ICMR opens opportunities for start-ups and MSMEs in medical devices sector

To boost local manufacturing of medical devices and diagnostics, the Indian Council of Medical Research (ICMR) has invited start-ups, research institutes, and non-governmental organisations (NGOs) to make small-scale versions of their devices. The initiative aims to help innovators refine these devices for large-scale production, prepare them for commercial use, strengthen India’s MedTech ecosystem, and improve preparedness for infectious diseases.

ICMR, under the Department of Health Research, is rolling out this support for test-batch manufacturing of indigenous devices and diagnostics, including software as a medical device, as part of its alignment with the government’s Viksit Bharat@2047 vision.

The council had launched initiatives such as MedTech Mitra and Patent Mitra to guide the development of health technologies addressing national priorities. The latest effort is meant to bridge the gap between prototypes and full-scale production by funding and facilitating test batches that comply with regulatory standards.

Start-ups, micro, small and medium enterprises (MSMEs), Department of Scientific and Industrial Research (DSIR)-recognised research and development centres, medical colleges and registered NGOs can seek the opportunity, provided they hold or obtain an MD-13 test licence, which is the Medical Device Test Licence under the Drugs and Cosmetics Act, 1940.

According to ICMR, this step will allow innovators to validate quality, reduce scale-up issues, and accelerate preclinical and clinical evaluations. The Indian medical devices industry is expanding steadily. According to the India Brand Equity Foundation (IBEF), the sector was valued at $12 billion (Rs 1,02,660 crore) in FY24 and has been growing at a compound annual growth rate (CAGR) of around 15 per cent in recent years. A separate estimate by EY projects that the market could touch US$ 50 billion by 2030, supported by rising demand, favourable policies, and infrastructure improvements.

The diagnostics devices segment is also expected to see sharp expansion. Market Research Future estimates that it was worth $2.99 billion in 2024 and could grow to US$ 17.74 billion by 2034, implying a CAGR of nearly 19.5%, driven by preventive healthcare, early detection, and wider availability of diagnostic services.

Meanwhile, demand for quality and regulatory compliance is spurring growth in device testing. Grand View Research estimates that the Indian market for medical device testing services stood at $781 million in 2024, and could reach $1.41 billion by 2030, growing at a CAGR of about 10.4%.

“ICMR’s drive to back Indian start-ups and innovators and teaming them with established large players puts locally made medical devices on the world map—powering Make in India and turning affordable health technology into India’s next global export story,” said Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD).

“A streamlined project management agency, a stronger focus on commercialisation, and procurement provisions rewarding innovation without creating monopolies would further strengthen the sector,” he added.