New Delhi: The Department of Pharmaceuticals (DoP) has invited industry comments on proposed additions and deletions in the existing list of medical devices exempted from Global Tender Enquiry (GTE) for public procurement of products that are not manufactured in India.
The revision process of the current list of 354 medical devices began in February this year, when device manufacturers submitted proposals for additions and deletions. The representations are open for public comments and objections until July 15 to finalize the revisions.
The department has received representations for the inclusion of 350 devices such as epidural anaesthesia kits, bedside ultrasound systems, multi-modal vacuum wound healing systems, and 1.5 Tesla MRI scanners, among others.
Stakeholders have also requested, exclusion of 235 products, including digital subtraction angiography systems, intraoperative radiotherapy machines, surgical navigation systems etc., citing increasing capital commitment and improvement in domestic production of such products.
Under the Make in India push, the government mandated public agencies to prioritize locally produced medical devices based on the calculation of local content. However, in 2024 for products not produced domestically, the Finance Ministry permitting procurement of select devices from overseas suppliers, for tenders up to Rs 200 crore.
“The 2024 exercise was largely comprehensive, a few advanced technologies that are not manufactured in India were missed out in the exemption list. We welcome the current review and hope it results in a complete, evidence-based framework that accurately reflects manufacturing realities and patient needs,” said Pavan Choudary, Chairman of multinational device makers industry body, MTaI.
Speaking for domestic manufacturers, Rajiv Nath, Forum Coordinator, AiMeD called for, “earmarking a share of public procurement” for products where companies have already taken test licenses, committed capital expenditure, or launched production but are yet to complete the three‑year market standing requirement.
Nath argued that, obtaining manufacturing approval for high-risk products —Class C and D — takes up to “9–15 months” and during this gestation period, companies struggle to service capital financing and fixed costs without sales revenue.
Currently, India has a high-import dependency in the medical devices sector and around 80-85 per cent of total device requirement is met through imports. In FY26, imports surged 17 per cent year-on-year to Rs 89,000 crore, largely driven by high-risk, technology-intensive products.
