The rules and regulations pertaining to drug license is governed by the Food Safety and Drug Administration Department of the concerned State Government.
Access to drugs and medicines are essential for ensuring good health of a Nation. However, the access to drugs and medicines must be restricted to ensure that such goods are not misused or abused by individuals. Hence, the government has laid down stringent law and regulations for manufacturing and distribution of drugs and medicines in India.
Regulation governing manufacture and sale of drugs are given in Drugs and Cosmetics Act, 1940 and rules framed thereunder. Control is exercised over drugs from the raw material stage during manufacture, sale, distribution and upto the time it is passed on to a patient or consumer by a Pharmacist in retail pharmacy, hospital or a dispensary.
In 1964, Ayurvedic and Unani drugs were also included under the Drugs and Cosmetics Act, 1940. However, a particular business entity may require different types of drug licence based on their business. In this article, we look at the procedure for obtaining drug license in India.