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Dr. Reddy’s Wins Regulatory Nod for Semaglutide Injection in India
The injection is approved for use in adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise. It can be used as a standalone therapy when metformin is unsuitable due to intolerance or contraindications, or in combination with other anti-diabetic medications.
- By Newsdesk
- New Delhi
- Oct 25, 2025
In a key regulatory milestone, Dr. Reddy’s Laboratories has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market a synthetic version of Semaglutide Injection in India. The approval covers formulations of 2 mg/1.5 mL (1.34 mg/mL), 4 mg/3 mL (1.34 mg/mL) and 8 mg/3 mL (2.68 mg/mL).
The injection is approved for use in adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise. It can be used as a standalone therapy when metformin is unsuitable due to intolerance or contraindications, or in combination with other anti-diabetic medications.
Dr. Reddy’s presented Phase III clinical trial data for these semaglutide formulations to the SEC panel, which reviewed their safety and efficacy profiles before recommending marketing authorisation.
Semaglutide belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class of drugs. It enhances insulin secretion in a glucose-dependent manner, delays gastric emptying, and reduces post-meal glucagon levels — mechanisms that collectively help improve glycaemic control in people with type 2 diabetes.
The approval comes with conditions requiring Dr. Reddy’s to submit post-marketing surveillance (PMS) data and periodic safety update reports (PSUR) in accordance with India’s New Drugs and Clinical Trials (NDCT) Rules, 2019.
As India faces a growing diabetes burden, the addition of Semaglutide to the domestic therapeutic landscape marks an important step forward, offering patients access to a newer, globally proven treatment option.