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Drug Regulator Urges Halt on Illegal Imports

New Delhi: India’s drug regulatory authority has directed the Customs office to halt the entry of refurbished medical devices into the country. This measure aims to curb the influx of unregulated products and ensure compliance with safety and quality standards.

In a letter addressed to the Principal Commissioner of Customs, India’s drug regulatory authority clarified that refurbished medical devices cannot be imported for sale and distribution under the existing Medical Devices Rules, 2017, as there are no provisions for their regulation. The letter, dated January 10, also highlighted that no licences are issued for the import of such devices.

Concerns have been mounting over the increasing influx of refurbished medical equipment into India. Domestic medical device manufacturers argue that these imports often bypass proper certification, posing significant risks to patient safety.

Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a public interest litigation in the Delhi High Court, highlighting concerns about reliability of these devices and the risks to patient safety. The clarification by the regulator is a “welcome move and a huge ‘Make in India’ investment enabler”, said Rajiv Nath, the forum coordinator at the Association of Indian Medical Device Industry.

He said India does not even permit import of pre-owned cars or iPhones, hence there is a huge need for this intervention. “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,” Nath added

News Sources: https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/halt-illegal-imports-of-refurbished-medical-gear-drug-regulator/articleshow/117310629.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

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