Central Drugs Standard Control Organisation

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the 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 implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).

Central Drugs Standard Control Organisation
Organisation overview
TypeRegulatory body
HeadquartersNew Delhi, India
Annual budgetUSD $ 256 million [1]
Minister responsible
Organisation executive
  • Dr. V. G. Somani, Drugs Controller General of India
Parent departmentDirectorate General of Health Services, Ministry of Health and Family Welfare
Websitecdsco.gov.in and www.cdscoonline.gov.in

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.

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[3]
  • New Drugs[4]
  • Medical Device & Diagnostics[5]
  • DCC-DTAB[6]
  • Import & Registration[7]
  • Biological[8]
  • Cosmetics[9]
  • Clinical Trials[10]

References
  1. "Centre allots Rs. 1750-cr to CDSCO to strengthen drug regulatory system across the country". Pharma Biz. Archived from the original on 1 October 2015. Retrieved 23 July 2014.
  2. Vardhan, Harsh. "Members : Lok Sabha". loksabhaph.nic.in. Lok Sabha Secretariat, Government of India.
  3. "BA/BE". cdsco.gov.in. Retrieved 2020-12-29.
  4. "New Drugs". cdsco.gov.in. Retrieved 2020-12-29.
  5. "Medical device & diagnostics". cdsco.gov.in. Retrieved 2020-12-29.
  6. "DTAB-DCC". cdsco.gov.in. Retrieved 2020-12-29.
  7. "Imports & Registration". cdsco.gov.in. Retrieved 2020-12-29.
  8. "biologicals". cdsco.gov.in. Retrieved 2020-12-29.
  9. "cosmetics". cdsco.gov.in. Retrieved 2020-12-29.
  10. "Committees". cdsco.gov.in. Retrieved 2020-12-29.
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