Indian government Approves National Medical Devices Policy, 2023 to Boost Healthcare Sector

Recently, The Union Cabinet, chaired by the Hon'ble Prime Minister Shri Narendra Modi, has approved the National Medical Devices Policy, 2023. The medical devices sector in India is an integral part of the Indian healthcare sector and has become even more important as India supported the domestic and global battle against the COVID-19 pandemic through large-scale production of medical devices and diagnostic kits. The market size of the medical devices sector in India is estimated to be $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.

The National Medical Devices Policy, 2023 aims to put in place a comprehensive set of focus areas for growth of the sector in a coordinated manner. The policy 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 is expected to help the Medical Devices Sector grow from present $11 Bn to $50 Bn by 2030.

The National Medical Devices Policy, 2023 envisions an accelerated growth path with a patient-centric approach and aims to emerge as the global leader in the manufacturing and innovation of medical devices by achieving a 10-12% share in the expanding global market over the next 25 years. The policy lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centered & Quality Care, Preventive & Primitive Health, Security, Research and Innovation and Skilled manpower.

The policy will facilitate and guide the medical devices sector through a set of strategies that will cover six broad areas of policy interventions. These strategies include regulatory streamlining, enabling infrastructure, facilitating R&D and innovation, attracting investments in the sector, human resources development, and trade promotion. The policy aims to enhance ease of doing research and business by creating a Single Window Clearance System for licensing of medical devices coopting all the stakeholder departments/organizations such as AERB, MeitY, DAHD, etc., enhancing the Role of Indian Standards like BIS and designing a coherent pricing regulation.

To establish and strengthen large medical device parks, clusters equipped with world-class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity as envisioned under the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti, would be pursued with the State Governments and Industry for better convergence and backward integration with the medical device industry.

To promote research & development in India, the policy envisages establishing Centers of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures, and support to start-ups. Along with existing schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership (PPP).

In conclusion, the National Medical Devices Policy, 2023 is expected to fulfill the potential of the sector, facilitate its orderly growth, and contribute to the goal of universal healthcare. Encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘make in India’ programs.