India's National Medical Devices Policy: A Strategic Boost to the Medical Devices Market

As we delve into the rapidly expanding Indian medical devices sector, it's impossible not to feel a sense of excitement and opportunity. This sunrise sector is not just a critical part of the Indian healthcare system but is also a cornerstone of the nation’s ambition to provide universal healthcare. India is set to become a global hub for medical technology and devices, with the market size projected to grow from the present $11 billion to $50 billion by 2030. This growth trajectory positions India as Asia's fourth-largest medical devices market and among the top 20 globally. With a current global market share of 1.5%, India aims to increase its share to 10-12% over the next 25 years.

But what does this mean for investors, innovators, and stakeholders in the healthcare sector? The answer lies in the comprehensive National Medical Devices Policy, 2023, which sets a clear roadmap for the sector's future. This policy isn't just about growth; it's about creating an ecosystem that fosters innovation, self-reliance, and quality care.

The National Medical Devices Policy, of 2023, aims to facilitate orderly growth in the sector, focusing on key areas such as access, affordability, quality, and innovation. Imagine a future where India's medical devices industry is self-reliant and a global leader, contributing significantly to healthcare solutions worldwide. The policy outlines strategies to build an enabling ecosystem for manufacturing, create a robust regulatory framework, and support training and capacity-building programs. It also emphasizes promoting higher education to nurture talent and skilled resources aligned with industry needs.

The challenge lies in further streamlining regulations to balance patient safety with product innovation while reducing compliance burdens and enhancing the ease of conducting research and business. To achieve this, the policy proposes establishing a "Single Window Clearance System" for licensing medical devices. This system will simplify interactions with various stakeholder departments, including the AERB, MeitY, and DAHD while strengthening the role of Indian standards such as the Bureau of Indian Standards (BIS). The goal is to create an environment that supports innovation and safety, ensuring India's competitiveness on the global stage.

The government's focus on infrastructure development is crucial for the growth of the medical device industry. The policy includes plans for large medical device parks and clusters with world-class infrastructure, strategically located near economic zones to enhance logistics connectivity. This initiative aligns with the National Industrial Corridor Program and the proposed National Logistics Policy 2021, aiming for seamless integration with the medical device sector.

To attract investments, the government permits 100% foreign direct investment (FDI) in the medical device sector. Similarly, for greenfield projects in the pharmaceutical sector, 100% FDI is allowed under the automatic route. For brownfield projects, up to 74% FDI is permitted under the automatic route, while investments exceeding 74% up to 100% require government approval.

The Department of Pharmaceuticals is implementing the "Promotion of Medical Devices Parks" scheme, with a total financial outlay of Rs. 400 crores. The scheme provides a maximum assistance of Rs. 100 crore per Medical Device Park, with the tenure running from FY 2020-2021 to FY 2024-2025. The selected projects will be managed by a State Implementing Agency (SIA). Proposals from 16 States and Union Territories were evaluated, and final approval for financial assistance of Rs. 100 crore each was granted to Uttar Pradesh, Tamil Nadu, Madhya Pradesh, and Himachal Pradesh.

In the realm of research and development, the policy encourages the establishment of Centers of Excellence in academic and research institutions. These centers, along with innovation hubs and 'plug and play' infrastructures, are set to become hotbeds for new ideas and breakthroughs.

To attract investments in this sector, additional measures are proposed beyond existing schemes to promote indigenous manufacturing, build competitiveness, and create a supportive ecosystem for the sector. It aims to encourage private investments by fostering risk-based financing through initiatives like promoting seed capital and series funding from venture capitalists and inviting them to screen and incubate start-ups. It also advocates for new financing models, such as blended finance, combining public and private funds. Furthermore, the policy seeks to leverage and build upon initiatives like the Start-up mission and programs like the Public Procurement (Make in India) Policy and Ayushman Bharat to support startups and promote domestic manufacturing in the medical devices sector.

A steady supply of skilled professionals is crucial for the sector's growth. The policy supports multidisciplinary courses for medical devices in existing institutions, ensuring that we have a future-ready workforce capable of meeting the evolving needs of the sector. Furthermore, partnerships with foreign academic and industry organizations are encouraged to keep pace with global advancements in medical technologies.

To position India as a global leader, the policy includes plans for a dedicated Export Promotion Council, tasked with overcoming market access challenges and promoting best practices. This effort aims to create more forums for knowledge sharing and networking among stakeholders, bolstering India's reputation as a hub for high-quality medical devices.

At Enventure, we believe in embracing these compelling strategies and being at the forefront of India's medical devices boom. The future of healthcare looks brighter than ever, and we invite you to join us on this exciting journey. Let's work together to shape the future of healthcare, not just in India, but globally. The time is now—are you ready to make a difference?