GLP1Base
Menu

Regulator: Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services

GLP-1 drugs and peptides in India

In India, the national medicines regulator, CDSCO, decides which new medicines can be sold. Semaglutide and tirzepatide are approved and sold on prescription, and cheaper Indian copies of semaglutide arrived in March 2026. Peptides such as BPC-157 have no approval, and in 2026 the regulator began cracking down on illegal sales and sneaky advertising of weight-loss injections.

Last verified 2026-09-29 · how we verify

Official regulator site

GLP-1 medicines

Semaglutide: Wegovy has been approved for adult weight management since 20 April 2022, with Ozempic and Rybelsus approved for type 2 diabetes. Wegovy additions recommended by the expert committee in 2026 include weight management in adolescents aged 12 and over with obesity (March 2026, with a Phase IV study condition and prescription by an endocrinologist or paediatrician) and a conditional liver-disease (MASH) indication (April 2026). Novo's core Indian patent expired in March 2026 and many Indian generics followed. Tirzepatide is approved for type 2 diabetes and chronic weight management, and no generic was found. Liraglutide has been approved since 2010, and dulaglutide and exenatide also have older approvals. Orforglipron was recommended for import and marketing by the expert committee on 20 May 2026 and is listed as pending because the final permission was not confirmed. The Health Ministry states these drugs are sold by retail only on prescription from endocrinologists and internal medicine specialists (for some indications, cardiologists).

Peptides

Unapproved peptides such as BPC-157, TB-500, GHK-Cu, ipamorelin and CJC-1295 have no CDSCO marketing permission in the records reviewed. Under the New Drugs and Clinical Trials Rules, 2019 they cannot lawfully be made for sale or distribution as medicines, and section 18 of the Drugs and Cosmetics Act, 1940 allows drugs to be made, sold or distributed only under a licence and in line with the Act. Import for sale needs CLA permission; personal import is limited to rule 36 of the Drugs Rules, 1945. CDSCO's public notice dated 18 May 2026 states that injectable preparations do not fall under the definition of cosmetics and that no cosmetic may be used as an injection, so an injected product cannot be sold as a cosmetic; topical cosmetics are regulated separately under the Cosmetics Rules, 2020. In the sources reviewed CDSCO has not named BPC-157 in an enforcement notice, so the position rests on the general new-drug rule and is 'not approved' rather than a named ban. Sport: the World Anti-Doping Agency's 2026 Prohibited List, which anti-doping bodies apply, names BPC-157 (non-approved substances, S0), TB-500 (S2.3), ipamorelin, CJC-1295, sermorelin and tesamorelin (S2.2.4), AOD-9604 (S2.2.3), kisspeptin in males (S2.2.1) and MOTS-c (S4.4.1) as prohibited at all times.

Advertising rules

The Health Ministry said an advisory issued on 10 March 2026 told manufacturers to avoid surrogate advertising and indirect promotion, including disease-awareness campaigns and off-label promotion of GLP-1 drugs. On 27 March 2026 it asked State and UT Drug Controllers to monitor print, electronic, digital, social media and outdoor advertising and to act under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Drugs and Cosmetics Act, 1940, coordinating with the Advertising Standards Council of India where needed. Penalties reported include licence cancellation and prosecution. Separately, rule 106 of the Drugs Rules, 1945 says no drug may claim to prevent or cure the conditions listed in Schedule J, which include diabetes and obesity.

Every molecule in India

MoleculeStatusWhat it meansVerified
AmycretinNot approvedNot approved in India; Novo Nordisk's amycretin (code NNC0487-0111) is only in CDSCO-permitted Phase III trialsDetails →source2026-09-29
AOD-9604Not approvedNot approved in India: no CDSCO marketing permission found for AOD-9604; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
BPC-157Not approvedNot approved in India: no CDSCO marketing permission found for BPC-157; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
Bremelanotide (PT-141)Not approvedNot approved in India: no CDSCO marketing permission found for bremelanotideDetails →source2026-09-29
Cagrilintide (and CagriSema)Not approvedNot approved in India; CagriSema is only in CDSCO-permitted Phase III trialsDetails →source2026-09-29
CJC-1295Not approvedNot approved in India: no CDSCO marketing permission found for CJC-1295; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
DSIP (delta sleep-inducing peptide)Not approvedNot approved in India: no CDSCO marketing permission found for DSIP; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
DulaglutideApprovedApproved in India (Eli Lilly) for type 2 diabetes; the expert committee backed adding an age-10-and-over indication in 2024Details →source2026-09-29
EcnoglutideNot approvedNot approved in India: no CDSCO marketing permission or Indian trial record found for ecnoglutideDetails →source2026-09-29
Elamipretide (SS-31)Not approvedNot approved in India: no CDSCO marketing permission found for elamipretideDetails →source2026-09-29
EloralintideNot approvedNot approved in India; Lilly's eloralintide (LY3841136) is only in CDSCO-permitted Phase III trialsDetails →source2026-09-29
EpitalonNot approvedNot approved in India: no CDSCO marketing permission found for Epitalon; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
ExenatideApprovedExenatide has an older CDSCO approval; whether it is still sold in India could not be confirmedDetails →source2026-09-29
GHK-Cu (copper peptide)Not approvedNot approved in India: no CDSCO marketing permission found for GHK-Cu; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
IpamorelinNot approvedNot approved in India: no CDSCO marketing permission found for Ipamorelin; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
KisspeptinNot approvedNot approved in India: no CDSCO marketing permission found for Kisspeptin; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
KPVNot approvedNot approved in India: no CDSCO marketing permission found for KPV; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
LiraglutideApprovedApproved in India since 2010 (Victoza) for type 2 diabetes; a weight-management version was recommended for an Indian maker in 2025Details →source2026-09-29
LL-37Not approvedNot approved in India: no CDSCO marketing permission found for LL-37; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
Maridebart cafraglutide (MariTide)Not approvedNot approved in India: no CDSCO marketing permission or Indian trial record found for maridebart cafraglutideDetails →source2026-09-29
MazdutideNot approvedNot approved in India: no CDSCO marketing permission or Indian trial record found for mazdutideDetails →source2026-09-29
Melanotan IINot approvedNot approved in India: no CDSCO marketing permission found for Melanotan II; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
MOTS-cNot approvedNot approved in India: no CDSCO marketing permission found for MOTS-c; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
NAD+Not approvedNot approved in India: no CDSCO marketing permission found for NAD+; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
OrforglipronUnder reviewUnder review: CDSCO's expert committee recommended import and marketing permission for Lilly's oral orforglipron in May 2026Details →source2026-09-29
PramlintideNot approvedNot approved in India: no CDSCO marketing permission found for pramlintideDetails →source2026-09-29
RetatrutideNot approvedNot approved in India; retatrutide is only in CDSCO-permitted Phase III trials run by Eli LillyDetails →source2026-09-29
SelankNot approvedNot approved in India: no CDSCO marketing permission found for Selank; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
SemaglutideGenerics availableApproved in India (Novo Nordisk's Wegovy and type 2 diabetes products); Indian generics on sale since March 2026, prescription-onlyDetails →source2026-09-29
SemaxNot approvedNot approved in India: no CDSCO marketing permission found for Semax; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
SermorelinNot approvedNot approved in India: no CDSCO marketing permission found for Sermorelin; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
SetmelanotideNot approvedNot approved in India: no CDSCO marketing permission found for setmelanotideDetails →source2026-09-29
SurvodutideNot approvedNot approved in India; survodutide (BI 456906) appears only in a CDSCO-permitted clinical trialDetails →source2026-09-29
TB-500 (thymosin beta-4 fragment)Not approvedNot approved in India: no CDSCO marketing permission found for TB-500; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
TesamorelinNot approvedNot approved in India: no CDSCO marketing permission found for tesamorelinDetails →source2026-09-29
TirzepatideApproved, restrictedApproved in India (Mounjaro) for type 2 diabetes and weight management, prescription-only; no approved generic foundDetails →source2026-09-29

For experts

The regulatory detail

Approval: CDSCO, under the Drugs Controller General (India), is the Central Licensing Authority. Under the New Drugs and Clinical Trials Rules, 2019, a drug not approved by the CLA is a 'new drug' (rule 2(1)(w)) and cannot be imported or made for sale or distribution without permission (rules 74, 75 to 76 and 80). Applications go to Subject Expert Committees, whose published recommendations often attach conditions such as prescriber restrictions, Phase IV studies and post-marketing surveillance; the committee has also cleared synthetic-origin generic semaglutide company by company. Compounding: the Act excludes 'compounding or dispensing' in the ordinary course of retail business from the definition of manufacture, and licence conditions require a registered pharmacist to supervise compounding at licensed premises. There is no US-style regime for producing copies of drugs, and the documents reviewed do not address bespoke compounding of an unapproved peptide, so that point is left open. Personal import: rule 36 of the Drugs Rules, 1945 lets a passenger bring in small quantities for exclusive personal use as bona fide baggage (not more than 100 average doses of a single drug, declared to Customs if asked); other personal imports need a permit backed by a doctor's prescription. Coverage and price: the sources reviewed describe private cash-pay sale, with reported March 2026 launch prices for Indian generic semaglutide varying widely by company and strength; I found no verified description of public reimbursement. Enforcement: after a 10 March 2026 advisory against surrogate promotion, CDSCO ran an audit drive covering online pharmacy warehouses, wholesalers, retail outlets and wellness and slimming clinics, and on 27 March 2026 (posted publicly 18 May 2026) asked State Drug Controllers to monitor the supply chain and advertising under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Drugs and Cosmetics Act, 1940. A CDSCO public notice dated 18 May 2026 states that injectables are not cosmetics, and a counterfeit-semaglutide alert was reported in July 2026.

Official sources we monitor

Recent changes in India

  1. 2026-03-21

    Generic semaglutide launches in India after Novo Nordisk's core patent expires

    On 21 March 2026 several Indian drugmakers, including Dr Reddy's, Zydus, Alkem, Sun Pharma and Glenmark, launched generic semaglutide products, described as day-one entry on expiry of Novo Nordisk's core Indian semaglutide patent.

Full timeline →

Sources (39)

  1. 01Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs (letter to State/UT Drug Controllers, 27 March 2026)Central Drugs Standard Control Organisation (CDSCO) · 2026-03-27 · accessed 2026-09-29
  2. 02Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)Central Drugs Standard Control Organisation (CDSCO) · 2026-08-10 · accessed 2026-09-29
  3. 03Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmeticsCentral Drugs Standard Control Organisation (CDSCO) · 2026-05-18 · accessed 2026-09-29
  4. 04India Tightens Surveillance on GLP-1 Weight Loss Drug SalesNews On AIR (All India Radio) · 2026-03-24 · accessed 2026-09-29
  5. 05Drug regulator warns pharma firms against surrogate ads, off-label promotion of weight loss drugsETV Bharat · 2026-03-25 · accessed 2026-09-29
  6. 06Generic semaglutide launches in India, including by Dr Reddy's, Zydus, Alkem, Sun Pharma, GlenmarkPearce IP · 2026-03-21 · accessed 2026-09-29
  7. 07CDSCO tightens semaglutide oversight after counterfeit alertWhalesbook · 2026-07-28 · accessed 2026-09-29
  8. 08The Drugs and Cosmetics Act, 1940 (CDSCO consolidated text)Central Drugs Standard Control Organisation (CDSCO) · 2022-11 · accessed 2026-09-29
  9. 09The New Drugs and Clinical Trials Rules, 2019 (CDSCO consolidated text)Central Drugs Standard Control Organisation (CDSCO) · 2023-02 · accessed 2026-09-29
  10. 10The Drugs and Cosmetics Act, 1940 and Rules, 1945 (rule 36 personal import; rule 65 licence conditions; rule 106 and Schedule J)Central Drugs Standard Control Organisation (CDSCO) · 2016 · accessed 2026-09-29
  11. 11World Anti-Doping Code International Standard: Prohibited List 2026World Anti-Doping Agency · 2025-09 · accessed 2026-09-29
  12. 12CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)Central Drugs Standard Control Organisation (CDSCO) · 2026-09-23 · accessed 2026-09-29
  13. 13CDSCO Public Notices indexCentral Drugs Standard Control Organisation (CDSCO) · 2026-09-14 · accessed 2026-09-29
  14. 14Recommendations of the SEC (Endocrinology & Metabolism) made in its 09 th/26 meeting held on 23.04.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-04-23 · accessed 2026-09-29
  15. 15Recommendations of the SEC (Endocrinology & Metabolism) made in its 13th/26 meeting held on 20.05.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-05-20 · accessed 2026-09-29
  16. 16Recommendations of the SEC Endocrinology & Metabolism made in its 12th/24 meeting held on 19.06.2024 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-06-19 · accessed 2026-09-29
  17. 17Recommendations of the SEC (Endocrinology & Metabolism) made in its 06th/26 meeting held on 23.03.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-03-23 · accessed 2026-09-29
  18. 18Recommendations of the SEC (Pulmonary) made in its 04th/26 meeting held on 23.03.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-03-23 · accessed 2026-09-29
  19. 19Recommendations of the SEC (Pulmonary) made in its 08th/26 meeting held on 08.07.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-07-17 · accessed 2026-09-29
  20. 20Recommendations of the SEC Endocrinology & Metabolism made in its 9th/24 meeting held on 09.05.2024 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-05-09 · accessed 2026-09-29
  21. 21Recommendations of the SEC (Endocrinology & Metabolism) made in its 13th meeting held on 17.06.2025 at CDSCO HQ New DelhiCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-06-17 · accessed 2026-09-29
  22. 22Recommendations of the SEC (Endocrinology & Metabolism) made in its 18th/26 meeting held on 06.08.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-08-06 · accessed 2026-09-29
  23. 23SEC Metabolism and Endocrinology: 25.04.2017Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2017-04-25 · accessed 2026-09-29
  24. 24Recommendations of the SEC (Endocrinology & Metabolism) made in its72nd meeting held on 16.12.2020 at CDSCOCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2020-12-16 · accessed 2026-09-29
  25. 25Recommendations of the SEC Endocrinology & Metabolism made in its 14th/24 meeting held on 13.08.24 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-08-13 · accessed 2026-09-29
  26. 26Recommendations of the SEC (Endocrinology & Metabolism) made in its 17th/26 meeting held on 16.07.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-07-16 · accessed 2026-09-29
  27. 27Recommendations of the SEC (Endocrinology & Metabolism) made in its 03th/26 meeting held on 05.02.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-02-05 · accessed 2026-09-29
  28. 28Recommendations of the SEC (Endocrinology & Metabolism) made in its 56th meeting held on 20.06.2019 at CDSCOCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2019-06-20 · accessed 2026-09-29
  29. 29SEC-(Endocrinology): 10.02.2017Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2017-02-10 · accessed 2026-09-29
  30. 30Recommendations of the SEC (Endocrinology & Metabolism) made in its 04th /25 meeting held on 06.02.2025 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-02-06 · accessed 2026-09-29
  31. 31Recommendations of the SEC (Endocrinology & Metabolism) made in its 05th /25 meeting held on 20.02.2025 at CDSCO (HQ)Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-02-20 · accessed 2026-09-29
  32. 32Recommendations of the SEC (Endocrinology & Metabolism) made in its 23 rd/25 meeting held on 18.11.2025 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-11-18 · accessed 2026-09-29
  33. 33Recommendations of the SEC (Endocrinology & Metabolism) made in its 18th/25 meeting held on 20.08.2025 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-08-20 · accessed 2026-09-29
  34. 34Recommendations of the SEC (Cardiovascular) made in its 07th/25 meeting held on 13.05.2025 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-05-13 · accessed 2026-09-29
  35. 35Recommendations of the SEC (Gastroenterology & Hepatology) made in its 16 th/25 meeting held on 11.12.2025 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-12-11 · accessed 2026-09-29
  36. 36Recommendations of the SEC (Endocrinology & Metabolism) made in its 19th/25 meeting held on 11.09.2025 at CDSCO (HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2025-09-11 · accessed 2026-09-29
  37. 37Recommendations of the SEC (Cardiovascular) made in its 17th/24 meeting held on 11.09.2024 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-09-11 · accessed 2026-09-29
  38. 38Recommendations of the SEC Endocrinology and Metabolism made in its 3rd/24 SEC meeting held on 13.02.2024 and 14.02.2024 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-02-13 · accessed 2026-09-29
  39. 39Recommendations of the SEC (Endocrinology & Metabolism) made in its 15th/26 meeting held on 24.06.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-07-02 · accessed 2026-09-29