CDSCO Panel Rejects Novo Nordisk Proposal to amend warning statement of Semaglutide Injection

New Delhi: Noting that post-marketing safety data in Indian patients is not presented, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected Novo Nordisk’s proposal for the amendment in the warning statement of Semaglutide Injection (0.25mg/0.5mg/1mg/1.7mg/2.4mg).

This came after Novo Nordisk India presented the proposal for amendment in the warning statement by including obstetricians, gynecologists, and bariatric surgeons.

Semaglutide injection is used along with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes.

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.

In the earlier SEC meeting, the committee recommended submitting the post-marketing safety data in the Indian population for evaluation by the committee.

The Committee noted that the drug is not yet launched in India. Furthermore, the expert panel noted that post-marketing safety data in Indian patients are not presented.

In line with the above, after detailed deliberation, the committee did not consider amendments to the warning statement at this stage.

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