New Delhi, Jan 17 Medical device manufacturers on Friday hailed the Central Drugs Standard Control Organization’s (CDSCO) move to stop imports of refurbished medical devices.
In a letter dated January 10, the CDSCO asked the customs office to not let refurbished medical devices enter the country. The move was aimed at curtailing the influx of such unregulated products.
"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,” read the letter from CDSCO to the Office of Principal Commissioner of Customs, New Delhi.
The Association of Indian Medical Device Industry (AiMeD) argued that the healthcare security of the country is already compromised with about 70 per cent of the current medical device requirements being met through imports.
These imports without any regulatory controls had further jeopardised the sector as nearly 60 per cent of the Rs 40,000 Crore of imports of medical electronic equipment were estimated to be of preowned equipment being dumped into India.
“We welcome MNCs to invest in India and make high technology equipment and make these affordable to the Indian patients as is being done in mobile phones and the automobile sector. A healthy competition is welcome,” said Rajiv Nath, Forum Co-Ordinator, AiMeD.
The domestic medical device manufacturers have been protesting 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.
“At a time when the domestic industry is already grappling with issues like negligible import tariff of 0 to 7.5 per cent on medical devices in India, allowing import of refurbished devices had further acted as a deterrent to the entrepreneurial spirits of the domestic manufacturing industry making India severely imports dependent,” Nath said.
AiMeD has demanded the import duties to be in the range of 10-15 per cent for medical devices to provide a level playing field to the domestic manufacturers.
Dr. Sudhir Srivastava, Past Chair of the Medical Device Committee at PHDCCI called the decision by CDSCO “a pivotal step towards reinforcing India’s self-reliance in medical technology”.
“Allowing refurbished medical devices into the country would have jeopardised the quality of healthcare, disincentivised local innovation, and undermined the spirit of the ‘Make in India’ initiative,” Srivastava added. The expert noted that Indian manufacturers are making significant strides in R&D, delivering cutting-edge solutions tailored to our healthcare needs.
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The experts noted that CDSCO’s move will safeguard both the future of healthcare innovation in India and the well-being of our patients.
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