Medical devices policy approved, to help sector grow to $50 billion in 5 years

The policy also plans to create a single-window approval process for medical device manufacturers to ensure quick approvals and an accountable system.

“Medical device manufacturing is a sunrise sector, but we import around 75% medical devices at present. The Department of Biotechnology is already working on research in the field, the Health Ministry on regulations, the Pharmaceutical Department on developing medical technology parks, and the Skill Development Ministry on training needed,” Union Health Minister Mansukh Mandaviya, who announced the Cabinet decision, said. “The policy is meant to bring together all the efforts for systematic development and expansion of the sector.”

Mandaviya said setting up of four medical device parks was approved last year in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.

A production-linked incentive was also announced for 26 medical device, with 19 already starting manufacturing, he said.

The scheme has committed an investment of Rs 1,206 crore, of which investment of Rs 714 crore has already been achieved. It aims to increase domestic manufacturing of high-end medical devices such as MRI, CT scan, mammogram, C-Arm, and X ray tubes.

Under the new policy, a single-window clearance system will be created for licensing of medical devices for ease of doing business. It envisions an increased role of agencies such as BIS to create standards for products, processes, and performance, and ensure quality to make the indigenous industry globally competitive.

As for enhancing infrastructure, the policy not only envisions medical device parks but also clusters equipped with world-class common infrastructure for smaller manufacturers. It aims to promote research through establishment of centres of excellence in academic and research institutes, create innovation hubs, and develop “plug and play” infrastructure for start-ups.

The policy also talks about attracting investment in the sector through government schemes such as Make in India, Ayushman Bharat, Heal in India, as well as private investments from venture capitalists and the public-private partnership model. “We will urge the world to come to India with FDI,” Mandaviya said.

Another focus area of the policy will be to create human resources by skilling professionals, creating multi-disciplinary courses for medical devices, and developing partnerships with foreign academic or industry organisations.

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMeD), said: “The policy details will hopefully help traders and importers to start investing in putting up factories and end the 70-80% import dependency and the ever rising import bill — last year imports shot up by a steep 41% to over Rs 63,000 crore. Entrepreneurs had stepped up during the pandemic to [follow the initiative of] Make In India to address the lockdown crisis and the need for a policy to align various ministries and departments was acutely felt.”

“We hope the recommendations of AIMeD and [the] Parliamentary committee are reflected in this policy and see this neglected sector flourish finally,” he said.