In a move aimed at bolstering India’s medical device manufacturing sector, the government has announced a comprehensive scheme for the Strengthening of the Medical Device Industry, with an outlay of Rs. 500 crore for the period between Financial Year 2024-25 and FY 2026-27. The initiative, which was disclosed in the Lok Sabha on recently in reply to a question raised by members,  Minister for Chemical & Fertilisers J P Nadda informed the members that it seeks to address key challenges in the sector, including import dependence, infrastructure gaps, skill shortages, and the need for advanced clinical studies.

The scheme is divided into several sub-schemes, each targeting critical aspects of the medical device industry, ranging from infrastructure development to research and promotion. The objectives are multifaceted, reflecting the growing importance of the medical device sector to India’s healthcare ecosystem, particularly in light of the ongoing push towards "Atmanirbhar Bharat" (self-reliant India) and the demand for high-quality medical devices.

One of the central features of the scheme is the allocation of Rs. 110 crore towards the creation of Common Facilities for Medical Device Clusters. This sub-scheme aims to bolster existing infrastructure by providing financial assistance for establishing common infrastructure facilities in medical device clusters. It will also focus on expanding the availability of medical device testing laboratories to improve manufacturing standards and ensure the production of high-quality devices.

In parallel, the scheme aims to address India’s high dependence on imports of key components and raw materials used in medical device manufacturing. A total of Rs. 180 crore has been earmarked for the Marginal Investment Scheme, which will offer one-time capital subsidies ranging from 10% to 20%, with a cap of Rs. 10 crore per project. The goal is to promote the domestic production of components, including in-vitro diagnostic devices, which have seen significant demand during the pandemic.

The scheme also allocates Rs. 100 crore to promote capacity building and skill development in the medical device sector. This investment aims to enhance education and research opportunities, with a particular focus on training human resources to meet the growing needs of the industry. Support will be provided for Masters’ Courses, diploma programs, and short-term training in medical devices, creating a pipeline of skilled professionals.

Another Rs. 100 crore has been allocated to support Medical Device Clinical Studies, aimed at improving the efficacy and safety of medical devices. This sub-scheme will provide financial backing for animal studies, clinical investigations, post-market follow-ups, and clinical performance evaluations of new in-vitro diagnostic devices (IVDs). This is expected to drive innovation and improve the global competitiveness of Indian medical devices.

Finally, the scheme includes a Rs. 10 crore outlay for the Medical Device Promotion Scheme, designed to support industry awareness through studies, workshops, exhibitions, and the creation of databases. This component of the scheme focuses on raising awareness of the medical device sector’s capabilities, fostering growth through knowledge sharing, and positioning India as a hub for medical device manufacturing.

This ambitious scheme is poised to address the gaps in India’s medical device sector, which has long been plagued by over-reliance on imports and inadequate infrastructure. By incentivizing domestic manufacturing, investing in skill development, and supporting clinical research, the government’s initiative has the potential to significantly enhance the sector’s growth and its contribution to both national and global healthcare needs.

With the global medical device market expanding rapidly, India’s growing manufacturing capabilities could play a key role in fulfilling both domestic demand and international markets. If successfully implemented, the Strengthening of Medical Device Industry scheme could reduce India’s dependency on foreign imports, improve healthcare outcomes, and contribute to the country’s status as a key player in global healthcare innovation.

While the scheme outlines several promising steps, the challenge will be in its execution, especially in creating the necessary infrastructure and ensuring the timely disbursement of funds to eligible projects. Moreover, aligning the promotion efforts with global standards and regulations will be crucial to the success of the initiative. The scheme’s success will depend on the active participation of industry stakeholders, from manufacturers to academic institutions, in shaping an ecosystem that fosters innovation, efficiency, and quality in the medical device sector.