223.184.198.51 at 12:58, 31 July 2021

2021-07-31T12:58:07Z

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{{Short description|Indian Apex Drug Regulatory Body}}
{{Infobox government agency
| agency_name = Central Drugs Standard Control Organisation
| type = Organisation
| nativename =
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| logo = File:Central Drugs Standard Control Organization.jpg
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| seal =
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| formed = 
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| jurisdiction =
| headquarters = [[New Delhi]], India
| region_code = 110004
| coordinates = {{coord|28.632309|77.235531|type:landmark_region:US|display=title}}
| motto =
| employees =
| budget = {{INRConvert|3358|c}} {{decrease}} (2021 - 2022) <ref>https://openbudgetsindia.org/dataset?tags=central+drugs+standard+control+organisation</ref>
| minister1_name = [[Narendra Modi|Narendra Modi (Prime Minister)]], Mansukh Mandavia
| minister1_pfo = [[Minister of Health and Family Welfare]]
| minister2_name =
| minister2_pfo = 
| deputyminister1_name =
| deputyminister1_pfo =
| deputyminister2_name =
| deputyminister2_pfo = 
| chief1_name = Dr. V. G. Somani
| chief1_position = Drugs Controller General of India
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| agency_type = Regulatory body
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| parent_department = Directorate General of Health Services, [[Ministry of Health and Family Welfare]]
| keydocument1 = 
| website = {{URL|https://cdsco.gov.in}} and
{{URL|www.cdscoonline.gov.in}}
| footnotes =
}}
The '''Central Drugs Standard Control Organisation''' ('''CDSCO''') is [[India]]'s national regulatory body for [[pharmaceuticals]] and [[medical device]]s. It serves a similar function to the [[European Medicines Agency]] of the [[European Union]], the [[Pharmaceuticals and Medical Devices Agency|PMDA]] of [[Japan]], the [[Food and Drug Administration]] (FDA) of the [[United States]], and the [[Medicines and Healthcare products Regulatory Agency]] of the [[United Kingdom]], and the [[National Medical Products Administration]] (NMPA) of China. The Indian government has announced its plan to bring all medical devices, including [[Implant (medicine)|implants]] and [[Birth control|contraceptives]] under a review of the Central Drugs and Standard Control Organisation (CDSCO).

Within the CDSCO, the [[Drug Controller General of India]] (DCGI) regulates pharmaceutical and medical devices and is positioning within the [[Ministry of Health and Family Welfare]]. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Divided into zonal offices, each one carries out pre-licensing and post-licensing inspections, [[Postmarketing surveillance|post-market surveillance]], and drug recalls (where necessary). Manufacturers who deal with the authority required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India.

Though the CDSCO has a good track record with the [[World Health Organization]], it has also been accused of past collusion with independent medical experts and pharmaceutical companies. CDSCO plans to open an international office in [[Beijing, China]].

== Divisions ==
Central Drugs Standard Control Organization has 8 divisions:

* BA/BE<ref>{{Cite web|title=BA/BE|url=https://cdsco.gov.in/opencms/opencms/en/bioequi_bioavail/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* New Drugs<ref>{{Cite web|title=New Drugs|url=https://cdsco.gov.in/opencms/opencms/en/Drugs/New-Drugs/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* Medical Device & Diagnostics<ref>{{Cite web|title=Medical device & diagnostics|url=https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* DCC-DTAB<ref>{{Cite web|title=DTAB-DCC|url=https://cdsco.gov.in/opencms/opencms/en/dcc-dtab-committee|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* Import & Registration<ref>{{Cite web|title=Imports & Registration|url=https://cdsco.gov.in/opencms/opencms/en/Departments/Headquarters/imports/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* Biological<ref>{{Cite web|title=biologicals|url=https://cdsco.gov.in/opencms/opencms/en/biologicals/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* Cosmetics<ref>{{Cite web|title=cosmetics|url=https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>
* Clinical Trials<ref>{{Cite web|title=Committees|url=https://cdsco.gov.in/opencms/opencms/en/Committees/|access-date=2020-12-29|website=cdsco.gov.in}}</ref>

==References==
{{Reflist}}

==External links==
*{{Official website|https://cdsco.gov.in}}
*[https://cdscoonline.gov.in/CDSCO/homepage SUGAM Online Licensing]

{{Authority control}}

[[Category:Medical and health organisations based in India]]
[[Category:Food safety organizations]]
[[Category:National agencies for drug regulation]]
[[Category:Regulators of biotechnology products]]
[[Category:Ministry of Health and Family Welfare]]
[[Category:Regulatory agencies of India]]

Central Drugs Standard Control Organisation - Revision history

223.184.198.51 at 12:58, 31 July 2021