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 or distributed
1. Patent or proprietary medicines (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. Vaccines, sera, toxins, toxoids, antitoxins, antigens and biological products of a like nature, for human or veterinary use: The standards maintained at the International Laboratory for Biological Standards, Statens Serum Institute, Copenhagen, and at the Central Veterinary Laboratory, Weybridge, 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.
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.
4A. Homoeopathic Medicines: (a) Drugs included in the Homoeopathic Pharmacopoeia of India — standards of identity, purity and strength specified in the current edition of that Pharmacopoeia and such other standards as may be prescribed. (b) Drugs not included in the Homoeopathic Pharmacopoeia of India but included in the Homoeopathic Pharmacopoeia of the United States of America, the United Kingdom or the German Homoeopathic Pharmacopoeia — standards of identity, purity and strength prescribed in the edition of such Pharmacopoeia for the time being in force and such other standards as may be prescribed. (c) Drugs not included in any of the above Pharmacopoeias — 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.
5. Other drugs: (a) Drugs included in the Indian Pharmacopoeia — standards of identity, purity and strength specified in the current edition of the Indian Pharmacopoeia and such other standards as may be prescribed; where such standards are not specified in the current edition but are specified in the immediately preceding edition, the standards in that preceding edition shall apply, together with such other standards as may be prescribed. (b) Drugs not included in the Indian Pharmacopoeia but included in the official Pharmacopoeia of any other country — standards of identity, purity and strength specified in the current edition of that official Pharmacopoeia and such other standards as may be prescribed; where such standards are not specified in the current edition but are specified in the immediately preceding edition, the standards in that preceding edition shall apply, together with such other standards as may be prescribed.
Source: The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), Second Schedule.
