Specific Requirements

Specific Requirements

Biological and other specific products of Schedules C and C (1) advertised and sold as proprietary medicine, proper name of the substance should appear on label of every ampoule or container. Proper name, Manufacturing Licence Number, Batch Number, statement of potency in units, expiry date, storage requirement, etc., should be mentioned.

For opthalmic solutions and suspensions, the additional requirement on lable is: "Use within one month if opening and not for injection."

The standard reference books are J.P, US.P, B.P, B.P.C, National Formulary of U.S., State Formulary of U.S.A, International Pharmacopoeia and Pharmacopoeia of Soviet Socialist Republic.

Mechanical Contraceptives

The label should contain -

1. Particulars specified in Schedule R,

2. Date of manufacturing,

3. Date upto which it retains its property,

4. Storage, in addition to other information.

Oral Contraceptives

In addition to general information, label should depict - date of manufacture and usage.

Drugs for export should be labelled as per rules prevailing in country of export or importing country. In Schedule E (1) drugs, label in red printing or printed against red background.