Daijiworld Media Network - New Delhi
New Delhi, Jun 23: The Department of Pharmaceuticals under the Central government has invited comments and objections from stakeholders regarding proposed amendments to the Global Tender Enquiry (GTE) Exemption List for Medical Devices.
In an official statement issued on Tuesday, the department said it had received multiple representations from industry stakeholders seeking additions, deletions and modifications to the existing exemption list following a public notice issued on February 11.
The ministry has now called upon all concerned parties, including domestic manufacturers, importers, industry associations, procurement agencies and healthcare institutions, to submit their views before July 15.
Stakeholders have been asked to send their responses via email to usmedicaldevices@pharma-dept.gov.in, with a copy marked to so-medicaldevices@pharma-dept.gov.in.
The government has requested that all comments or objections be supported by relevant data and evidence wherever applicable.
Information sought includes details regarding the availability or absence of domestic manufacturing capacity, the number of Indian manufacturers and importers, and the annual production and supply capability within the country.
Stakeholders have also been asked to provide information related to import dependence, alternative sources of supply, applicable standards and certifications, regulatory approvals and any procurement-related challenges.
The department said submissions should additionally assess the potential impact on public procurement systems, patient access, affordability, availability and the overall quality of healthcare services.
Technical, clinical, regulatory, commercial and procurement-related justifications may also be included to support the recommendations.
Comments and objections must be submitted in the prescribed format against the relevant entries listed in columns E to I of the proposal document.
The subject line of the email should clearly state: “Comments/Objections on Proposed Amendments to the GTE Exemption List of Medical Devices.”
The department cautioned that submissions received after the deadline or without adequate supporting information may not be considered.
The Global Tender Enquiry (GTE) Exemption List is a policy mechanism that allows government hospitals and public procurement agencies to invite global bids for specific medical devices and purchase equipment from international suppliers.
Under existing rules, the government generally restricts global tenders for procurements below ?200 crore to encourage domestic manufacturing under the Make in India and Atmanirbhar Bharat initiatives.
However, devices included in the GTE exemption list are exempt from these restrictions, enabling foreign companies to participate in the bidding process.
The primary basis for granting an exemption is the absence of adequate domestic manufacturing capability, either in terms of quality, scale or technological sophistication.
The framework is designed to ensure that government hospitals, critical care centres and research institutions continue to have uninterrupted access to advanced, specialised and life-saving medical technologies that may not yet be sufficiently available within the country.