The Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India is the National Regulatory Authority (NRA) of India.
Under the Drugs and Cosmetics Act, CDSCO has many responsibilities which includes approval of Drugs to direct Clinical Trials, Providing standards for Drugs, quality checking of imported Drugs in the country and coordinating with the State Drug Control Organizations for the activities by providing expert advice, training keeping in mind the uniformity in the implementation of the Drugs and Cosmetics Act.
Moreover, CDSCO along with State Drug Control Organizations is together responsible for permit of licenses of a certain specialized types of critical Drugs.