Under the Drugs and Cosmetics Act 1940 and Rules 1945 the Ministry of health and Family Welfare passed a set of laws giving authority to the Drugs Controller General of India (DCGI) to regulate the quality of drug product and drug substance imported into India or manufactured in India . The DCGI is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs .
