Dr. Reddy's Laboratories gets CDSCO Panel nod to manufacture and market Oral Semaglutide Tablets
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Dr. Reddy's Laboratories Limited for manufacturing and marketing Semaglutide Tablets in strengths of 3 mg,7 mg, and 14 mg for the treatment of Type 2 Diabetes Mellitus.
This came following the firm’s application for a grant of permission to manufacture and market Semaglutide Tablets 3 mg, 7 mg and 14 mg, which was deliberated on 13.01.2026.
Oral semaglutide, a GLP-1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus, and may also be used in combination with other medicinal products for diabetes management.
However, it has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with Type 1 diabetes mellitus.
In an earlier SEC meeting, the committee recommended the conduct of an inspection of two clinical trial sites involved in the Phase III clinical trial (Protocol No. DRL-IND-NDA28-SEM/2024, Version 2.0 dated 12.02.2025), selected based on risk-based criteria.
The Inspection of 02 sites was conducted accordingly and the report was discussed before the committee.
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.
After detailed deliberation, based on the outcome of the said inspection, the Committee recommended for grant of permission to manufacture and market Semaglutide Tablets 3 mg, 7 mg and 14 mg for the following indication:
"Oral Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Also, in combination with other medicinal products for the treatment of Type 2 diabetes."
Limitations of Use
• Has not been studied in patients with a history of pancreatitis.
• Not indicated for use in patients with type 1 diabetes mellitus.
