Submit Post Marketing Safety Data of Indians: CDSCO Panel Tells Novo Nordisk on Semaglutide Warning Statement
New Delhi: In response to the proposal presented by the drug major Novo Nordisk for the amendment in the warning statement for the antidiabetic drug Semaglutide, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit post-marketing safety data of the Indian population.
This came after the drug major Novo Nordisk presented the proposal for amendment in the warning statement for the inclusion of Obstetricians Gynaecologists and bariatric surgeons in the approved warning statement i.e. “To be sold by retail on the prescription of an Endocrinologist, and Internal medicine”.
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. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood sugar (glucose).
Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms like augmented insulin secretion (glucose-dependent), inhibition of glucagon release, and suppressed hepatic gluconeogenesis; thereby reducing both fasting as well as postprandial glucose.
At the recent SEC meeting for Endocrinology and Metabolism held on the 13th and 14th of February 2023, the expert panel reviewed the proposal for amendment in the warning statement for the inclusion of Obstetricians and Gynaecologists and bariatric surgeons in the approved warning statement i.e. “To be sold by retail on the prescription of an Endocrinologist, and Internal medicine”.
The committee noted that the approved drug has not yet been launched in India for marketing.
After detailed deliberation, the committee recommended the firm submit post-marketing safety data of the Indian population for further evaluation by the committee.
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