India’s relatively nascent medtech sector has potential, regulators are reviewing policies but will implementation live up to intent? Two policies under review seek to balance the growth aspirations of India’s growing medtech manufacturing base, while incentivising global medtech investments. But good intentions on paper are only half the job. Even that is questionable, when the proposal doesn’t seem to follow conventional logic.
Let’s first consider the Ministry of Health & Family Welfare’s proposal to further amend the Medical Devices Rules, 2017 to rationalise/shorten manufacturing licences timelines for medical devices is appreciated by both Indian and MNC medtech companies.
The proposal is to shorten approval periods—from 140 to 115 days for Class B devices (which include low to moderate risk devices such as blood pressure monitors, hypodermic needles and pulse oximeters) and from 105 to 90 days for higher-risk Class C & D devices (which include high-risk devices such as cardiac stents, hip and knee implants, and other orthopaedic implants).
Rajiv Nath, Forum Coordinator, AiMeD notes that it is “puzzling that lower-risk Class B devices take longer to clear than higher-risk Class C & D — regulatory timelines should reflect risk, not reverse it.”
AiMeD’s statement thus asks for “greater clarity on the rationale behind retaining longer approval timelines for lower-risk Class B devices than for higher-risk Class C & D devices, which inherently require more rigorous technical evaluation and regulatory scrutiny.”
The association, which represents the Indian medtech sector, further suggests that CDSCO should consider publishing data on the actual versus prescribed licensing timelines achieved over the past two financial years across different device categories. Greater transparency on common deficiencies in applications that lead to repeated queries and delays would also help manufacturers improve submission quality and enable faster approvals, reasons Nath/AiMeD.
Summing up the next steps and the real worry, Nath/AiMed points out that policymakers’ excellent intentions must now be matched by faster execution at both the Central Licensing Authority (CLA) and State Licensing Authorities (SLAs). Predictable and time-bound approvals are critical for manufacturers investing in greenfield facilities, as prolonged licensing delays result in idle capital, underutilised skilled manpower, increased financing costs, and slower commercialisation. Streamlined implementation will strengthen India’s competitiveness as a global medical devices manufacturing hub, concludes the statement.
Reacting to the same proposed amendments, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) pointed out that the mandatory pre-licence Quality Management System (QMS) audit by a Notified Body establishes a critical quality checkpoint before any licence is granted, which directly strengthens patient safety and raises compliance standards across the sector.
Choudary added that another significant amendment is the introduction of defined timelines for site audits and compliance verification bringing long-overdue predictability to the licensing process. This is a meaningful ease-of-doing-business reform, which will further reduce regulatory uncertainty, enabling better planning, and lowering compliance costs, especially for MSMEs. Another significant policy amendment open to comments, is the Department of Pharmaceuticals’ Global Tender Enquiry (GTE) Exemption List of Medical Devices.
MTaI’s Choudary explains that many MTaI members manufacture in India and strongly support the growth of domestic manufacturing. MTaI believes products that are available locally in sufficient quantities and at the required quality standards can be procured domestically. However, where advanced technologies are not manufactured in India, or domestic capacity is insufficient to meet clinical needs, continued GTE exemptions remain essential.”
“While 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. 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 added.
AiMeD is understandably less enthused with the proposal to expand the GTE exemption list and will be sharing detailed manufacturing capabilities and capacities with both DoP and DPIIT to ensure that products already made in India are removed from the exemption list.
Nath makes the point that for products where Indian manufacturers have already taken test licenses, 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. He suggests that this could be through fast-track market access or financial support via tariff review. Even a nominal increase in customs duty—from the current 0–7.5 per cent range to 7.5–10 per cent—would provide essential protection and encourage investment.
AiMeD’s statement stresses that imports of medical devices into India continue to rise year-on-year. Last financial year alone, imports surged by 17 per cent, reaching `89,000 crore compared to `76,000 crore the previous year. This trend underscores the urgent need to strengthen domestic manufacturing.
AiMed also reasons that developing any high-technology medical equipment is inherently challenging. For Class C and D devices, obtaining drug manufacturing approval can easily take 9–15 months. During the gestation period, highly skilled staff remain underutilised 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, suggested Nath.
As these proposed policy amendments reveal, regulators are moving in the right direction. What needs to pick up is the pace of implementation.
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com