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Medical devices manufacturers led by the Association of Indian Medical Device Industry (AiMeD) has raised concerns over the decision of the ministry of environment, forest and climate change (MoEFCC) to approve import of refurbished and reconditioned medical devices despite the central drug regulator's restriction on imports and the matter being currently sub judice before the courts. They added that such approvals risk undermining regulatory integrity and creating an uneven playing field for domestic innovators.
The 151st meeting of the Expert Committee for Appraisal of Applications for Import/Export of hazardous and other wastes, held on November 12, 2025, has recommended import of refurbished or high end high value used medical devices including CT and MRI scanners, and robotic surgery systems following application from companies including Philips India, Wipro GE Healthcare, and ADN Services among others.
Rajiv Nath, forum coordinator, AiMeD, said, “The decision of the Expert Committee at MoEFCC to allow a few traders to import preowned medical equipment is very disconcerting and in conflict with earlier National Policy decisions whether from preventing India to be a dumping ground for e- waste or the National Medical Devices Policy that seeks to invite investment in green field projects to encourage manufacturing of medical devices and reduce our ever-increasing imports bills and dependence".
"We do hope that MoH&FW (ministry of health and family welfare) and CDSCO (Central Drugs Standard Control Organisation) will not allow import License for these pre owned equipment to safeguard patient safety concerns as well as of the brave entrepreneurs who had got motivated by Dept of Pharma’s PLI scheme...," added Nath.
"....we don’t allow preowned I- Phone or cars to protect domestic industry so why not same predictable principles being applied for medical equipment imports?“ he asked.
Gaurav Agarwal, managing director, Innvolution Healthcare Pvt Ltd, said, “India is being turned into a dumping ground for technologies rejected elsewhere. A critical question must be asked: when these machines finally reach the end of their life, will the country of origin take them back for safe disposal or is India expected to absorb the environmental, safety, and economic burden?"
He added that this practice not only discourages Indian innovation and investment but also sends a dangerous message that Indian patients deserve lower standards.
Viswanathan Santhanagopalan, managing director, Sequoia Healthcare, said, “Government tendering frequently disadvantages Indian HEHV device makers by demanding unnecessary advanced features and foreign certifications (CE, FDA) instead of relying on Indian standards like BIS. This undermines the Atmanirbhar Bharat agenda".
Identical import duties on new and used medical equipment allow refurbished global systems to compete directly with high-value Indian devices, suppressing domestic demand and discouraging local innovation and scale-up, he averred.
The absence of a comprehensive safety and regulatory framework for used equipment sales and third-party service providers creates patient safety risks and enables an unregulated market that erodes the competitiveness of compliant Indian manufacturers, maintained Santhanagopalan.
R.S. Kanwar, director overseas operations, Allengers Medical Systems Ltd., said, “As a responsible stakeholder in India’s healthcare industry, I believe the import of refurbished medical equipment poses a direct threat to the quality and safety of patient care in our country. These machines often carry outdated technology, unpredictable performance, and unreliable spare-part support, resulting in frequent breakdowns and compromised diagnostic accuracy."
Many refurbished systems do not meet the latest global safety standards, and their shorter lifespan and hidden defects create avoidable risks during critical medical procedures, he alleged. India's focus should be on adopting modern, efficient, and locally manufactured equipment that ensures long-term reliability, better clinical outcomes, and supports the growth of India’s medical technology ecosystem.
Srinivasa Reddy, senior vice president, SS Innovations, said, “Allowing refurbished medical devices into India at this stage sends the wrong message to manufacturers who have invested years in building world-class technologies domestically. Approvals granted outside the established regulatory framework put patient safety at direct risk. When CDSCO has clearly stated that refurbished devices cannot be imported, parallel permissions only create confusion and unfair advantage.”
Stakeholders have also highlighted that the Patient Safety and Access Initiative of India Foundation has filed a writ petition before the Delhi High Court seeking a ban on refurbished imports, warning that India risks becoming a dumping ground for used medical equipment. Notices have been issued to multiple ministries, and the matter remains sub judice.
Further, the CDSCO issued a clarification on 10th January, 2025 confirming that refurbished medical devices are not permitted for import under current Medical Devices Rules, exposing a direct conflict between regulatory policy and MoEFCC’s recent approvals.
They have urged MoEFCC to immediately reconsider and revoke the recent approvals, align decisions with CDSCO’s regulatory framework, and prevent India from becoming a destination for obsolete medical technology.
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