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Drugs Controller General of India

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Drugs Controller General of India (DCGI) is a 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. Drug Controller General of India, comes under the Ministry of Health & Family Welfare.[1] DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

DCGI

The government on 14 August 2019 appointed VG Somani as Drug Controller General of India (DCGI). 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.[2][3]

Function

DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.

  • Acting as appellate authority in case of any dispute regarding the quality of drugs.
  • 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.[4]

Zonal Offices Of CDSCO (Central Drugs Standard Control Organisation)

The central government have established 4 zonal offices of CDSCO at Mumbai, Kolkata, Chennai, and Ghaziabad, various Sub-Zonal offices and Port offices, which works in close collaboration with the state control administration and assist them in securing uniform enforcement of the Drug Act.

References

  1. ^ CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (accessed on 18 Oct 2014) archived 2014.10.23
  2. ^ 4 SEP 2012, ET BUREAU, Economic Times Pharmaceutical companies told to submit safety reports on new drugs every 6 months (accessed on 4 Sept 2012)
  3. ^ "Govt appoints VG Somani as new Drug Controller General". Moneycontrol.
  4. ^ Medical devices Rules, 2017_gsr78E [full citation needed]


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