The Medical devices segment is an integral part of the Indian healthcare industry. This sunrise sector has demonstrated sustained growth in this decade. This industry has drawn significant investments recently, and new MedTech startups are being incorporated with encouraging frequency. The industry has a high import dependency, with 80 per cent of medical devices imported into the country.

The Indian Government notified the New Medical Devices Policy 2023 (NMDP2023) in April 2023. This forward-looking policy outlines an extensive range of measures to foster the growth and advancement of India’s healthcare industry, explicitly emphasizing the medical devices sector. The NMDP outlines a clear vision to increase India’s share in the global medical device market from the current ~1.5 per cent to more than 10 per cent within the next couple of decades. Furthermore, it aims to grow the sector from USD ~11 bn to USD 50 bn by 2030.

This is a pivotal policy. The NMDP2023 aims to foster a competitive domestic industry, reduce India’s import dependency, and make quality healthcare affordable and accessible to the Indian populace. The policy’s main objective is commendable, but does its framework sufficiently propose a mechanism to achieve this? A closer examination reveals a multitude of possibilities.

Noteworthy Components of the NMDP2023

One of the most prominent aspects of the NMDP2023 centers around the creation of ‘Medical Devices Parks’ across the nation. The policy endeavors to establish eight such parks by 2023, offering state-of-the-art manufacturing and testing facilities. This will address one of the pressing concerns for domestic manufacturers – high capital investment. The setting up of medical device parks will reduce the cost of production by 30 per cent, making it more lucrative for domestic manufacturing.

Further, the NMDP2023 also tackles regulatory concerns by proposing a unique, harmonised regulatory framework that syncs with international standards. This is a step in the right direction as it would infuse global confidence in Indian products and ensure product efficacy and safety. However, the precise nature and application of these benchmark international standards within the context of Indian domestic regulations remain to be seen.

Promises and Potential Challenges

While the NMDP2023 holds substantial promise, it is pivotal to acknowledge the potential challenges that may arise in its implementation. Prominent among these is India’s ‘Make in India’ initiative. Although the NMDP2023 supports the ‘Make in India’ initiative through local production of medical devices, a careful balance must be struck to ensure we encourage healthy competition and foreign investment. While promoting local manufacturing, we must ensure that India remains an attractive market for alien medical device companies. We need to strike a balance between fostering indigenous industry and ensuring the availability of cutting-edge foreign innovations.

The second concern relates to the execution of the Medical Devices Parks. Ensuring consistent quality and the availability of advanced technology across all these parks would be a challenging task.

The Road Ahead

The NMDP2023, though ambitious, is a vital step towards transforming India’s medical device industry. This reality also finds resonance in India’s Finance Minister Nirmala Sitharaman’s quote: “NMDP2023 is our firm step forward towards bridging the gap in the health sector… Towards a healthier and Aatmanirbhar India”.

One underrated feature of this policy is a dedicated Export Promotion Council, which will push Made-in-India products, providing opportunities for MSMEs and startups to take their products into the global market. Streamlining regulations and focusing on human resource development will guarantee a steady flow of new devices and workforce to cater to our vast population.

The policy is an impressive culmination of the GOI’s various initiatives, such as Make-in-India to boost domestic manufacturing, Heal in India to benefit patient cases, and Build in India to encourage innovation and access to cutting-edge technology. There has never been a better time to be a medical device company in India.

While the policy brings hope and substantial potential, its practical implementation will be a game-changer. This includes nurturing a conducive ecosystem that encourages innovation, research, and development in the medical devices industry. The alignment of various stakeholders, including innovators, manufacturers, and regulatory bodies, will be crucial to the policy’s success.

Views expressed by Jatin Mahajan, Member of Working Group on Policy, ASSOCHAM; Co-Chair, CII Delhi State Sub Committee on Healthcare & Wellness, CII Northern Region; Secretary, ASSOCIATION OF DIAGNOSTICS MANUFACTURERS OF INDIA; Managing Director, J Mitra & Company

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