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| Drugs Controller General of India | |
|---|---|
Incumbent Dr. Rajeev Singh Raghuvanshi | |
| Ministry of Health and Family Welfare | |
| Constituting instrument | Drugs and Cosmetics Act, 1940 |
| Deputy | Drugs Controller General of India |
Drugs Controller General of India (DCGI) is the head of department of theCentral Drugs Standard Control Organization of theGovernment of India responsible for approval oflicences of specified categories ofdrugs such as blood and blood products,IV fluids,vaccines, and sera in India. Drugs Controller General of India, comes under theMinistry of Health & Family Welfare.[1] DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.
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.[2]
The government on 1 February 2023 appointed Dr. Rajeev Singh Raghuvanshi as Drug Controller General of India. The government earlier on 14 August 2019 appointed Dr. VG Somani as Drug Controller General of India (DCGI). Dr. VG Somani succeeded S Eswara Reddy, the interim DCGI who was appointed in February 2018. DCGI heads the Indian drug regulatory body the Central Drugs Standard Control Organisation (CDSCO), whose functions include ensuring the quality of drugs and cosmetics sold in the country, approval of new drugs and regulating clinical trials.[3][4]
The central government have established 6 zonal offices of CDSCO (Central Drugs Standard Control Organisation) atMumbai,Kolkata,Chennai, andGhaziabad,Hyderabad,Ahmedabad,[5] various Sub-Zonal offices and Port offices, which works in close collaboration with the state control administration and assist them in securing uniformenforcement of the Drug Act.[6]