Domestic Medical Device Leaders cry foul against move to do away with Policy Restrictions
New Delhi: The union government mandarins seem to be at it again, diametrically opposed to Prime Minister Narendra Modi’s categorically stated stand. ‘Import of refurbished medical devices’ lobby has again reared its ugly head to kill ‘Make in India’ triumphs in medical device domain. Seeing move to surreptitiously get policy restrictions on import of second hand medical devices done away with, domestic medical device leaders and make in India enthusiasts have cried foul and have said in no uncertain terms that patient safety, clinical outcomes, and public trust are non-negotiable. They say there is serious patient safety aspect involved.
The government has put policy restrictions on import of second hand medical devices to shelter genuine and world class ‘made in India’ medical devices but, in cahoots with some government officials, the import lobby is out to get those restrictions removed. If they succeed, India will be dumped with second hand medical devices to the utter detriment of Indian patients and ‘Make in India’ enthusiasm. It will be rank negation of lofty aims of Atmanirbhar Bharat and Viksit Bharat.
The Association of Indian Medical Device Industry (AiMeD) has strongly opposed any move to reconsider or relax policy restrictions on importing refurbished or pre-owned medical equipment, especially without a robust, enforceable regulatory framework benchmarked to global standards like IMDRF. AiMeD has urged the Government to uphold the ban, enforce CDSCO oversight, and bolster local innovation for a safe healthcare future.
Rajiv Nath, Forum Coordinator, AiMeD has said, ‘ Patient safety, clinical outcomes, and public trust remain non-negotiable. Refurbished devices pose risks from unknown histories, inconsistent performance, limited traceability, and shortened lifespans—issues unverifiable through post-facto checks alone. Just as Prime Minister Narendra Modi rejected imports of pre-owned Apple iPhones, urging Apple and Foxconn to establish manufacturing plants in India—much like for car manufacturers—healthcare demands even stricter vigilance, where lives hang in the balance. Countries like Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan, and Peru totally disallow such imports to safeguard public health. India must prioritize new, indigenously manufactured devices under Make in India, Atmanirbhar Bharat, and the Medical Devices Policy, rather than becoming a dumping ground for end-of-life equipment.’
He has added, ‘For Indian equipment, beyond extended warranties and AMCs, AiMeD calls for MDR amendments treating remanufacturing/refurbishing as unique, traceable batches—released only after individual calibration, testing, and recall mechanisms, akin to new equipment batches.’
PLI scheme beneficiaries echo this amid CDSCO regulatory enforcement review confusion and ongoing unchecked open resale in large volumes. “Consistent policy support, not import liberalization, will scale our Cathlab imaging innovations,” says Gaurav Aggarwal, MD, Involution Technologies.
“Robotic surgery is a precision-driven discipline where safety, reliability, and traceability are non-negotiable. Allowing refurbished or pre-owned medical equipment without a globally benchmarked regulatory framework introduces unacceptable clinical risk. India must strengthen indigenous innovation under Make in India, not open doors to uncertain, end-of-life technology.” reaffirmed Dr. Sudhir Srivastav, CMD, SS Innovations and creator of best in class Made in India surgical robot SSiMantra
‘It’s a fallacy that consumers gain from affordable access by pre-owned equipment. Does any clinic display the life of equipment? The last calibration date ? The discounted rate of utility of a decade old equipment like a pre-owned dialysis machine or a CT or MRI versus a new one in same facility ? “ added Mr Nath .
“BPL’s growth under PLI demands rejection of these imports,” asserted Mr Sunil Khurana Executive Chairman, BPL Medical.
Out of Rs 76000 Cr total import of medical devices last year 48000 Cr Rs is medical electronics. It is estimated Rs 12-15000 Cr of unauthorized trade of pre-owned medical equipment without any regulatory oversight is ongoing- just google India Mart and be flooded with offers.
They have red flagged saying , ‘ This is highly unsafe for patients if no calibration being done and legalising it means good bye to any Make in india efforts and next pandemic we will again be scurrying for Indian make ventilators and oxygen concentrators etc.’
