Indian MedTech industry raises alarm over refurbished device imports

New Delhi: Recent approvals permitting the import of refurbished and reconditioned medical devices have prompted debate within India’s healthcare and medical technology sector.

Industry representatives say the approvals raise questions around regulatory consistency, particularly as the Central Drugs Standard Control Organisation (CDSCO) has stated that refurbished medical equipment is not permitted for import under the current Medical Devices Rules and the matter is presently before the courts. They add that overlapping permissions could create uncertainty in regulation and affect competition for domestic manufacturers.

Manufacturers point out that the move undermines Indian innovators who have developed advanced platforms—including surgical robotic systems—entirely within the country. Allowing the entry of depreciated foreign equipment that has already completed much of its commercial lifecycle elsewhere threatens to flood the market with outdated technology. India, they caution, must not become a dumping ground for medical electronic waste disguised as refurbished equipment.

Rajiv Nath, Forum Coordinator, AiMeD, said the decision by the Ministry of Environment, Forest & Climate Change (MoEFCC) to permit limited imports of pre-owned medical equipment conflicts with national policy objectives. He noted that while India discourages the import of used consumer products to protect domestic manufacturing, similar safeguards are not being applied to medical devices, despite higher patient safety and environmental risks. Nath urged the Ministry of Health & Family Welfare and CDSCO to withhold import licences for refurbished equipment to protect both patients and entrepreneurs encouraged by the Production Linked Incentive (PLI) scheme.

Echoing these concerns, Gaurav Agarwal, Managing Director, Innvolution Healthcare, said the inflow of second-hand equipment represents an unregulated backdoor entry that compromises patient safety and erodes domestic manufacturing. He highlighted that much of the refurbished inventory comprises obsolete or near end-of-life machines rejected by developed markets. Agarwal questioned whether exporting countries would take responsibility for safe disposal once these machines fail, warning that India would otherwise bear the environmental and economic burden.

Viswanathan Santhanagopalan, Managing Director, Sequoia Healthcare, pointed to structural disadvantages faced by Indian manufacturers, including government tenders that prioritise foreign certifications over Indian standards and identical import duties for new and used equipment. He added that the absence of a comprehensive regulatory framework for used-device sales and third-party servicing poses patient safety risks and weakens compliant domestic players.

R.S. Kanwar, Director – Overseas Operations, Allengers Medical Systems, said refurbished equipment often carries outdated technology, unpredictable performance, and limited spare-part support, increasing breakdowns and diagnostic inaccuracies. He warned that lowering technological benchmarks at a time of rapid healthcare advancement would undermine long-term clinical outcomes and industry growth.

Srinivasa Reddy, Senior Vice President, SS Innovations, said permitting refurbished imports sends the wrong signal to manufacturers who have invested heavily in building globally competitive technologies in India. He stressed that approvals granted outside established regulatory processes compromise patient safety and create unfair advantages, urging an immediate rollback.

Stakeholders have also flagged a regulatory contradiction: while India penalises older vehicles on environmental grounds, refurbished medical devices—despite directly affecting patient lives—are being permitted. Medical devices, they argue, warrant even stricter oversight.

The controversy follows MoEFCC’s decision to allow imports of refurbished high-value equipment such as robotic surgical systems, MRI and CT scanners. Industry representatives say this undermines Make in India and places domestic innovators at a severe disadvantage after years of R&D investment.

Patient safety advocates have further noted 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. The CDSCO, in a clarification dated 10 January 2025, reiterated that such imports are not permitted under existing rules, exposing a direct conflict between regulatory authorities.

Concerns have also been raised over enforcement consistency, with reports that one company granted fresh approvals had previously imported refurbished equipment without mandatory clearances—an issue currently before the court.

Industry leaders have urged MoEFCC to revoke the recent approvals, align policy with CDSCO’s regulatory framework, and prevent India from becoming a destination for obsolete medical technology. They emphasise that refurbished devices—often cosmetically upgraded but technologically outdated—cannot match the reliability, lifespan, service support, or safety of new equipment, potentially affecting diagnostic accuracy, surgical outcomes, and overall quality of care.