Recent approvals permitting the import of refurbished and reconditioned medical devices have sparked widespread concern across India’s healthcare ecosystem. Over the past decade, the country has invested heavily in indigenous research, engineering, and manufacturing to develop world-class medical technologies under the “Make in India” vision. Against this backdrop, granting such approvals threatens to erode regulatory credibility and disrupt a carefully built domestic innovation landscape.
Moreover, despite the Central Drugs Standard Control Organisation (CDSCO) clearly prohibiting the import of refurbished medical equipment—and with the issue currently sub judice before the courts—these approvals risk creating regulatory inconsistency and an uneven playing field for Indian manufacturers.
Undermining Domestic Innovation and Manufacturing
Not only does the influx of refurbished equipment weaken India’s medical device industry, but it also directly undermines innovators who have developed advanced technologies, including surgical robotic systems, entirely within the country. At the same time, the Ministry of Environment, Forest & Climate Change’s (MoEFCC) decision to allow such imports carries significant implications for domestic manufacturing.
While Indian companies continue to design cutting-edge, globally competitive devices, the entry of depreciated foreign machines threatens to flood the market with technologies that have already exhausted their commercial lifecycle elsewhere. Consequently, India risks becoming a dumping ground for obsolete medical electronic waste under the guise of refurbishment.
Industry Leaders Voice Strong Objections
Rajiv Nath, Forum Coordinator, AiMeD, stated that the Expert Committee’s decision at MoEFCC to allow select traders to import pre-owned medical equipment is deeply concerning. According to him, this move contradicts earlier national policy decisions aimed at preventing India from becoming an e-waste dumping ground and undermines the National Medical Devices Policy, which seeks to attract greenfield investments, boost local manufacturing, and reduce import dependence. He further expressed hope that the Ministry of Health & Family Welfare and CDSCO would deny import licences for pre-owned equipment to protect patient safety and the entrepreneurs encouraged under the Department of Pharmaceuticals’ Production Linked Incentive (PLI) scheme. Drawing a parallel, he questioned why predictable protections applied to pre-owned phones or cars are not extended to medical equipment imports.
Similarly, Gaurav Agarwal, Managing Director, Innvolution Healthcare Pvt Ltd, warned that the unchecked inflow of refurbished and second-hand medical equipment represents an unregulated backdoor entry that compromises patient safety and systematically dismantles India’s domestic manufacturing ecosystem. He noted that much of this inventory consists of obsolete or near end-of-life equipment already discarded by developed markets. While the Prime Minister has articulated a clear vision for Make in India and Atmanirbhar Bharat in healthcare, continued tolerance of such imports, he argued, directly sabotages this national mission. Agarwal also raised critical environmental concerns, questioning whether exporting countries would reclaim these machines at the end of their life or leave India to bear the disposal, safety, and economic burden.
Policy Inconsistencies and Tendering Challenges
Adding to these concerns, Mr. Viswanathan Santhanagopalan, Managing Director, Sequoia Healthcare, highlighted systemic disadvantages faced by Indian manufacturers in government tenders. He pointed out that tenders often demand unnecessary advanced features and foreign certifications such as CE or FDA approvals, while overlooking Indian standards like BIS. This approach, he noted, contradicts the Atmanirbhar Bharat agenda.
Furthermore, identical import duties on new and used medical equipment allow refurbished global systems to compete directly with high-value Indian devices. As a result, domestic demand weakens, and local innovation and scale-up efforts suffer. Compounding the issue, the absence of a comprehensive regulatory and safety framework for used equipment and third-party service providers creates patient safety risks and enables an unregulated market that erodes the competitiveness of compliant Indian manufacturers.
Patient Safety at Risk
R.S. Kanwar, Director – Overseas Operations, Allengers Medical Systems Ltd., emphasised that importing refurbished medical equipment poses a direct threat to patient care quality and safety. He explained that such machines often rely on outdated technology, deliver unpredictable performance, and lack reliable spare-part support. Frequent breakdowns and compromised diagnostic accuracy, he warned, can have serious consequences during critical procedures. Instead of lowering technological benchmarks, Kanwar urged India to prioritise modern, efficient, and locally manufactured equipment that ensures long-term reliability and better clinical outcomes.
Echoing this view, Srinivasa Reddy, Senior Vice President, SS Innovations, stated that allowing refurbished devices at this stage sends the wrong signal to manufacturers who have invested years in building world-class technologies domestically. He stressed that approvals granted outside the established regulatory framework place patient safety at direct risk. With CDSCO clearly prohibiting such imports, parallel permissions only create confusion and unfair advantages. Reddy strongly called for an immediate reversal of these approvals.
Regulatory Contradictions and Legal Challenges
What further intensifies concern is the clear regulatory contradiction. CDSCO, the sole statutory authority for medical devices, has clarified that refurbished devices cannot be imported under the current Medical Device Rules. Yet, allowing refurbished medical equipment while penalising even 10-year-old vehicles on environmental grounds highlights a stark inconsistency. Given that medical devices directly impact patient lives, stakeholders argue that they must adhere to even stricter standards.
In addition, the Patient Safety and Access Initiative of India Foundation has filed a writ petition before the Hon’ble Delhi High Court seeking a ban on refurbished imports. The petition warns that India risks becoming a dumping ground for used medical equipment. Notices have already been issued to multiple ministries, and the matter remains under judicial consideration. CDSCO’s clarification dated 10 January 2025 further exposed the direct conflict between existing regulations and MoEFCC’s recent approvals.
Questions on Enforcement and Accountability
As per the press release, industry representatives have also raised alarms over enforcement consistency. Notably, one company recently approved by MoEFCC had earlier imported refurbished medical devices worth several crores without the required approvals—a violation currently under judicial scrutiny. Despite this history of non-compliance, authorities granted fresh approval, prompting serious questions about regulatory enforcement and the message conveyed to potential violators.
Call for Immediate Corrective Action
Finally, stakeholders emphasise that refurbished devices—despite repairs and cosmetic upgrades—cannot match the reliability and performance of new equipment. New medical devices typically maintain optimal functionality over a ten-year lifecycle, whereas refurbished systems often suffer diminished performance due to prior use. In addition, such devices usually lack the latest technological advancements, come with limited warranties, inadequate service support, and higher failure rates, all of which can negatively affect treatment quality and surgical outcomes.
Therefore, industry leaders and patient safety advocates have urged MoEFCC to immediately reconsider and revoke the recent approvals. They have also called for alignment with CDSCO’s regulatory framework to protect patient safety and safeguard India’s rapidly growing medical device manufacturing ecosystem.