India’s New Medical Devices Policy Aims to Boost Industry Growth and Innovation

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The new medical devices policy, which has been approved by the Union Cabinet of India, has set the objective of expanding the industry from its present size of $11 billion to $50 billion within the next five years. The policy’s primary goal is to promote an all-encompassing approach to the industry’s development by establishing a conducive environment for manufacturing and innovation, simplifying regulatory frameworks, and providing training in accordance with industry demands.

According to Union Health Minister Mansukh Mandaviya, medical device manufacturing is a sunrise sector, yet the country imports approximately 75% of medical devices at present. He said that 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.

The policy envisions increased domestic manufacturing of high-end medical devices such as MRI, CT scan, mammogram, C-Arm, and X-ray tubes. It commits an investment of Rs 1,206 crore, of which Rs 714 crore has already been achieved. The scheme aims to create a production-linked incentive for 26 medical devices, with 19 already starting manufacturing.

Under the new policy, a single-window clearance system will be created for licensing of medical devices, enabling ease of doing business. It envisions an increased role of agencies such as BIS to create standards for products, processes, and performance, ensuring quality and making the indigenous industry globally competitive. The policy also aims to promote research by establishing centers of excellence in academic and research institutes, creating innovation hubs, and developing “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. It aims to create human resources by skilling professionals, creating multi-disciplinary courses for medical devices, and developing partnerships with foreign academic or industry organizations.

The goal is to become a global leader in medical device manufacturing and innovation, with a patient-centric approach, and achieve a 10-12% share in the expanding global market over the next 25 years. The newly approved policy aims to promote the growth of the medical devices sector in India from $11 billion to $50 billion by 2030. The policy outlines a roadmap for achieving various missions, including ensuring access and universality, affordability, quality, patient-centered care, preventive and promotive health, security, research and innovation, and skilled manpower.

The National Medical Devices Policy, 2023, is poised to facilitate the rapid growth of India’s medical devices sector. It seeks to attain universal access to high-quality medical devices, foster innovation and research, and bolster the country’s medical device industry. By implementing this policy, India will be able to establish itself as a global frontrunner in the manufacturing and innovation of medical devices.


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