Medical device makers seek separate law to regulate industry

The Association of Indian Medical Device Industry (AiMeD) has asked the central government to streamline regulations governing medical device manufacturing by enacting a separate law. Currently, medical devices are regulated by the drug authorities as the rules concerning these products are covered under the Drugs and Cosmetics Act.

The association's comment came after the government notified the new National Medical Devices Policy on May 2. According to Rajiv Nath, forum coordinator, AiMeD, Drugs and Cosmetics Act has no compounding provisions for even minor oversights. The separate law should not treat medical device manufacturers as criminals, he said. Europe, Canada, Japan, Brazil, etc have all separate laws that govern the medical device industry, he added.

The AiMeD also called for tariff corrections to make investments in the medical device sector more attractive for both global and domestic companies. "Along with investment, there should be R&D innovation. And a separate law for medical devices. This will give developers and manufacturers the freedom to make innovative products," Nath said.

The organisation also wants the government to improve academic courses and upskill regulators and professionals in the field of medical devices. Operationalisation of the new Export Promotion Council was also sought.

In a virtual press conference, AiMeD thanked the central government for drafting the new policy. "It's excellent and a great Start. Many points are a broad stroke and not clearly spelled out but that's expected in a Policy to give much needed direction to over 20 stakeholder ministries and departments," Nath said.

"We hope for speedy implementation of the policy. We hope the government accepts the recommendations of the Parliament Committee to have a separate law, separate department, tariff correction and price control and other measures as it will give direct benefit to consumer and industry," Nath added.

Speaking on the occasion, GSK Velu, chairman and managing director of Trivitron, said the new policy is expected to provide the necessary impetus to reduce import dependency in the medical devices sector and make India a global medical device manufacturing destination. "If implemented along with preference for buying locally made products, I am sure the Indian medical devices sector will grow like the domestic pharmaceuticals industry in the next 10-15 years," Velu said.

Gaurav Aggarwal, managing director of Innvolution Imaging Technologies Pvt Ltd, said the policy will fuel medical device manufacturing in India and will help realise the goal of the Indian medical device industry reaching $50 billion by 2025.