National Medical Devices Policy 2023: Attracting Advanced MedTech Ecosystem

The policy aims to promote the sector's growth, increase access and affordability of medical technology, and establish India as a global leader.

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The Union Cabinet, chaired by Prime Minister Shri Narendra Modi, has given its nod to the National Medical Devices Policy, 2023 (NMDP), which aims to provide a comprehensive framework for the growth and development of the medical devices sector in India. The sector’s market size is estimated to be $11 billion (approximately 90,000 Cr) in 2020, with a share of 1.5% in the global medical device market. The policy focuses on creating an enabling ecosystem for manufacturing, promoting innovation, streamlining regulations, providing training and capacity-building programs, and fostering talent through higher education. It is expected to facilitate the growth of the medical devices sector in an orderly manner, ensuring access, affordability, quality, and innovation. Encouraging domestic investments and production of medical devices complements the government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs. Overall, the policy is a significant step towards realizing the full potential of the medical devices sector in India and contributing towards the goal of universal healthcare.

The Policy, approved by the Union Cabinet, aims to establish India as a global leader in the manufacturing and innovation of medical devices. It sets a vision to achieve a 10-12% share in the expanding global market over the next 25 years and to increase the sector’s contribution to $50 billion by 2030. To promote the medical device sector, the policy outlines six broad areas of policy interventions: regulatory streamlining, enabling infrastructure, facilitating R&D and innovation, attracting investments, human resources development, and brand positioning and awareness creation. The policy is expected to place the medical devices sector on an accelerated path of growth with a patient-centric approach to meet the evolving healthcare needs of patients. Initiatives like the National Industrial Corridor Program and the proposed National Logistics Policy 2021 will further support the growth of the medical device sector in India.

The National Medical Devices Policy, 2023, is a significant step towards providing an enabling policy and regulatory framework to the medical devices sector in India. The policy aims to promote the sector’s growth, increase access and affordability of medical technology/devices, and establish India as a global leader in the manufacturing and innovation of medical devices.

Initial comments from the industry are encouraging, and they are looking forward to seeing the final gazette notification of the policy. Welcoming the NMDP, Pavan Choudary, Chairman MTaI, said, Though we still have to go through the fine print, we are encouraged by the spotlight turned on R&D. While India has only 1.5% of the global medical device market, it has 8% share of the MedTech R&D workforce already. This is a fertile and proven area to focus on.

In addition, the skilling and upskilling of healthcare workers auger well for patient care and workforce exports. Adjacent to this announcement, we have also noted that the government plans to open 157 nursing colleges. This is another well-chosen space as it is estimated that new technologies like AI, which may make the desktop healthcare worker (even many doctors) redundant, will not adversely impact the nursing staff. So this policy has a note of enduring prudence to it.

The emphasis on creating a systematic brand positioning and awareness creation program is long-due and laudable.

From what is available in the public domain, a policy harnesses both the domestic and international currents to forge the path ahead optimally.

One of the critical aspects of the policy is regulatory streamlining, which aims to enhance the ease of doing research and business while balancing patient safety with product innovation. Measures such as creating a Single Window Clearance System for licensing medical devices and enhancing the role of Indian standards like BIS will undoubtedly attract advanced MedTech companies to invest and operate in India. However, the policy needs to ensure that regulatory measures are manageable and that it compromises patient safety, the quality of medical devices, and healthcare delivery.

The second crucial aspect of the policy is enabling infrastructure, which includes establishing and strengthening large medical device parks and clusters equipped with world-class common infrastructure facilities. These measures are essential in attracting advanced MedTech companies with access to high-quality infrastructure and skilled human resources. However, there needs to be a concerted effort to ensure that the infrastructure is evenly distributed across the country and accessible to all sections of people. This is essential to ensure that the benefits of the medical devices sector reach all sections of society and not just the privileged few.

Facilitating R&D and innovation is another critical policy aspect that will attract advanced MedTech companies to invest and operate in India. The policy envisages promoting research and development in India, establishing centres of excellence, innovation hubs, and supporting start-ups. These measures are crucial in attracting advanced MedTech companies to the forefront of innovation and research. However, there needs to be a robust intellectual property framework that protects the interests of companies investing in R&D in India.

Attracting investments in the sector and human resource development are also essential aspects of the policy that will attract advanced MedTech companies to invest and operate in India. Private investments, funding from venture capitalists, and public-private partnerships are crucial in ensuring the sector’s growth. Skilling, reskilling, and upskilling of professionals in the medical device sector are essential to meet the evolving needs of the industry. However, the policy needs to ensure that there is no brain drain of skilled professionals from the country, which may impact the healthcare delivery system in India.

Finally, brand positioning and awareness creation are crucial in attracting advanced MedTech companies to invest and operate in India. The policy envisages creating a dedicated Export Promotion Council for the sector and promoting more forums to bring together various stakeholders. However, the policy needs to ensure that brand positioning and awareness creation are not just limited to exports but also focus on increasing access and affordability of medical technology/devices to all sections of people in India.

As a final point, the National Medical Devices Policy, 2023, is a step in the right direction towards attracting advanced MedTech companies to invest and operate in India. The policy aims to provide an enabling policy and regulatory framework, promote growth, and increase access and affordability of medical technology/devices. However, the policy needs to ensure that regulatory measures do not compromise patient safety, infrastructure is accessible to all sections of people, there is a robust intellectual property framework, skilling of professionals does not result in brain drain, and brand positioning and awareness creation focus on increasing access and affordability of medical technology/devices to all sections of people in India.