Central Drugs Standard Control Organisation (CDSCO)

Subject – Governance

Context – Expert panel clears Covaxin for emergency use in 218 age group

Concept –

Covaxin is the country’s first indigenous, whole-virion, inactivated vaccine developed by Bharat Biotech in collaboration with the Indian Medical Research Council (ICMR) and the National Institute of Virology (NIV).

To know about CDSCO, please click here.

CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare.
- The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).

Drugs Controller General of India

Drugs Controller General of India (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 such as blood and blood products, IV fluids, vaccines, and sera in India.
Drugs Controller General of India, comes under the Ministry of Health & Family Welfare.
DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
Function
- DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.
- Preparation and maintenance of national reference standard.
- To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions
- Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation)
- With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules.
  - Out of four Classes of medical devices from Class A to Class D, DCGI will be the direct licensing authority for Class C and Class D devices, whereas it will coordinate licensing for Class A and B devices through State drug controllers, who will act as State Licensing Authority or SLA.