India's Medical Device Sector Grapples with Refurbished Imports Amid Trade Talks
As India advances its bilateral trade agreements, the importation of refurbished medical equipment has become a highly contentious issue within the medical devices industry. Domestic manufacturers are raising alarms about potential patient safety hazards and unfair market competition, while multinational corporations are pushing for a globally-aligned regulatory framework to permit these imports under strict oversight.
Government Committee and Intensified Debate
Recently, the health ministry established a committee to develop a policy for imported refurbished medical devices, a move that has heightened concerns among local players. Industry sources indicate that this debate has gained momentum alongside India's trade negotiations with the United States. "The push has come into sharper focus as India negotiates a trade deal with the US, which could include market access for such medical devices over the next few years," they stated.
Import Statistics and Regulatory Gaps
Total imports of medical devices in India last year reached Rs 76,000 crore, with Rs 48,000 crore attributed to medical electronics. It is estimated that approximately one-third of these imports consist of illegal pre-owned medical equipment. Industry experts have noted that such imports have been occurring for years without adequate regulatory supervision, posing significant risks.
Domestic Opposition and Safety Concerns
The Association of Indian Medical Device Industry (AiMeD) has strongly opposed any relaxation of policy restrictions on importing refurbished medical equipment. Rajiv Nath, Forum Coordinator of AiMeD, emphasized the dangers, stating, "In the absence of proper calibration, refurbished devices are highly unsafe for patients. They pose risks from unknown histories, inconsistent performance, limited traceability, and shortened lifespans." He urged India to prioritize new, indigenously-manufactured devices under the 'Make in India' initiative and the Medical Devices Policy, rather than becoming a dumping ground for end-of-life equipment.
Support from Multinational Corporations
In contrast, the Medical Technology Association of India has welcomed the government's move. Its chairman, Pavan Choudary, advocated for a time-bound, globally-aligned policy, saying, "As India actively pursues free trade agreements, we urge the adoption of a framework that permits refurbished devices only when managed through original equipment manufacturers. This ensures clear legal accountability, robust service support, and stringent patient safeguards."
Industry Voices and Growth Concerns
Sunil Khurana, executive chairman of BPL Medical, argued that the growth of domestic production under the Production Linked Incentive (PLI) scheme necessitates the rejection of these imports. Similarly, Sudhir Srivastav, CMD of SS Innovations, a robotic surgery firm, warned, "Allowing refurbished medical equipment without a globally benchmarked regulatory framework introduces unacceptable patient risk."
This ongoing debate underscores the complex balance between fostering international trade and ensuring domestic safety and economic growth in India's rapidly evolving medical device sector.
