The recent approvals granted for the import of refurbished and reconditioned medical devices raise serious concerns for India’s healthcare ecosystem, which has invested years of indigenous research, engineering, and manufacturing to build world-class technologies under the “Make in India” vision. Despite CDSCO’s clear ban on the import of refurbished medical equipment and with the matter currently sub judice before the courts such approvals risk undermining regulatory integrity and creating an uneven playing field for domestic innovators.
This practice not only weakens the domestic medical device industry but actively undermines the work of innovators who have built advanced platforms such as surgical robotic systems ground-up in India. This has critical implications of MoEFCC’s decision to permit refurbished medical equipment Imports. While Indian manufacturers continue to create cutting-edge, globally competitive devices, the entry of old, depreciated, foreign machines threatens to flood the market with technology that has already lived its commercial life elsewhere. India cannot afford to become a dumping ground for medical electronic waste under the guise of refurbished equipment.
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 and CDSCO will not allow import Liscense 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 – 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?“
Gaurav Agarwal, Managing Director, Innvolution Healthcare, said, “The unchecked inflow of refurbished and second-hand medical equipment into India is an unregulated backdoor entry that seriously compromises patient safety and systematically destroys India’s domestic medical manufacturing ecosystem. A large part of this refurbished inventory consists of obsolete or near end-of-life equipment that has already served its full utility in developed markets. While Prime Minister Narendra Modi has laid a clear and ambitious vision for Make in India and Atmanirbhar Bharat in healthcare, the continued tolerance of such imports directly sabotages this national mission. 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? This practice not only discourages Indian innovation and investment but also sends a dangerous message that Indian patients deserve lower standards. If this continues, it will cripple our goal of building a world-class, self-reliant medical device industry and severely undermine India’s healthcare sovereignty.”
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. 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.”
R.S. Kanwar, Director Overseas Operations, Allengers Medical Systems, 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. At a time when India is rapidly advancing its healthcare capabilities, we must avoid lowering the technological benchmark by depending on obsolete imports. Instead, our 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. India must not become a dumping ground for outdated equipment. We strongly urge an immediate reversal of these approvals.”
What makes the matter more concerning is the regulatory contradiction: CDSCO the only statutory authority for medical devices has already clarified that refurbished devices cannot be imported under current Medical Device Rules. Allowing refurbished imports while penalising 10-year-old vehicles for environmental risk exposes a stark inconsistency. Medical devices, which directly impact patient lives, must adhere to even stricter standards.
India’s medical device industry and patient safety advocates have raised urgent concerns over the recent decision of the Ministry of Environment, Forest & Climate Change (MoEFCC) to permit the import of refurbished and reconditioned medical devices, including robotic surgical systems, MRI machines, CT scanners and other high-value equipment. Manufacturers state that such imports undermine the “Make in India” initiative and place domestic innovators who have invested years of R&D and significant resources in developing advanced technologies at a severe disadvantage.
Stakeholders have also highlighted that 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, 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 Central Drugs Standard Control Organisation (CDSCO) issued a clarification on 10 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.
A particularly concerning issue raised is that one of the companies newly approved by MoEFCC had previously imported refurbished medical devices worth several crores without any required approvals a violation currently before the Hon’ble Court. Despite this non-compliance, fresh approval has been granted to the same company, raising questions about enforcement consistency and the message sent to potential violators.
Industry representatives warn that importing unregulated and previously used medical equipment poses serious risks to patient safety. 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. Immediate corrective action, they say, is essential to protect patients and safeguard India’s growing medical device manufacturing ecosystem.
Refurbished devices, which undergo repairs and cosmetic updates, cannot replicate the functionality and reliability of new equipment. New medical devices maintain optimal performance throughout their lifecycle, typically lasting around ten years, while refurbished options may show diminished functionality due to prior use. Additionally, refurbished devices often lack the latest technological advancements and come with lower warranties, inadequate service support, and higher failure rates, all of which can impact the quality of treatment and surgical outcomes.