A joint conference was organised in New Delhi on Saturday by Association of Indian Medical Device Industry (AiMeD) and Biotech Consortium India Limited (BCIL) supported by Department of Pharmaceuticals (DoP) on comprehensive regulation of medical devices.

The discussion highlighted the current state of the beleaguered domestic industry of Indian medical devices. The private sector urged the government to expedite steps to end the 80-90 per cent import dependence forced on the industry, which results into an import bill of over Rs 38,837 Crore. "Expedite steps for patients' protection, stronger quality & safety regulations, price control, to make medical devices and quality treatment accessible and affordable and ethical indigenous manufacturing viable", said a statement.

Dr. Vinod Paul, Member, NITI Aayog, emphasized on the need for integrated efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry. He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to safe, effective and quality medical devices to the patients is incorporated in government policies.

Gurmit Chugh, Joint Coordinator (AiMeD) said that the manufacturers have been confused with informally choosing of products and notifying them as drugs. "They seek a comprehensive regulatory framework that allows for adequate transition and is predictable. Only then will investments speed up as they get discouraged to be regulated as Drugs," said Chugh. GST on medical devices is in favour of imports and is detrimental to Make in India, he added.

"MSME sector has been worst hit with huge job losses...MSME dominated medical domestic manufacturing which took a hit post GST as imports became 11 per cent cheaper. Imports of medical devices are up by record 24 per cent, from 31,386 crore in 2017-2018 to 38,837 crore in 2018-2019", said the private sector statement.

The private sector sought a pro-active policy formulation to regulate medical devices differently than drugs, as it will lead to free market dynamics and keep regulations simple, consumer friendly and incentivise 'Make in India'. "The Indian Medical Device Industry is very hopeful that right from trade margin rationalization to ensuring a separate set of legislation and regulatory framework to govern the medical device sector and everything in between will be looked afresh and hastened up by Modi Government to galvanise the domestic medical device manufacturing sector." said Rajiv Nath, Forum Coordinator, AiMeD.