Reaction of AIMED on definition of medical devices amended in the FDI Policy

“This is just housekeeping and tidying up”, said Rajiv Nath, Forum Coordinator, AiMeD.

FDI policy on pharmaceuticals sector inter-alia provides that definition of medical device as contained in the FDI Policy would be subject to amendment in the Drugs and Cosmetics Act. As the definition of Medical Devices as contained in the FDI policy of Medical Devices is complete in itself, it has been decided to drop the reference to Drugs and Cosmetics Act from FDI policy. Further, it has also been decided to amend the definition of ‘medical devices’ as contained in the FDI Policy.

“DoP should learn from DiPP and MoH&FW and delink devices from pharmaceutical after treating devices as sub sector of pharmaceutical (drugs). Both are medical healthcare products but different and need different policies to boost investment in this sector. We have always welcomed 100 per cent greenfield investment in India for medical devices but are opposed to 100 per cent auto route without oversight of DoP for brownfield takeover of the few indigenous medical device manufacturers who have been providing an alternate affordable access to cost effective desi brands ” said Nath.