Product Standards and Labeling Requirements for Pharmaceuticals in India: An Overview

No drug can be imported, manufactured, stocked, sold or distributed in India unless it meets the quality and other standards laid down in the Drug and Cosmetics Act 1940 (DCA). For patent or proprietary medicines (medicines not listed in the Indian or other pharmacopoeia), the product should comply with the ingredients displayed in the prescribed manner on the label or container and such other standards as may be indicated. The Drugs and Cosmetics Rules (DCR) contains these standards.

There are general standards for all patent or proprietary medicines, tablets, capsules, liquid orals, injections and ointments. In patent medicines excluding antibiotics and enzymes, the content of active ingredients shall not be less than 90% and not more than 110% of the labeled contents. In the case of drugs included in the Indian pharmacopoeia (IP), the drug must comply with the standards of identity, purity and strength specified in the current edition of the IP (or if not specified in the current IP, then in the previous IP), as well as such other standards as may be perscribed. Similar standards apply to drugs not in the IP, but included in the official pharmacopoeia of another country. Standards are also prescribed for other types of drugs such as sera, antigens and other biological products.

The Central Government has the power to prohibit the import, manufacture or sale of any drug, including those that are deemed as “irrational drug combinations.” For instance, the import and manufacture of Fenfluramine and dexfenfluramine is prohibited. Other banned drugs include fixed dose combinations of vitamins with anti-inflammatory agents, tranquilizers or analgesics or tetracycline and vitamin C.

As per the Standards of Weights and Measures Act, 1976 (SWM) and the Packaged Commodities Rules, 1977 (PCR) made thereunder, an imported package (whether of drugs or any other item) has to bear the name and address of the importer (in addition to that of the manufacturer), and the retail price thereof. The SWM also prescribes the size and contents of the principal display panel to be on each container. Other labeling requirements include the date of manufacture, batch number, and the drug license number under which it is manufactured (if manufactured in India) or the import license number (if the product is imported). The label must be printed in indelible ink and must contain the trade name as well as the proper name of the medicine, the net contents in terms of weight, measure, volume, etc., in addition to the active ingredients.