By TIOL News Service

NEW DELHI, NOV 09, 2024: TO provide a big boost to the medical devices industry, the Union Minister of Chemicals & Fertilizers and Health & Family Welfare, Jagat Prakash Nadda, launched the Scheme for Strengthening the Medical Device Industry today. Anupriya Patel, Union Minister of State for Chemicals and Fertilizers and Health & Family Welfare and Arunish Chawla, Secretary, Department of Pharmaceuticals along with officials of the department and representatives of industry were also present on the occasion.

The scheme is a comprehensive scheme which targets critical areas of the medical device industry, covering manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure and industry promotion.

Union Minister for Chemicals and Fertilizers, JP Nadda while addressing the gathering said that this scheme is going to be a gamechanger and it will not only help the industry but will also be a long leap in making India self-reliant. He also said "these interventions may look small but the outcomes are big. He also said that the government led by Prime Minister Narendra Modi is a government of action and the PLI scheme itself is something which has opened new paths. The minister said that " it is just a start" and congratulated the department of Pharmaceuticals for the initiatives and sought Industry's support for the success of the scheme.

The Union Minister for Chemicals and Fertilizers  appealed to the Industry to make good use of the scheme and assured the industry of all help from the Government stating that the Department is there to provide all support.

Speaking on the occasion, Minister of State for Chemicals and Fertilizers Anupriya Patel said that this scheme will provide a boost to the entire sector of Medical Devices. She also said that "Medical Device has become an important pillar of the healthcare industry and we find them in everyday life and everybody is aware of its significance as its demand is continuously rising. The Government is also designing the policies and schematic support to promote this industry".

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 billion and is expected to grow to billion by 2030.

The new scheme has a total outlay of 500 Crores. It consists of five sub-schemes which are as follows –

Despite government support, the medical device manufacturing sector in India faces challenges. One of the primary challenge is lack of infrastructure. Through the sub-scheme for common facilities for medical devices 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 Masters' and short-term courses. Under the sub-scheme support up to Rs.21 crore for Masters' courses in central government institutions; and 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 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 exports councils by providing financial assistance to organize conferences and other events that promote medical device-related activities. It will also support 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.