12 months
(5) No person shall donate blood and no blood bank shall draw blood from a person,
suffering from any of the diseases mentioned below, namely:
a. Cancer
b. Heart disease
c. Abnormal bleeding tendencies
d. Unexplained weight loss
e. Diabetes-controlled on insulin
i. [(f) Hepatitis infection]
(g) Chronic nephritis
(h) Signs and symptoms, suggestive of AIDS
(i ) Liver diseases
(j) Tuberculosis
(k) Polycythemia Vera.
(l) Asthma
(m) Epilepsy
(n)Leprosy
(o)Schizophrenia
(p)Endocrine disorders
I. GENERAL EQUIPMENTS AND INSTRUMENTS: –
1. For blood collection room:
i) Donor beds, chairs and tables: These shall be suitably and comfortably
cushioned and shall be of appropriate size.
ii) Bedside table
iii) Sphygmomanometer and Stethoscope
iv) Recovery beds for donors.
v) Refrigerators, for storing separately tested and untested blood, maintaining
temperature between 2 to 6 degree centigrade with digital dial thermometer,
recording thermograph and alarm device, with provision for continuous power
supply.
vi) Weighing devices for donor and blood containers.
______________________________________________________________________
· Subs. by G.O.I Notification G.S.R. No.40 (E) Dt 29-01-2001.
329
2. For haemoglobin determination:
3. For temperature and pulse determination.
4. For blood containers:

(i) Copper sulphate solution (specific gravity 1.053)
(ii) Sterile lancet and impregnated alcohol swabs.
(iii) Capillary tube (1.3 x 1.4 x 96mm) or Pasteur pipettes)
(iv) Rubber bulbs for capillary tubings.
(v) Sahli’s haemoglobinometer / Colorimetric method.
(i) Clinical thermometers
(ii) Watch (fitted with a second-hand) and a stop-watch.
(a) Only disposable PVC blood bags shall be used (closed system) as per
specifications of IP/USP/BP.
(b) Anti-coagulants: The anti-coagulant solution shall be sterile, pyrogen-free and
of the following composition that will ensure satisfactory safety and efficacy of
the whole blood and/or for all the separated blood components.
Note 1. (i) In case of single/double/triple/quadruple blood collection bags used
for blood component preparations,CPDA blood collection bags may
be used.
(i) Citrate Phosphate Dextrose Adenine solution (CPDA) or Citrate
Phosphate Dextrose Adenine – 1 (CPDA-1) – 14 ml solution shall be
required for 100ml of blood.
330
5. Emergency equipments/items:

6 Accessories: –
(ii) Acid Citrate Dextrose solution (A.C.D. with Formula -A) I.P. – 15 ml
solution shall be required for 1—ml blood,
(iii) Additive solution such as SAGM, ADSOL, NUTRICEL may be
used for storing and retaining Red Blood Corpuscles upto 42 days.
Note 2. The licensee shall ensure that the anti-coagulant solutions are of a
licensed manufacturer and the blood bags in which the said solutions
are contained have a certificate of analysis of the said manufacturer.
(i) Oxygen cylinder with masks, gauge and pressure regulator
(ii) 5 percent Glucose or Normal Saline
(iii) Disposable sterile syringes and needles of various sizes.
(iv) Disposable sterile I.V. infusion sets.
(v) Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or
Dexamethasone, Metoclorpropamide injections.
(vi) Aspirin.
(i) Such as blankets, emesis basins, haemostats, set clamps, sponge forceps, gauze,
dressing jars, solution jars, waste cans.
(ii) Medium cotton balls, 1.25 cm adhesive tapes.
(iii) Denatured spirit, Tincture Iodine, green soap or liquid soap.
(iv) Paper napkins or towels.
(v) Autoclave with temperature and pressure indicator.
(vi) Incinerator
(vii) Stand-by generator
331
7. Laboratory equipment
viii) Hand-lens for observing tests conducted in tubes.
(ix) Serological graduated pipettes of various sizes.
(x) Pipettes (Pasteur)
(xi) Glass slides
(xii) Test tubes of various sizes / micrometer plates (U or V type) P
xiii) Precipitating tubes 6mm x 50mm of different sizes and glass beakers of different
sizes.
(xiv) Test tube racks of different specifications
(xv) Interval timer electric or spring wound.
J SPECIAL REAGENTS :
(1) Standard blood grouping sera Anti A, Anti B and Anti C with known controls.
Rh typing sera shall be in double quality and each of different brand or if from
the same supplier each supply shall be of different lot numbers,
(2) Reagents for serological tests for syphilis and positive sera for controls.
(3) Anti Human Globulin Serum (Coomb’s serum)
(4) Bovine Albumin 22 percent Enzyme reagents for incomplete antibodies.
(5) ELISA or RPHA test kits for Hepatitis and HIV I & II
(6) Detergent and other agents for cleaning laboratory glass wares.
(i) Refrigerators, for storing diagnostic kits and reagents, maintaining a temperature
between 4 to 6 degree centigrade (plus/minus 2 degrees centigrade) with digital
dial thermometer having provision for continuous power supply.
(ii) Compound Microscope with low and high power objectives
(iii) Centrifuge Table Model
(iv) Water bath: having range between 37 degree centigrade to 56 degree centigrade.
(v) Rh viewing box in case of slide technique
(vi) Incubator with thermostatic control
(vii) Mechanical shakers for serological tests for Syphilis.
(xviii) Wash bottles.
(xix) Filter papers
(xx) Dielectric tube sealer
(xxii) Plain and EDTA vials
(xxii) Chemical balance (wherever necessary)
(xxiii) ELISA reader with printer, washer and micropipettes.
(xvi) Equipment and materials for cleaning glass wares adequately.
(xvii) Insulated containers for transporting blood, between 2 degree centigrade to 10
degree centigrade temperatures, to wards and hospitals.
332
K. TESTING OF WHOLE BLOOD :
NOTE (a) Blood samples of donors in pilot tube and the blood samples of the
recipient shall be preserved for 7 days after issue.
(b) The blood intended for transfusion shall not be frozen at any stage.
(c) Blood containers shall not come directly in contact with ice at any stage.
L. RECORDS :
The records which the licensee is required to maintain shall include interalia the
following particulars, namely: –
_________________________________________________________________
* Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001.w.e.f.01.06.2001
(1) It shall be responsibility of the licensee to ensure that the whole blood collected,
processed and supplied conforms to the standards laid down in the Indian
Pharmacopoeia and other tests published, if any, by the Government.
(2) Freedom from HIV antibodies (AIDS) Tests – Every licensee shall get samples
of every blood unit tested, before use, for freedom from HIV 1 and HIV II
antibodies either from laboratories specified for the purpose by the Central
Government or in his own laboratory. The results of such testing shall be
recorded on the label of the container.
(3) Each blood unit shall also be tested for freedom from *[(Hepatitis B surface
antigen and Hepatitis C Virus antibody)] VDRL and malarial parasite and
results of such testing shall be recorded on the label of the container.
(1) Blood donor record : It shall indicate serial number, date of bleeding, name, address
and signature of donor with other particulars of age, weight, hemoglobin, blood
grouping, blood pressure, med ical examination, bag number and patient’s detail for
whom donated in case of replacement donation, category of donation (voluntary /
replacement) and deferral records and signature of Medical Officer In charge.
333
( (5) Records of A.C.D./C.P.D/CPD-A/SAGM bags giving details of manufacturer, batch
number, date of supply and results of testing
.
(6) Register for diagnostic kits and reagents used: name of the kits/reagents, details of
batch number, date of expiry and date of use.
(7) Blood bank must issue the cross matching report of the blood to the patient together
with the blood unit.
(8) Transfusion adverse reaction records.
(9) Records of purchase, use and stock in hand of disposable needles, syringes, blood
bags, shall be maintained.
NOTE : The above records shall be kept by the licensee for a period of five years.
M LABELS :
The labels on every bag containing blood and/or component shall contain the
following particulars, namely;
(1) The proper name of the product in a prominent place and in bold letters on the bag.
(2) Name and address of the blood bank
(3) Licence number
________________________________________________________________________
**Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001.w.e.f.01.06.2001.

(2) Master records for blood and its components: It shall indicate bag serial number, date
of collection, date of expiry, quantity in ml. ABO/Rh Group, results for testing of
HIV I and HIV II antibodies, Malaria, V.D.R.L. **[( Hepatitis B surface antigen and
Hepatitis C Virus antibody)] and irregular antibodies (if any), name and address of
the donor with particulars, utilization issue number, components prepared or
discarded and signature of the Medical Officer in charge.
(3) Issue register: It shall indicate serial number, date and time of issue, bag serial
number, ABO/Rh Group, total quantity in ml, name and address of the recipient,
group of recipient, unit/institution, details of cross-matching report, indication for
transfusion.
(4) Records of components supplied: quantity supplied, compatibility report, details of
recipient and signature of issuing person.
334

(4) Serial number
(5) The date on which the blood is drawn and the date of expiry as prescribed under
Schedule P to these rules.
(6) A colored label shall be put on every bag containing blood. The following color
scheme for the said labels shall be used for different groups of blood:
Blood Group Color of the label
O Blue
A Yellow
B Pink
AB White
(7) The results of the tests for **[(Hepatitis B surface antigen and Hepatitis C Virus
antibody)] syphilis, freedom from HIV I and HIV II antibodies and malarial
parasite.
(8) The Rh. Group
(9) Total volume of blood, the preparation of blood, nature and percentage of anticoagulant.
(10) Keep continuously temperature at 2 degree centigrade to 6 degree centigrade for
whole human blood and/or components as contained under III of Part XII B.
(11) Disposable transfusion sets with filter shall be used in administration equipment.
(12) Appropriate compatible cross-matched blood without atypical antibody in recipient
shall be used.
(13) The contents of the bag shall not be used if there is any visible evidence of
deterioration like haemolysis, clotting or discoloration.
(14) The label shall indicate the appropriate donor classification like “Voluntary Donor”
or “Replacement Donor” in no less prominence than the proper name.
________________________________________________________________________
**Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001.w.e.f.01.06.2001
335
NOTES :
1. In the case of blood components, particulars of the blood from which such
components have been prepared shall be given against item numbers (5), (7), (8),
(9) and (14).
2. The blood and/or its components shall be distributed on the prescription of a
Registered Medical Practitioner.
I I. BLOOD DONATION CAMPS.
A blood donation camp may be organized by –
(a) a licensed designated Regional Blood Transfusion Centre ; or
(b) a licensed Government blood bank; or
**[(c) the Indian Red Cross society; or
(d) a licensed blood bank run by registered voluntary or charitable organizations
recognized by State or Union Territory Blood Transfusion Council)]
NOTES:
(i)“ Designated Regional Blood Transfusion Centre” shall be a center approved and
designated by a Blood Transfusion Council constituted by a State Government to
collect, process and distribute blood and its components to cater to the needs of the
region and that center has also been licensed and approved by the Licensing Authority
and Central Licence Approving Authority for the purpose.
(ii) The designated Regional Blood Transfusion Centre, Government blood bank and
Indian Red Cross Society shall intimate within a period of seven days, the venue where
the blood camp was held and details of group wise blood units collected in the said
camp to the Licensing Authority and Central Licence Approving Authority.
For holding a blood donation camp, the following requirements shall be fulfilled/complied
with, namely: –
(A) Premises, personnel etc.

(a) Premises under the blood donation camp shall have sufficient area and the
location shall be hygienic so as to allow proper operation, maintenance and
cleaning.
_______________________________________________________
**Subs. by G.O.I Notification G.S.R. No.218(E) dt 28-03-2001
336
(b) All information regarding the personnel working, equipment used and facilities
available at such a Camp shall be well documented and made available for inspection,
if required, and ensuring –
(i) Continuous and uninterrupted electrical supply for equipment used in the
Camp;
(ii) Adequate lighting for all the required activ ities;
(iii) Hand-washing facilities for staff;
(iv) Reliable communication system to the central office of the
Controller/organizer of the Camp;
(v) Furniture and equipment arranged within the available space;
(vi) Refreshment facilities for donors and staff;
(vii) Facilities for medical examination of the donors;
(viii) Proper disposal of waste.
(B) Personnel for Out-door Blood Donation Camp:
To collect blood from 50 to 70 donors in about 3 hours or from 100 to 200 donors in
5 hours, the following requirements shall be fulfilled / complied with:
(i) One Medical Officer and two nurses or phlebotomists for managing 6-8
donor tables.
(ii) two medico social workers
(iii) three blood bank technicians
(iv) two attendants
(v) vehicle having a capacity to seat 8-10 persons, with provision for carriage
of donation goods including facilities to conduct a blood donation camp.
(C) Equipments :

1. BP apparatus
2. Stethoscope
3. Blood bags (single, double, triple, quadruple)
4. Donor questionnaire
5. Weighing device for donors
6. Weighing device for blood bags
7. Artery forceps, scissors
8. Stripper for blood tubing
9. Bed sheets, blankets/mattress
10. Lancets, swab stick/tooth picks
11. Glass slides
12. Portable Hb meter/copper sulphate
337
13. Test tube (big) and 12x100mm (small)
14. Test tube stand
15. Anti-A, Anti-B and Anti-AB, Antisera and Anti-D
16. Test tube sealer film
17. Medicated adhesive tape
18. Plastic waste basket
19. Donor cards and refreshment for donors
20 Emergency medical kit
21 Insulated blood bag containers with provisions for storing between 2
degree centigrade to 10 degree centigrade.
22. Dielectric sealer or portable tube sealer
23. Needle destroyer (wherever necessary)
III. PROCESSING OF BLOOD COMPONENTS FROM WHOLE BLOOD BY A
BLOOD BANK
The Blood components shall be prepared by blood banks as a part of the Blood Bank
services. The conditions for grant or renewal of licence to prepare blood components shall
be as follows: –
A ACCOMMODATION
(1) Rooms with adequate area and other specification, for preparing blood
components depending on quantum of workload shall be specified in item
B under the heading “1. BLOOD BANKS/BLOOD COMPONENTS’ of
this Part.
(2) Preparation of Blood components shall be carried out only under closed
system using single double, triple or quadruple plastic bags except for
peroration of Red Blood Cells Concentrates, where single bags may be
used with transfer bags.
B EQUIPMENT :
(i) Air Conditioner;
(ii) Laminar air flow bench;
(iii) Suitable refrigerated centrifuge;
(iv) Plasma expresser;
(v) Clipper and clips and or dielectric sealer;
(vi) Weighing device;
(vii) Dry rubber balancing material;
(viii) Artery forceps, scissors;
(ix) Refrigerator maintaining a temperature between 2 degree centigrade to 6
degree centigrade, a digital dial thermometer with recording thermograph
and alarm device, with provision for continuous power supply;
(x) Platelet agitator with incubator (wherever necessary)
(xi) Deep freezers maintaining a temperature between minus 30 degree
338
centigrade to minus 40 degree centigrade and minus 75 degree centigrade
to minus 80 degree centigrade;
(xii) Refrigerated Water bath for Plasma Thawing;
(xiii) Insulated blood bag containers with provisions for storing at appropriate
temperature for transport purposes;
C. PERSONNEL:
The whole time competent technical staff meant for processing of Blood
Components (that is Medical Officer, Technical Supervisor, Blood Bank
Technicians and Registered Nurse) shall be as specified in item C, under the
heading “ 1. BLOOD BANKS/BLOOD COMPONENTS” of this Part.
D. TESTING FACILITIES:
General: Facilities for A, B, AB and O groups and Rh(D) grouping.
[*(Hepatitis B surface antigen and Hepatitis C Virus antibody)] VDRL, HIV
and HIV II antibodies and malarial parasites shall be mandatory for every
blood unit before it is used for the preparation of blood components. The
results of such testing shall be indicated on the label.
E. CATEGORIES OF BLOOD COMPONENTS:
(1) CONCENTRATED HUMAN RED BLOOD CORPUSCLES:
The product shall be known as “Packed Red Blood Cells” that is Packed
Red Blood Cells remaining after separating plasma from human blood.
General Requirements:
(a) Storage: Immediately after processing, the Packed Red Blood Cells shall be
kept at a temperature maintained between 2 degree centigrade to 6 degree
centigrade.
(b) Inspection: The component shall be inspected immediately after separation
of the plasma, during storage and again at the time of issue. The product
shall not be issued if there is any abnormality in color or physical
appearance or any indication of microbial contamination.
(c)
Suitability of Donor: The source of blood for Packed Red Blood Cells shall
be obtained from a donor who meets the criteria for Blood Donation as
specified in item H under the heading “I. BLOOD BANKS/BLOOD
COMPONENTS” of this Part.
__________________________________________________________________
*Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001 w.e.f. 01.06.2001
339
(d) Testing of Whole Blood: Blood from which Packed Red Blood Cells are
prepared shall be tested as specified in item K relating to Testing Of Whole
Blood under the heading “I. BLOOD BANKS/BLOOD COMPONENTS”
of this Part.
(e) Pilot samples: Pilot samples collected in integral tubing or in separate pilot
tubes shall meet the following specifications:
(i) One or more pilot samples of either the original blood or the Packed
Red Blood Cells being processed shall be preserved with each unit of
Packed Red Blood Cells, which is issued.
(ii) Before they are filled, all pilot sample tubes shall be marked or
identified so as to relate them to the donor of that unit or Packed Red
Blood Cells.
(iii) Before the final container is filled or at the time the final product is
prepared, the pilot samples tubes accompanying a unit of Packed Red
Blood Cells, shall be attached in a tamper-proof manner that shall
conspicuously identify removal and re-attachment.
(iv) All pilot sample tubes, accompanying a unit of packed red blood cells,
shall be filled immediately after the blood is collected or at the time the
final product is prepared, in each case, by the person who performs the
collection of preparation.
F PROCESSING:
(i) Separation: Packed Red Blood Cells shall be separated from the whole
blood, —
(a) if the whole blood is stored in ACD solution within 21 days, and
(b) if the whole blood is stored in CPDA-1 solution, within 35 days, from
the date of collection. Packed Red Blood Cells may be prepared either
by centrifugation done in a manner that shall not tend to increase the
temperature of the blood or by normal undisturbed sedimentation
method. A portion of the plasma, sufficient to ensure optimal cell
preservation, shall be left with the packed Red Blood Cells.
(ii) Packed Red Blood Cells Frozen: Cryophylactic substance may be added
to the Packed Red Blood Cells for extended manufacturer’s storage not
warmer than minus 65 degree centigrade provided the manufacturer
submits data to the satisfaction of the Licensing Authority and Central
Licence Approving Authority, as adequately demonstrating through invivo cells survival and other appropriate tests that the addition of the
substance, the material used and the processing methods results in a final
340
product meets the req uired standards of safety, purity and potency for
Packed Red Blood Cells, and that the frozen product shall maintain those
properties for the specified expiry period.

(iii) Testing: Packed Red Blood Cells shall conform to the standards as laid
down in the Indian Pharmacopoeia.
(2) PLATELETS CONCENTRATES:
The product shall be known as “Platelets Concentrates” that is platelets
collected from one unit of blood and re-suspended in an appropriate volume
of original plasma.
General Requirements:
(i) Source: The source material for platelets shall be platelet rich plasma
or buffy coat which may be obtained from the whole blood or by
plateletpheresis.
(ii) Processing :
(a) Separation of buffy-coat or platelet-rich plasma and platelets and resuspension of the platelets shall be in a closed system by centrifugal
method with appropriate speed, force and time.
(b) Immediately after collection, the whole blood or plasma shall be
held in storage between 20 degree centigrade to 24 degree
centigrade. When it is to be transported from the venue of blood
collected to the processing laboratory, during such transport action,
the temperature as close as possible to a range between 20 degree
centigrade to 24 degree centigrade shall be ensured. The platelet
concentrates shall be separated within 6 hours after the time of
collection of the unit of whole blood or plasma.
(c) The time and speed of centrifugation shall be demonstrated to
produce an unclamped product, without visible haemolysis, that
yields a count of not less than 3.5 x 10 10 (3.5 x 10 raised to the
power of 10) and 4.5 x 10 10 (4.5 x 10 raised to the power ten) i.e.
platelets per unit from a unit of 350ml and 450ml blood
respectively. One percent of total platelets prepared shall be tested
of which 75 per cent of the units shall conform to the above said
platelet count.
(d) The volume of original plasma used for re-suspension of the
platelets shall be determined by the maintenance of the pH of not
less than 6 during the storage period. The pH shall be measured on a
sample of platelets which has been stored for the permissible
341
maximum expiry period at 20 degree centigrade to 24 degree
centigrade.
(e) Final containers used for platelets shall be colorless and transparent
to permit visual inspection of the contents. The caps selected shall
maintain a hermetic seal to prevent contamination of the contents.
The container material shall not interact with the contents, under the
normal conditions of the storage and use, in such a manner as to
have an adverse effect upon the safety, purity, potency, or efficacy
of the product. At the time filling, the final container shall be
marked or identified by number so as to relate it to the donor.
(iii) Storage: Immediately after re-suspension, platelets shall be placed in
storage not exceeding for a period of 5 days, between 20 degree
centigrade to 24 degree centigrade, with continuous gentle agitation of
the platelet concentrates maintained throughout such storage
(iv) Testing: The units prepared from different donors shall be tested at the
end of the storage period for –
(a) Platelet count;
(b) pH of not less than 6 measured at the storage temperature of the
unit;
(c) measurement of actual plasma volume;
(d) one percent of total platelets prepared shall be tested for
sterility;
(e) the tests of functional viability of the platelets shall be done by
swirling movement before issue.
(f) if the results of the testing indicate that the product does not
meet the specified requirements, immediate corrective action
shall be taken and records maintained;
(v) Compatibility Test: Compatible transfusion for the purpose of variable
number of Red Blood Cells, A, B, AB and O grouping shall be done if
the platelets concentrate is contaminated with red blood cells.
(3) GRANULOCYTE CONCENTRATES:
(i) Storage: It shall be kept between 20 degree centigrade to 24 degree centigrade
for a maximum period of 24 hours;
(ii) Unit of granulocytes shall not less than 1 x 1010 (i.e. 1 x 10 raised to the
power of 10) when prepared on cell separator.
(iii) Group specific tests/HLA test wherever required shall be carried out.
(4) FRESH FROZEN PLASMA:
342
Plasma frozen within 6 hours after blood collection and stored at a
temperature not warmer than minus 30 degree centigrade, shall be
preserved for a period of not more than one year.
(5) CRYOPRECIPITATE:
Concentrate of anti-hemophiliac factor shall be prepared by thawing of the fresh
plasma frozen stored at minus 30 degree centigrade.
(a) Storage:
Cryoprecipitate shall be preserved at a temperature not higher than minus 30
degree centigrade and may be preserved for a period of not more than one year
from the date of collection.
(b) Activity:
Anti-hemophiliac factor activity in the final product shall be not less than 80
units per bag. One percent of the total cryoprecipitate prepared shall be tested
of which seventy five percent of the unit shall conform to the said
specification.
(6) PLASMAPHERESIS, PLATELETPHERESIS, LEUCAPHERESIS, USING A CELL
SEPARATOR.
An area of 10 square meters shall be provided for apheresis in the blood bank.
The blood banks specifically permitted to undertake the said apheresis on the
donor shall observe the criteria as specified in item H relating to Criteria for
blood donation “I Blood Banks/Blood Components” of this Part. The written
consent of the donor shall be taken and the donor must be explained, the
hazards of apheresis. The Medical Officer shall certify that the donor is fit for
apheresis and it shall be carried out by a trained person under supervision of
the Medical Officer.
(A) PLASMAPHERESIS,PLATELETPHERESISANDLEUCAPHERESIS:
The donors subjected to plasmapheresis, plateletpheresis and leucopheresis
shall, in addition to the criteria specified in item H relating to the CRITERIA
FOR BLOD DONATION, under the heading “I. BLOOD BANKS/BLOOD
COMPONENTS” of this Part being observed, be also subjected to protein
estimation on post-pheresis/first sitting whose results shall be taken as
reference for subsequent pheresis/sitting. It shall also be necessary that the
total plasma obtained from such donor and periodicity of Plasmapheresis shall
be according to the standards described under validated Standard Operating
Procedures.
NOTE :
(i) At least 48 hours must elapse between successive apheresis and not
more than twice in a week.
343
(ii) Extracoporeal blood volume shall not exceed 15% of donor’s
estimated blood volume.
(iii) Platelet pheresis shall not be carried out on donors who have taken
medication containing Asprin within 3 days prior to donation.
(iv) If during plateletpheresis or leucapheresis, RBCs cannot be retransfused then at least 12 weeks shall elapse before a second
cytapheresis procedure is conducted.
(B) MONITORING FOR APHERESIS:
Before starting apheresis procedure, hemoglobin or haematocrit shall be done.
Platelet count, WBC counts, differential count may be carried out. In repeated
plasmapheresis, the serum protein shall be 6 gm./ml.
(C) COLLECTION OF PLASMA:
The quantity of plasma separated from the blood of donor shall not exceed 500
ml. per sitting and once in a fortnight or shall not exceed 1000 ml per month.
PART XII C
I. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS.
The blood products shall be manufactured in a separate premises other than that
meant for blood bank. The requirements that are essential for grant or renewal of licence to
manufacture blood products such as Albumin, Plasma Protein Fraction, Immunoglobins and
Coagulation Factor Concentrates, shall be as follows, namely: –
A. GENERAL REQUIREMENTS:
1. Location and surroundings, buildings and water supply:
The requirements as regards location and surrounding, buildings and water supply
as contained in paragraphs 1.1.1, 1.1.2, 1.1.3 of Part 1 of Schedule M shall apply
mutatis mutandis to the manufacture of blood products.
2. Disposal of waste and infectious materials:
(i) The requirements as regards dis posal of waste and infectious materials as
contained in paragraph 1.1.4 of Part 1 of Schedule M shall apply mutatis
mutandis to the manufacture of blood products.
(ii) Proper facility shall also be provided for potentially infectious materials,
particularly HIV I & HIV II *[(Hepatitis B surface antigen and Hepatitis C
Virus antibody)] through autoclaving, incineration or any other suitable
validated methods.
344
3. Health, clothing and sanitation personnel:
(i) The requirement as contained in paragraph 3 of Part 1
of Schedule M shall be complied with.
(ii) The personnel working in the manufacturing areas shall be
vaccinated against Hepatitis B virus and other infectious
transmitting diseases
4. Requirements for manufacturing area for Blood Products:
(i) For the manufacture of blood products, separate enclosed areas
specifically designated for the purpose shall be provided. These areas be
provided with air locks for entry and shall be essentially dust free and
ventilated with an air supply. Air supply for manufacturing area shall be
filtered through bacteria retaining filters (HEPA Filters) shall be at a
pressure higher than in the adjacent areas.
The filters shall be checked for performance on installation and
periodically thereafter all records thereof shall be maintained.
(ii) Interior surfaces (walls, floors and ceilings) shall be smooth and free
from cracks; they shall not shed matter and shall permit easy cleaning
and disinfection. Drains shall be excluded from aseptic areas.
Routine microbial counts of the manufacturing area shall be carried out
during manufacturing operations. The results of such counts shall be
checked against well documented in-house standards and records
maintained.
Access to the manufacturing areas shall be restricted to a minimum
number of authorized personnel. Special procedures for entering and
leaving the manufacturing areas shall be prominently displayed.
(iii) Sinks shall be excluded from aseptic areas. Any sink installed in other
clean areas shall be of suitable material such as stainless steel, without an
overflow, and be supplied with water of potable quality. Adequate
precautions shall be taken to avoid contamination of the drainage system
with dangerous effluents and airborne dissemination of pathogenic
micro-organisms.
___________________________________________________________________
*Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001 w.e.f. 01.06.2001.
345
(iv) Lighting, air-conditioning, ventilation shall be designed to maintain a
satisfactory temperature and relative humid ity to minimize
contamination and to take account of the comfort of personnel working
with protective clothing.
(v) Premises used for the manufacture of blood products shall be suitably
designed and constructed to facilitate good sanitation.
(vi) Premises shall be carefully maintained and it shall be ensured that repair
and maintenance operations do not present any hazard to the quality of
products. Premises shall be cleaned and, where applicable, disinfected
according to detailed written validated procedures.
(vii) Adequate facilities and equipments shall be used for the manufacture of
blood products derived from blood plasma.
(viii) All containers of blood products, regardless of the stage of manufacture,
shall be identified by securely attached labels. Cross contamination shall
be prevented by adoption of the following measures, namely –
(a) processing and filling shall be in segregated areas;
(b) manufacture of different products at the same time shall be
avoided;
(c) simultaneous filling of the different products shall be avoided;
(d) ensure transfer, containers/materials by means of airlocks, air
extraction, clothing change and careful washing and
decontamination of equipment;
(e) protecting containers/materials against the risk of contamination
caused by re-circulation of untreated air or by accidental re-entry
of extracted air;
(f) using container that are sterilized or are of documented low
“bioburden”,
(ix) Positive pressure area shall be dedicated to the processing area
concerned;
(x) Air-handling units shall be dedicated to the processing area concerned;
(xi) Pipe work, valves and vent filters shall be properly designed to facilitate
cleaning and sterilization. Valves on fractionation / reacting vessels shall
be completely steam sterilisable. Air vent filters shall be validated for
their designated use.
346
5. Ancillary Areas :
(i) Rest and refreshment rooms shall be separated from other areas.
(ii) Facilities for changing and storing clothes and for washing and toilet
purposes shall be easily accessible and appropriate for the number of users.
Toilets shall not be connected directly with production or storage areas.
(iii) Maintenance workshops shall be separated from production areas.
Wherever parts and tools are stored in the production area, they shall be
kept in rooms or lockers reserved for that use.
(iv)Animal houses shall be well isolated from other areas with separate
entrance.
COLLECTION AND STORAGE OF PLASMA FOR FRACTIONATION
(A) COLLECTION:
(1) Plasma shall be collected from the licensed Blood Banks through a cold chain
process and stored in frozen condition not warmer than minus twenty degree
centigrade.

(2) Individual plasma shall remain in quarantine till it is tested for *[( Hepatitis B
and Hepatitis C Virus antibody)], HIV I and HIV II.
(3) A sample from pooled – lot plasma of about 10-12 units of different donors shall
be tested for [(Hepatitis B and Heptitis C Virus antibody)] HIV I and HIV II
and if the same sample found negative, only then it shall be taken up for
fractionation.
(B) STORAGE AREA :
(1) Storage areas shall be of sufficient space and capacity to allow orderly
storage of the various categories of materials, intermediates, bulk and
finished products, products in quarantine, released, rejected, returned, or
recalled products.
(2) Storage areas shall be designed or adopted to ensure good storage
containers. In particular, they shall be clean, dry and maintained within
temperature required for such storage and where special storage
conditions are required (e.g. temperature, humidity), these shall be
provided, checked and monitored.
________________________________________________________________________
*Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001 w.e.f. 01.06.2001
347
(3) Receiving and dispatch bays shall protect materials and products from the
weather and shall be designed and equipped to allow containers of
incoming materials to be cleaned, if necessary, before storage.
(4) Where quarantine status is ensured by storage in separate areas, these
areas shall be clearly marked and their access restricted only to authorized
personnel.
(5) There shall be separate sampling area for raw materials. If sampling is
performed in the storage area, it shall be conducted in such a way so as to
prevent contamination or cross-contamination.
(6) Segregation shall be provided for the storage of rejected, recalled, or
returned materials or products.
(7) Adequate facility shall be provided for supply of ancillary material, such
as ethanol, water, salts and polyethylene glycol. Separate facilities shall
be provided for the recovery of organic solvents used in fractionation.
C. PERSONNEL :
1. Manufacture :
The manufacture of blood products shall be conducted under the active
direction and personal supervision of competent technical staff, consisting of
at least one person who shall be a whole time employee, with one year
practical experience in the manufacture of blood products / plasma
fractionation and possesses –-
(a) Post-graduate degree in Medicine – M.D. (Mic robiology /
Pathology / Bacteriology / Immunology / Biochemistry) ; or
(b) Post graduate degree in Science (Microbilogy); or
(c) Post-graduate degree in Pharmacy (Microbiology), from a
recognized University or Institution.
2. Testing :
The head of the testing unit shall be independent of the manufacturing unit
and testing shall be conducted under the active direction and personal
supervision of competent technical staff consisting at least one person who
shall be a whole time employee. The Head of the testing unit shall have
eighteen months practical experience in the testing of drugs, especially the
blood products and possesses –
348
(a) Post-graduate degree in Pharmacy or Science – (Chemistry /
Microbiology / Bio-chemistry); or
(b) Post-graduate degree in Medicine – M.D (Microbiology / Pathology /
Biochemistry), from a recognized University or Institution.
D. PRODUCTION CONTROL :
(1) The production area and the viral inactivation room shall be centrally airconditioned and fitted with HEPA filters having Grade C (Class 10,000)
environment as given in the Table below.
(2) The filling and sealing shall be carried out under aseptic conditions in
centrally air-conditioned areas fitted with HEPA Filters Grade A or as the
case may be grade B (Class 100) environment given in the said Table.
TABLE
AIR CLASSIFICATION SYSTEM FOR MANUFACTURE OF STERILE
PRODUCTS.
Maximum number of particles permitted per m3
MAXIMUM NUMBER OF
PARTICLES PERMITTED PER m
3
MAXIMUM NUMBER OF
VIABLE
MICROORGANISM
PERMITTED PER m
3
GRADE 0.5 – 5 micron Less than 5
micron
A (Class 100)
(Laminar – Airflow
workstation)
3500 None Less than 1
B (Class 100) 3500 None Less than 5
C (Class 10000) 3,50,000 2000 Less than 100
(3) The physical and chemical operations used for the manufacture of plasma
fractionation shall maintain high yield of safe and effective protein.
(4) The fractionation procedure used shall give a good yield of products meeting
the in-house quality requirements as approved by the Licensing Authority and
Central Licence Approving Authority reducing the risk of microbiological
contamination and protein denaturation to the minimum.
(5) The procedure adopted shall not affect the antibody activity and biological
half-life or biological characteristics of the products.
349
E. VIRAL INACTIVATION PROCESS :
The procedure used by the licensee to inactivate the pathogenic organisms such
as enveloped and non-enveloped virus, especially infectivity from HIV I & HIV II,
**[(Hepatitis B surface antigens and Hepatitis C Virus antibody)], the viral
inactivation and validation methods adopted by the licensee, shall be submitted for
approval to the Licensing Authority and Central Licence Approving Authority.
NOTES:
(1) No preservative (except stabilizer to prevent – protein denaturatin such as
glycine, sodium chloride or sodium caprylate) shall be added to Albumin,
Plasma Protein Fraction, Intravenous Immunoglobulins or Coagulation Factor
Concentrates without the prior approval of Licensing Authority and Central
Licence Approving Authority.
(2) The licensee shall ensure that the said stabilizers do not have deleterious
effect on the final product in the quality present so as not to cause any untoward
or adverse reaction in human beings.
F. QUALITY CONTROL:

Separate facilities shall be provided for Quality Control such a Hematological, Biochemical, Physico-chemical, Microbiological, Pyrogens, Instrumental and Safety
testing. The Quality Control Department shall have inter alia the following principal
duties, namely :-
(1) To prepare detailed instructions for carrying our test and analysis.
(2) To approve or reject raw material, components, containers, closures, in –
process materials, packaging material, labeling and finished products.
(3) To release or reject batch of finished products which are ready for
distribution.
(4) To evaluate the adequacy of the conditions under which raw materials, semifinished products and finished products are stored.
(5) To evaluate the quality and stability of finished products and when necessary
of raw materials and semi-finished products.
* *Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001 w.e.f. 01.06.2001
350
6) To review production records to ensure that no errors have occurred or if
errors have occurred that they have been fully investigated.
(7) To approve or reject all procedures, or specifications impacting on the
identity, strength, quality and purity of the product.
(8) To establish shelf-life and storage requirements on the basis of stability tests
related to storage conditions.
(9) To establish and when necessary revise, control procedures and
specifications.
(10)
(11)
To review complaints, recalls, returned or salvaged products and
investigations conducted there under for each product.
To review Master Formula Records/Cards periodically.
G. TESTING OF BLOOD PRODUCTS:
The products – manufactured shall conform to the standards specified in the Indian
Pharmacopoeia and where standard of any product is not specified in the
Pharmacopoeia, the standard for such product shall conform to the standard specified
in the United States Pharmacopoeia or the British Pharmacopoeia. The final products
shall be tested for freedom from HIV I and HIV II antibodies *[(Hepatitis B surface
antigen and Hepatitis C Virus antibody)]
H. STORAGE OF FINISHED PRODUCT ;
(i) The final products shall be stored between two degree centigrade to eight degree
centigrade, unless otherwise specified by the Central Licence Approving
Authority.
(ii)The shelf-life assigned to the products by the licensee shall be submitted for
approval to the Licensing Authority and Central Licence Approving Authority.
I. LABELLING :
The products manufactured shall be labeled as specified in the Indian
Pharmacopoeia, the British Pharmacopoeia or the United Stated Pharmacopoeia
which shall be in addition to any other requirement stated under Part IX or Part X of
these rules. The labels shall indicate the results of test for *[(Hepatitis B surface
antigen and Hepatitis C Virus antibody)] freedom from HIV I and HIV II antibodies.
______________________________________________________
*Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001 w.e.f. 01.06.2001
351
J. RECORDS:
The licensee shall maintain records as per Schedule U and also comply with Batch
manufacturing records as specified in Paragraph 9 part 1 of Schedule M and any other
requirement as may be directed by Licensing Authority and Central Licence
Approving Authority.
K. MASTER FORMULA RECORDS:
The licensee shall maintain Master Formula Records relating to all manufacturing and
quality control procedures for each product, which shall be prepared and endorsed by
the competent Technical Staff, i.e. Head of the manufacturing unit. The Master
Formula Records shall contain –
(i) the patent or proprietary name of the product along with the generic name, if any,
strength and the dosage form;
(ii) a description or identification of the final containers, packaging materials, labels
and closures to be used;
(iii) the identity, quantity and quality of each raw material to be used irrespective of
whether or not it appears in the finished product. The permissible overage that
may be included in a formulated batch shall be indicated;
(iv) a description of all vessels and equipments and the sizes used in the process;
(v) manufacturing and control instructions along with parameters for critical steps
such as mixing, drying, blending, sieving and sterilizing the product;
(vi) the theoretical yield to be expected from the formulation at different stages of
manufacture and permissible yield limits;
(vii) detailed instructions on precautions to be taken in the manufacture and storage of
drugs and of semi finished products; and
(viii) the requirements in-process quality control tests and analysis to be carried out
during each stage of manufacture including the designation of persons or
departments responsible for the execution of such tests and analysis.
II. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS
FROM BULK FINISHED PRODUCTS.
Where the blood products, such as Albumin, Plasma Protein Fraction, Immunoglobulins and
Coagulation Factor Concentrates are manufactured through the manufacturing activities of
filling and sealing the blood products from bulk powder or solution or both, the requirements
as they apply to the manufacture of blood products from whole blood shall apply mutates
mutandis to such manufacture of blood products, unless other requirements have been
approved by the Central Licence Approving Authority.
_____________________________________________________________________
*Subs. by G.O.I Notification G.S.R. No.40(E) dt 29-01-2001 w.e.f. 01.06.2001
352

1
PART XIII – GENERAL
1. For the purposes of this Schedule, any test or method of testing described in the
Indian Pharmacopoeia shall be deemed to be a method approved by the Licensing Authority.
2. The Licensing Authority shall publish in the Official Gazette from time to time
particulars of any test or method of testing approved by him.
2
SCHEDULE F(I)
PART 1- VACCINES
(A) PROVISIONS APPLICABLE TO THE PRODUCION OF BACTERIAL VACCINES.
1. Definition- (1) This part of the Schedule applies to bacterial vaccines made from any
micro-organism pathogenic to man or other animal and to vaccines made from other microorganisms which have any antigenic value.
(2). For the purposes of this part of the Schedule, a bacterial vaccine means a sterile
suspension of a killed culture of the micro-organism from which the vaccine derives its name
or a sterile extract or derivative of a micro-organism, or a pure suspension of living microorganisms which have been previously made avirulent.
2. Staff of Establishment- A competent expert in bacteriology with sufficient experience
in the manufacture and standardisation of biological products shall be in charge of the
establishment responsible for the production of bacterial vaccine and he shall be assisted by a
staff adequate for carrying out the tests required during the preparation and standardisation of
the vaccines.
3. Proper Name- The proper name of any vaccine shall be the name of the microorganism from which it is made followed by the word “Vaccine”
1Renumbered under Government of India Notification No. F-18-1/46, dated 18-6-48
2Added under Government of India, Ministry of Health F.P., W.H and U.D. Notification No. F.1-6/62-D,
dated 2-7-1969
353
unless this Schedule otherwise provides or if there is no other special provision in the
Schedule, some other name as approved by the Licensing Authority. Provided that in the case
of the undermentioned preparations the proper name of the vaccine may be as follows:-
1. Anthrax Spore Vaccine (Living).
2. Blackquarter Vaccine.
3. Enterotoxaemia Vaccine.
4. Fowl Cholera Vaccine.
5. Haemorrhagic Septicaemia Adjuvant Vaccine.
6. Haemorrhagic Septicaemia Vaccine (Broth).
*[7. Multi Component Clostridial Vaccine.
8. Hemorrhagic Septicaemia Vaccine – Alum Treated.]
4. Records.- Cultures used in the preparation of vaccine before being manipulated into a
vaccine, should be thoroughly tested for identity by the generally accepted tests applicable to
the particular micro -organisms.
The permanent records which the licensee is required to keep shall include amongst others, a
record of the origin, properties and characteristics of the cultures.
5. Combined Vaccines- Vaccines may be issued either singly or combined in any
proportion in the same container. In the case of combination of vaccines, a name for the
combined vaccine may be submitted by the licensee to the Licensing Authority, and if
approved, may be used as the proper name of the vaccine.
6. Preparation- Bacterial vaccines, simple or polyvalent, are prepared from selected
cultures after careful examination for their identity, specificity, purity and antigencity. They
may be prepared in the following manner:-
(a). Formal Cultures or Bacterins- The selected pure culture strain or strain are grown in a
suitable fluid medium, at an optimum temperature, for an appropriate period. The pure
growth is then exposed to the action of solution of Formaldehyde I.P. in suitable
concentration and temperature. The product is finally filled in suitable sterilised containers
which are subsequently sealed.
(b) Vaccine of Bacteri