LexThe DRUGS AND COSMETICS ACT AND RULES
Punjab · state statute
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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
(23 OF 1940)
(As amended up to the 30th June, 2005)
and
THE DRUGS AND COSMETICS RULES, 1945
(As amended up to the 30th June, 2005)
LIST OF AMENDING ACTS AND ADAPTATION ORDERS
1. The Repealing and Amending Act, 1949 (40 of 1949).
2. The Adaptation of Laws Order, 1950 .
3. The Part B States (Law s) 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 0f 1964).
8. The Drugs and Cosmetics (Amendment) Act, 1955 19 of 1972).
9. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982).
10. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982).
11. The Finance Act, 1993 (22 of 1995).
12. The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995).
_________
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 …………………………………… ” Repealed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
_________
CONTENTS
Pages
The Drugs and Cosmetics Act, 1940 (23 of 1940) …………. 1 −30
The Drugs and Cosmetics Rules, 1945 ……. . . ……………... 31 −546
iii
THE DRUGS AND COSMETICE 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 LABORATORY
AND THE DRUGS CONSULTATIVE COMMITTEE
5. The Drugs Technical Advisory Board.
6. The Central Drugs Laboratory.
7. The Drugs Consultative Committee.
7A. Sections 5 and 7 not to apply to 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.
Drugs and Cosmetics Act, 1940 iv
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.
CHAPTER IV A
PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS
Drugs and Cosmetics Act, 1940 v
33A. Application of Chapter IV A.
Sections
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.
33-I. 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.
Drugs and Cosmetics Act, 1940 1
THE DRUGS AND COSMETICS ACT, 1940
ACT NO. 23 OF 19401
[10th April, 1940.]
An Act to regulate the import, manufacture, distribution and sale of drugs 2[and cosmetics];
WHEREAS it is expedient to regulate the 3[import, manufacture, distribution and sale] of drugs 2[and cosmetics];
AND WHEREAS the Le gislature of all the Provinces have passe d resolutions in terms of section 103 of th e
Government of I ndia Act , 1935 (26 Geo. 5, c. 2), i n rel ation t o such of the abo ve-mentioned matters and m atters
ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act;
It is hereby enacted as follows:-
CHAPTER I
INTRODUCTORY
1. Short title, extent and commencement.⎯(1) This Act may be called the Drugs 2[and Cosmetics] Act, 1940.
(2) It extends to the whole of India 4 * * *.
(3) It shall c ome into forc e at once; but Chap ter I II s hall take effec t only from such date5 as the Central
Government may, by notification in the Official Gazette, a ppoint in this behalf, and Chapter IV sh all take effect in a
particular State only from such date5 as the State Government may, by like notification, appoint in this behalf:
6[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 (19 of 1972), as the Central Government
may, by notification in the Official Gazette, appoint in this behalf.]
2. Application of other l aws not barred.⎯The provisions of th is Act sh all b e i n add ition 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,⎯
7[(a) “ 8[Ayurvedic, Siddha or Unani] drug” includes all medicines intended for internal or external use for
or in the diagnosis, treatment, mitigation or prevention of 8[disease or disorder in human beings or animals, and
manufactured] exclusively in accordance with the formulae described in, the authoritative books of 9[Ayurvedic,
Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]
9[(aa) “the Board” means—
(i) in relation to 9[Ayurvedic, Sidd ha or Unani] dr ug, th e 9[Ayurvedic, Siddh a an d Un ani 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;]
_________________________________________________________________________________________________
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.
2. Ins. by Act 21 of 1962, s. 2 (w.e.f. 27-7-1964).
3. Subs. by the A.O. 1950, for certain words.
4. The words “except the State of Jammu and Kashmir” omitted by Act 19 of 1972, s .2. (w.e.f. 31-5-1972).
5 1st April, 1947; see Notifn. 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 St ates of Delhi, Ajmer and Coor g on the 1 st April, 1947, see ibid., Chapters III and IV ca me 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 ca me into force in the Union ter ritory of Dadr a 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; t o Goa, Da man and Diu by Reg. 11 of 1963, s. 3 a nd Sch. and to Laccadive , Minicoy and
Amindivi Islands by Reg. 8 of 1965. s.3 and Sch.
6. Added by Act 19 of 1972, s. 2.
7 Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
8. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
9. Cl. (a) was relettered as cl. (aa) by Act 13 of 1964 s. 2, (w.e.f. 15-9-1964).
Drugs and Cosmetics Act, 1940 2
1 [2 [(aaa)] “cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into,
or ot herwise appl ied t o, t he hum an bo dy o r any part t hereof fo r cl eansing, beautifying, p romoting attractiveness, or
altering the appearance, and includes any article intended for use as a component of cosmetic 3* * * ;]
4[(b) “drug” includes—
5[(i) all medicines for internal or ext ernal use of h uman beings or animals and al l substances intended to be
used for or in the diagnosis, treatment, mitigation or prevention of any disease o r 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 the 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;]
7[(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;]
8[(c) “Government Analyst” means—
(i) in relation to 9[Ayurvedic, Si ddha or Unani] drug, a Government Analyst ap pointed by the 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;]
10* * * * *
11[(e) “Inspector” means—
(i) in relation to 9[Ayurvedic, Siddha 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;]
12[13[(f)] “manufacture” in re lation t o a ny drug 14[or c osmetic] i ncludes any p rocess or part of a p rocess for
making, altering, ornamenting, finishing, packing, labelling, breaking up or o therwise treating or ado pting
any drug 14[or cosmetic] with a view to its 15[sale or distribution] but does not include the compounding or
dispensing 16[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;]
17[(g)] “to import”, with its grammatical variations and cognate expressions means to bring into 18[India];
___________________________________________________________________________________________________________________________________________
1. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).
2. Cl. (aa) relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
3. omitted by Act 68 of 1982, s.3, certain words.
4. Subs. by Act 11 of 1955, s. 2, for cl. (b).
5. Subs. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983).
6. Subs. by Act 13 of 1964, s. 2, for “vermins” (w.e.f. 15-9-1964).
7. Ins. by Act 68 of 1982, s.3 (w.e.f. 1-2-1983).
8. Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f.15-9-1964).
9. Subs. by Act 68 of 1982 s.2, for “Ayurvedic (including sidda) or Unani” (w.e.f. 1-2-1983).
10. Cl. (d) omitted by Act 19 of 1972, s. 3.
11. Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).
12. Ins. by Act 11 of 1955, s. 2.
13. Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).
14. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).
15. Subs. by Act 68 of 1982, s.3, for “sale and distribution”(w.e.f. 1-2-1983).
16. Subs. by Act 21 of 1962 s. 4, for “or the packing of any drug”.
17. 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).
18. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
Drugs and Cosmetics Act, 1940 3
1[2[(h)] “patent or proprietary medicine” means,—
(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all form ulations 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 m edicine, a d rug which is a re medy or prescription presented in a
form ready for in ternal or external administration of human beings or animals and which is not included in the
edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by
the Central Government after co nsultation with the Drugs Technical Advisory Board constituted under sectio n
5;]
3[2[(i)] “prescribed” means prescribed by rules made under this Act.]
4* * * * *
5[3A. Construction of references to any law not i n force or an y functionary not in existence i n the St ate of
Jammu and Kashmir.—An y 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 6[or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter
IV 6[or Chapter IVA], as the case may be.
C HAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABOURATORY AND
THE DRUGS CONSULTATIVE COMMITTEE
5. The Dr ugs Technical Advisory B oard.— (1) The Cen tral Go vernment sh all, as so on as m ay be, co nstitute 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.
7[(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;
_________________________________________________________________________________________________
1. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983).
2. 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).
3. Subs. by Act 11 of 1955, s. 2, for cl. (e).
4. Cl. (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, s. 3 and Sch.
5. Ins. by Act 19 of 1972, s. 4 (w.e.f. 31-5-1972).
6. Ins. by Act 13 of 1964, s. 3 (w.e.f. 15-9-1964).
7. Subs. by s. 4, ibid., for sub-section (2) (w.e.f. 15-9-1964).
Drugs and Cosmetics Act, 1940 4
(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 an Indian university or a
college affiliated thereto;
(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) Th e B oard m ay co nstitute sub -committees and m ay ap point t o su ch su b-committees fo r su ch 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:
Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of
any drug or class of drugs 2[or cosmetic or class o f cosmetics] shall be carried out at th e Central Research Institute,
Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in
respect of suc h drug or class of drugs 2[or such cosmetic or class of cosmetics] shall be exercise d by the Direct or 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;
3* * * * *
(d) the procedure for the submission to the said Laboratory 4[under Chapter IV or Chapter IVA] of samples of
drugs 2[or cosmetics] for analysis or test, the forms of Laboratory’s reports thereon and the fees payable in respect
of such reports;
_________________________________________________________________________________________________________________________
1. Subs. by Act 13 of 1964, s. 4, for the proviso (w.e.f. 15-9-1964).
2. Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964).
3. Cls. (b) and (c) omitted by Act 11 of 1955, s. 4.
4. Subs. by Act 13 of 1964, s. 5, for “under Chapter IV” (w.e.f. 15-9-1964).
Drugs and Cosmetics Act, 1940 5
(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry ou t its
functions;
(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (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 Cen tral Government, the State Governments and the Drugs
Technical Advisory Board on any other matter tending to secure uniformity throughout 1[India] in the administration of
this Act.
(2) Th e D rugs Consultative Co mmittee s hall co nsist o f two repres entatives o f th e Cen tral Go vernment to be
nominated by t hat G overnment and o ne re presentative o f eac h St ate Go vernment t o be n ominated by t he 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.
2[7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.— Nothing contained in sections 5 and 7
shall apply to 3[Ayurvedic, Siddha or Unani] drugs.]
CHAPTER III
4[IMPORT OF DRUGS AND COSMETICS]
8. Standards of quality.— 5[(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 6[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 t han three months’ notice of its inten tion so to do , may by a li ke notification add to or otherwise amend 6[the
Second Sc hedule], fo r t he p urposes of th is Ch apter, and th ereupon 6[the Seco nd Sc hedule] shal l be deem ed t o be
amended accordingly.
7[9. Misbranded drugs.—For th e purposes of this Chapter a drug shall be deemed to be misbranded—
(a) if it is so coloure d, coated, powdered or polishe d that damage is conceal ed 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 anyt hing accompanying the drug bea rs any statement, design or device which
makes any false claim for the drug or which is false or misleading in any particular.]
8[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 i t has be en prepared, p acked o r st ored under i nsanitary co nditions w hereby it may have been
contaminated with filth or whereby it may have been rendered injurious to health; or
_________________________________________________________________________________________________________________________
1. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
2. Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964).
3. Subs. by Act 68 of 1982, s. 2 for certain words (w.e.f. 1-2-1983).
4. Subs. by s. 4, ibid, for “IMPORT OF DRUGS” (w.e.f. 1-2-1983).
5. Subs. by Act 21 of 1962, s. 6, for sub-section (1) (w.e.f. 27-7-1964).
6. Subs. by Act 13 of 1964, s. 7, for “the Schedule” (w..e.f. 15-9-1964).
7. Subs. by Act 68 of 1982, s. 5, for s. 9 (w.e.f. 1-2-1983).
8. Subs. by s. 6, ibid. (w.e.f. 1-2-1983).
Drugs and Cosmetics Act, 1940 6
(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.
9B. Spurious drugs.— Fo r 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 imit ation of, or a su bstitute for, another drug or resembles another drug in a manner likely to
deceive or be ars upon it or upon its label or contai ner the nam e of a nother 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.—Fo r 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) i f t he l abel or co ntainer or a nything ac companying the cosm etic bears any stat ement wh ich is false o r
misleading in any particular.
9D. Spurious cosmetics.—Fo r 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 su bstitute for, another cosmetic or resembles another cosmetic in a manner
likely to deceive or bears upon it or upon its label or cont ainer 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. Pr ohibition of im port of certain drugs or c osmetics.— From su ch date1 as m ay be fixed by t he C entral
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;
3[(b) any misbranded drug 4[or misbranded or spurious cosmetic;]
_________________________________________________________________________________________________
1. 1st April, 1947 for cls. (a), (b), (c), (e) and (f) and 1st April 1949 for cl. (d) see Notifn. No.18- 12/46-D (I), dated the 11th February 1947, Gazette of
India, 1947, Pt. 1, P. 189 as amended by Notifn. No.F.1-2/48-D (1), dated the 29th September,1948.
1st April, 1953 for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal,Tripura, Vindhya Pradesh and M anipur; vide Notifn. 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).
3. Subs. by s. 8, ibid., for cl. (b) (w.e.f. 27-7-1964).
4. Subs. by Act 68 of 1982, s.7, for “or misbranded cosmetic” (w.e.f. 1-2-1983).
Drugs and Cosmetics Act, 1940 7
1[(bb) any 2[adulterated or spurious] drug;]
(c) an y d rug 3[or co smetic] for th e im port o f wh ich a licen ce is p rescribed, o therwise th an under, an d in
accordance with, such licence;
4[(d) any pat ent or p roprietary medicine, unl ess t here i s di splayed i n t he pre scribed manner o n t he l abel or
container thereof 5[the true formula or list of active ingredients contained in it, together with the quantities thereof;]
(e) any d rug which by m eans o f any st atement, desi gn or device acc ompanying i t or by any ot her m eans,
purports or claim s to cure or mitigate any suc h disease or ailm ent, or to have any s uch ot her e ffect, as m ay be
prescribed;
3[(ee) any co smetic cont aining a ny i ngredient w hich may render i t unsa fe o r ha rmful for use un der t he
directions indicated or recommended;]
(f) any drug 3[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.
6* * * * *
7[10A. Power of Central Government to prohibit import of dru gs and cosmetics in public interest .—Witho ut
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 su ch quantity for which there is n o therapeutic justification and that in the
public interest it is necessa ry or expedient so to do t hen, that Government may, by notifi cation in the Official Gazet te,
prohibit the import of such drug or cosmetic.]
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 cu stoms and to good s, the import of which is prohibited by section 18 of the Sea C ustoms Act,
18788 (8 of 1878) shall, subject to the provisions of section 13 of this Act, apply in respect of drugs 9[and cosmetics] the
import o f which i s prohibited u nder t his Chapter, a nd o fficers o f C ustoms and of ficers em powered under t hat Act t o
perform the duties imposed thereby on a 10[Commissioners of Customs] and other officers of Customs, shall have the
same powe rs i n res pect of s uch drugs 9[and co smetics] a s th ey h ave for th e ti me being i n respect of s uch goods as
aforesaid.
11[(2) Without prejudice to the provisions of sub -sections (1), the 10[Commissioners of C ustoms] any officer of the
Government authorized by the Central Government in this behalf, may detain any imported package which he suspects to
contain a ny d rug 9[or cosm etic] t he im port of which i s pr ohibited u nder th is Ch apter and sh all forthwith rep ort such
detention to the Drugs Controller, India, and, if necessary, forward the package or sample of any suspected drug 9[or
cosmetic] found therein to the Central Drugs Laboratory.]
12. Power of Central Government to make rules.—( 1) The Central Government may, 12[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:
_________________________________________________________________________________________________
1. Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, s.7, for “adulterated” (w.e.f. 1-2-1983).
3. Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964).
4. Subs. by Act 11 of 1955, s. 5, for cl. (d).
5. Subs. by Act 68 of 1982, s.7, for certain words (w.e.f. 1-2-1983).
6. Explanation omitted by s.7, ibid. (w.e.f. 1-2-1983).
7. Ins. by s. 8, ibid. (w.e.f. 1-2-1983).
8. Now see the Customs Act, 1962.
9. Ins. by Act 21of 1962, s. 9 (w.e.f. 27-7-1964).
10. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”.
11. Subs. by Act 11 of 1955, s. 6, for sub-section (2).
12. Subs. by Act 68 of 1982, s.9, for certain words (w.e.f. 1-2-1983).
Drugs and Cosmetics Act, 1940 8
1[Provided t hat cons ultation with t he B oard m ay be di spensed wi th i f t he C entral Government i s of opi nion t hat
circumstances h ave arisen wh ich ren der it n ecessary to mak e ru les wi thout su ch co nsultation, but in su ch a case th e
Board s hall be con sulted within si x m onths of t he m aking of t he rules an d t he C entral Go vernment shal l t ake i nto
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 2[or cosmetics or classes o f cosmetics] for the import of which a
licence is re quired, 3[and prescribe the form and conditions of s uch licences, t he authority empowered to iss ue 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 2[or cosmetic] is
of standard quality;
(c) prescribe, in respect of biological and org anometallic co mpounds, t he units o r m ethods o f
standardization;
4[(cc) prescribe under clause (d) of 5[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 6[to prevent, cure or
mitigate] and such other effects which such drug may not purport or claim to have;
(e) prescribe th e conditions subj ect to wh ich small q uantities of drugs, the im port 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 2[or c osmetics] may be i mported, and p rohibit t heir i mport at any
other place;
(g) require the date of m anufacture and the date of ex piry of potency to be clearly and t ruly stated on t he
label or container of any specified imported drug or class of such drug, and prohibit the import of the said drug or
class of drug after the expiry of a specified period from the date of manufacture;
(h) regulate t he s ubmission by im porters, and t he secu ring, o f sam ples of drugs 2[or c osmetics] fo r
examination, t est or anal ysis by t he C entral Dr ugs La boratory, a nd pre scribe the fee s, if a ny, payable for s uch
examination, test or analysis;
(i) prescribe the evidence to be supplied, whether by accompanying documents or ot herwise, of the quality
of d rugs 2[or cosm etics] soug ht t o be i mported, t he pr ocedure of officers of C ustoms i n deal ing wi th such
evidence, and the manner of storage at places of import of drugs 2[or cosmetics] detained pending admission;
(j) provide for the ex emption, conditionally or otherwise, from all or any of th e provisions of this Chapter
and the ru les made th ereunder of dr ugs 2[or c osmetics] imported for t he p urpose only of t ransport t hrough, an
export from, 7[India];
(k) prescribe the conditions to be observed in the pac king in bottles, packages or other containers, of imported drugs 2[or
cosmetics] 8[including the use of packing material which comes into direct contact with the drugs];
(l) regulate th e mo de of lab eling dru gs 2[or co smetics] i mported fo r sale in p ackages, an d 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 ad ded to or contained in
any imported drug, prohibit the import 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;
_________________________________________________________________________________________________________________________
1. Ins. by Act 11 of 1955, s. 7.
2. Ins. by Act 21of 1962, s. 10 (w.e.f. 27-7-1964).
3. Subs. by Act 68 of 1982, s. 9, for certain words (w.e.f. 1-2-1983).
4. Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964).
5. Subs. by Act 68 of 1982, s. 9, for “section 9B” (w.e.f. 1-2-1983).
6. Subs. by Act 11 of 1955, s. 7, for “to cure or mitigate”.
7. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
8. Ins. by Act 68 of 1982, s. 9 (w.e.f. 1-2-1983).
Drugs and Cosmetics Act, 1940 9
(n) require that the 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 1[or cosmetic or class of cosmetics].
2[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 may extend
to five thousand rupees;
(b) any drug or c osmetic other t han a d rug o r c osmetic refe rred to i n clause (a), th e i mport 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 may extend to five hundred rupees, or with both;
(c) any drug or cosmetic in contravention of the provisions 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 may ex tend to
five thousand rupees, or with 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 whic h may extend to five years, or with fine wh ich 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 im prisonment fo r a term wh ich m ay extend to one year, or w ith fine wh ich m ay ex tend t o one th ousand
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 provisions of section 11.]
14. C onfiscation.— Where a ny o ffence p unishable u nder sect ion 13 has bee n com mitted, t he c onsignment of t he
drugs 3[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.
15. Jurisdiction.— No Court in ferior to that 4[of a Metrop olitan Magistrate or of a Judicial Magistrate of the first
class] shall try an offence punishable under section 13.
CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF 5[DRUGS AND COSMETICS]
16. Standards of quality.— 6[(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 7[the Second Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]
(2) The 8[Central Go vernment], after co nsultation with th e Bo ard and after g iving 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
7[the Second Schedule] for the purposes of this Chapter, and thereupon 7[the Second Schedule] shall be deemed to be
amended accordingly.
________________________________________________________________________________________________________________________
1. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964).
2. Subs. by Act 68 of 1982, s.10, for s.13 (w.e.f. 1-2-1983).
3. Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964).
4. Subs. by Act 68 of 1982, s. 11, for certain words (w.e.f. 1-2-1983).
5. Subs. by s. 12, ibid ., for “DRUGS” (w.e.f. 1-2-1983).
6. Subs. by Act 21 of 1962, s. 12, for sub-section (1) (w.e.f. 27-7-1964).
7. Subs. by Act 13 of 1964, s. 11, for “the Schedule” (w.e.f 15-9-1964).
8. Subs. by Act 11 of 1955, s. 8, for “State Government”.
Drugs and Cosmetics Act, 1940 10
1[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
betapeutic 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.
17A. 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 the 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.
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 imitation of, or is a su bstitute for, another drug or resembles another drug in a manner likely to
deceive or be ars upon it or upon its label or containe r the nam e of anot her drug unleExcerpt shown. Open the full act in Lexace.