The Central Drugs Standard Control Organization (CDSCO) under 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, Provide standards for Drugs, quality check of imported Drugs in the country and coordinate 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 certain specialized type of critical Drugs.
Role of Central Drugs Standard Control Organization
Under the Drug & Cosmetics Act, the arrangement of manufacture, sale & distribution of Drug is firstly the priority of State Authorities while Central Authorities are only responsible for the giving permission to new drugs, clinical experiment in the country, providing standards for drugs, to check quality of the imported drugs, coordinating with the State Authorities.
CDSCO is also a part of giving permission to specified categories of drugs such as blood and blood products, I. V. Fluids, Vaccine.