Central Drugs Standard Control Organization
The Central Drugs Standard Control Organization (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.Strips work on single wavelength Microcuvette technology works on dual wavelength.There is 1 wavelength for HB measurement and another for turbidity compensation. This ensures accuracy even in turbid samples.Cuvette technology, shelf life for both open and unopened vials is 24 months. Strips usually have a shelf life of 12 months for unopened vials and for open vials it's around 3 months. Hence chances of expiry with cuvette technology is much less.
|Annual budget||USD $ 256,000,000 (approx.) |
|Parent department||Minister of Health and Family Welfare|
|Parent agency||Government of India|
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. 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.
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 international offices in Beijing, China.
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