New Delhi: The popular weight loss and diabetes drug Tirzepatide — marketed as Mounjaro and Zepbound in the US — is likely to hit the markets in India though there has been no confirmation on its launch date.
The drug has received a go ahead for import and marketing from the apex drug regulator’s subject expert committee. The final approval from the Drug Controller General of India (DCGI) based on this recommendation is awaited.
The committee has approved the import of single dose vials and prefilled pens of the injectable drug in six different doses, ranging from 2.5 mg to 12.5 mg. If the company rolls out the drug, it would become the first of the category to become available in India. While the oral version of its competition Novo Nordisk’s Semaglutide has been approved and is available in India for diabetes management, the higher dose, injectable version meant for weight-loss isn’t.
Eli Lilly in a statement to The Indian Express said: “Lilly has received marketing authorization for Type 2 Diabetes indication for Tirzepatide in India. Application for obesity indication is undergoing review by CDSCO ( Central Drugs Standard Control Organisation). Launch timelines for India have not been confirmed yet.”
The committee’s approval is based on two global clinical trials, which also included a significant number of participants from India. “After detailed deliberation, the committee recommended grant of permission for import and marketing of Tirzepatide…” according to the minutes of the meeting of the subject expert committee on endocrinology and metabolism held last month.
“The approval by the committee is based purely on objective criteria, including whether the trial shows the promised results, whether the trial is well designed to study the objectives, and whether there are enough participants from India, and whether the impact in the Indian group is the same as the global group. Any global trial with 10% Indian participants is likely to get approval. And, these trials by the big companies are usually well designed and do consider the Indian population as it is a significant market. These were the considerations made by the committee for the marketing approval,” said one of the committee members. “The only issue is…we do not know the long term impacts yet,” said the member.
The expert said that issues such as who needs the drug and how many can afford it have not been considered by the committee. “However, doctors have to select the patients very carefully while prescribing the drug. It should not be given to people with a history of pancreatic diseases, disorders of the endocrine systems, and nausea and vomiting,” the expert said.
