CDSCO allows Lilly to launch weight-loss drug Mounjaro in pen format

Mounjaro

India’s drug regulator has given  the nod to Eli Lilly’s once-a- week Mounjaro (tirzepatide) injection in the KwikPen format, giving a boost to the American pharma major’s expansion into the country growing diabetes and obesity care market.

Prefilled pen devices come with fixed doses and are easier to self-administer than vials, especially for elderly or mobility-challenged patients.

“The approval of Mounjaro® KwikPen® marks a step forward in the care of people living with type 2 diabetes and obesity,” said Winselow Tucker, president and general manager, Lilly India. “It supports a more personalised approach to treatment.”

The Central Drugs Standard Control Organisation’s approval comes on the heels of rival Novo Nordisk’s launch of Wegovy, also in a pen formulation, intensifying competition in the high-growth GLP-1 receptor agonist segment.

While Wegovy targets weight loss and cardiovascular risk reduction, Mounjaro brings a dual-action mechanism, activating both GIP and GLP-1 receptors, offering benefits in both type 2 diabetes and chronic weight management.

The KwikPen is a multi-dose, single-patient-use prefilled pen designed for once-weekly administration. It will be available in six dose strengths ranging from 2.5 mg to 15 mg, allowing physicians to tailor treatment to individual patient needs.

India, home to more than 100 million people with diabetes and nearly as many with obesity, represents a critical market for the next-generation metabolic therapies.

The pen format is expected to improve adherence and convenience, especially as the country sees rising demand for self-administered, long-acting injectables, expert say.

Mounjaro’s mechanism not only improves insulin secretion and sensitivity but also reduces appetite and fat mass, making it a compelling option in a market where obesity is linked to over 200 health complications, the company has said.

With this launch, Lilly joins a growing list of global pharma players betting on India’s metabolic disease burden and shifting treatment preferences. The move also signals a broader trend of pen-based delivery systems becoming the standard for chronic disease management in India.