The Department of Pharmaceuticals under the Centre has called for input from stakeholders regarding proposed changes to the Global Tender Enquiry (GTE) Exemption List for Medical Devices. Stakeholders were invited to share their views on the existing list after a public notice was issued on February 11. Various parties, including domestic manufacturers, importers, and healthcare institutions, have been urged to submit their feedback by July 15 through email.
Stakeholders have been requested to provide relevant information to support their comments or objections, such as details on domestic manufacturing capacity, the number of manufacturers and importers, and annual production capacity in India. Additionally, they are asked to address issues like import dependence, availability of alternative sources, standards compliance, and potential impacts on public procurement and healthcare quality.
The Department emphasized the need for stakeholders to submit comments or objections in the prescribed format against the relevant entries in the list. The GTE Exemption List allows public hospitals and government agencies to procure foreign-made medical equipment through global tenders, bypassing the usual restrictions on purchases exceeding Rs 200 crore to promote domestic manufacturing.
This regulatory framework ensures that critical healthcare facilities have access to advanced medical technologies that may not be domestically manufactured at the required quality or scale. The Department highlighted that comments or objections lacking adequate supporting information and those received after the deadline may not be considered for amendments.
