The Union Ministry of Environment, Forest and Climate Change has recently given its green signal for import of refurbished and reconditioned medical devices. 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 and high-value used medical devices including CT and MRI scanners, and robotic surgery systems following application from some companies. The Environment Ministry’s decision to allow a few traders to import preowned medical equipment is in direct conflict with the 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 greenfield projects to encourage manufacturing of medical devices and reduce the country’s ever-increasing import bills and dependence. It may be recalled that the Central Drugs Standard Control Organisation had 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 Environment Ministry’s recent approvals. Besides, the issue is now sub judice as the Patient Safety and Access Initiative of India Foundation had 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 as of now. There can be no two opinions about the fact that allowing refurbished medical devices into India at this stage will send the wrong message to the manufacturers who have invested years in building world-class technologies domestically. Besides, approvals granted outside the established regulatory framework will put patient safety at direct risk. When the Central Drugs Standard Control Organisation has clearly stated that refurbished devices cannot be imported under Medical Devices Rules, parallel permissions will only create confusion and unfair advantage.
Quite understandably, the medical devices manufacturers led by the Association of Indian Medical Device Industry (AiMeD) are up in arms against the Union Environment Ministry’s approval for import of refurbished and reconditioned medical devices. The industry association argues that the recent decision will prove to be against the Modi government's 'Make in India' and 'Aatmanirbhar Bharat' initiatives, and will be a major setback for the domestic manufacturing capabilities of the medical devices industry which has shown some remarkable growth and investment in recent years under the 'Make in India' initiative. It is a fact that in recent years, the domestic medical devices industry has developed devices meeting international quality standards, which are widely used in both Indian and international healthcare institutions. Over the last ten years, India has shown significant growth in local content and has become export-oriented for many critical, high-end, and high-value medical devices. In such a background, the Environment Ministry’s decision to permit refurbished medical devices to compete with locally made new products sounds irrational as the Ministry’s latest salvo will prove to be a big blow to the nascent medical devices industry in the country, which is trying to stand on its own feet. The industry is apprehensive that the latest decision will open the ground for large-scale dumping of older technology and electronic waste from other countries. It is a fact that in a country like ours where laws are followed in its violation rather than compliance, there is always a risk of importing contaminated products which will hurt the interests of gullible patients. We cannot leave the poor patients at the mercy of sub-standard, obsolete and unreliable medical devices which have been discarded in other countries. The country should not be allowed to be the dumping ground for unsafe pre-owned medical equipment. There is some merit in the argument of the industry. The Union Health Ministry should immediately intervene in the matter. |