Govt seeks views on exempting 350 medical devices from GTE norms

The pharmaceuticals department has invited stakeholder comments on proposed changes to the list of 350-plus medical devices exempt from GTE rules, with submissions open until February

The Department of Pharmaceuticals (DoP) has sought stakeholder comments from the medical device industry over amendments to the list of medical devices exempted from restrictions related to floating of Global Tender Enquiry (GTE) by public procurement agencies.

 

This comes after the DoP last week released a draft list of 354 devices that government bodies can procure bypassing the local procurement clause for essential advanced technology not readily available in India.

 

“The department may also meet some domestic and MNC industry stakeholders over the next week to seek their suggestions regarding any further additions or removal from this list,” a person in the know told Business Standard.

 

He added that until then, the industry has been asked to submit any suggestion or objections on the list via email till February 28, 2026.

 

Under the DoP’s Public Procurement (Preference to Make in India) Order, 2017, public procurement agencies are directed to prioritise purchasing pharmaceutical formulations from local suppliers. Class-I suppliers must have ≥80 per cent local content, while Class-II suppliers require 50 per cent to <80 per cent local content.

 

However, as some of the goods of the required quality or specifications may not be available in the country, the government had noted that it is necessary to also look for suitable competitive offers from abroad.

 

The Department of Expenditure (DoE) of the Union finance ministry had then amended the General Financial Rules, 2017, empowering the ministry or department concerned to seek tender globally through GTEs.

 

The amendment states that no GTE shall be invited for tenders up to ₹200 crore or such limit as may be prescribed from time to time.

 

“However, in exceptional cases where the ministry or department feels that there are special reasons for GTE, it may record its detailed justification and seek prior approval for relaxation to the rule from the competent authority for tenders below such limits,” the DoE said in its office memorandum dated February 17, 2025.

 

Such a list of 354 GTE-exempted medical devices was then formed in June 2024. It was later amended in February 2025, with changes to a few nomenclatures of medical devices.

 

“The list was in limbo for over a year due to confusion over the effects of the US tariffs on medical devices. With the trade deal agreed upon, the department may find it easy to finalise the GTE exemption list,” another industry executive added.