Following the response from industry bodies and medical device makers, the department of pharmaceuticals (DoP) has sought comments to bring changes to the Global Tender Enquiry (GTE) exemption list of medical devices.
The review of the exemption list would allow the government to strike a balance between pushing the domestic manufacturing while also ensuring that patients continue to have access to advanced medical technologies that are not yet made locally.
In February this year, the DoP had asked for the industry’s feedback on the existing GTE exemption list, and various stakeholders had requested addition, deletion and modification of products under the list.
While submitting comments, stakeholders are requested to furnish relevant supporting information to justify the modifications. This includes availability or non-availability of domestic manufacturing capacity, annual production and supply capacity within India for specific devices, import dependence and availability of alternative sources, procurement-related issues, among others.
The present list, notified in 2024 and valid until March 2027, contains 354 devices such as imaging systems, critical care equipment, surgical technologies and specialised implants. The GTE exemption list was introduced under the Public Procurement (Preference to Make in India) framework.
It permits government hospitals and procurement agencies to bypass local content requirements and import specific medical devices when adequate domestic manufacturing is unavailable.
Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), said that while the 2024 exercise was largely comprehensive, a few advanced technologies that are not manufactured in India were missed out in the exemption list.
“We hope that this review results in a complete, evidence-based framework that accurately reflects manufacturing realities and patient needs. Any exclusion of technologies that are not adequately available in India risks limiting patient access to critical medical innovations and could adversely affect healthcare outcomes,” he said.
DoP said that all stakeholders, including domestic manufacturers, importers, industry associations, procurement agencies and healthcare institutions, have been requested to submit their comments along with supporting information before July 15.
The GTE exemption list remains a contentious issue between domestic and multinational medical device makers. Indian companies have repeatedly sought the removal of several products from the list, arguing they now possess the capability to manufacture them locally.
MNCs, on the other side, have pushed for the inclusion of a wider range of advanced medical devices, stating that these technologies are still not manufactured in India and therefore require import exemptions.