Published Oct 23, 2026 | 7:00 AM ⚊ Updated Oct 23, 2026 | 7:00 AM
Wegovy is used alongside a reduced-calorie diet and increased physical activity for long-term weight management in adults.
Synopsis: India’s wait for Wegovy weight-loss tablets continues as CDSCO seeks additional Indian study data from Novo Nordisk before further evaluating its marketing application. While the tablet has received approval overseas, the regulator has sought evidence on bioequivalence and formulation. Separately, Torrent Pharmaceuticals received permission to conduct a semaglutide diabetes trial.
India’s wait for Wegovy weight-loss tablets continues, with the Central Drugs Standard Control Organisation (CDSCO) seeking additional evidence from Novo Nordisk India before proceeding with its application to import and market the drug’s oral formulation.
At its 23 September meeting, the Subject Expert Committee (SEC) on Endocrinology and Metabolism reviewed the company’s proposal to market semaglutide tablets in strengths of 1.5 mg, 4 mg, 9 mg and 25 mg under the Wegovy brand. The committee did not grant permission and asked the company to submit additional data for further evaluation.
The decision comes as oral Wegovy advances in overseas markets. The UK approved the tablet for weight management in June 2026, followed by European Commission authorisation in July. However, the proposed tablets have not received final marketing permission in India, according to recommendations from the September meeting.
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The SEC has asked the company to provide three sets of additional evidence.
First, it sought any bioavailability or bioequivalence (BA/BE) study conducted in India for the proposed formulations. If no such study was available, the SEC recommended that the company conduct one with Indian participants.
The first requirement concerns bioavailability and bioequivalence, two related but distinct concepts. Bioavailability refers to how much of a medicine reaches the bloodstream and how quickly. Bioequivalence assesses whether two formulations deliver the active drug at sufficiently similar rates and levels under specified conditions.
“Any BA/BE study for Semaglutide Tablets (rDNA Origin) 1.5 mg/4 mg/9 mg/25 mg (R2 formulations) conducted in India. If not, the firm is recommended to conduct a BA/BE study in Indian participants,” said SEC.
These measurements help regulators evaluate whether a formulation performs as expected. The committee has asked for India-specific evidence for the proposed formulations, although its recommendations do not establish that the tablets are unsafe or ineffective.
Second, the committee asked for Indian clinical trial data for the formulations. Third, it sought study results to justify or correlate the varying concentrations of SNAC in the proposed tablets.
The second requirement, Indian clinical trial data, would provide evidence from studies conducted in Indian participants. The committee did not specify a deadline for submission or when it might reconsider the application.
The third requirement concerns SNAC, or salcaprozate sodium, an absorption-enhancing ingredient used in oral semaglutide formulations. Semaglutide is a peptide medicine that would otherwise be broken down in the digestive tract and poorly absorbed when swallowed. SNAC helps the drug survive and cross the stomach lining, allowing it to enter the bloodstream.
The SEC specifically sought “the study results to justify or corelate SNAC in varying concentration” in the proposed Wegovy tablet strengths.
In other words, the committee wants supporting evidence explaining the different SNAC concentrations across the formulations. Its recommendation leaves the application open for further evaluation rather than granting final marketing permission.
The SEC’s recommendations stated: “After detailed deliberation, the committee recommended that the firm submit the following for further evaluation before the committee.”
Wegovy contains semaglutide, a medicine belonging to a class called glucagon-like peptide-1 (GLP-1) receptor agonists. These medicines mimic the action of the natural GLP-1 hormone, which helps regulate appetite and blood sugar. They can increase feelings of fullness, reduce hunger and help people eat less.
Wegovy is used alongside a reduced-calorie diet and increased physical activity for long-term weight management in adults with obesity, or those who are overweight and have at least one weight-related medical condition. It is also approved in India to reduce the risk of certain major cardiovascular events in eligible adults with established cardiovascular disease and obesity or overweight.
Novo Nordisk launched injectable Wegovy in India in June 2025. The once-weekly injection was positioned as a treatment for chronic weight management, rather than a short-term cosmetic slimming product.
The proposed tablet offers a different way to take the same active medicine. Instead of a weekly injection, oral Wegovy is designed for daily use, with the dose gradually increased. The UK-approved regimen begins at 1.5 mg daily and progresses through 4 mg and 9 mg to a 25 mg maintenance dose.
International clinical evidence has supported the tablet’s approval in some markets. The European Commission’s July announcement cited results from the OASIS clinical trial programme, including approximately 17% weight loss with oral semaglutide 25 mg compared with 3% with placebo in the relevant trial analysis, alongside lifestyle intervention. These results are trial averages, not a guarantee of individual outcomes.
The UK approved oral Wegovy in June 2026, while the European Commission authorised it across the European Union in July. Novo Nordisk has also reported availability in the United States and the United Arab Emirates. Approval and commercial launch are separate milestones, so authorisation in a country does not necessarily mean the medicine is immediately available at every pharmacy.
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The same SEC meeting considered a separate proposal from Torrent Pharmaceuticals to conduct a Phase-III clinical trial of semaglutide tablets in strengths of 1.5 mg, 4 mg and 9 mg in adults with type 2 diabetes.
The committee recommended permission to conduct the trial.
“The firm presented proposal to conduct Phase III Clinical Trial Study titled ‘A randomized, multi-centric, double-blind, double-dummy, active-controlled, parallel-group, phase-III, clinical trial to evaluate the efficacy and safety of semaglutide oral tablets in adult patients of type 2 diabetes mellitus’,” the SEC said.
“After detailed deliberation, the committee recommended for grant of permission to conduct the Phase III Clinical trial as presented by the firm,” it added.
This is a separate regulatory decision from Novo Nordisk’s application. Torrent’s proposal concerns a clinical trial for type 2 diabetes, not permission to market its tablets specifically for weight loss.
(Edited by Majnu Babu).
