Centre launches ₹500 crore medical device scheme; industry welcomes

Centre has launched a new scheme to push the MedTech industry in India.

With a total outlay of Rs 500 crore, the ` Scheme for Strengthening the Medical Device Industry’ targets critical areas of the MedTech industry covering manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure and industry promotion

Union Minister of Health and Family Welfare JP Nadda said the scheme is going to be a game changer and it will not only help the industry but will also be a long leap in making India self-reliant.

He appealed to the industry to make good use of the scheme and assured all help from the government.

Minister of State for Chemicals and Fertilizers Anupriya Patel said that this scheme will provide a boost to the MedTech sector.

“Medical devices have become an important pillar of the healthcare industry. Everybody is aware of their significance as the demand is continuously rising. The government is also designing the policies and schematic support to promote this industry,” she said.

The medical device industry is an essential pillar of healthcare delivery. From diagnostic machines to surgical instruments, and from stents to prosthetics, medical devices are critical for the prevention, diagnosis, and treatment of diseases. India’s medical device market is valued at approximately $14 billion and is expected to grow to $30 billion by 2030.

The new scheme has a total outlay of Rs 500 Crores. It consists of five sub-schemes which include:

Despite government support, the medical device manufacturing sector in India faces challenges. One of the primary challenges is the lack of infrastructure. Through the sub-scheme for common facilities for medical device clusters, the Central Government will provide financial assistance to medical device clusters for creating common infrastructure facilities such as R&D labs, Design and Testing Centre, Animal Labs, etc. for the manufacturers located in the cluster. Support for strengthening existing Testing Facilities or setting up new ones will be provided to National/State/Private institutions. Grant of up to Rs. 20 Crore will be provided for Common Facilities and up to Rs. 5 crore for Testing Facilities.

The second sub-scheme providing marginal investment support is designed to deepen the MedTech supply chain in the country, by focusing on manufacturing of key components, raw materials, and accessories within the country. This sub-scheme aims to reduce dependence on imported components. Currently, most raw materials and key components are imported, making Indian manufacturers reliant on external supplies for medical device production. This sub-scheme offers a one-time capital subsidy of 10-20%, with a maximum cap of Rs 10 crore per project.

The third sub-scheme focuses on capacity building and skill development for the medical device sector. Its goal is to develop a skilled technical workforce capable of designing and developing MedTech products. The Central Government will offer financial support for running various Master’ and short-term courses. Under the sub-scheme, support up to Rs.21 crore for Masters’ courses in central government institutions, Rs. 10,000 per candidate for short-term courses, and Rs. 25,000 per candidate for Diploma courses to NCVET-approved institutes will be available.

The fourth sub-scheme is a pioneering initiative designed to assist both established companies and start-ups in conducting clinical studies. The scheme enables medical device developers and manufacturers to apply for financial support for animal studies and if successful then for human trials to validate MedTech products. Financial support of up to Rs 2.5 Crore will be provided for animal studies. For clinical investigation of investigational devices and post-market clinical follow-ups on approved devices, a maximum of Rs 5 Crore is available to generate clinical data. Additionally, up to Rs 1 Crore can be granted for clinical performance evaluations of new in-vitro diagnostic products. This sub-scheme is expected to significantly benefit the industry, by addressing a long-standing need for support in clinical studies. It will promote the safety and efficacy of medical devices produced in India and also help Indian manufacturers in obtaining product registrations in international markets.

The last sub-scheme aims to support industry associations and export councils by providing financial assistance to organize conferences and other events that promote medical device-related activities. It will also support the conduct of surveys and studies.

The future of the Indian medical device industry looks very promising. Indian companies are already advancing and delivering innovative solutions at a fraction of the cost compared to their international competitors. The Government of India is actively working to create a conducive environment for developing high-quality medical devices within the country.

Industry welcomes
Welcoming the scheme, AiMeD said it will give impetus to medical device manufacturing.

“Indian Medical Devices manufacturers, who had shifted to pseudo manufacturing, will now again be motivated to become actual manufacturers and produce complete set of products and their components in-house. The budgetary allocation may seem small and humble. However, this is ground groundbreaking strategy and it will have a multiplying impact. It will help to achieve the Prime Minister’s vision to make India the leading hub of medical devices manufacturing globally as announced in the National Medical Devices Policy 2023, “ said AiMeD.

Medical Technology Association of India (MTaI) said the scheme serves as a fine example of an evidence-based simulation package.

“The scheme derives its focus on five critical aspects: manufacturing of essential components and accessories, skill development, support for clinical studies, development of shared infrastructure, and industry promotion. The medical device industry stands to gain significantly from this inclusive scheme, which would benefit both startups and established companies and will leverage both local and global currents. The industry promotion stimulus will pave the way for vitally important market research and marketing of the industry to the world,” said Pavan Choudary, Chairman, MTaI.
MB Bureau