The Department of Pharmaceuticals (DoP) has sought the stakeholders to submit their comments and suggestions regarding the amended list of 354 medical devices that has been exempted from the restrictions related to floating of Global Tender Enquiry (GTE) by the public procurement agencies.
The Department of Expenditure, on June 28, 2024, issued an order exempting 354 medical devices from the local procurement clause, allowing the procurement agencies to float global tender for purchase of these devices. The list was later amended in February, 2025, following suggestions regarding changes in the nomenclature of certain medical devices.
The exemption for these products, based on the general relaxation under Rule 161(iv) of the General Financial Rules (GFR), 2017, is valid till March 31, 2027 or till further orders.
The DoP has now invited comments and suggestions from all the stakeholders for the amended list, with a deadline of February 28, 2026. The comments and suggestions have to be sent in a prescribed format to the medical devices division of the Department in its email address, it added.
The stakeholder has to mention the name and serial number of medical devices in the list against which objection is raised or suggestion for inclusion in the GTE list, provide name and details of the local manufacturing entity including their license number and domestic manufacturing capacity and mismatch between domestic demand and manufacturing capacity, among others.
It may be noted that the DoP has issued a guideline on December 30, 2020, for implementing the provisions of Public Procurement (Preference to Make in India) Order (PPO), 2017, to encourage Make in India and promote manufacturing and production of goods and services related to pharmaceutical sector in India with a view to enhance income and employment.
Under the guideline, the public procurement agencies should purchase minimum local content for pharmaceutical formulations from Class I local suppliers - suppliers with local content equal or more than 80 per cent - and Class II local suppliers - with local content of more than 50 per cent but less than 80 per cent. Another categorisation as per the guideline is the non-local suppliers, who have local content less than or equal to 50 per cent.
However, considering that some of the goods of the required quality, specifications etc., may not be available in the country and it is necessary to also look for suitable competitive offers from abroad, the Department of Expenditure (DoE) amended the General Financial Rules, 2017 empowering the concerned ministry or department to seek tender globally through GTEs.
While the amendment said that no GTE shall be invited for tenders up to Rs. 200 crore or such limit as may be prescribed by the DoE from time to time, 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.
Such a list of 354 medical devices were released in June, 2024, which was later amended with changes to a few nomenclatures of medical devices, in February, 2025. The amendments were to change the nomenclature of a device to cardiac output monitoring system, instead of flow track cardiac output monitoring; non-invasive fluid management monitoring system, instead of bioreactance non-invasive fluid management monitoring system; and Dual segment/Dual pump torsional/transversal phacoemulsification system, instead of Dual pump transversal phaco machine for micro-incision cataract surgery, among others. |