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DRUGS AND COSMETICS ACT

Ministry of Law and Justice

Act nº 23 of 1940


  • Chapter I
  • Chapter II
  • Chapter III. Import of Drugs and Cosmetics
  • Chapter IV. Manufacture, Sale and Distribution of Drugs and Cosmetics
  • Chapter IVA. Provisions Relating to Ayurvedic, Siddha and Unani Drugs
  • Chapter V. Miscellaneous
  • Schedules
  • Amending Acts
  • Act nº 23 of 1940

Preamble

THE DRUGS AND COSMETICS ACT, 1940

[Act, No. 23 of 1940]1

[10th April, 1940]

PREAMBLE

An Act to regulate the import, manufacture, distribution and sale of drugs2[and cosmetics].

WHEREAS it is expedient to regulate the3[import, manufacture, distribution and sale] of drugs2[and cosmetics];

AND WHEREAS the Legislatures of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935 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;

It is hereby enacted as follows:--

1. For Statement of Objects and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for the Report of the Select Committee, see Gazette of India, 1940, Pt. V. 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 25th August, 1941.

2. Inserted by Act 21 of 1962, Section 2 (w.e.f. 27-7-1964).

3. Substituted by the A.O. 1950, for certain words.


Chapter I

Section 1. Short title, extent and commencement

(1) This Act may be called the Drugs1[and Cosmetics] Act, 1940.

(2) It extends to the whole of India2[* * *].

(3) It shall come into force at once; but Chapter III shall take effect only from such date3as 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 date6 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 date5after 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.]

1. Inserted by Act 21 of 1962, Section 3 (w.e.f. 27-7-1964).

2. The words "except the State of Jammu and Kashmir" omitted by Act 19 of 1972, Section 2 (w.e.f. 31-5-1972).

3. 1st April, 1947; see Notification No.F. 28(10) (3) 45H(I), dated 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 1st April, 1947, see Notification No. F. 28 (10)(3) 45H(I), Chapters III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on 1st April, 1953, vide Notification No. S.R.O. 663, dated 30th March, 1953, Gazette of India. Pt. II, Section 3, p. 451.

Chapter IV came into force in the Union Territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968, see Notification No. ADM/Law/117(74), dated 20th July, 1968, Gazette of India, Pt. III, Section 3, p. 128. The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, Section 2 and Schedule I; to Pondicherry by Reg. 7 of 1963, Section 3 and Schedule I; to Goa, Daman and Diu by Reg. 11 of 1963, Section 3 and Schedule and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965, Section 3 and Schedule

4. Added by Act 19 of 1972, Section 2 (w.e.f. 31-5-1972).

5. 24th August, 1974, vide Notification No. S.O. 2185, dated 9th August, 1974, published in the Gazette of India, 1974, Pt. II, Section 3(ii), p. 2331.


Section 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.

Section 3. Definitions

In this Act, unless there is anything repugnant in the subject or context,--

1 [(a) "2 [Ayurvedic, Siddha or Unani] drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 3 [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 4 [Ayurvedic, Siddha and Unani Tibb system of medicine], specified in the First Schedule;]

5 [(aa) "the Board" means--

(i) in relation to 2 [Ayurvedic, Siddha or Unani] drug, the 6 [Ayurvedic, Siddha and 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;]

5 [7 [(aaa)] "cosmetic" means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied 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 8 [* * *];]

9 [(b) "drug" includes--

10 [(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 the human body or intended to be used for the destruction of 11 [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;]

12 [(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;]

13 [(c) "Government Analyst" means--

(i) in relation to 2 [Ayurvedic, Siddha or Unani] drug, a Government Analyst appointed 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;]

14 [* * *]

15 [(e) "Inspector" means--

(i) in relation to 4[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;]

16 [(f) "manufacture" in relation to any drug 17 [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 13 [or cosmetic] with a view to its 18 [sale or distribution] but does not include the compounding or dispensing 19 [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;]

20 [(g)] "to import", with its grammatical variations and cognate expressions means to bring into 21 [India];

22 [(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 the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;]

23 [(i) "prescribed" means prescribed by rules made under this Act.]

24 [* * *]

1. Inserted by Act 13 of 1964, Section 2 (w.e.f. 15-9-1964).

2. Substituted by Act 68 of 1982, Section 2, for "Ayurvedic (including Siddha) or Unani" (w.e.f. 1-2-1983).

3. Substituted by Act 68 of 1982, Section 3, for "disease in human beings, mentioned in, and processed and manufactured" (w.e.f. 1-2-1983).

4. Substituted by Act 68 of 1982, Section 3, for "Ayurvedic (including Siddha) or Unani (Tibb) system of medicine" (w.e.f. 1-2-1983).

5. Original clause (a) relettered as clause (aa) and Substituted by Act 13 of 1964, Section 2 (w.e.f. 15-9-1964).

6. Substituted by Act 68 of 1982, Section 3, for "Ayurvedic and Unani Drugs Technical Advisory Board" (w.e.f. 1-2-1983).

7. Clause (aa) Inserted by Act 21 of 1962, Section 4 (w.e.f. 27-7-1964) and relettered as clause (aaa) by Act 13 of 1964, Section 2 (w.e.f. 15-9-1964).

8. The words "but does not include soap" omitted by Act 68 of 1982, Section 3 (w.e.f. 1-2-1983).

9. Substituted by Act 11 of 1955, Section 2, for clause (b) (w.e.f. 15-4-1955).

10. Substituted by Act 68 of 1982, Section 3, for sub-clause (i) (w.e.f. 1-2-1983).

11. Substituted by Act 13 of 1964, Section 2, for "vermins" (w.e.f. 15-9-1964).

12. Inserted by Act 68 of 1982, Section 3 (w.e.f. 1-2-1983).

13. Substituted by Act 13 of 1964, Section 2, for clause (c) (w.e.f. 15-9-1964).

14. Clause (d) omitted by Act 19 of 1972, Section 3 (w.e.f. 31-5-1972).

15. Substituted by Act 13 of 1964, Section 2 for clause (e) (w.e.f. 15-9-1964).

16. Clause (bbb) Inserted by Act 11 of 1955, Section 2 (w.e.f. 15-4-1955) and relettered as clause (f) by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961)

17. Inserted by Act 21 of 1962, Section 4 (w.e.f. 27-7-1964).

18. Substituted by Act 68 of 1982, Section 3, for "sale and distribution" (w.e.f. 1-2-1983)

19. Substituted by Act 21 of 1962, Section 4, for "or packing of any drug".

20. Clauses (c), (d) and (e) relettered as clauses (g), (h) and (i) respectively by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961).

21. Substituted by Act 3 of 1951, Section 3 and Schedule, for "the States".

22. Clause (d) relettered as clause (h) by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961) and Substituted by Act 68 of 1982, Section 3 (w.e.f. 1-2-1983).

23. Clause (e) Substituted by Act 11 of 1955, Section 2 (w.e.f. 15-4-1955) and relettered as clause (i) by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961).

24. Clause (f) Inserted by the A.O. 1950 and omitted by Act 3 of 1951, Section 3 and Schedule.


Section 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir

1[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.]

1. Inserted by Act 19 of 1972, Section 4 (w.e.f. 31-5-1972).


Section 4. Presumption as to poisonous substances

Any substance specified as poisonous by rule made under Chapter III or Chapter IV1[or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV1[or Chapter IVA], as the case may be.

1. Inserted by Act 13 of 1964, Section 3 (w.e.f. 15-9-1964).


Chapter II

Section 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.

1[(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 the Indian Veterinary Research Institute, Izatnagar, ex officio;

(vi) the President of the Medical Council of India, ex officio;

(vii) the President of the Pharmacy Council of India, ex officio;

(viii) the Director of the 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 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:

2[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.

1. Substituted by Act 13 of 1964, Section 4, for sub-section (2) (w.e.f. 15-9-1964).

2. Substituted by Act 13 of 1964, Section 4, for the Proviso (w.e.f. 15-9-1964).


Section 6. The Central Drugs Laboratory

(1) The Central Government shall, as soon as may be, establish 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 drugs1[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 drugs1[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 of the said Laboratory3[under Chapter IV or Chapter IVA] of samples of drugs1[or cosmetics] for analysis or test, the forms of the 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 purposes of the proviso to sub-section (1).

1. Inserted by Act 21 of 1962, Section 5 (w.e.f. 27-7-1964).

2. Clauses (b) and (c) omitted by Act 11 of 1955, Section 4 (w.e.f. 15-4-1955).

3. Substituted by Act 13 of 1964, Section 5, for "under Chapter IV" (w.e.f. 15-9-1964).


Section 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 matter tending to secure uniformity throughout1[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.

1. Inserted by Act 3 of 1951, Section 3 and Schedule, for "the States".


Section 7A. s 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs

1[7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs

Nothing contained in sections 5 and 7 shall apply to2[Ayurvedic, Siddha or Unani] drugs.]

1. Inserted by Act 13 of 1964, Section 6 (w.e.f. 15-9-1964).

2. Substituted by Act 68 of 1982, Section 2, for "Ayurvedic (including Sidha) or Unani" (w.e.f. 1-2-1983).


Chapter III
Import of Drugs and Cosmetics

1. Substituted by Act 68 of 1982, Section 4, for the heading under "IMPORT OF DRUGS" (w.e.f. 1-2-1983).


Section 8. Standards of quality

1[(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 in2[the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic complies 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 amend2[the Second Schedule], for the purposes of this Chapter, and thereupon2[the Second Schedule] shall be deemed to be amended accordingly.

1. Substituted by Act 21 of 1962, Section 6, for sub-section (1) (w.e.f. 27-7-1964).

2. Substituted by Act 13 of 1964, Section 7, for "the Schedule" (w.e.f. 15-9-1964).


Section 9. Misbranded drugs

1[9. 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 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. Substituted by Act 68 of 1982, Section 5, for section 9 (w.e.f. 1-2-1983).