Following the ‘Approach Paper to National Medical Device Policy, 2022’ published by the Ministry of Chemicals and Fertilizers (MCF) on May 10, 2022, which laid down a roadmap for accelerated growth of the medical devices sector while promoting safety and quality, the National Medical Devices Policy, 2023 (“Policy”) was notified by the MCF on May 03, 2023. The vision of the Policy is to help India emerge as a global leader in the manufacturing and innovation of medical devices by achieving a 10-12% share in the expanding global market. 

The mission of the Policy inter alia includes:

• universal access to good quality medical devices
• ensuring affordability of medical devices
• focusing on quality of medical devices in order to enhance global positioning, acceptability and competitiveness
• enhancing the quality of care based on clinical outcomes and convenience of the patients;
• creating and evolving a modern eco-system; and
• facilitating skilled manpower. 

 

Further, the government's strategies to promote medical device sector include:

• setting up a single window clearance system for facilitating licensing of medical devices
• enabling infrastructure - setting up large medical device parks, medium-sized medical devices clusters, enhancing the number of medical device testing laboratories in proximity to economic zones and centres of excellence in premier academic and research institutions
• facilitating R&D - promote innovation and Research and Development (R&D)
• attracting investments in the sector - promote indigenous manufacturing, build competitiveness and promote an ecosystem for manufacturing and leverage initiatives such as Public Procurement Policy (Make in India)
• human resource development - develop a skilling ecosystem, aligned to the Skill India Program, and ensure supply of a skilled work force such as scientists, regulators, health experts, managers, and technicians; and
• brand positioning and awareness creation - build global competitiveness by creation of a dedicated Export Promotion Council and promote additional forums for stakeholder knowledge sharing and awareness. 

Introduction of this Policy by the Indian government is a vital and progressive step for the medical sector which would lead to easy access of best quality medical devices at competitive prices to consumers. The initiative will boost local manufacturing – a step much needed - and also end dependency on imports for critical life saving devices.

Source: Remfry & Sagar

The vision of the Policy is to help India emerge as a global leader in the manufacturing and innovation of medical devices by achieving a 10-12% share in the expanding global market.