Serial 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.] |