‘Contradicts Atmanirbhar Bharat’: CDSCO shuts door on refurbished medical device imports

India’s apex drug regulator Central Drugs Standard Control Organisation (CDSCO) has put an end to the vexed issue of the import of refurbished medical devices by clarifying that the current rules do not provide for granting licences for the import of such devices.

"There is no specific provision for regulation of refurbished medical devices under Medical Devices Rules 2017. Hence no licence is issued for import of such devices and it cannot be imported into the country for sale and distribution,” a communication from CDSCO to the Office of Principal Commissioner of Customs, New Delhi, on January 10 says.

The domestic medical device manufacturers have been protesting against the import of second-hand medical devices for several months stating the import of refurbished and pre-owned medical devices, despite similar devices being manufactured in India is against the government’s policy of encouraging “Atma Nirbhar” or self-reliance.

“A stop to import of refurbished medical equipment is a true policy intervention that will guard the domestic industry against dumping of equipment with uncertain quality, and will also help the patients in receiving appropriate medical care thereby bringing the best value of cost for them and for the payers, including insurance agencies. This is a welcome and much awaited long-due intervention,” Dr Jitendra Sharma, Managing Director, Andhra Pradesh Med Tech Zone (AMTZ), Vishakapatnam, says.

The problem arose after an office memorandum (OM) issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC) allowed the import of pre-owned medical equipment into India. Though the MoEFCC permission was with respect to e-waste management concerns, this approval was not in line with other regulators like CDSCO. While the CDSCO clarification will end the import of second-hand medical devices for now, the health ministry may have to come out with an unequivocal policy decision on the matter.

“We hope that the policy review underway at the Ministry of Health will consider alignment with National Medical Devices Policy 2023, which envisions India to emerge as the leading manufacturing hub of medical devices. We welcome MNCs to invest in India and make these high technology equipment in India and make these affordable to Indian patients as being done in mobile phones and the automobile sector. A healthy competition is welcome," Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices (AiMed), says. In October 2024, domestic medical device manufacturers had asked MoEFCC and the Health & Family Welfare (MoHFW) to review the permission given for such imports.