Conduct CT in India: CDSCO Panel tells Novo Nordisk India For new formulation of Semaglutide tablets
New Delhi: In line with the proposal for approval of Semaglutide tablets 1.5 mg, 4 mg, 9 mg of new formulation based on the bioequivalence (BE) studies conducted in USA and Canada, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Novo Nordisk India to conduct clinical trial in India to establish safety and efficacy of Semaglutide tablets 1.5 mg, 4 mg, 9 mg of new formulation in Indian population.
This came as Novo Nordisk India sought approval for Semaglutide tablets of 1.5 mg, 4 mg, and 9 mg of a new formulation based on the BE studies conducted in the USA and Canada.
In light of earlier SEC recommendations dated 11.09.2024, the firm presented the difference in the manufacturing process of approved formulation of Semaglutide tablets 3 mg, 7 mg and 14 mg and proposed new formulation of Semaglutide tablets 1.5 mg, 4 mg, 9 mg along with regulatory approval status of Semaglutide tablets 1.5 mg, 4 mg, 9 mg of new formulation.
The committee noted that semaglutide tablets 3 mg, 7 mg, and 14 mg are approved for marketing in India. The firm has claimed that Semaglutide tablets 1.5 mg, 4 mg, and 9 mg of the new formulation are equivalent to the approved doses of Semaglutide tablets 3 mg, 7 mg, and 14 mg, respectively.
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
At the recent SEC meeting for Endocrinology and Metabolism held on 25th March 2025, the expert panel noted the difference in the manufacturing process of approved formulations of Semaglutide tablets 3 mg, 7 mg, and 14 mg and proposed new formulations of Semaglutide tablets 1.5 mg, 4 mg, and 9 mg, along with the regulatory approval status of Semaglutide tablets 1.5mg, 4 mg, and 9 mg of new formulation.
After detailed deliberation, the committee recommended conducting a clinical trial in India to establish the safety and efficacy of Semaglutide tablets 1.5 mg, 4 mg, and 9 mg of the new formulation in the Indian population.
