Semaglutide to be sold only on prescription of Endocrinologist, PG Medicine in India: CDSCO Committee
New Delhi: In a major development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has called for selling of anti-diabetic drug, Semaglutide by retail only on the prescription of a Registered Endocrinologist or Physician with PostGraduate qualification in Medicine in India.
The recommendation came in wake of a proposal moved by Novo Nordisk India Pvt. Ltd. with the expert panel seeking for amendment in the warning statement mentioned in the import and market permission issued to the firm for Semaglutide.
In 2019, an oral version of Novo Nordisk's diabetes drug semaglutide was approved by the US Food and Drug Administration (USFDA), however, the drug is unavailable in India till date.
Sold under the brand names Ozempic and Rybelsus outside India, Semaglutide acts like human glucagon-like peptide-1 so that it increases insulin secretion, thereby increasing sugar metabolism. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Besides diabetes, the company has been investigating once-weekly subcutaneous semaglutide 2.4 mg as a potential treatment for obesity as well. A few days ago Novo Nordisk had announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for subcutaneous semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for weight management.
Meanwhile, in India, it had sought permission for amendment in the warning statement mentioned in the import and market permission issued to the firm.
After detailed deliberation, the CDSCO committee, which advises the DCGI on applications seeking approvals for new drugs, vaccines, recommended the company for approval of the 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".