Medical Devices Policy Gets Cabinet Approval, To Help Sector Grow To $50 Billion By 2030

Prime Minister Narendra Modi led Union Cabinet on Wednesday (26 April) approved the National Medical Devices Policy, 2023 to help the industry  grow from present $11 billion to $50 billion by 2030.

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.

The policy aims to increase India’s share in the global market from the current 1.5 per cent to 12 per cent over the next 25 years.

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

According to a government release, the policy envisions accelerated growth path for the medical devices sector with a patient-centric approach.

It also envisions making India as the global leader in the manufacturing and innovation of medical devices by "achieving 10-12 per cent share in the expanding global market over the next 25 years". 

"Policy is expected to help the Medical Devices Sector grow from present $11 billion to $50 billion by 2030," the release said.

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.

It also aims to promote research through centres of excellence in academic and research institutes, innovation hubs, and "plug and play" infrastructure for start-ups.

The policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership (PPP) in the sector.

It also envisages the creation of a dedicated Export Promotion Council for the sector under the Department which will be an enabler to deal with various market access issue.

"The Government of India has already initiated implementation of PLI Scheme for medical devices and support for setting up of four Medical devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh," it said.

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

Further, under the PLI scheme, total of 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc.

Remaining 12 products will be commissioned in near future, the release said.

According to the release, the medical devices sector is expected to realise its full potential, with the strategies such as building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programs and promoting higher education to foster talent and skilled resources in line with the industry requirements.

Encouraging domestic investments and production of medical devices complements the government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programmes, the release said.