DoP Shortlists Patented, Unlaunched Drugs for Global Tender Exemption, See Full List
PRIP Scheme
New Delhi: In a move that could significantly reshape India's pharmaceutical procurement landscape, the Department of Pharmaceuticals (DoP) has issued a public notice inviting objections from domestic manufacturers on the proposed inclusion of several patented, proprietary and high value formulations under the Global Tender Enquiry (GTE) exemption list.
The exercise stems from the Department of Expenditure’s January 2025 order that exempted 128 drugs and vaccines—up to Rs 200 crore—from the applicability of GTE under Rule 161 of the General Financial Rules (GFR) 2017, an exemption valid until March 31, 2027.
The latest notice, issued with the approval of the competent authority, follows representations from the Directorate General of Armed Forces Medical Services (DGAFMS), the Indian Council of Medical Research (ICMR), several central procurement bodies, and pharmaceutical industry stakeholders. These agencies have sought inclusion of additional formulations in the GTE exemption list, citing either the absence of domestic manufacturing capacity or the urgent need for critical patented therapies.
The notice issued by Department of Pharmaceuticals, mentioned,
"Subsequent to the exemption of 128 drugs/vaccines for tenders up to 200 crore until 31.3.2027 or till further orders from the applicability or Global Tender Enquiry (GTE) under rule 161 (iv) of the General Financial Rule, 2017 ,vide Department of Expenditure's OM no. 4/1/2023-PPD (Pt.), dated 15.1.2025, this Department has received requests from
(a) the Directorate General of Armed Forces Medical Services and the Indian Council of Medical Research for
(i) inclusion of certain formulations under the GTE exemption list: or/and
(ii) identification of local manufacturer for certain formulation ; and
(b) Central Government procuring agencies and the pharmaceutical industry for inclusion of patented or proprietary formulations under the GTE exemption list, on account of absence of domestic manufacturing."
Annex A of the notice lists more than fifty formulations across oncology, immunology, endocrinology, cardiology, rare diseases, and critical-care nutrition. The list includes high-cost biologics such as Eculizumab, Tremelimumab, Brentuximab Vedotin, and Palivizumab, along with next-generation therapies like Tirzepatide, Enfortumab Vedotin, Selpercatinib, and Gene therapy Onasemnogene Abeparvovec. Several formulations are either patented, proprietary, or yet to be launched in the Indian market.
This extensive list represents the drugs and therapeutic products that various government agencies and industry bodies want to bring under the Global Tender Enquiry (GTE) exemption, meaning they could be procured without inviting international competitive bids—but only if there is no domestic manufacturer.
The Department has clarified that before granting GTE exemptions, it must ensure that no Indian manufacturer currently produces these formulations. To this end, the DoP has invited objections from domestic manufacturers, who may contest the inclusion of any drug by demonstrating local manufacturing capability.
"Against this backdrop, local manufacturers are hereby invited to submit objections (based on domestic manufacturing availability) against inclusion of any formulations listed at Annex A in the GTE exemption list, in the form set out at Annex B, by 05.12.2025 through email sent to SO PharmaPolicy@.pharma-dept.gov.in" the notice added.
Drugs under consideration for inclusion in Global Tender Enquiry (GTE) exemption list in FY 2025-26 Request received from Industry (Part-I)
s. No | Pharmaceutical formulation and strength | Status- Patented or Proprietary (based on submission from industry) |
1. | Pancreatin Minimicrospheres 10000, 25000, 40000 | Patented |
2. | Venetoclax 1Omg, 50 mg and 100mg | Patented |
3. | Botulinum Toxin Type A 200U Powder for solution for Injection | Patented |
4. | Evolocumab Solution for Injection l40mg/ml (r-DNA origin) | Patented |
5. | Enfortumab Vedotin — 20 mg and 30 mg powder concentrate for solution for infusion | Patented |
6. | Gilteritinib - 40 mg film-coated tablets | Patented |
7. | Eculizumab Concentrate for solution for infusion 300 mg (10mg/ml) | Proprietary |
8. | Tremelimumab Concentrate for Solution for infusion 20 mg/ml (25 mg/ 1.25 ml and 300 ing/ 15 ml presentations) | Proprietary |
9. | Budesonide 1 60mcg + Glycopyrronium 7.2mcg + Formoterol Fumarate Dihydrate 5 mcg inhalation preparations | Patented |
10. | Darolutamide 300 mg Film-coated Tablets | Patented |
11. | Dienogest + Estradiol vale rate Film-coated tablet, 3 mg + 3 mg | Proprietary |
12. | Peg interferon Beta-lA 125mcg/0.5 ml PFS | Patented |
13. | Alteplase 20mg and 50mg | Proprietary |
14. | Lemborexant 5mg and 10 mg Tablet | Patented |
15. |
b) Tirzepatide 5 mg/0.5ml, c) Tirzepatide 7.5 mg/0.5ml d) Tirzepatide 10 mg/0.5m1
| Patented |
f) Tirzepatide 15 mg/0.5ml All solution for injection in a singte dose vial/ PFS | ||
16. | Teclistamab Solution for Injection 50mg and l53 mg | Patented |
17. | Gusclkumab Solution for Injection 100 mg | Patented |
18. | Methylphenidate Hydrochloride Extended-Release Tablets l8mg, 36mg and 54mg | Proprietary |
l9. | Follitropin Alfa 450IUf0.75ml (33mcg/0.75 ml) | |
20. | Ceritinib Hard Gelatin Capsule 150 Mg | |
21. | Ofatumumab 20 mg/0.4 mL solution for injection in pre-filled syringe | Proprietary |
22. | Erenumab solution for injection 70 mgfml in pre-filled syringe | Patented |
23. | Turoctocog Alfa Pegol (Glyoopegylated r-DNA origin Factor Vf11- 500 IU/1000 IU/l 500 fU/2000 lU | Patented |
24. | Dcgludec 100 IU/ml in 3 ml Pre-filled syringes (PFS)/Pcnfill | Patented |
25. | Insulin fkgludec 70% + Insulin Aspart 30 % 100 IU/ml in 3rn1 PFSfPenfill | Patented |
26. | Etonogestrcl Implant 68mg’(Radiopaque} | |
27. |
Hormone Injection l.P.)
| Proprietary |
28. | Romosozumab (r-DNA origin) Injection | Patented |
29. | .a) 100 u/ml Iniulin glargine with 50 mcg/ml Lixisenatide b) 100 u/ml Insulin glargine with 33 mcg/ml Lixisenatide | Paiented |
30. | a) Pegylated Liposomal lrinotecan 4.3 mg/ml concentrate for dispersion for infusion | Patented |
31. |
tablets
tablets | Proprietari |
32. | Sulbutiamine 200 mg | Proprietary |
33. | Piribedil S0m8 |
34. | Perindopril Erbumine 8mg + Indapamide 2.5mg | Proprietary |
35. |
c) Perindopril Erbumine 8mg + Amlodipine Besilate Tablets 5 | Proprietary |
36. |
Besilate IP Tablets (2.5 mg)
| Proprietary |
37. | Brentuximab Vedotin 50 mg | Proprietary |
38. | Vedolizumab 300 mg | Patented |
39. | Velaglucerase Alfa (r-DNA Origin) 400 Units | Proprietary |
40. | Agalsidase alfa (r-DNA origin) - I mg/ml | Proprietary |
41. | Coagulation Factor IX (Recombinant) | Proprietary |
42. | Rurioctocog Alfa Pegol (PEGy lated Recombinant Human FVII I) | Proprietary |
43. | Toripalimab inj | Patented |
44. | Entrectinib (100mg & 200 mg) | Patented |
45. | Sodium Zirconium Cyclosilicate Powder for Oral Suspension *s & 10 g | Patent (applied for) |
46. | Belumosudil Tablet 200mg | Patented |
47. | Palivizumab solution for injection 50 mg/0.5 mL | Proprietary |
48. | Plazomicin | Patented |
49. | Aminoven Infant 10% 100 ml Each 100 ml contains: active constituents: L-leucine 1.30 g, L-isoleucine 0.80 g, L -lysine acetate 1.20 g, L- lysine 0.851 g. L-methionine 0.312 g, L-pheny lalanine 0.375 g, L- threonine 0.440 g, L-tryptophan 0.201 g, L-valine 0.900 g. L-arginine | Proprietary |
0.750 g, L-histidine 0.476 g, Glycine 0.415 g, Taurine 0.040 g, L- serine 0.767 g, L-alanine 0.930 g, L-proline 0.971 g, N-acety 1-L- tyrosine 0.5176 g, L-tyrosine 0.420 g, N-acetyl-L-cysteine 0.070 g, L-cysteine 0,052 g. L-malic acid 0.262 g, Water for injections q.s.Total amino acids 100 g/l, Total nitrogen content 14.9 g/l, Theor.osmolarity 885 mosm/1 | ||
50. | SmofLipid 20% (100 ml, 250 ml, 500inl) Parenteral lipid emulsion with a combination of 4 different oils in concentrations : 30oz’»Soyabean oil, 30% MCT, 23% Olive Oil and I 5% Fish oil with a Omega 6: Omega 3 ratio of 2.5:1. | Proprietary |
5 1. | Omegaven 10% 50 ml Injection Intravenous Fat Emulsion with Omega 3 Fatty Acids, Highly refined fish oil 10 g , Eicosapentaenoic acid (EPA)1.25-2.82g. Docosahexaenoic acid (DHA) 1.44-3.09 g, alpha tocopherol as antioxidant., Glycerol, Purified egg phosphate, sodium oleate, sodium hydroxide. | Proprietary |
52. | SMOFKabiven Central 1477 ml New Generation 3 Chambered Bag for parenteral nutrition (IV injection for central line) 1477 ml containing combination of SMOFlipid 20%; refined soyabean oil 16.9 g, Medium Chain triglycerides 16.9 g, Refinded Olive Oil 14.1 g and Fish oil rich in Omega-3-acids 8.4 g as source of calories with 75 g Amino acids,taurine, zinc, electolytes and 42% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 1600 total calories in 1477 ml - 1300 non protein energy | Proprietary |
53. | SMOFKabiven Central 1970 ml New Generation 3 Chambered Bag for parenteral nutrition (1 V injection for central line) 1970 ml containing combination of SMOFlipid 20%; refined soyabean oil 22.5 g, Medium Chain triglycerides 22.5 g, Refinded Olive Oil 18.8 gm and Fish oil rich in Omega-3-acids 11.3 g with 100 gm Amino acids,taurine, zinc, electolytes and 42% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 2100 total calories in 1970 ml -1700 non protein energy | Proprietary |
54. | SMOFKabiven Central 986 ml New Generation 3 Chambered Bag for parenteral nutrition (I V injection for central line) 986 ml containing combination of SMOFlipid 20%; refined soyabean oil I 1.3 g, Medium Chain triglycerides 1 1.3 g, Refinded Olive Oil 9.4 gm and Fish oil rich in Omega-3-acids 5.6 g with 50 g Amino acids,taurine, zinc, electolytes and 42% Glucose solution with enviornment friendly bag material having tamper evident arrows fiaps providing 1 100 total calories in 986 ml - 900 non protein energy | Proprietary |
55. | SMOFKabiven Peripheral 1206 ml New Generation 3 Chambered Bag for patenteral nutrition (IV injection for peripheral line) 1206 ml containing combination of SMOFlipid 20°Z»; refined soyabean oil 10.2 g, Medium Chain triglycerides 10.2 g, Refinded Olive Oil 8.5 gm and Fish oil rich in Omega-3-acids 5.1 g with 38 g Amino acids,taurine, zinc, electolytes and l3k» Glucose solution with enviornment friendly bag material having tamper evident artows flaps providing 800 total calories in 1206 ml -700 non protein energy | Proprienuy |
56. | SMOFKabiven Peripheral 1448 ml New Genemtion 3 Chambered Bag for parenteral nutrition (lV injection for peripheral line) 1448 ml containing combination of SMOFlipid 20°Z»; refined soyabean oil I 2.3 g, Medium Chain triglycerides 12.3 g, Refinded Olive Oil 10.1 g and Fish oil rich in Omega-3-acids 6.1 g with 46 g Amino acids,taurine, zinc, electolytes and 13% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 1000 total calories in 1448 ml -800 non protein energy | Proprietary |
57. | SMOFKabiven Peripheral 1904 ml New Generation 3 Chambered Bag for parenteral nutrition (lV injection for peripheral line) 1904 ml containing combination of SMOFlipid 20°/»; refined soyabean oil 16.1 g, Medium Chain triglycerides 16.1 g, Refinded Olive Oil 13.4 g and Fish oil rich in Omega-3-acids 8 g with 60 g Amino acids,taurine, zinc, electolytes and 13% Glucose solution with enviornment friendly bag material having tamper evident arrows flaps providing 1300 total calories in 1904 ml -1100 non protein energy | Proprietary |
58. | Nirsevinub solution 50mg and l0Omg (r-DNA origin} | Patented |
S9. | Cross linked Sodium Hyaluronate 1-2.9 mDA, 22mg/ml (88mg/4mI) with Triamcinolone Hexacetonide l8mg (4mI Prefilled Syringe) | Proprietary |
60. | Semaglutide 0.25 mg/0.5 mg/ 1 mg/1.7 mg/2.4 mg solution for Injection (r-DNA origin) in PFS | Patented |
61. | Pneumococcal polysaccharide conjugate vaccine (adsorbed) I.P., 20- valent | Patented |
62. | Niraparib Tablets 100 mg | Patented |
63. | Dostarlimab concentrate for solution for infusion 500 mg/10 mL | Patented |
64. | tablets- 30 mg/90 mg/180 mg | Proprietary |
6S. | Concizumab Injection l5mgf1.5 mL, 60rng/l.5 md, 150mg/1.5 mL, 300mg/3 mL | Patented |
66. | Aztreonam 1.5g + Avibactam 0.5g powder for concentrate for solution for Infusion | Proprietary |
67. | R iniegepant 75mg | Patented |
Medicines yet to be launched - Request received from Industry (Part-2)
S. No | Pharmaceutical Formulation & strength, along with primary molecule(s) | Proprietary/Patent |
1. | Mavacamten Capsules 2.5mg, 5mg, 1Omg, l5mg | Proprietary |
2. | Sotatercept 45 mg and 60 mg | Patented |
3. | Ivosidenib 250 mg film-coated tablets | Patented |
4. | Crovalimab 240mg/2 ml | Patented |
5. | Selpercatinib 40mg/80mg Capsules | Patented |
6. | Mirikizumab 300mg/ 15 ml (20mg/ml) single dose vial, Mirikizumab 100mg/ml solution in a single dose pre- filled syringe | Patented |
7. | Insulin human Inhalation powder (r DNA origin) 4 units/8 units/12 units per cartridge plus Inhaler | Proprietary |
8. | Onasemnogene abeparvovec | Proprietary |
Request received from procuring entities (Part-3)
S. No | Pharmaceutical Formulation & strength, along with primary molecule(s) | Name of Procurer |
1. | Tab. Dienogest 2 smg | ESIC |
2. | Levonorgestrel releasing lntrauterine System- 52 | ESIC |
3. | Anti-Inhibitor Coagulant Complex, Steam treated 1000 IU with 20 ml Sterile Water for Injection | ERIC |
4. | Tab Saxagliptin 05 mg | DGAFM S |
5. | Eye Drop Povidine 20 mg/ml preservative free comod System. | DGA FMS |
6. | Eye Drop Travoprost with Polyquad | DGA FMS |
7. | Eye Drop Timolol Maleate preservative free comod system | DGA FMS |
8. | Eye Drop Sodium Hyaluronate 1 mg/ml, Preservative free, Phosphate ftee, with comod system | DGAFMS |
9. | IV Infusion 4% Succenylated Gelatin Bottle of 500 ml | DGAFMS |
Annex B
To:
Department or Pharmaceuticals Ministry of Chemicals and Fertilizers Government of India
Shastri Bhawan, New Delhi — I I0 OOI
Subject: Exemption from Global Tender Enquiry under rule I 61(iv) of the General Financial Rules, 2017 — Objections against inclusion of formulations listed at Annex A to Public Nulice to. 1/2025 — regarding
Reference is invited to the Public Notice No. [/2025 issued by the addressee Department inviting objections from local manufacturers (based on domestic manufacturing availabllity) against inclusion of formulations listed at Annex A to the said notice under the Global Tender Enquiry (GTE) exemption list.
- In this connection, 1 give below the details of information regarding the formulation objected against for inclusion in the GTE exemption list on account of its domestic manufacturing availability with necessary particulars are furnished as under:
S. no | Details | Information |
1 | Name, serial number and parts of formulation from Annex-A against which objection is raised | |
Name of the local manufacturing entity' | ||
3 | Address of the registered office and manufacturing location (complete postal address) | |
Contact details, email id and phone numbers (mobi le and office) | ||
5 | Generic name of locally manufactured drug and its strength | |
6 | Brand name of drus Mentioned against S. no. 5 | |
7 | Local content percentage of the drug as per the DP1IT OM dated 19.7.2024 | |
8 | Manufacturing capacity per annum | |
9 | Manufacturing license (mandatory) | |
10 | Patent certificate, if any. |
- The aforesaid information is true and correct to the best of my knowledge and nothing material has been concealed lhcrerrom.
Place: Date:
Yours faithfully,
(Signature of the authorised signatory) Name: Designation:
To view the official notice, click the link below:
