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Drugs and Cosmetics Act, 1940

THE SECOND SCHEDULE

(See sections 8 and 16)

STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, SOLD, STOCKED OR EXHIBITED FOR SALE FOR DISTRIBUTED

S No.

Class of drug

Standard to be complied with
1 Patent or proprietary medicines [(Note: Ins. by Notification No. S.O. 887, dated 19th March, 1966, Gazette of India, Pt. II, Sec.3(ii), p.819) 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 Substances commonly known as vaccines, sera, toxine, toxoids, antitoxins, and antigens and biological products of such nature. The standards maintained at the International Laboratory for Biological Standards, Stantans Seruminstitut, Copenhagen, and such further standards of strength, quality and purity as may be prescribed.
3 Vitamins, hormones and analogous products. The standards maintained at the International Laboratory for Biological Standards, National Institute for Medical Research, London, and such further standards of strength, quality and purity as may be prescribed.
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 of vermin or insects which cause disease in human beings or animals. Such standards as may be prescribed.
4-A. (Note: Subs. by Notification No. S.O. 820, dated 6th June, 1978, Gazette of India, Pt. II, Sec. 3(ii), p.1471) Homoeopathic Medicines:

(a) Drugs included in the Homoeopathic Pharmacopoeia of India. 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.

(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. 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.

(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. The formula or list of ingredients displayed in the prescribed manner on the lable of the container and such other standards as may be prescribed by the Central Government].
5 [(Note: Subs. by Notification No. S.O. 885, dated 4th August, 1973, Gazette of India, Pt. II, Sec. 3(ii), p.1643.) Other drugs:

(a) Drugs included in the Indian Pharmacopoeia.

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.

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.


(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 strength shall be those occurring in such immediately preceding edition of such official Pharmacopoeia and such other standards as may be prescribed.]

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