Central Drugs Standard Control Organization (CDSCO), Director General of Health Services, Ministry of Health & Family Welfare, Govt. of India is the regulatory authority for approval of new drugs, clinical trials, laying down the standards for drugs and control over the quality of imported drugs. The CDSCO exercises its power/functions in terms of the provisions of the Drugs & Cosmetics Act, 1940 and Rules made thereunder. One of the main interventions of the central government to achieve its Public health objectives is to ensure that drugs available to the public are efficacious and conforms to prescribed quality of standards regulatory control over to the quality, safety and efficacy of drugs in the country is exercised through a central legislation called the Drugs and cosmetics Act, 1940 and the rules made there under.
In order to achieve public health objectives as laid down of Ministry of Health & Family Welfare i.e. drugs available to the public are safe, efficacious and conforms to prescribed quality standards, it is necessary to have a strong regulatory authority in order to build a robust regulation for its uniform, enforcement throughout the country. A strong legislation and its legal enforcement is the major backbone of a functional NRA. Accordingly to strengthen drug regulatory system, CDSCO has organized various types of training i.e. Induction training for new incumbents in CDSCO, Risk Based Inspection phase I, II, III & IV and Investigation and Prosecution for experienced CDSCO & States Officials.