New Medical Device rules to come up: Centre

New Delhi : The government has assured an "early action" to resolve issues related to regulatory and fiscal matters raised by the medical devices industry, India Inc said.

It has also assured that new Medical Device Rules would be notified at the earliest, Ficci said in a statement.

The issues were deliberated upon during a meeting convened by the Prime Minister's Office yesterday.

Office bearers of the top industry associations in medical devices industry such as CII, Association of Indian Medical Device Manufacturers, Ficci and Medical Technology Association of India gave a detailed presentation to the PMO.

The issues raised were related to ease of doing business, regulation, fiscal imperatives, manufacturing, promoting exports and encouraging innovations, to make India an attractive destination for investment in medical devices sector, CII said.

"A detailed discussion on streamlining regulatory issues was held on which the government assured an early action," it said.

It also said the government acknowledged the uniqueness of medical devices sector vis-a-vis pharmaceuticals.

"The participating associations were informed that the new Medical Device Rules would be notified at the earliest," it said, adding the Ministry of Health & Family Welfare also announced that the new Bill would be tabled in the winter session of Parliament.

"An attractive fiscal package coupled with the streamlining of regulation will help attract global investment and greenfield and brownfield expansion in India," Ficci Medical Device Forum Chairman Probir Das said.

The meeting was chaired by Principal Secretary to the Prime Minister and held in presence of senior officials from NITI Ayog, Ministry of Health and Family Welfare, Department of Pharmaceuticals and Department of Revenue.

Ficci said the medical devices sector has a tremendous potential for growth.

"Despite the immense opportunity, it remains shackled in an unpredictable regulatory environment, which is expected to change very soon, and is also impeded by concerns around pharma style price control and an abysmally low market penetration, which shall need a gradual increase in public spend and awareness campaigns," it added.

CII Medical Technology Division Chairman Himanshu Baid said that the investment in healthcare will boost the sector and an added focus on promoting exports will add value.

"The issue of incentives to attract overseas and domestic investors to build factories for not only import substitution but also targeting the global market was discussed in the meeting," AIMED Forum Coordinator Rajiv Nath said.