New Delhi: The Department of Pharmaceuticals (DoP) has proposed to add 11 more drugs including insulin and monoclonal antibodies to the list of 84 drug formulations it has mentioned in November, 2025, to be exempted from Global Tender Enquiry (GTE), under the General Financial Rules, 2017, for tenders up to Rs. 200 crore.
The addition of these patented and non-patented and proprietary formulations is following the requests from the pharmaceutical industry for inclusion into the list, on the ground of non-availability of domestic manufacturing.
“Local manufacturers are hereby invited to submit objections (based on domestic manufacturing availability) against inclusion of any formulations … in the GTE exemption list, in the form …. by 19.01.2026 through email…,” said the DoP in a latest notice.
The additional formulations under consideration for inclusion in GTE exemption list in FY 2025-26 include patented products such as donanemab 350 mg/20 ml (17.5 mg/ml) solution for IV infusion in a single-dose vial (r-dna origin), marstacimab 150mg/ml, elranatamab 44mg/1.1 ml (40mg/ml) and 76mg/1.9ml (40mg/ml) (r-dna origin), and injection tildrakizumab 100 mg/ml.
Proprietary formulations such as tocilizumab injection 162mg/0.9ml (in pre-filled syringe for subcutaneous use), insulin lispro I.P. (r-DNA origin) in pre-filled pen 100IU/ml, 3ml solution for injection, insulin lispro I.P. (r- DNA origin), 100 IU/ml prefilled pen, insulin lispro IP (r- DNA origin), solution for injection in prefilled pen 200 u/ml, insulin lispro ultrarapid (UR) injection 100 units/ml, solution for injection as 3ml prefilled pen, and insulin lispro ultrarapid (UR) injection 100 units/ml, solution for injection as 3ml cartridge.
The DoP, in November, said that it is considering inclusion of 84 drug formulations including patented and proprietary products, medicines yet to be launched, among others in the list of drugs and vaccines exempted from GTE, under the General Financial Rules, 2017, for tenders up to Rs. 200 crore.
It released the list with three parts, based on requests from the Director General of Armed Forces Medical Services and Indian Council of Medical Research for inclusion of these formulations and multiple strengths of some of these formulations under the GTE Exemption list, or identification of local manufacturers for certain formulations.
It may be noted that in the middle of 2024, the Department of Expenditure (DoE) under the Ministry of Finance has issued an order enabling government procurement of 128 drugs and vaccines for tenders up to Rs 200 crore through GTE by exempting these drugs from the relevant rule in the General Financial Rules (GFRs), 2017 till March 31, 2027.
The Union health ministry has been seeking exemptions from the GFRs rules for certain drugs and medical devices from time to time in order to facilitate purchase of these products through GTE, after checking availability of these formulations in the local market.
Health ministry and DoP have also been taking efforts to identify the local manufacturers for several products, so that the Central government’s procurement agencies such as Ministry of Railways and Employee’s State Insurance Corporation (ESIC) can include the local manufacturer’s details for purchase of these drugs and medical devices as per the stipulations of GFRs. The list of these drugs and medical devices are also collected from the Central Procuring Agencies, for this purpose.
The DoE, in April, 2023, issued an office memorandum exempting 364 medical devices and 70 drugs from the mandate for purchase from local manufacturers, and later, in December, 2023, added 15 more drugs into this list. These drugs and medical devices were exempted from the relevant GFRs Rule till March 31, 2014.
