Drugs Controller General of India: Difference between revisions

Created by 2409:4072:910:EAC3:0:0:10A9:78B1
Last edited October 18, 2024
Zonal Offices Of CDSCO: Madras name is no more in use its changed to Chennai many years ago
 
enhanced structure after review and cleaned formatting for consistency
 
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{{Short description|Director of CDSCO}}
{{cleanup|reason=this article is confusing, unorganized, and poorly written.|date=November 2019}}
{{cleanup|reason=this article is confusing, unorganized, and poorly written.|date=November 2019}}


{{Infobox official post
{{Infobox official post
| post = Drugs Controller General of India
| post = Drugs Controller General of India
| incumbent = Dr. V. G. Somani
| incumbent = Dr. Rajeev Singh Raghuvanshi
| department = [[Ministry of Health and Family Welfare]]
| department = [[Ministry of Health and Family Welfare]]
| constituting_instrument = [[Drugs and Cosmetics Act, 1940]]
| constituting_instrument = [[Drugs and Cosmetics Act, 1940]]
| deputy = Deputy Drugs Controller General of India
| image =  
| image =  
| deputy = Drugs Controller General of India
}}
}}
{{Use dmy dates|date=July 2019}}
{{Use dmy dates|date=July 2019}}
'''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 [[License|licences]] of specified categories of [[drugs]] such as blood and blood products, [[IV fluids]], [[vaccine]]s, and sera in India. Drugs Controller General of India, comes under the [[Ministry of Health and Family Welfare|Ministry of Health & Family Welfare]].<ref>[http://cdsco.nic.in/forms/Default.aspx CENTRAL DRUGS STANDARD CONTROL ORGANIZATION] (accessed on 18 Oct 2014) [https://web.archive.org/web/20141023113749/http://cdsco.nic.in/forms/Default.aspx archived 2014.10.23]</ref> DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in 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 [[License|licences]] of specified categories of [[drugs]] such as blood and blood products, [[IV fluids]], [[vaccine]]s, and sera in India. Drugs Controller General of India, comes under the [[Ministry of Health and Family Welfare|Ministry of Health & Family Welfare]].<ref>[http://cdsco.nic.in/forms/Default.aspx CENTRAL DRUGS STANDARD CONTROL ORGANIZATION] (accessed on 18 Oct 2014) [https://web.archive.org/web/20141023113749/http://cdsco.nic.in/forms/Default.aspx archived 2014.10.23]</ref> DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
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== Governance ==
== Governance ==
The government 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.<ref>4 SEP 2012, ET BUREAU, Economic Times [http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/pharmaceutical-companies-told-to-submit-safety-reports-on-new-drugs-every-6-months/articleshow/16244666.cms Pharmaceutical companies told to submit safety reports on new drugs every 6 months] (accessed on 4 Sept 2012)</ref><ref>{{Cite web|url=https://www.moneycontrol.com/news/business/announcements/govt-appoints-vg-somani-as-new-drug-controller-general-4338301.html|title=Govt appoints VG Somani as new Drug Controller General|website=Moneycontrol}}</ref>
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.<ref>4 SEP 2012, ET BUREAU, Economic Times [http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/pharmaceutical-companies-told-to-submit-safety-reports-on-new-drugs-every-6-months/articleshow/16244666.cms Pharmaceutical companies told to submit safety reports on new drugs every 6 months] (accessed on 4 Sept 2012)</ref><ref>{{Cite web|url=https://www.moneycontrol.com/news/business/announcements/govt-appoints-vg-somani-as-new-drug-controller-general-4338301.html|title=Govt appoints VG Somani as new Drug Controller General|website=Moneycontrol|date=14 August 2019 }}</ref>


== Zonal Offices Of CDSCO ==
== Zonal Offices Of CDSCO ==

Latest revision as of 14:56, 18 October 2024


Drugs Controller General of India
Incumbent
Dr. Rajeev Singh Raghuvanshi
Ministry of Health and Family Welfare
Constituting instrumentDrugs and Cosmetics Act, 1940
DeputyDrugs 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.[1] DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

Function[edit | edit source]

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.[2]

Governance[edit | edit source]

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]

Zonal Offices Of CDSCO[edit | edit source]

The central government have established 6 zonal offices of CDSCO (Central Drugs Standard Control Organisation) at Mumbai, Kolkata, Chennai, and Ghaziabad, 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 uniform enforcement of the Drug Act.[6]

References[edit | edit source]

  1. CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (accessed on 18 Oct 2014) archived 2014.10.23
  2. "Medical Device Rules G.S.R. 78 (E)" (PDF).
  3. 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)
  4. "Govt appoints VG Somani as new Drug Controller General". Moneycontrol. 14 August 2019.
  5. "Introduction". cdsco.gov.in. Retrieved 25 December 2020.
  6. "Zonal Offices - CDSCO". www.cdsco.gov.in. MoHFW, Government of India.

External links[edit | edit source]