Drug advisory board proposes stringent norms for medical devices

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  1. Drugs Technical Advisory Board (DTAB) has recommended that the Centre should include all medical devices in the country under the Drugs and Cosmetics Act,1940 in a phased manner.Currently,the government regulates 27 notified medical devices under the law.
  2. Recommendations of DTAB to the Government are binding in nature.The Health Ministry will now be required to issue either separate rules or an executive order based on these recommendations and the Central Drugs Standard Control Organisation (CDSCO) will implement the rules thereafter.
  3. When these rules are implemented,this will lead to medical devices being treated as drugs with (a)more stringent tracking systems (b)mandatory reporting of all adverse reactions and (c)registration of device before it is allowed into the market.
  4. However,this decision has not been appreciated by the Association of Indian Medical Device Industry(AIMED) which has sought for a separate medical devices-specific law.
  5. DTAB is highest statutory decision-making body on technical matters related to drugs in the country.It was constituted as per the Drugs and Cosmetics Act,1940.It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.
  6. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device.It functions under the Drugs and Cosmetics Act,1940.CDSCO comes under Directorate General of Health Services,Ministry of Health & Family Welfare.