Second Schedule : DC Act 1940
The Drugs And Cosmetics Act 1940
1.[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 :
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Class of drug(1):
1.Patent or proprietary medicines 2.[other than Homoeopathic medicines]
Standard to be complied with(2):
The formula of list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed.
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Class of drug(1):
2. 3.[Substances commonly known as vaccines, seratoxins, toxoids, antitoxins and antigens and biological products of like nature, for human use or for veterinary use.
Standard to be complied with(2):
The standards maintained at the International Laboratory for Biological Standards, Stantans Serum Institute, Copenhagen and at the Central Veterinary Laboratory, Weybridge Surrey, U.K., and such other laboratories recognized by the World Health Organization from time to time, and such further standards of strength, quality and purity, as may be prescribed.]
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Class of drug(1):
4.[*]
Standard to be complied with(2):
4.[*]
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Class of drug(1):
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.
Standard to be complied with(2):
Such standards as may be prescribed.
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Class of drug(1):
5[2.[4-A. Homoeopathic Medicines.
(a) Drugs included in the Homoeopathic Pharmacopoeia of India
(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.
Standard to be complied with(2):
a) 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) 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) The formula or list of ingredients displayed in the prescribed manner on the label of the containder and such other standards as may be prescribed by the Central Government].]
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Class of drug(1):
6.[5. Other drugs:
(a) Drugs included in the Indian Pharmacopoeia
(b) Drugs not included in the Indian Pharmacopoeia but which are included in the official Pharmacopoeia of any other country.
Standard to be complied with(2):
a) in the edition of the Indian Pharmacopoeia 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 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) 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 of such official Pharmacopoeia and such other standards as may be prescribed.]]
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1. Subs. by Act 13 of 1964, S. 31, for the Schedule.
2. Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt. II, Sec. 3 (ii), p. 819.
3. Subs. by Notifn. No. G.S.R. 299(E), dated the 23rd April 1984.
4. Entry 3 omitted by Notifn. No. G.S.R. 299(E), dated the 23rd April, 1984.
5. Subs. by G.S.R. 820 (E), dt. 6-6-1978, for item 4A, earlier Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt.II, Sec. 3 (ii), p. 819.
6. Subs. by Notifn. No. G.S.R. 885, dated the 4 th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643, for itemĀ
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