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Updated At: Sep 15, 2022 07:26 AM (IST)

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India's growing dependence on imports for critical medical devices has led the Parliamentary Committee on Health to demand a standalone legislation to regulate the sector and a separate regulator to create a pathway for faster approvals to quality products.

India imports 88 per cent of the implants, 63 per cent of all surgical instruments and 52 per cent of electronic equipment, including CT scans and MRIs.

The import of medical devices has been rising and increased from USD 6,240.55 million in 2020-21 to USD 8,539.5 million in 2021-11, while exports rose only very marginally over the corresponding period from USD 2,532 million to USD 2,923.16 million.

Almost 80 per cent (by value) of the domestic medical devices requirements are met by imports, with the House committee, in its latest report on the need for self-reliance in the sector, asking the government to provide incentives or encourage preferential purchase for domestically manufactured products in government procurement. The Health Ministry has, meanwhile, formed a panel to draft the new Drugs, Medical Devices and Cosmetics Bill and has no plans to have a separate law for medical devices, which are defined as drugs under the Drugs and Cosmetics Act, 1940, and regulated as such.

“The department should ensure that in all public procurement, preference is given to Indian-manufactured medical devices having domestic content of at least 50%,” said the committee. It said three segments — electronic equipment, implants and surgical instruments —account for highest imports in the medical devices sector. “These segments include highly important and widely used high-end technology devices, such as CT scanners, MRI, ultrasound and X-Ray machines, knee and hip implants, dental fixtures, cancer diagnostics and other surgical instruments. Manufacturing of high-end technology devices would require an evolved medical devices sector having a robust research and development infrastructure,” the report of the panel titled “Medical Devices: Regulation and Control” said.

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