Schedule THE SECOND SCHEDULE.. THE SECOND SCHEDULE.

The Drugs and Cosmetics Act, 1940

Bare Act

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

Class of drug Standard to be complied with

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. Substances commonly known as

vaccine, seratoxines, toxoids, anti -

toxins and antigens and biological

products like nature, for human use or

for veterinary use.

The standards maintained at the Inter-

national Laboratory for Biological Stan-

dards, 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.]

[* * * * *

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.

(b) Drugs not included in the Homoeo-

pathic Pharmacopoeia of India but

which are included in the Homoeo-

pathic Pharmacopoeia of United

States of America or the United

Kingdom or the German

Homoeopathic Pharmacopoeia.

pathic Pharmacopoeia of India or the

United States of America, or the

United Kingdom or the German

Homoeopathic Pharmacopoeia.

[5. Other drugs :

(a) Drugs included in the Indian

Pharmacopoeia.

Standards of identity, purity and strength

specified in the edition of the Homoeo-

pathic 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 stan-

dards 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 Phar-

macopoeia 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.

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 Phar-

macopoeia 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.]]