CDSCO

CDSCO

Subject : National Legislations

Context: A subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) has given approval to Bharat Biotech to launch the first phase of clinical trial of an intranasal vaccine candidate for COVID-19.

Concept:

Central Drugs Standard Control Organisation (CDSCO):

• The Central Drugs Standard Control Organisation (CDSCO) – under Directorate General of Health Services, Ministry of Health & Family Welfare.
• It is the National Regulatory Authority (NRA) of India.
• CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
• It regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940.
• Headquarters – New Delhi.

Major functions of CDSCO:

• Under the Drugs and Cosmetics Act, CDSCO is responsible for
• approval of drugs,
• conduct of clinical trials,
• laying down the standards for drugs,
• control over the quality of imported drugs in the country and
• Coordination of the activities of State drug control organizations.