India Seeks Industry Input on Medical Device Procurement List
The Indian government is revising its list of medical devices exempt from local tender requirements and invites industry feedback.
Government Initiative to Revise Medical Device List
The Department of Pharmaceuticals (DoP) in India is actively seeking input from industry stakeholders regarding the revision of the Global Tender Enquiry (GTE) exemption list for medical devices. This list is crucial as it allows public agencies to procure medical products that are not manufactured within the country. The current list includes 354 devices, and the revision process commenced in February of this year.
Industry Proposals and Public Feedback
Manufacturers have submitted proposals for additions and deletions to the list, and these are now open for public comments and objections until July 15. The DoP has received requests to include 350 new devices such as epidural anaesthesia kits, bedside ultrasound systems, multi-modal vacuum wound healing systems, and 1.5 Tesla MRI scanners. Conversely, stakeholders have also proposed the removal of 235 products, including digital subtraction angiography systems and intraoperative radiotherapy machines, citing increased local production capabilities and capital commitments.
Make in India Initiative and Procurement Policies
Under the 'Make in India' initiative, the government has mandated that public agencies prioritize the procurement of locally manufactured medical devices. This policy is based on the calculation of local content. However, for products not produced domestically, the Finance Ministry has permitted procurement from overseas suppliers for tenders up to Rs 200 crore. This policy was first implemented in 2024, though some advanced technologies were reportedly overlooked in the initial exemption list.
Industry Reactions
Pavan Choudary, Chairman of the Medical Technology Association of India (MTaI), expressed optimism about the current review. He hopes it results in a comprehensive framework that accurately reflects the manufacturing landscape and patient needs. On the other hand, Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), has advocated for allocating a portion of public procurement to domestic products. He emphasized that companies that have invested in production but have not yet met the three-year market standing requirement should be supported.
Challenges in Domestic Production
Nath highlighted the challenges faced by domestic manufacturers, particularly in obtaining manufacturing approvals for high-risk products classified under Class C and D. These approvals can take between 9 to 15 months, during which companies struggle with capital financing and fixed costs without sales revenue.
Import Dependency and Market Dynamics
India remains heavily dependent on imports for its medical devices, with approximately 80-85% of the total device requirement being met through imports. In the fiscal year 2026, imports surged by 17% year-on-year, reaching Rs 89,000 crore. This increase was largely driven by high-risk, technology-intensive products that are not yet manufactured domestically.
The ongoing revision of the GTE-exempt medical device list is a crucial step in balancing the need for advanced medical technologies with the government's push for local manufacturing. The outcome of this revision will likely have significant implications for both domestic manufacturers and international suppliers.