Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services
Is Retatrutide legal in India?
Not approved as a medicine here.
Retatrutide has no CDSCO marketing permission. CDSCO's expert committee cleared Eli Lilly Phase III protocols for LY3437943 (retatrutide) from 2024, including trials reviewed by the cardiovascular committee, and a trial with a safety-reporting condition in December 2025. Trial permission is not approval to sell. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).
Last verified 2026-09-29 · how we verify
Retatrutide elsewhere
Sources (4)
- 01Recommendations 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
- 02Recommendations 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
- 03Recommendations 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
- 04Manufacturing 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