On 26 April 2023, the Government of India (GOI) approved the National Medical Device Policy 2023.
The Medical Devices sector is an integral part of the healthcare industry. It is a sunrise sector that has witnessed sustained growth in the past decade. The sector has seen significant investments recently and new MedTech start-ups are coming up each passing day. The sector has high import dependency, with 80% of total medical devices being imported into the country. Recognizing this concern, the GOI announced Production Linked Incentives (PLI) and the set up of dedicated Medical Device parks in the country in 2020 and 2021.
With these steps as the foundation, the GOI has formulated a holistic policy framework to accelerate further growth and provide the necessary support to fulfill this potential. With this aim, the GOI announced the National Medical Device Policy (NMDP) 2023. The policy aims to put across a coordinated effort to develop the sector in a holistic manner. The medical device sector is a complex combination of multiple disciplines and there is a need for a coherent approach to promote the sector. The NMDP aims to facilitate the growth of the sector to meet public objectives of access, affordability, availability, quality, and continuous innovation. The policy will help realize the sector's full potential by building on various existing and new initiatives, such as enabling the manufacturing ecosystem, focusing on innovation, research, and development, creating a skilled talent pool, and streamlining and creating a robust regulatory framework.
The NMDP outlines a clear vision where it intends to increase India's share in the global medical device market from the current ~1.5% to more than 10% within the next couple of decades. Furthermore, it aims to grow the sector from the current USD ~11 billion to USD 50 billion by 2030. Additionally, as part of its mission statement, the policy lays out a clear roadmap for accelerating growth of the sector to achieve public health objectives as stated above. It has also outlined strategies in six broad areas of the policy to promote the sector, which are given below:
- Regulatory - To increase the ease of doing business and research, the policy will streamline activities by creating a Single Window Clearance System for licensing of devices with the cooperation of various agencies and stakeholders.
- Infrastructure - The GOI has already announced the set up of dedicated medical device parks and will combine them with manufacturing clusters equipped with world-class common infrastructure facilities. These parks and clusters will be in proximity to economic zones and will gain logistic support via the National Industrial Corridor Program and the proposed National Logistics Policy.
- Facilitating R&D and Innovation - The policy aims to promote R&D in India in conjunction with the proposed Department of Pharmaceutical's (DoP) proposed National Policy on R&D and Innovation in the Pharma–MedTech sector. Further, it aims to establish centers of excellence in academic institutions, innovation hubs, etc.
- Attracting Investments - The policy will encourage private investments, venture capital funding, and Public-Private Partnership opportunities in conjunction with existing schemes and initiatives like Make-in-India, Start-up India, Ayushman Bharat Mission, etc.
- Human Resource Development - The policy aims
to add a steady stream of skilled labor to the sector and envisages
the following steps:
- Leverage available resources in the Ministry of Skill Development and Entrepreneurship for reskilling and upskilling.
- Policy to support dedicated multidisciplinary courses in existing institutions to ensure the availability of skilled manpower.
- Partner with foreign academic/industry associations to develop medical technologies.
- Brand Position and Awareness - The policy envisages addressing various market access issues by creating a dedicated Export Promotion Council, initiating studies/projects to learn best practices, and promoting more forums to bring stakeholders for sharing knowledge and building a network.
Conclusion
The NMDP is a significant step towards promoting the domestic production of medical devices. It will catalyze the growth and progress of the medical device industry in India. One underrated feature of this policy is a dedicated Export Promotion Council which will push Madein-India products, thereby providing opportunities for MSMEs and start-ups to take their products into the global market. Additionally, streamlining regulations and focusing on human resource development will ensure a steady flow of new devices and workforce to cater to our huge population.
We believe NDMP is an integral part of the government's overall vision and, therefore should be construed together with the government's Union Budgets for the year that prioritized critical areas such as healthcare infrastructure development, upskilling professionals, R&D innovation, etc. The government's emphasis on job creation, upskilling, reskilling, and economic development demonstrates its commitment to building a robust and thriving economy. The financial support provided by the government, for instance, the 'National Health Mission,' is strengthening the public health system and promoting the upgradation of existing infrastructure and the construction of new ones to better serve the people.
Overall, the latest National Medical Devices Policy 2023 and the government's constant focus on the key areas through various initiatives in the healthcare sector is likely to have a positive impact on India's future growth and development. The policy has the potential to be a game-changer for the industry as it focuses on all the challenges that the sector faces and lays out steps to address them in a holistic manner. The policy is an impressive culmination of the GOIs various initiatives such as Make-inIndia - to boost domestic manufacturing, Heal in India - to benefit patient cases, and now Build in India - encouraging innovation and access to cutting-edge technology. There has never been a better time to be a medical device company in India.
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