Wegovy Tablets for Weight Management: CDSCO Panel Seeks More Data from Novo Nordisk
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has sought additional data from Novo Nordisk India on its proposal to import and market Semaglutide Tablets (r-DNA Origin) in strengths of 1.5 mg, 4 mg, 9 mg and 25 mg under the brand name WEGOVY.
The expert panel asked the company to submit India-specific bioavailability/bioequivalence (BA/BE) and clinical trial data for the proposed R2 formulations. It also sought study results justifying or correlating the varying concentrations of SNAC across the proposed tablet strengths.
The recommendations came during the SEC (Endocrinology & Metabolism) meeting held on September 23, 2026, at which the company presented its proposal seeking permission to import and market the product.
The proposed product, WEGOVY®, is intended for use in combination with a reduced-calorie diet and increased physical activity for the following indications:
- To reduce excess body weight and maintain weight reduction over the long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition.
- To reduce the risk of major adverse cardiovascular events, comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, in adults with established cardiovascular disease and either obesity or overweight.
During the meeting, the company presented the clinical study results of “Pioneer Plus”, in which Indian subjects had participated.
The primary objective of the study was “To confirm superiority of oral Semaglutide 25mg and 50mg once daily versus oral Semaglutide 14mg once daily on HbA1c reduction in subjects with T2D on stable dose of 1-3 OADs”.
The secondary objective was “To confirm superiority of oral Semaglutide 25mg and 50mg once daily versus oral Semaglutide 14mg once daily on body weight reduction in subjects with T2D on stable dose of 1-3 OADs”.
Thus, the study evaluated HbA1c reduction and body weight reduction in subjects with type 2 diabetes receiving stable doses of one to three oral antidiabetic drugs.
The study was conducted in three cohorts, with an initial dose of semaglutide 3 mg tablets once daily. The dose was then escalated to semaglutide 7 mg tablets once daily, followed by semaglutide 14 mg tablets once daily. The final maintenance dose was either semaglutide 14 mg, 25 mg or 50 mg tablets once daily, depending on the cohort.
The company also presented other clinical studies of semaglutide 25 mg and 50 mg tablets conducted abroad.
After detailed deliberation, the committee recommended that the company submit the following for further evaluation before the panel:
Any BA/BE study conducted in India for Semaglutide Tablets (r-DNA Origin) 1.5 mg, 4 mg, 9 mg and 25 mg—the R2 formulations. If no such study has been conducted, the company was recommended to conduct a BA/BE study in Indian participants.
Any clinical trial data generated in India for Semaglutide Tablets (r-DNA Origin) 1.5 mg, 4 mg, 9 mg and 25 mg—the R2 formulations.
Study results to justify or correlate SNAC at varying concentrations in Semaglutide Tablets (r-DNA Origin) 1.5 mg, 4 mg, 9 mg and 25 mg under the WEGOVY® brand.
