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

Is Tirzepatide legal in India?

Approved, restrictedApproved in India (Mounjaro) for type 2 diabetes and weight management, prescription-only; no approved generic found

Approved, but with limits on who can get it or how.

CDSCO's expert committee noted in February 2024 that the tirzepatide pre-filled pen was already approved, and in June 2024 recommended import and marketing permission for chronic weight management, with a Phase IV study condition. In June 2026 the committee declined a request to drop the BMI cut-off from the weight indication, saying Asian and US definitions of obesity differ, and said it does not treat tirzepatide as first-line for diabetes without other conditions. The Health Ministry says these drugs are sold by retail only on prescription from endocrinologists and internal medicine specialists. I found no CDSCO record of a generic tirzepatide being approved.

Last verified 2026-09-29 · how we verify

Tirzepatide elsewhere

Sources (4)

  1. 01Recommendations 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
  2. 02Recommendations 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
  3. 03Recommendations 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
  4. 04India Tightens Surveillance on GLP-1 Weight Loss Drug SalesNews On AIR (All India Radio) · 2026-03-24 · accessed 2026-09-29