Eli Lilly's popular drug Mounjaro stuck at Indian regulators' counter

Eli Lilly's Mounjaro, a blockbuster diabetes medication and a highly popular obesity treatment is still awaiting approval from CDSCO despite a SEC clearance

Pharmaceutical firm Eli Lilly is still awaiting approval from India’s drug regulator to market its popular weight loss drug Tirzepatide, despite a subject matter committee clearing the drug for use earlier this week, according to a report by The Economic Times. 

“The top drug regulator’s subject expert committee (SEC) has thus far approved its import and marketing for diabetes, not for weight loss,” the business-daily reported, citing the company. 

The firm added that the review of the ‘obesity’ indication is currently being conducted by the Central Drugs Standard Control Organisation (CDSCO). The drug, known as Mounjaro for type 2 diabetes treatment and as Zepbound for weight loss in the US, has been available under the brand Mounjaro in the US since 2022, while Zepbound received US FDA approval in November 2023. The company has not yet finalised the launch timeline for the drug in India.

Earlier this year, Eli Lilly CEO David Ricks said that the company anticipated launching Mounjaro in India next year. He highlighted the increasing significance of weight loss as a segment and noted that the company invested $11 billion in innovative research last year. “We are aiming to launch in India next year... we remain confident that if supply conditions permit, we can introduce the drug in India by 2025,” the report cited Ricks as saying.

Expert panel recommends approval for weight-loss drug

This week, an Indian government-approved expert panel recommended that the country’s drug regulator approve the import and sale of Eli Lilly’s Mounjaro, a blockbuster diabetes medication and a highly popular obesity treatment, according to a document on a government website.

About Mounjaro: the popular weight-loss drug

Mounjaro, chemically known as tirzepatide, and Zepbound, along with Novo Nordisk’s Wegovy and Ozempic, are GLP-1 receptor agonists designed to manage blood sugar levels in type 2 diabetes patients. These drugs also slow digestion, increasing the feeling of fullness, thus making them popular for weight loss.

India has the world’s second-largest population of type 2 diabetes patients and a high obesity rate. According to the World Obesity Federation Atlas, around 11 per cent of Indian adults will be obese by 2035. The global market for weight-loss drugs is projected to exceed $100 billion by the end of the decade.

The expert panel also suggested that Lilly submit the necessary manufacturing and controls data.