New Delhi: The Union Well being Ministry’s plan to manage using refurbished high-end medical gadgets, amid a blanket ban on their imports, has drawn robust opposition from the home MedTech companies in India.
Responding to a question within the Rajya Sabha final week, Anupriya Patel, Minister of State, Ministry of Well being and Household Welfare, shared that the ministry has constituted a committee on ‘Coverage on regulation of refurbished medical gadgets’.
The committee will study “the scope of refurbished medical gadgets, methodology to guage the security, efficiency, and remaining helpful lifetime of refurbished medical gadgets & counsel steerage for waste disposal of such refurbished gadgets.”
Nevertheless, citing threat to affected person security and menace to native producers, the Affiliation of Indian Medical Machine Business (AiMeD) in a press release mentioned, “We strongly oppose any transfer to rethink or chill out coverage restrictions on importing refurbished or pre-owned medical gear, particularly and not using a sturdy, enforceable regulatory framework benchmarked to world requirements like IMDRF.”
“We urge the federal government to uphold the ban, implement CDSCO oversight, and bolster native innovation for a protected healthcare future,” the physique added.
Talking for home companies, Rajiv Nath, Discussion board Coordinator, AiMeD mentioned, “Nations like Indonesia, Thailand, China, completely disallow such imports to safeguard public well being and India should prioritise new, indigenously manufactured gadgets underneath Make in India, Atmanirbhar Bharat, and the Medical Units Coverage, reasonably than turning into a dumping floor for end-of-life gear.”
With excessive finish gadgets similar to surgical robots, Dr Sudhir Srivastav, CEO and Chairman, SS Improvements, added, “such gadgets are utilized in procedures that require precision-driven self-discipline, and allowing refurbished or pre-owned medical gear and not using a globally benchmarked regulatory framework introduces unacceptable scientific threat.”
In the meantime, Pavan Choudary, Chairman, Medical Expertise Affiliation of India (MTaI), a MNC consultant, mentioned, “The federal government’s resolution to arrange a committee to border a coverage on refurbished medical gadgets can place India as a premier electronics restore hub for the International South.”
“It would facilitate superior coaching for healthcare staff in Tier-2 and Tier-3 cities and strengthen the Electronics Restore Companies Outsourcing (ESRO) initiative,” he added.
The import of refurbished medical gadgets has lengthy been some extent of competition between native and multinational producers.
Worldwide gamers contend that refurbishing gear can scale back prices for hospitals and finally profit sufferers, home companies nevertheless, stress that it might undermine their development transition from high-volume to high-value segments.
Over potential price advantages for sufferers, Nath mentioned, “clinics not often disclose the lifespan of their gadgets and the discounted utility of decade-old gear—similar to a pre-owned dialysis machine, CT scanner, or MRI—in contrast with a brand new gadget in the identical facility is seldom clear.”
In 2023, India allowed the import of refurbished medical gadgets after the Ministry of Surroundings, Forest and Local weather Change (MoEFCC) framed it as a measure to help the nation’s e-waste administration efforts.
Nevertheless, citing coverage ambiguities, the central regulatory authority, CDSCO, later disallowed their import, informing the Director Basic of Customs that no provision at the moment permits such imports.
The marketplace for refurbished medical gadgets in India is estimated to account for round 10 per cent of the whole market and is basically concentrated in Tier-2 and Tier-3 cities.
AiMed representatives declare that, whereas India’s whole medical gadgets is estimated at round Rs 76,000 crore (2025), the trade sees an “unauthorised commerce of Rs 12-15000 crore value preowned medical gear with none regulatory oversight is ongoing.”
Notably, in 2024, a affected person advocacy group, the Affected person Security and Entry Initiative of India Basis (PSAIIF) had filed a public curiosity litigation within the Delhi Excessive Court docket, elevating issues over the large-scale unlawful import of high-end and high-value used medical gear apart from important care, (Refurbished HEHV medical gear).
The PIL was later rejected, noting that there are not any provisions underneath the present laws.
Globally, regulated markets such because the US and EU allow using refurbished medical gadgets, which account for roughly 7–9% of whole medical gear volumes.
Different developed states like Japan, UK, Australia and many others. allow the import and sale of pre-owned medical gear in accordance with their laws.
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