Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services
Is Survodutide legal in India?
Not approved as a medicine here.
Survodutide has no CDSCO marketing permission. CDSCO's cardiovascular expert committee approved amendments to a Boehringer Ingelheim trial protocol (1404-0040) run through IQVIA in September 2024 and May 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
Survodutide elsewhere
Sources (3)
- 01Recommendations 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
- 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
- 03Manufacturing 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