Drug Controller General of India_00.1
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Drug Controller General of India (DCGI)

Drug Controller General of India- Relevance for UPSC Exam

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

Drug Controller General of India_50.1

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Drug Controller General of India- Context

  • 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.

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Drug Controller General of India- Key Points

  • 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.

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Central Drugs Standard Control Organization (CDSCO)

  • 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.

 

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