National Medical Devices Policy [UPSC Notes]

The cabinet has approved a new policy framework for the medical devices sector to promote growth and self-reliance, with the goal of reaching $50bn in market size by 2030. In this article, you can learn more about the new National Medical Devices Policy for the IAS exam.

National Medical Devices Policy, 2023

Vision and Mission: The policy aims to accelerate the growth of the medical device sector in India and make it self-reliant.

• The vision is to become a global leader in the manufacturing and innovation of medical devices and hence achieve a 10-12% share in the global market over the next 25 years.
• The mission of the policy is to provide access and universality, affordability, quality, patient-centred and quality care, preventive and promotive health, security, research and innovation, and skilled manpower.

Strategies to Promote the Medical Devices Sector: The policy outlines six broad areas of policy interventions to promote the medical device sector:

1. Regulatory streamlining
2. Enabling infrastructure
3. Facilitating R&D and innovation
4. Attracting investments
5. Skilling and trade promotion
6. Promotion of domestic manufacturing

Each of these areas is discussed below.

1. Regulatory Streamlining: The policy aims to improve the ease of doing business and research while balancing patient safety with product innovation. It proposes measures such as the creation of a single window clearance system for the licensing of medical devices, enhancing the role of Indian standards like BIS, and designing coherent pricing regulations.
2. Enabling Infrastructure: The policy envisages the establishment and strengthening of large medical device parks and clusters equipped with world-class common infrastructure facilities in proximity to economic zones. It will be pursued with state governments and industry for better convergence and backward integration with the medical device industry.
3. Facilitating R&D and Innovation: The policy aims to promote research and development in India and establish centres of excellence in academic and research institutions. It also proposes innovation hubs, plug-and-play infrastructures, and support for start-ups.
4. Attracting Investments in the Sector: The policy proposes measures to attract investments in the sector, including schemes like the PLI scheme for medical devices. The policy also aims to facilitate domestic manufacturing of medical devices to complement the government’s “Atmanirbhar Bharat” and “Make in India” programs.
5. Skilling and Trade Promotion: The policy proposes measures to provide support in training and capacity-building programs and promote higher education to foster talent and skilled resources in line with the industry requirements. This will help in developing a skilled workforce for the medical device sector.
6. Promotion of Domestic Manufacturing: The policy gives a push for domestic investments and production of medical devices to complement the government’s “Atmanirbhar Bharat” and “Make in India” programs. This will help in reducing the dependency on imports and promoting the domestic manufacturing of medical devices.

National Medical Devices Policy – Expected Outcomes

• Increased investment in R&D and innovation, leading to the development of new and improved medical devices.
• Streamlined regulatory processes, reducing barriers to entry and facilitating faster approvals for new medical devices.
• Boosted local manufacturing, creating jobs and reducing the country’s reliance on imports.
• Improved access to medical devices, particularly in rural and remote areas of the country.
• Increased exports of medical devices, generating revenue and boosting India’s reputation as a leading medical device manufacturer.
• The overall growth of the medical devices sector, with the aim of reaching a market size of $50bn by 2030.

National Medical Devices Policy:- Download PDF Here