Cabinet Approves National Medical Devices Policy

The Union Cabinet approved the National Medical Devices Policy, 2023, in its meeting on Wednesday.

The market size of the medical devices sector in India is estimated to be $11 billion, or approximately Rs 90,000 crore, as of 2020 and its share in the global medical device market is estimated to be 1.5%, according to a press release.

"(The) sector is on a growth track and has an enormous potential to become self-reliant and to contribute towards the goal of universal healthcare," it said.

The government has already initiated implementation of the production-linked incentive scheme for medical devices and support for setting up of four medical devices parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.

Under the PLI scheme for medical devices, 26 projects have been approved with a committed investment of Rs 1,206 crore and an investment of Rs 714 crore has been achieved so far.

Out of these:

• Fourteen projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started. It includes linear accelerator, MRI scan, CT-scan, mammogram, C-Arm, MRI coils, high end X-ray tubes.

• Remaining 12 products will be commissioned in the near future.

• Five projects out of total 26 projects have been approved recently under Category B for domestic manufacturing of 87 products or product components.

"Building upon these measures, a holistic policy framework to accelerate this growth and fulfil the potential of the sector is the need of the hour," it said.

The National Medical Devices Policy, 2023, is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation.

Encouraging domestic investments and production of medical devices complements the Union government's self-reliant India and 'Make in India' programmes.

The policy is expected to propel the sector to cater to healthcare needs of not only India, but also the world, it said.

Vision And Mission

• Emerge as global leader in the manufacturing and innovation of medical devices by achieving 10–12% share globally over the next 25 years.

• The policy is expected to help the sector grow from $11 billion at present to $50 billion by 2030.

• Lay a roadmap for accelerated growth of the medical devices sector to achieve access and universality, affordability, quality, patient-centred and quality care, preventive and promotive health, security, research and innovation, and skilled manpower.

Strategies To Promote Sector

• Single window clearance system for licensing of medical devices, enhancing the role of Indian standards like the Bureau of Indian Standards and designing coherent pricing regulation will be followed.

• Establishment of large medical device parks, clusters with world-class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity.

• Promote research and development innovation, establish centres of excellence and support startups.

• Attract private investments in the sector.

• Measures to have a steady supply of skilled workforce.

• Creation of a dedicated export promotion council for the sector under the department. It will be an enabler to deal with various market access issues.