The Subject Expert Committee (SEC), advising the national drug regulator on drug and trial approvals, has recommended the import and marketing approval of Eli Lilly’s weight loss medication, Mounjaro, in India. This recommendation includes a condition that the company must conduct phase IV clinical trials and adhere to quality standards.
Eli Lilly’s proposal requested permission to import and market six dosages of the drug tirzepatide in both single-dose prefilled pens and single-dose vials. The company supported its request with India-specific clinical study reports from two global studies that included India as a participant.
Eli Lilly highlighted that the pre-filled pen formulation has been approved in the United States, European Union, United Kingdom, United Arab Emirates, Hong Kong, Kuwait, and Qatar. Additionally, the tirzepatide single-dose vials are approved in the US, EU, and Egypt for chronic weight management.
The SEC, after thorough deliberation, recommended granting permission for the import and marketing of all six dosages of tirzepatide in both single-dose prefilled pens and vials. This approval is contingent on the company conducting a phase IV clinical trial and fulfilling the requirements for Chemistry, Manufacturing, and Controls (CMC) data. The company is required to submit the phase IV clinical trial protocol to the Central Drugs Standard Control Organisation (CDSCO) within three months from the approval date for further review by the committee.
The drug, marketed under the brand names Mounjaro and Zepbound in various countries, was approved by the US Food and Drug Administration (FDA) in May 2022. Mounjaro is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes.
As reported by Pharmabiz, Eli Lilly has announced plans to launch the drug in various countries and has made deals to expand manufacturing capacity. The company emphasizes that Mounjaro represents a new class of medications for adults with type 2 diabetes, working by directly activating GIP and GLP-1 pathways to help regulate blood sugar.