Is Cagrilintide (and CagriSema) legal in India?

Cagrilintide, alone or combined with semaglutide (CagriSema), has no CDSCO marketing permission. CDSCO's expert committee recommended permission for a Novo Nordisk CagriSema Phase 3b trial in May 2024 and approved a trial protocol amendment in June 2025. In March 2026 it asked for more safety and dose-justification data, including for children and adolescents, on two Phase IIIa protocols, and in August 2026 it recommended permission for both, on condition that Indian paediatric growth charts are also used. 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).