On April 26, 2023, the Union Cabinet approved the National Medical Devices Policy, 2023 (“Policy“). A press release issued on the same date1 (“Press Release“) detailed the backdrop leading up to this approval and what lies in store for the future.
The Policy was formulated upon recognition of essentiality of the medical devices sector in general and the pivotal role it continues to play in the domain of healthcare—particularly in the context of India’s fight against the Covid-19 pandemic through the large scale production of medical devices and diagnostic kits—with the goal of inching closer towards greater access, however unprecedented the circumstances may be. The Press Release underlined the crucial nature of the medical devices industry by stating that the estimated market-size of the medical devices sector in India was $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.
To add to the aforesaid context of the essentiality and quick-growing nature of the medical devices industry, the requirement of streamlining the various roles and responsibilities of various departments of Central and State Government in relation to the diverse medical devices industry was also highlighted in the Press Release. The aforesaid backdrop highlighted the requirement of a holistic policy framework to accelerate the growth and fulfil the potential of the medical devices sector, complementing the Government of India’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs.
The Press Release highlighted the following salient features of the Policy :
1. Vision: Taking up a patient-centric approach to establish India’s presence as a global leader in terms of the manufacture and innovation of medical devices, by achieving a 10-12% share in the global market over the next 25 years, and $50 billion in the domestic market by 2030.
2. Mission: The goals under the Policy to achieve the aforesaid vision are listed as access and universality, affordability, quality, patient centred and quality care, preventive and promotive health, security, research and innovation, and skilled manpower.
3. Strategies to Promote Medical Device Sector: The policy interventions that would be put into motion for the achievement of the aforesaid vision were detailed as under:
a. Regulatory Streamlining: The Press Release highlights that prioritising the ease of doing research and business, patient safety and product innovation, the following measures will be followed pursuant to the Policy: (i) ‘Single Window Clearance System’ for the licensing of medical devices (subsuming all stakeholder departments); (ii) enhancing the role of Indian standards (like BIS); and (iii) designing a coherent pricing regulation.
b. Enabling Infrastructure: The Press Release also highlights that infrastructure that aids the achievement of the aforesaid vision i.e., large medical device parks, clusters equipped with robust infrastructure facilities in proximity to economic zones with the necessary logistics connectivity would be achieved in collaboration with the State governments.
c. Facilitating Research, Development, and Innovation: The Press Release stipulates that the facilitation of research, development and innovation in relation to medical devices shall be in parallel to the proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India; and steps would be taken to encourage the same in academic and research institutions, and support provided to start-ups.
d. Attracting Investments in the Sector: The Policy also encourages investments in the medical devices sector from venture capitalists, other private investors and by way of public-private-partnerships (PPPs), over and above the pre-existing schemes in this relation.
e. Human Resources Development: The Press Release highlights that the Policy shall place focus on the skilling, upskilling and reskilling professionals in the sector (across roles in the value chain) by working in collaboration with the Ministry of Skill Development and Entrepreneurship, supporting multidisciplinary courses for medical devices in existing institutions and partnering with foreign academies and organisations.
f. Brand Positioning and Awareness Creation: The Policy stipulates that an Export Promotion Council shall be established to deal with issues relating to market access by initiating studies and projects to imbibe global practices of manufacturing the skilling and promoting forums for stakeholders to come together, share knowledge and build networks.
The vision outlined for the Policy and the cogent steps detailed for the achievement thereof indicate that the Government of India has taken copious notes of the gaps in this sector which were brought to light by the Covid-19 pandemic, and that another industry would now be positioned join the collective mission to ensure better access to healthcare.
1 https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1919984
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