The Subject Expert Committee (SEC), an advisory body to India’s national drug regulator, has recommended granting permission for the import and marketing of Eli Lilly’s weight loss drug, Mounjaro, in India. This recommendation is contingent upon the company conducting phase IV clinical trials and meeting quality standards.
Eli Lilly sought approval to import and market six doses of tirzepatide (2.5mg/0.5 ml, 5mg/0.5ml, 7.5mg/0.5 ml, 10mg/0.5ml, 12.5mg/0 .5ml, and 15mg/0.5 ml) in both single-dose prefilled pens and vials for chronic weight management. The proposal included India-specific clinical study reports from global studies that involved Indian participation.
The SEC for endocrinology and metabolism, in its meeting on June 19, reviewed the proposal and recommended approval under the condition that Eli Lilly conducts phase IV trials and submits comprehensive Chemistry, Manufacturing, and Controls (CMC) data.
“The committee has recommended granting permission for import and marketing of tirzepatide in various dosage forms, subject to the firm conducting phase-IV clinical trials and fulfilling CMC requirements,” stated the SEC.
Eli Lilly’s tirzepatide formulations in prefilled pens are already approved in several countries including the US, EU, UK, UAE, Hong Kong, and Kuwait, while the single-dose vials have approvals in the US, EU, and Egypt for chronic weight management.
The SEC has instructed Eli Lilly to submit the phase IV clinical trial protocol to the Central Drugs Standard Control Organisation (CDSCO) within three months of drug approval. Internationally, the drug is marketed under the brands Mounjaro and Zepbound.
Eli Lilly highlighted that Mounjaro, approved earlier by the US FDA for adults with type-2 diabetes, represents a novel class of medicines that activate GIP and GLP-1 pathways to regulate blood sugar levels.
The company plans to introduce Mounjaro in multiple countries and has already initiated steps to expand its manufacturing capabilities to support the global launch of the drug.