STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS
MANUFACTURED FOR SALE, SOLD, STOCKED OR EXHIBITED FOR SALE OR
DISTRIBUTED
Class of drug Standard to be complied with
1. Patent or proprietary medicines 1
[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
[2. Substances commonly known as
vaccine, seratoxines, toxoids, antitoxins and antigens and biological
products like nature, for human use or
for veterinary use.
The standards maintained at the International Laboratory for Biological Standards, Stantans Serum Institute, Copenhagen
and at the Central Veterinary Laboratory,
Way bridge 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.]
3
[* * * * *
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
[4A. 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.
5
[5. Other drugs :
(a) Drugs included in the Indian
Pharmacopoeia.
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.
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.
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.]
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.
1. Ins. by notification No. S.O. 887, dated 19th March, 1966, Gazette of India, Pt. II, s. 3 (ii), p. 819.
2. Subs. by notification No. G.S.R. 299 (E), dated 23-4-1984.
3. Omitted, ibid.
4. Subs. by notification No. S.O. 820, dated the 6th June, 1978, Gazette of India, 1978, Pt. II, s. 3 (ii), p. 1471.
5. Subs. by notification No. S.O. 885, dated 4th August, 1973, Gazette of India, 1973, Pt. II, s. 3 (ii), p. 1643.
42
Class of drug Standard to be complied with
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
immeiately 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 preceding the standards
of identity, purity and strength shall be those
occurring in such immediately preceding
edition of such official Pharmacopoeia and
such other standards as may be prescribed.]]