The National Medical Device Policy 2023 (“Policy”) was approved by the Union Cabinet on 26th April 2023, and was thereafter published on 2nd May 2023.
The salient features of the Policy are highlighted below:
- Aims and Objectives: The Policy aims to ensure access to patent-centric, innovative and affordable healthcare products of excellent quality for better healthcare outcomes, consequently achieving 10-12% share in the expanding global market over the next 25 years and lays down the following missions for achieving accelerated growth of the medical devices sector:
- Access to and universality of good quality medical devices and healthcare across all ages.
- Affordability through enhancement of domestic manufacturing capacity and capability for newer technologies.
- Giving importance to the quality of products manufactured in the country to enhance global positioning, acceptability and competitiveness.
- Improvement through patient centered & quality care through improvement of clinical outcomes and convenience of the patients (such as early diagnosis of diseases and increased accuracy in treatment).
- Giving importance to preventive and promotive health enabling individuals to lead a healthier lifestyle by achieving extensive application of medical devices in early screening and diagnosis for early detection/prevention and management of diseases.
- Ensuring medical devices security (on par with drug and food security of the country), through development of strong local manufacturing capabilities and a resilient supply chain for inputs or raw materials.
- Encourage and sustain innovation and research in the sector to enable technology driven medical devices with IoTs & AI, nanotechnology, etc.
- Facilitate future-ready skilled manpower aligned to the multidisciplinary nature of medical device technologies
- Strategies to Promote Medical Device Sector: The Policy provides a set of strategies covering six areas which have been identified based on the “current challenges facing the sector as well as the opportunities that lie ahead for fulfilling the potential of the sector”. These are as follows:
- Regulatory streamlining through inter alia the setting up of a Single Window Clearance System for licensing of medical devices, gradual expansion of the standards developed by Bureau of Indian Standards (BIS) and sectoral standards development organisations in terms of processes, products, wireless technologies and performances; development of framework for a coherent pricing regulation, facilitation of research and development of market-ready products; etc.
- Setting up of enabling infrastructure such as the strengthening of large medical device parks and medium sized medical devices clusters and testing laboratories for medical devices and the phased manufacturing of critical components to allow for uninterrupted supply of such components.
- Facilitating R&D and innovation by acknowledging the role new technologies such as 5G, 6G, IoTs and AI can play in innovation, and establishing Centers of Excellence, Innovation hubs, start-ups, clinical settings, funding agencies, plug and play infrastructures etc. to create a health technology ecosystem.
- Attracting investments in the Sector through private route and public procurement policies (such as Make In India) to promote indigenous manufacturing, competitiveness and creating a manufacturing friendly ecosystem.
- Human Resources Development through a skilled workforce, across the value chain such as scientists, regulators, health experts, managers, technicians.
- Brand positioning and awareness creation through a dedicated Export Promotion Council for the sector to manage issues pertaining to market access and building global competitiveness. Further, the Policy envisages extensive engagement with industry stakeholders to foster innovation.
- Monitoring and Evaluation of Strategies: The Policy recognises the Sustainable Development Goals outlined in the National Health Policy, 2017 and states that quantitative output/outcome metrics will be developed to measure the impact of the strategies proposed under the Policy in due consultation with NITI Aayog, in addition to the regular monitoring of economic indicators such as market size, exports and Foreign Direct Investments.
The Policy is a much-needed step to streamline the medical devices sector and provides broad principles for strengthening the same. However, since the specifics pertaining to the practical implementation of this policy is unknown at this point of time, stakeholders in the med-tech industry have sought clarity on the granular details of the Policy, which is the need of the hour given the extensive stakeholder consultation has already taken place on the subject. Additionally, while the Policy provides broadly addresses “regulatory streamlining” it does not include any specific details on how streamlining this sector will reduce regulatory approvals and compliances to enhance ease of doing business. Also, the Policy does not expressly deal with the position of wearables technology in the healthcare sector, unlike the erstwhile National Health Policy, 2017 which expressly recognized the integral role of wearables technology.
Reportedly, the Government has already started implementing its associated PLI schemes with the establishment of medical device parks and the domestic manufacturing of high-end medical devices. A National Medical Device Policy with granular details on implementation and crystallized frameworks is much needed since it will provide the desired momentum and impetus to India’s vision of becoming a global manufacturing hub.
2023 Policy – https://egazette.nic.in/WriteReadData/2023/245630.pdf
Press release – https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1919984
National Health Policy 2017 – https://main.mohfw.gov.in/sites/default/files/9147562941489753121.pdf