Govt plans to table Medical Device Act in Parliament during winter session

The government is reportedly planning to table the new Medical Device Act in the forthcoming winter session of the Parliament. In fact, the Prime Minister’s Office (PMO) on July 11, 2016 convened a meeting on promoting Make in India initiative in the medical devices sector.

In the meeting, which was attended by leading associations in medical device industry including FICCI, Association of Indian Medical Device Manufacturers, CII and Medical Technology Association of India, a series of issues such as ease of doing business, regulation, fiscal imperatives, scaling manufacturing, promoting exports, encouraging innovations and to make India an attractive destination for investment in medical device sector were discussed.

A detailed discussion on streamlining regulatory issues was held on which the government assured an early action. The uniqueness of medical devices, as different from pharmaceuticals was acknowledged and the participating associations were informed that the new Medical Device Rules would be notified at the earliest. The Ministry of Health & Family Welfare also announced that the new Medical Device Act would be tabled in the forthcoming winter session of the Parliament. No new medical devices would be notified till this new Act is passed.

According to Probir Das, chairman FICCI Medical Device Forum, an attractive fiscal package coupled with the streamlining of regulation will help attract global investment and greenfield & brownfield expansion in India.

“An added focus on promoting exports will add value. On the other hand, continued investment in healthcare will help expand the market of medical devices increasing India’s attractiveness as a manufacturing destination,” commented said Himanshu Baid, chairman - CII Medical Technology Division.

“Medical Devices sector has emerged as a focus sector in Make in India aspirations of the country. It has a tremendous potential to grow with a huge demographic dividend on demand side and India’s R&D innovation capabilities on the supply side. 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 will need a gradual increase in public spend and awareness campaigns,” said FICCI in a post-meeting press release.