Halt import of refurbished medical devices: Drug regulator to Customs Dept

India’s drug regulator Central Drugs Standard Control Organisation (CDSCO) has asked the Customs Department to prevent the entry of refurbished medical devices, in a move to curb the entry of unregulated products.

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In a letter to the Principal Commissioner of Customs, the CDSCO said there was no specific provision for regulation of refurbished devices.

“All the medical devices are regulated under the Medical Devices Rules, 2017. However, there is no specific provision for regulation of refurbished medical devices under the said rules. Hence, no licence is issued for import of such devices and it cannot be imported under Medical Devices Rules for sale and distribution,” the CDSCO said.

There has been a growing concern about the import of refurbished medical devices. Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a PIL in the Delhi High Court, highlighting concerns about reliability of these devices and the risks to patient safety.

Gaurav Agarwal, managing director, Innvolution Healthcare, said, “This decisive clarification reinforces the regulatory framework designed to ensure the highest standards of patient safety.”

Dr Sudhir Srivastava, past chair of the Medical Device Committee at PHD Chamber of Commerce and Industry, said, “Allowing refurbished medical devices would have jeopardised the quality of healthcare, disincentivised local innovation and undermined ‘Make in India’.”