New Delhi, June 23 (IANS) The Centre’s Department of Pharmaceuticals has invited comments from stakeholders on the proposals received for amendments to the Global Tender Enquiry (GTE) Exemption List of Medical Devices.

Following a public notice, issued on February 11, seeking feedback on the existing GTE Exemption List, the Department received representations from various stakeholders requesting addition, deletion or modification of entries under the list.

All stakeholders concerned, including domestic manufacturers, importers, industry associations, procurement agencies and healthcare institutions, have been requested to submit their comments, views, or objections, if any, along with supporting information on or before July 15 through email at usmedicaldevices@pharma-dept.gov.in with a copy to so-medicaldevices@pharma-dept.gov.in, according to an official statement issued on Tuesday.

While submitting comments or objections, stakeholders are requested to furnish relevant supporting information in the justification, wherever applicable, including availability or non-availability of domestic manufacturing capacity; details and number of domestic manufacturers and importers; annual production and supply capacity within India, it said.

Other information required to be submitted includes import dependence and availability of alternative sources; applicable standards, certifications, and regulatory approvals; procurement-related issues, if any; likely impact on public procurement, patient access, availability, affordability, and quality of healthcare services.

Besides any other technical, clinical, regulatory, commercial, or procurement-related justification can also be submitted, the official statement said.

Comments and objections may be submitted in the prescribed format against the provided relevant entries (column ‘E’ to ‘I’). The subject line of the email should be clearly mentioned as: “Comments/Objections on Proposed Amendments to the GTE Exemption List of Medical Devices”.

The statement also mentions that comments or objections received after the stipulated date or without adequate supporting information may not be considered.

The GTE Exemption List of Medical Devices is a regulatory framework that permits public hospitals and government procurement agencies to float global tenders and purchase foreign-made medical equipment.

Normally, the government restricts global tenders for purchases under Rs 200 crore to promote domestic manufacturing under the Make in India and Atmanirbhar Bharat initiatives. However, the GTE exemption list bypasses these restrictions, allowing foreign suppliers to bid. The primary criterion for inclusion on the exemption list is that the specific medical device is not manufactured domestically at the required quality or scale.

It ensures that critical care facilities, government hospitals, and research institutes have uninterrupted access to advanced, life-saving, and specialised medical technologies

–IANS

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