The Department of Pharmaceuticals (DoP) has invited stakeholders to submit comments on proposed amendments to the Global Tender Enquiry (GTE) Exemption List for medical devices.
The move follows a public notice issued on February 11, 2026, seeking feedback on the existing exemption list covering 354 medical devices. In response, the department received representations from various stakeholders requesting additions, deletions and modifications to the current list.
The DoP has called on all concerned stakeholders — including domestic manufacturers, importers, industry associations, procurement agencies, healthcare institutions and other interested parties — to provide comments, views or objections on the proposed amendments.
Stakeholders submitting feedback have been requested to include supporting information wherever applicable, including details on:
· Availability or non-availability of domestic manufacturing capacity
· Details and number of domestic manufacturers and importers
· Annual production and supply capacity within India
· 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
· Any other technical, clinical, regulatory, commercial, or procurement-related justification.
Comments and objections can be submitted by July 15, 2026, via email to usmedicaldevices@pharma-dept.gov.in with a copy to so-medicaldevices@pharma-dept.gov.in.
The complete list of proposed amendments is available through the document link shared by the department.
