Call for a separate medical device patient safety law separate from drugs

AiMeD & BCIL Conference asks for ending the confusion by regulating all medical devices by an incredible regulatory framework

AIMED, BCIL, Biotech Consortium India Limited, BCIL, Department of Pharmaceuticals, New Delhi, Vinod Paul, Niti Aayog, VG Somani, Joint Drugs Controller, CDSCO, Coordinator, Gurmit Chugh, Rajiv Nath, CIF import

A first of its kind joint conference “Comprehensive Regulation of Medical Devices” was organised by Association of Indian Medical Device Industry (AiMeD) & Biotech Consortium India Limited (BCIL) supported by Department of Pharmaceuticals (DoP) in New Delhi.

Dr Vinod Paul, Member, NITI Aayog during his inaugural speech emphasised on the need for integrated efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry for the society. He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to safe, effective and quality medical device to the patients are kept in all Govt. policies.

Dr VG Somani, Joint Drugs Controller, CDSCO, said, “Regulations need to encourage – Make in India & Made in India.  To improve brand value, credibility and acceptance of Made in India medical devices, all medical devices need to be regulated at one go and not item by item.”

“The manufacturers have been confused with informally choosing of products and notifying them as drugs. They seek a predictable and comprehensive regulatory framework that allows for adequate transition and is predictable. Only then will investments speed up as they get discouraged to be regulated as Drugs,” said Gurmit Chugh, Jt. Coordinator, (AiMeD).

Voicing the concerns of Domestic Medical Devices Industry, Rajiv Nath, Forum Coordinator, AIMED, said,  “Medical devices are not drugs though both are medical products but differ in approach in marketing. We have been specifically seeking trade margin caps on devices notified as drugs but from first point of sale in supply chain, which as per us is when 1st sale takes place and GST is applied 1st time e.g. when goods enter country (on the CIF import landed price for imported and Ex-factory price for Indian). This will maintain parity between Indian & overseas manufacturers.”

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