“The apex drug regulator’s subject expert committee (SEC) has so far given a go-ahead for its import and marketing for diabetes and not for weight loss,” Elli Lilly told ET, adding that the “obesity” indication is undergoing review by the Central Drugs Standard Control Organisation (CDSCO). The drug is marketed under the brand name Mounjaro for type 2 diabetes treatment and as Zepbound for weight loss, in the US. Mounjaro has been available in the US since 2022 while Zepbound was approved by the US FDA in November 2023. The company said it has yet to firm up the schedule for launching the drug in India.
Earlier this year, Eli Lilly CEO David Ricks had told ET that the company expected to launch Mounjaro in India next year. With the emergence of weight loss as a major segment, he said the company had stepped up innovative research, on which it spent $11 billion last year. “We are aiming to launch in India next year… at this stage, we still feel confident that if the supply situation allows us, we should be able to bring that drug to India in 2025,” Ricks had told ET.
In June, an SEC under the CDSCO recommended the regulatory approval for two formulations of Tirzepatide – pre-filled pens and single-dose vials. The panel’s recommendation followed review of data from the drug’s global clinical trials, which included Indian participants.
“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 said in its order, a copy of which was seen by ET. The Drug Controller General of India will take a final call on the SEC recommendation, said people in the know.
