In force · As amended up to 2026-08
1. 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. Ins. by Act 21 of 1962, s. 3 (w.e.f. 27-7-1964).
5. The words "except the State of Jammu and Kashmir" omitted by Act 19 of 1972, s. 2.
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 the 11th February, 1947, Gazette of India, 1947, Pt. I, p 189 as amended by notification No. F-1-2/48-D(I), dated the 29th September, 1948, 1st April, 1953, for the State of H.P., 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.
(a) any drug[1] [or cosmetic] which is not of standard quality;
2[(b) any misbranded drug 3[or misbranded or spurious cosmetics];]
4[(bb) any 5[adulterated or spurious;] drug;]
(c) any drug[1] [or cosmetic] for the import of which a licence is prescribed, otherwise than under, in accordance with, such licence;
6[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof[7] [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;
1 [(ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;]
1. Patent or proprietary medicines[1] [other than Homoeopathic medicines].
The formula or list of ingredients displayed in the prescribed manner on the label or container and such other standards as may be prescribed.
- 2 [2. Substances commonly known as vaccine, seratoxines, toxoids, antitoxins and antigens and biological products like nature, for human use or for veterinary use.
The standards maintained at the International Laboratory for Biological Standards, Stantans Serum Institute, Copenhagen and at the Central Veterinary Laboratory, Way bridge Surrey, U. K., and such other laboratories recognised by the World Health Organisation from time to time, and such further standards of strength, quality, and purity, as may be prescribed.]
3[* * * * *
4. Substances (other than food) intended
Such standards as may be prescribed.
to affect the structure or any function
- of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.
Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
- 4[4A. Homoeopathic Medicines:
- (a) Drugs included in the Homoeopathic Pharmacopoeia of India.
(f) any drug[1] [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.
8* * * * *
9[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.]
CHAPTER I
INTRODUCTORY
1. Short title, extent and commencement. —(1) This Act may be called the Drugs[4] [and Cosmetics] Act, 1940.
(2) It extends to the whole of India[5] * * *.
(3) It shall come into force at once; but Chapter III shall take effect only from such date[6] 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 date[6] as the State Government may, by like notification, appoint in this behalf :
Central Government may, by notification in the Official Gazette, appoint in this behalf, and
7[Provided that in relation to the State of Jammu and Kashmir*, Chapter III shall take effect only from such date[[8]] 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.]
from such date[[8]] after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972
- (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.
Standards of identity, purity and strength prescribed for the drugs 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 or 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 and such other standards as may be prescribed.
- 5[5. Other drugs : (a) Drugs included in the Indian Pharmacopoeia.
1. Ins. by notification No. S.O. 887, dated 19th March, 1966, Gazette of India, Pt. II, s. 3 (ii), p. 819.
2. Subs. by notification No. G.S.R. 299 (E), dated 23-4-1984.
3. Omitted, ibid.
4. Subs. by notification No. S.O. 820, dated the 6th June, 1978, Gazette of India, 1978, Pt. II, s. 3 (ii), p. 1471.
5. Subs. by notification No. S.O. 885, dated 4th August, 1973, Gazette of India, 1973, Pt. II, s. 3 (ii), p. 1643.
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Standard to be complied with
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 immeiately 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.
- (b) Drugs not included in the Indian Pharmacopoeia but which are included in the official Pharmacopoeia of any other country.
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.
In case the standards of identity, purity and strength for drugs are not specified in the edition of such 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 such official Pharmacopoeia and such other standards as may be prescribed.]]
1. The Explanation omitted by Act 68 of 1982, s. 14 (w.e.f. 1-2-1983).
2. Ins. by Act 13 of 1964, s. 14 (w.e.f. 15-9-1964).
3. Ins. by Act 68 of 1982, s. 15 (w.e.f. 1-2-1983).
4. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
5. Subs. by Act 13 of 1964, s. 15, for certain words (w.e.f. 15-9-1964).
6. Subs. by Act 68 of 1982, s. 16, for "adulterated" (w.e.f. 1-2-1983).
7. Cl. (aa) ins. by Act 11 of 1955, s. 10, omitted by Act 13 of 1964, s. 15 (w.e.f. 15-9-1964).
8. Subs. by Act 13 of 1964, s. 15, for sub-section (3) (w.e.f. 15-9-1964).
Source: India Code