Central Drugs Standard Control Organisation

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.[The government has announced its plan to bring all medical devices, including implants and contraceptives, under the view of the Central Drugs and Standard Control Organisation (CDSCO) But Some instruments, Equipments with IVD will not cover in Medical Device rule Such as hemoglobinometer based micro cuvette technology which is reagent free because Micro cuvette is under the category of plastic disposable which is only used for sample collection and this category is not regulated under the provision of Class II of IVD Medical device rules.

Central Drugs Standard Control Organisation
Organisation overview
TypeRegulatory body
HeadquartersNew Delhi, India
Annual budgetUSD $ 256,000,000 (approx.) [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

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed.[3][4] Manufacturers who deal with the authority are required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India.[5]

Though the CDSCO has a good track record with the World Health Organization,[6] it has also been accused of past collusion with independent medical experts and pharmaceutical companies.[7] CDSCO plans to open international offices in Beijing, China.[8]

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. "India's Central Drugs Standard Control Organization (CDSCO)". Pacific Bridge Medical. Dec 29, 2012. Archived from the original on 2012-12-17. Retrieved Dec 29, 2012.
  4. "Central Drugs Standard Control Homepage". Ministry of Health and Family Welfare, Government of India. Dec 29, 2012. Archived from the original on January 28, 2013. Retrieved Dec 29, 2012.
  5. "Certification Process". India Certification – Your expert for India Certifications. Retrieved 2019-11-04.
  6. Kounteya Sinha, TNN (Dec 15, 2012). "Indian vaccine industry passes WHO quality test with flying colours". Times of India. Retrieved Dec 29, 2012.
  7. Ross Colvin and Kaustubh Kulkarni (May 10, 2012). "Collusion Discovered Between Central Drugs Standard Control Organization (CDSCO), Pharma Firms". International Business Times. Retrieved Dec 30, 2012.
  8. Kounteya Sinha, TNN (Dec 22, 2012). "India to open first drug inspection office in Beijing". Times of India. Retrieved Dec 29, 2012.
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