Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services
Is Tirzepatide legal in India?
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)
- 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
- 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
- 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
- 04India Tightens Surveillance on GLP-1 Weight Loss Drug SalesNews On AIR (All India Radio) · 2026-03-24 · accessed 2026-09-29