A panel of experts approved by the Indian government has recommended that the country's drug regulator approve the import and sale of Eli Lilly's Mounjaro, a leading diabetes medication and a highly sought-after obesity treatment, according to a document posted on a government website on Monday.
Eli Lilly's Mounjaro, also known chemically as tirzepatide, along with Zepbound and competitors like Novo Nordisk's Wegovy and Ozempic, are part of a class of therapies called GLP-1 receptor agonists, designed to manage blood sugar levels in patients with type 2 diabetes. These treatments also slow down digestion, aiding patients in feeling fuller for longer, which has made them extremely popular for weight loss.
After thorough consideration, the committee advised granting permission for the import and marketing of specific doses of tirzepatide for chronic weight management, subject to the condition that the company conduct a Phase 4 clinical trial (post-marketing surveillance), according to a notification dated June 19.
The committee provides recommendations to India's drug regulator regarding drug approvals and trials. "A recommendation from the subject expert committee is akin to the penultimate step in the approval process," explained Sheetal Sapale, vice-president of research firm Pharmarack. Eli Lilly has not yet responded to a request for comment from Reuters. CEO David Ricks previously mentioned to Reuters that the company anticipated launching Mounjaro in India as early as next year.
India has the second-highest number of individuals with type 2 diabetes globally and significant obesity rates. By 2035, approximately 11% of Indian adults are projected to be obese, according to the World Obesity Federation Atlas. The global market for weight-loss drugs is expected to reach at least $100 billion by the end of the decade. The expert panel also noted that Lilly must submit the necessary manufacturing and controls data.
The notification was initially reported by The Indian Practitioner, a local medical journal.
