Last Updated on December 31, 2023 by The Health Master
The subject expert committee (SEC) at the Central Drugs Standard Control Organization (CDSCO) has permitted sale of Novo Nordisk India’s anti-diabetic medicine ‘semaglutide’ on prescription of a registered endocrinologist or physician with postgraduate qualification in medicine only.
Novo Nordisk India has submitted a proposal to SEC seeking permission for amendment in warning statement mentioned in import and market permission issued to the firm for semaglutide.
After detailed deliberation, the committee on December 16, 2020 recommended for approval of amendment of warning to mention the statement as “To be sold by retail on the prescription of a registered endocrinologist or physician with postgraduate qualification in medicine only”.
Semaglutide which is being sold under brand name ‘Ozempic’, ‘Rybelsus’ outside the country acts like human glucagon-like peptide-1 (GLP-1) so that it increases insulin secretion, thereby increasing sugar metabolism.
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It also appears to enhance growth of ß cells in the pancreas, which are the sites of insulin production. On the other hand it inhibits glucagon, which is a hormone that increases blood sugar.
It additionally reduces food intake by lowering appetite and slows down digestion in the stomach. In this way it works in body fat reduction.
The drug is yet to be launched by Novo Nordisk in India.
GLP-1 drugs are non-insulin treatments for people with type-2 diabetes. It was first derived from a compound found in the saliva of the Gila monster, lizards that are native to the southwestern US.
An injection version of semaglutide (Ozempic) was approved in the United States in December 2017, and in the European Union, Canada, and Japan in 2018.
An oral version of the anti-diabetic drug had received approval from the US Food and Drug Administration (USFDA) in September 2019. The drug was also approved by the European Union in April 2020.
It is the first GLP-1 receptor protein treatment that does not need to be injected.
One of semaglutide’s advantages over other anti-diabetic drugs is that it has a long duration of action, thus, only once-a-week injection is sufficient.
Once launched in India, the drug can make a huge difference since there are more than 7.2 crore patients here and the numbers are only expected to grow to 13.4 crore by 2025.
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