Central Drugs Standard Control Organisation

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Central Drugs Standard Control Organisation
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Organisation overview
TypeRegulatory body
HeadquartersNew Delhi, India
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Annual budget₹3,358 crore (US$350 million) Decrease (2021 - 2022) [1]
Minister responsible
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Organisation executive
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  • Rajeev Singh Raghuvanshi, Drugs Controller General of India
Parent department
Directorate General of Health Services, Ministry of Health and Family Welfare
Websitecdsco.gov.in and www.cdscoonline.gov.in

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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union. The Indian government has announced its plan to bring all medical devices, including implants and 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, 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.

Divisions

Central Drugs Standard Control Organization has 8 divisions:

  • BA/BE[2]
  • New Drugs[3]
  • Medical Device & Diagnostics[4]
  • DCC-DTAB[5]
  • Import & Registration[6]
  • Biological[7]
  • Cosmetics[8]
  • Clinical Trials[9]

Criticism

The CDSCO has been criticized for having far lower standards for drug approval than the United States' Food and Drug Administration and European Union's European Medicines Agency. In a 2015 interview, the current Drugs Controller General, G. N. Singh, admitted that if the CDSCO held Indian pharmaceutical manufacturers to American standards, most would fail.[10][11]

See also

References

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  1. ^ Page Module:Citation/CS1/styles.css has no content."Datasets - Open Budgets India".
  2. ^ Page Module:Citation/CS1/styles.css has no content."BA/BE". cdsco.gov.in. Retrieved 2020-12-29.
  3. ^ Page Module:Citation/CS1/styles.css has no content."New Drugs". cdsco.gov.in. Retrieved 2020-12-29.
  4. ^ Page Module:Citation/CS1/styles.css has no content."Medical device & diagnostics". cdsco.gov.in. Retrieved 2020-12-29.
  5. ^ Page Module:Citation/CS1/styles.css has no content."DTAB-DCC". cdsco.gov.in. Retrieved 2020-12-29.
  6. ^ Page Module:Citation/CS1/styles.css has no content."Imports & Registration". cdsco.gov.in. Retrieved 2020-12-29.
  7. ^ Page Module:Citation/CS1/styles.css has no content."biologicals". cdsco.gov.in. Retrieved 2020-12-29.
  8. ^ Page Module:Citation/CS1/styles.css has no content."cosmetics". cdsco.gov.in. Retrieved 2020-12-29.
  9. ^ Page Module:Citation/CS1/styles.css has no content."Committees". cdsco.gov.in. Retrieved 2020-12-29.
  10. ^ Page Module:Citation/CS1/styles.css has no content.Eban, Katherine (2019). Bottle of Lies. HarperCollins. pp. 368–369. ISBN 9780062338785.
  11. ^ Page Module:Citation/CS1/styles.css has no content.Dey, Sushmi (30 January 2014). "If I Follow Us Standards, I Will Have to Shut Almost All Drug Facilities: G N Singh". Business Standard. Retrieved 3 July 2025.

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