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Forum Coordinator, AiMeD expresses concern over Centre’s proposal for regulation

In response to the news item that. “The Centre has proposed that the country’s apex drug regulatory body, Central Drugs Standard Control Organization, be empowered to regulate the manufacture of drugs or cosmetics, instead of the state drug regulators as is the practice currently, according to the revised draft of a bill that has been sent for inter-ministerial consultations. However sale, including that of medical devices will continue to be regulated by state governments,” Forum Coordinator, AiMeD, Rajiv Nath has expressed concern.

Nath commented on the news item published by Medical Buyer on Linkedin,  “Have medical devices been weaned away as had been sought by AiMeD and Parliament Committee to have a separate law for medical devices instead of copy pasting provisions of drugs and drug inspector onto medical devices? The text keeps referring to drugs and cosmetics mainly (?)

Having a sharing of responsibility and no overlap between centre and state is what’s been suggested by AiMeD for over a decade – Centre to regulate manufacturing and imports, and State to regulate trading, logistics and warehousing of resellers.

Centre need not hire an army of inspectors to inspect oversea and Indian manufacturing sites but delegate this and rely on 3rd certification bodies for QMS/GMP compliance through competent auditors is also another strategic issue recommended by AiMeD and now partially implemented on Class B and some Class A devices – but needs to be for all categories especially C & D High Risk devices.

Even US FDA and Japanese PMDA give a waiver on factory inspection by their inspectors if manufacturing site is MDSAP audited and certified by 3rd party accredited and notified certification bodies- India needs to follow these international best practices for ensuring patient safety and higher compliance.”
MB Bureau

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