Draft GTE Exemption List 2026: What Medical Device Companies Need to Know

In India, it is not possible for central government departments, and public institutions and procurement bodies that receive central government funding, to procure medical devices and equipment above INR 5,00,000, without inviting bids from the public. Non-local suppliers, that is, suppliers of imported medical devices, are generally eligible to bid for the tenders only when a ‘Global Tender Enquiry’ or GTE is issued. However, as per financial discipline rules of Central Government, GTE cannot be issued for procurement less than INR 2000 Million, and that too only if India-manufactured medical devices and equipment are unavailable.

Rule 161(iv)(b) of General Financial Rules, 2017 lays down an exception to the above financial discipline when the Department of Expenditure (Procurement Policy Division) publishes a list of medical device categories to which the threshold of INR 2000 Million will not be applicable while inviting bids from non-local suppliers.

The GTE Exemption List of medical devices has been maintained and periodically revised since 2022, starting with 128 devices and currently standing at 354 devices as of 2026.

The 2026 Review

In February 2026, the DoP invited comments from all stakeholders including domestic manufacturers, importers, industry associations, procurement agencies, healthcare institutions, and other interested parties, on whether entries in the 354 device list should be added, deleted, or modified. Through the E-Samiksha portal, the DoP received several submissions from importers, domestic manufacturers, government procurement bodies as well as civil society. The importers naturally wanted more devices to be covered or existing devices to be retained, the domestic manufacturers wanted existing devices to be deleted, the government procurement bodies wanted the list of be rationalized on account of difficulties it had faced inviting tenders, and civil society wanted to maximize competition.

The DoP has now made the submissions received from stake holders public. Two excel sheets have been made available: one listing existing GTE exempted devices for which deletion or modification has been proposed, and a second listing new devices proposed by stakeholders for inclusion in the list.

The current publicly circulated proposals include over 200 new devices being sought for addition, and proposals for deletion or renaming of a substantial number of existing entries.

The deadline for submitting comments or objections on these proposals is 15 July 2026.

Implications for the Medical Device Industry

For importers and multinational medical device companies, a device's presence on the GTE list will allow them greater ability to participate in government tenders.

For domestic manufacturers, the list represents a carve-out that protects imported products from preference rules, so deletions from the list will protect the domestic market.

Key Considerations for Stakeholders

Importers and foreign manufacturers should review both annexures against their product portfolio. If a device they supply is on the deletion list, they need to file a well-reasoned objection by 15 July. Simply asserting that domestic alternatives are inadequate will not be sufficient. The Department has specifically asked for data on domestic manufacturing capacity, import dependence, applicable regulatory standards, clinical utility, procurement impact, and supply availability. Responses that are detailed, evidence based, and address the specific deletion rationale raised by the opposing stakeholder will carry significantly more weight. The format for submitting information is available within the two abovementioned excel sheets.

For devices that are not yet on the list at all, the current cycle does not permit new addition applications.

Domestic manufacturers who want devices deleted should similarly use this window to reinforce their capacity claims with concrete evidence. Submissions are most effective when they go beyond general statements and are supported by verifiable evidence, including CDSCO approvals, procurement history, production capacity, import statistics, technical specifications, market share data, and any clinical or regulatory considerations demonstrating why continued exemption is, or is not, justified.

Next steps

Once stakeholder comments are considered, the Department is expected to issue a revised GTE Exemption List. While the timeline for publication has not been announced, the revised list will likely remain in force until the next review cycle and may influence procurement decisions across central government hospitals and agencies for the foreseeable future.

Companies whose products are affected should therefore treat the present consultation as a critical opportunity to shape the final outcome.