Zydus Lifesciences Gets CDSCO Panel Nod to Market Semaglutide Injection for Type 2 Diabetes
New Delhi: Drug major Zydus Lifesciences Limited has received a key regulatory clearance from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) for the manufacture and marketing of Semaglutide Injection 15 mg/3 ml (synthetic origin) for the treatment of Type 2 Diabetes Mellitus, following acceptance of its Phase III clinical trial (CT) study report.
The recommendation was made by the SEC (Endocrinology & Metabolism) at its meeting held on 09 December 2025, after the company presented the Phase III CT study report along with detailed clinical data from each participating trial site.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for weight management and metabolic control. GLP-1 is a physiological hormone that helps regulate blood glucose levels by stimulating insulin secretion, reducing glucagon release, and slowing gastric emptying. Semaglutide, which is structurally similar to human GLP-1, binds selectively to GLP-1 receptors and exerts glucose-dependent effects that support weight reduction and metabolic balance.
At the recent meeting, the firm complied with the committee’s earlier recommendations and presented the required data for Semaglutide Injection 15 mg/3 ml (Synthetic Origin) intended for the management of adults with inadequately controlled Type 2 Diabetes Mellitus.
After detailed deliberation, the committee accepted the Phase III CT study report and recommended the grant of permission for the manufacture and marketing of Semaglutide injection 15 mg/3 ml (synthetic origin) for the following indication, with the condition for submission of PMS/PSUR data as per the NDCT Rules, 2019.
Indication:
Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy, when metformin is considered inappropriate due to intolerance or contraindications.
• in addition to other medicinal products for the treatment of diabetes.
