Drug Controller General of India (DCGI)

Drugs Controller General of India

Drug Controller General of India- Relevance for UPSC Exam

GS Paper 2: Indian Constitution- Statutory, regulatory and various quasi-judicial bodies.

Recently, the Central government has constituted a committee for framing/preparing new drugs, cosmetics, and medical device laws.
The eight-member panel is headed by Drug Controller General of India (DCGI) V.G. Somani.

About DCGI: Drug Controller General of India is the head of the Central Drugs Standard Control Organization (CDSCO) in India.
DGCI is the central licensing authority for medical devices which fall under the Medical Device Rules 2017.
Parent Ministry: CDSCO headed by Drug Controller General of India, functions under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Key Functions of Drug Controller General of India: DCGI is responsible for-
- Establishing standards for the manufacturing, sales, import, and distribution of drugs in India.
- Regulating medical and pharmaceutical devices.
- Acting as an appellate authority in case of any dispute with respect to the quality of the drug.
- Preparing and maintaining the national reference standard for drugs.
- Ensuring uniformity in the implementation of the Drugs and Cosmetics Act.

About CDSCO: It is the central drug regulatory authority in India headed by Drug Controller General of India and functions under the Ministry of Health and Family Welfare.
- Headquarter: New Delhi. It also has six zonal offices.
Mandate of CDSCO: To bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy, and quality of the medical product manufactured, imported, and distributed in the country.
Key responsibilities of the 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 by providing expert advice with a view of brings about uniformity in the enforcement of the Drugs and Cosmetics Act.
- Registration of foreign manufacturers of drugs and medical devices whose products are to be imported into the country.
- Grant of licenses to import drugs by Government hospitals or Medical Institutions for the use of their patients.
- Recommend banning of drugs considered harmful or sub-therapeutic under section 26A drugs and Cosmetics Act.