Change in definition of MedTech in FDI policy, AIMeD opposes 100% FDI via auto route

The Association of Indian Medical Device Industry (AIMED) has stated that while it always welcomed 100 percent greenfield investment in India for medical devices, it at the same time is opposed to 100 percent auto-route

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New Delhi: The Union Cabinet chaired by the Prime Minister Mr Narendra Modi, has given its approval to a number of amendments in the Foreign Direct Investment (FDI) Policy. As per the government of India, these are intended to liberalise and simplify the FDI policy so as to provide ease of doing business in the country, leading to larger FDI inflows contributing to the growth of investment, income and employment.

The FDI policy on pharmaceuticals sector inter-alia provides that definition of the ‘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.

“This is just housekeeping and tidying up,” mentioned Mr Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) in his reaction on the amendment of the definition of ‘medical devices’in FDI Policy. He added further: “Department of Pharmaceuticals (DoP) should learn from Department of Industrial Policy and Promotion (DIPP) and Ministry of Health and Family Welfare (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.”

On the percentage of FDI and its route of flow into medical device sector, Mr Nath said, “We have always welcomed 100 percent greenfield investment in India for medical devices but are opposed to 100 percent auto-route without the 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.”

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