Industry split, govt reviews import policy on refurbished med devices

NEW DELHI: As India pushes ahead with bilateral trade agreements, the issue of importing refurbished medical equipment has emerged as a contentious flashpoint in the medical devices sector.

Domestic players have warned against easing restrictions, flagging patient safety risks and concerns over unfair competition, while MNCs are advocating a globally-aligned framework to allow wider access to refurbished devices under stringent regulatory oversight.Recently, the health ministry constituted a committee to frame a policy for imported refurbished med devices, raising concerns among domestic players.

Industry sources said the debate has intensified alongside India-US trade talks. "The push has come into sharper focus as India negotiates a trade deal with US, which could include market access for such med devices over next few years," they told TOI.Total imports of medical devices last year stood at Rs 76,000 crore. Of this, Rs 48,000 crore are med electronics, with an estimated one-third being illegal pre-owned medical equipment.

Such imports without any regulatory oversight have been ongoing for years, industry experts told TOI.Domestic industry body, Association of Indian Medical Device Industry (AiMeD) has opposed the move to relax policy restrictions on importing refurbished medical equipment, saying its highly unsafe for patients in the absence of inadequate calibration."In case of locally-made devices, refurbished imports should only be allowed with a robust, enforceable regulatory framework benchmarked to global standards.

Refurbished devices pose risks from unknown histories, inconsistent performance, limited traceability, and shortened lifespans. India must prioritise new, indigenously-manufactured devices under 'Make in India', and the Medical Devices Policy, rather than becoming a dumping ground for end-of-life equipment," Rajiv Nath, Forum Coordinator, AiMeD said.Rival firm, Medical Technology Association of India welcomed the govt move.

"As India actively pursues FTAs, we urge the adoption of a time-bound, globally aligned policy. Such a framework should permit the use of refurbished devices only when managed through original equipment manufacturers, ensuring clear legal accountability, robust service support and stringent patient safeguards," its chairman Pavan Choudary said.BPL's growth under PLI demands rejection of these imports, said Sunil Khurana, executive chairman, BPL Medical. "Allowing refurbished medical equipment without a globally benchmarked regulatory framework introduces unacceptable patient risk," Sudhir Srivastav, CMD, SS Innovations, a robotic surgery firm, said.