New Medical Devices Policy: A Holistic Approach to Boosting India's Medical Device Industry

The Union Cabinet approved a new medical devices policy on Wednesday, aimed at promoting industry growth in India from the current $11 billion to $50 billion over the next five years. The policy is designed to create an enabling ecosystem for manufacturing and innovation, streamline regulations, and develop skills in line with industry requirements. Its primary goal is to increase India’s share in the global market from 1.5% to 12% over the next 25 years.

The policy aims to create a single-window approval process for medical device manufacturers, ensuring quick approvals and an accountable system. This is in line with the government's push to make India a hub for medical device manufacturing. The Department of Biotechnology is 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. The policy aims to bring together all the efforts for systematic development and expansion of the sector.

The Cabinet also approved the setting up of four medical device parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh, which were announced last year. The policy includes a production-linked incentive for 26 medical devices, with 19 already starting manufacturing. The scheme has committed an investment of Rs 1,206 crore, of which 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.

The policy also focuses on enhancing infrastructure, including medical device parks and clusters equipped with world-class common infrastructure for smaller manufacturers. It aims to promote research through the establishment of centers of excellence in academic and research institutes, create innovation hubs, and develop “plug and play” infrastructure for start-ups.

The policy 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. It hopes to urge the world to come to India with FDI.

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 organizations. 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 address the lockdown crisis and the need for a policy to align various ministries and departments was acutely felt.

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMeD), hopes the policy recommendations of AIMeD and the Parliamentary committee are reflected in the policy and see this neglected sector flourish finally. The new policy provides a much-needed impetus for India to develop its medical device industry and become self-reliant in the sector. With the government's push for the Make in India campaign, it is expected to boost local manufacturing and reduce import dependence.

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