New Delhi: A top panel under the Central Drugs Standard Control Organisation (CDSCO) — India’s national regulatory body for pharmaceuticals and medical devices — has recommended regulatory approval to import and market the type 2 diabetes and obesity drug tirzepatide in the country. But the drug is likely to be available in the country only next year, ThePrint has learnt. Indianapolis-based pharmaceutical firm Eli Lilly and Company sells tirzepatide under the brand names Mounjaro and Zepbound.
Mounjaro has been available in the US since 2022, and is indicated for diabetes. Zepbound was approved as a drug for weight management by the US Food and Drug Administration (FDA) in 2023. In June this year, a subject expert committee (SEC) under the CDSCO recommended the regulatory approval for two formulations of tirzepatide – pre-filled pens and single-dose vials.
The panel made this recommendation after reviewing data from the drug’s global clinical trials, which also included Indian participants. These drugs should be administered as injections on a weekly basis. “After detailed deliberation, the committee recommended for grant of permission for import and marketing of tirzepatide 2.
5mg/0.5ml, 5mg/0.5ml, 7.
5mg/0.5ml, 10mg/0.5ml, 12.
5mg/0.5ml and 15mg/0.5ml solution for injection in a single dose prefilled pen and in a single dose vial for chronic weight management subject to condition that firm should conduct phase-IV clinical trial,” the SEC (endocrinology and metabo.
