No Long-Term Safety Data: CDSCO Panel Denies Novo Nordisk's proposal to amend warning statement of Semaglutide
New Delhi: Citing that there is no real world long-term safety data for Novo Nordisk's antidiabetic drug Semaglutide tablets (3 mg, 7 mg, 14 mg), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the proposed amendment in the warning statement of the proposed drug.
This came after Novo Nordisk presented the additional safety data in the Indian population for the proposed change in the warning statement of the drug product Semaglutide tablets 3 mg, 7 mg, and 14 mg from “To be sold by retail on the prescription of a Registered Endocrinologist or Physician with Post graduate qualification in medicine” to “To be sold by retail on the prescription of Registered Medical Practitioner”.
The committee noted that real-world long-term safety data is not available with the firm.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating. Semaglutide is a GLP-1 agonist that works by reducing appetite, delaying gastric emptying, increasing insulin release, and lowering the amount of glucagon released. Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity.
At the recent SEC meeting for Endocrinology and Metabolism held on 29th January 2025, the expert panel reviewed the additional safety data in the Indian population for the proposed change in the warning statement of the drug product Semaglutide tablets 3mg, 7mg, 14mg from “To be sold by retail on the prescription of a Registered Endocrinologist or Physician with Post graduate qualification in medicine” to “To be sold by retail on the prescription of Registered Medical Practitioner”.
After detailed deliberation, the committee did not consider the firm's request for the proposed amendment in the warning statement.
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