The current GTE exemption list of 354 medical devices, notified in 2024 and valid until March 2027 | Photo Credit: Getty Images

Medical device makers are putting together their lists of products that are produced in the country, and those that are not locally manufactured , as part of the Centre’s review of a list that guides public procurement of medical devices.

The Department of Pharmaceuticals has received stakeholder suggestions to add or delete products from the Global Tender Enquiry (GTE) Exemption List of Medical Devices, it said, on the process that kicked off earlier this February. Industry has till July 15 to send in their suggestions.

The domestic industry, though, is divided, with some calling for exemptions to “advanced technologies” not made locally, while others urge the government to outline a basket of products and encourage local manufacturers to make them.

The current GTE exemption list of 354 medical devices, notified in 2024 and valid until March 2027, was developed through a rigorous and consultative process involving all relevant stakeholders, said the Medical Technology Association of India (MtaI).

“The guiding principle behind GTE exemptions has been to ensure patient access to medical technologies that are not yet adequately manufactured in India. Many MTaI members manufacture in India and strongly support the growth of domestic manufacturing,” said Pavan Choudary, Chairman MtaI.

“While the 2024 exercise was largely comprehensive, a few advanced technologies that are not manufactured in India were missed out in the exemption list,” he said.

“Any exclusion of technologies that are not adequately available in India risks limiting patient access to critical medical innovations and could adversely affect healthcare outcomes,” he said, adding that quality products that are available locally can be procured domestically.

Market assurance

The Association of Indian Manufacturers of Medical Devices (AiMed) are also in the process of mapping local manufacturing capabilities and capacities to ensure that products made in India are removed from the exemption list.

“For products where Indian manufacturers have already taken test licences, committed capital expenditure, or launched production but are yet to complete the three‑year market standing requirement, there must be a mechanism to earmark a share of public procurement,” said Rajiv Nath, AiMed Forum Coordinator. Stressing the need for domestic manufacturing, he said, medical device imports continue to rise — posting a 17 percent increase to ₹89,000 crore last financial year, compared to ₹76,000 crore in the previous year.

Developing high‑technology medical equipment is inherently challenging, he said, and the approval for Class C and D devices take 9–15 months. “During this gestation period, highly skilled staff remain underutilized while companies struggle to service capital financing and fixed costs without sales revenue. Other countries address this by offering market assurance — guaranteed sales volumes at attractive target prices — to motivate investment. India must adopt similar measures to ensure our manufacturers are not disadvantaged,” he added.

Published on June 23, 2026