Second draft of medical device regulations disappointing: Industry

‘The proposed regulations will legalise pseudo manufacturing, drive jobs out of India’

Stating that they were ‘absolutely disappointed’ with the second draft of the medical devices regulations, notified by the Union Health Ministry on Wednesday, those in the industry maintain that it will be a fatal blow to the domestic medical device industry.

The new norms demand that medical device manufacturers follow different labelling requirements than globally accepted standards and have shorter expiry dates for products.

“We are utterly disappointed, shocked! Why are we working at cross purposes,” said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Manufacturers (AIMED), a lobby group of the domestic medical device industry.

“The latest draft regulations are an assault on ‘Make in India’ programme. The proposed regulations will legalise pseudo manufacturing, result in closure of domestic manufacturing and drive jobs out of India,” he added.

The latest regulations are being seen by the domestic industry as yet another blow to domestic manufacturing as well as to the ‘Make in India’ efforts in medical device sector.

“While globally accepted standards for medical devices is 10 year expiry date, these norms mandate a 5-year expiry. This will hurt the industry a lot,” said another source on condition of anonymity.

The proposed norms will be in public domain for the next month, giving the industry time to give feedback on the latest version of the notification.

Domestic medical device industry is now quite worried about the future viability of domestic manufacturing unless some of the self-inflicting clauses are not reversed or corrected.

‘On the downslide’

“Manufacturing in India is on the downslide and no bigger example is there than medical devices. Already simple devices earlier made in India, like thermometers and stethoscopes and hot water bottles, have got outsourced to China. The government is not only losing an opportunity to drive manufacturing back into India and attract investment but, by distorting the definition of ‘manufacturer’ to include someone who gets the medical device made by another company on his behalf, will now legalise pseudo manufacturing,” say Mr. Nath.