Centre Reviews GTE Exemption for 11 Specialty Drugs, Domestic Pharma Asked to Raise Objections
New Delhi: The Department of Pharmaceuticals (DoP), under the Ministry of Chemicals and Fertilizers, has invited objections from domestic drug manufacturers on the proposed inclusion of 11 additional pharmaceutical formulations in the Global Tender Enquiry (GTE) exemption list for FY 2025-26, citing claims of non-availability of domestic manufacturing.
In a Public Notice No. 1/2026 dated January 9, 2026, the department said it has received requests from the pharmaceutical industry seeking exemption from GTE under Rule 161(iv) of the General Financial Rules, 2017 for certain patented, non-patented and proprietary formulations, over and above the 84 formulations already notified earlier in November 2025.
According to Annex A of the notice, the additional formulations under consideration include several high-end biologics and specialty drugs, such as Donanemab, Marstacimab, Elranatamab, Tildrakizumab, Remifentanil, Tocilizumab (pre-filled syringe), and multiple Insulin Lispro and Insulin Lispro Ultrarapid presentations. Most of these products are listed as patented or proprietary, based on submissions from industry.
The department has now called upon local manufacturers to submit objections, if any, based on domestic manufacturing availability, against the inclusion of these formulations in the GTE exemption list. Objections must be submitted in the prescribed format (Annex B), along with details such as manufacturing licence, production capacity, local content percentage, and patent status.
The objections are to be sent via email to so-pharmapolicy@pharma-dept.gov.in by January 19, 2026.
The public notice, issued with the approval of the competent authority, is part of the government’s ongoing effort to balance public procurement flexibility with the objective of promoting domestic pharmaceutical manufacturing.
Additional formulations under consideration for inclusion in Global Tender Enquiry (GTE) exemption list in FY 2025–26
S. No. | Pharmaceutical formulation and strength | Status – Patented or Proprietary (based on submission from industry) |
1. | Donanemab 350 mg/20 ml (17.5 mg/ml) solution for IV infusion in a single-dose vial (r-DNA origin) | Patented |
2. | Marstacimab 150 mg/ml | Patented |
3. | Elranatamab 44 mg/1.1 ml (40 mg/ml) and 76 mg/1.9 ml (40 mg/ml) (r-DNA origin) | Patented |
4. | Inj. Tildrakizumab 100 mg/ml | Patented |
5. | Remifentanil hydrochloride 1 mg & 2 mg vial | Not patented |
6. | Tocilizumab injection 162 mg/0.9 ml (in pre-filled syringe for subcutaneous use) | Proprietary |
7. | Insulin Lispro I.P. (r-DNA origin) in pre-filled pen 100 IU/ml, 3 ml solution for injection | Proprietary |
8. | Insulin Lispro I.P. (r-DNA origin), 100 IU/ml pre-filled pen | Proprietary |
9. | Insulin Lispro I.P. (r-DNA origin), solution for injection in pre-filled pen 200 IU/ml | Proprietary |
10. | Insulin Lispro Ultrarapid (UR) injection 100 units/ml, solution for injection as 3 ml pre-filled pen | Proprietary |
11. | Insulin Lispro Ultrarapid (UR) injection 100 units/ml, solution for injection as 3 ml cartridge | Proprietary |
To view the official notice, click the link below:
