Present difference of approved and proposed formulation: CDSCO tells Novo Nordisk's Semaglutide tablet

New Delhi: In response to the proposal presented by the drug major Novo Nordisk to import and market the antidiabetic drug Semaglutide tablets 1.5 mg, 4 mg, and 9 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to present the specific difference/improvement between the manufacturing process of the approved formulation and the proposed formulation along with the approval status of the proposed product in the NRA (National Regulatory Agencies) of the country of origin for further review by the committee.

This came after Novo Nordisk presented the proposal to import and market Semaglutide tablets 1.5 mg, 4 mg and 9 mg along with the results of bio-equivalence study data generated in the US and Canada.

The firm has claimed that Semaglutide tablets 1.5 mg, 4 mg, 9 mg are equivalent to the approved doses of Semaglutide tablets 3 mg, 7 mg and 14 mg, respectively, due to the new formulation.

The committee has noted that the drug is not yet approved anywhere, including the NRA of the country of origin.

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

The mechanisms through which semaglutide delivers its benefits in lowering blood glucose levels and promoting weight loss involve the activation of GLP-1 receptors primarily located in the gastrointestinal tract, pancreas, and brain.

At the recent SEC meeting for Endocrinology and Metabolism held on September 11, 2024, the expert panel reviewed the proposal to import and market Semaglutide tablets 1.5 mg, 4 mg, and 9 mg, along with the results of bio-equivalence study data generated in the US and Canada.

After detailed deliberation, the committee recommended that the firm should present the specific difference/improvement between the manufacturing process of the approved formulation and the proposed formulation, along with the approval status of the proposed product in the NRA of country of origin for further review by the committee.

Also Read: CDSCO issues Cancelled permission List manufacturers