Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services
Is Amycretin legal in India?
Not approved as a medicine here.
Amycretin has no CDSCO marketing permission. CDSCO expert-committee records from March and July 2026 show Phase III trial protocols for Novo Nordisk's NNC0487-0111, the development code for amycretin, being cleared or reviewed for Indian sites. 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
Amycretin elsewhere
Sources (3)
- 01Recommendations 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
- 02Recommendations 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
- 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