Novo Nordisk Gets CDSCO Panel Nod for Rybelsus Label Update, Aligned with EMA
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval of an updated package insert for Rybelsus tablets (3 mg, 7 mg, and 14 mg), manufactured by Novo Nordisk (India) Private Limited.
The decision came during the SEC meeting held on August 20, 2025, at CDSCO headquarters in New Delhi. Novo Nordisk presented its proposal to update the package insert (Version February 2025) in line with the European Medicines Agency (EMA) approval.
The firm presented the proposal for update in Package Insert (Version February 2025) for the changes in the Sections of Special Warnings and Precautions for use, Drug Interactions, Use in special populations and Undesirable effects of the drug product Rybelsus 3 mg, 7mg and 14 mg tablets in line with EMA approval.
After detailed deliberation, the committee recommended, "for approval of updated package insert Version February 2025 of the said drug product for the proposed changes."
Rybelsus (oral semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of type 2 diabetes mellitus. It lowers blood glucose by enhancing insulin secretion, reducing glucagon, and delaying gastric emptying. Unlike most GLP-1 receptor agonists, which require subcutaneous injection, Rybelsus is taken orally once daily, providing a non-injectable option for patients.
Novo Nordisk, the innovator of semaglutide, markets both the injectable (Ozempic) and oral (Rybelsus) formulations globally. The updated package insert ensures that healthcare professionals in India receive the latest approved safety, interaction, and usage information aligned with EMA standards, helping clinicians optimize diabetes management.
