Sun Pharma Gets CDSCO Panel Nod to Market Semaglutide Injection in Weight Loss Indication
New Delhi: Drug major Sun Pharmaceutical Industries 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 Solution for Injection (synthetic origin) for chronic weight management, following acceptance of its Phase III clinical trial (CT) report.
The approval covers multiple strengths of Semaglutide Solution for Injection, including 0.25 mg/0.5 ml, 0.5 mg/0.5 ml, 1 mg/0.5 ml, 1.7 mg/0.75 ml, and 2.4 mg/0.75 ml.
The Committee specified that the drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition, such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
Earlier, the Medical Dialogues Team had reported that at the SEC meeting for Endocrinology and Metabolism held on 25 March 2025, the expert panel had reviewed the bioequivalence (BE) study report of Semaglutide Solution for Injection along with the revised clinical trial protocol (ICR/23/013, Version 3.0 dated 16 January 2025) and had granted permission to Sun Pharma to conduct the Phase III clinical trial.
At the recent meeting, the firm presented the Phase III CT report for the indication of chronic weight management.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
After detailed deliberation, at the recent SEC meeting, the committee accepted the Phase III CT report and recommended the grant of permission for manufacture and marketing of Semaglutide Solution for 0.25 mg/0.5 ml, 0.5 mg/0.5 ml, 1 mg/0.5 ml, 1.7 mg/ 0.75 ml and 2.4 mg/0.75 ml (Synthetic origin) for the following indication, subject to condition that the firm should conduct PMS study:
Indication
It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of
• 30 kg/m² or greater (obesity) or
• 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Accordingly, the expert panel suggested that the firm should submit a Post-Marketing Surveillance (PMS) study protocol to CDSCO within 03 months from the date of approval of the drug product for review by the committee.
