|
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.] |
