CDSCO Wegovy pill review stalls as experts seek Indian data

India's drug regulator has held back the oral form of Wegovy and asked Novo Nordisk for more evidence. The CDSCO Wegovy pill review stalled at a Subject Expert Committee meeting on 23 September, according to recommendations the agency posted on 19 October. The panel wants Indian absorption data, Indian clinical data and an explanation of how the tablets use their absorption enhancer. It set no deadline. The same meeting cleared three Roche trials of petrelintide and several semaglutide studies by Indian firms.

What the committee asked Novo Nordisk to provide

Novo Nordisk India asked for permission to import and market semaglutide tablets under the Wegovy brand in four strengths. The proposed uses match the injection: long term weight management with diet and exercise in adults with obesity, or overweight with at least one related condition, and reduction of major heart events in adults with established cardiovascular disease. The company presented results from PIONEER PLUS, a type 2 diabetes trial that enrolled Indian participants and tested higher daily oral strengths against the existing top strength. It also showed studies run abroad. The committee did not reject the file. It recommended that the firm return with more data for further evaluation, which leaves the application open but without a decision.

The minutes list three requests. First, any bioavailability or bioequivalence study of the four tablet strengths conducted in India, and if none exists, a new one in Indian participants. Second, any clinical trial data for those formulations gathered in India. Third, study results that justify the different concentrations of SNAC across the strengths. The minutes label the tablets as R2 formulations, a term the document does not define further. The committee gave no reasons in writing beyond the requests themselves, and nothing in the text says the product is unsafe or ineffective. The committee recommendations document is a four page table covering eight items from the same session. The minutes record no response from the company.

Why SNAC sits at the centre of the CDSCO Wegovy pill review

Semaglutide is a peptide. Swallowed on its own, most of it would be broken down in the gut before it could reach the blood. The oral form solves that with salcaprozate sodium, known as SNAC, an ingredient that protects the drug in the stomach and helps it cross the stomach lining. How much SNAC a tablet carries can change how much semaglutide gets through. That is why the committee asked for data linking SNAC levels to each strength. Bioavailability describes how much of a medicine reaches the bloodstream and how fast. Bioequivalence asks whether two versions deliver the drug at closely matching rates and levels. Regulators often ask for such studies when a formulation changes or when local populations have not been studied.

The committee gave no reasons in writing beyond the requests themselves, and nothing in the text says the product is unsafe or ineffective.

Those questions carry weight for a daily tablet because only a small share of a swallowed dose is absorbed, and that share can vary. The CDSCO Wegovy pill review therefore turns partly on chemistry, not only on weight loss figures from abroad. The committee did not say whether foreign absorption studies were unconvincing or simply not specific enough to India. Earlier oral semaglutide tablets for diabetes, sold as Rybelsus, came in a different set of strengths, and the minutes do not say how the panel weighed that history. For readers following the global rollout, our report on the first GLP 1 pill for weight management covers the trial evidence behind the product and the approval that came first.

Where oral Wegovy stands outside India

The tablet is already authorised in several markets. Novo Nordisk said in a 15 July release that the European Commission had approved the Wegovy pill across the European Union, after a positive opinion from the European Medicines Agency's human medicines committee in May. The company called it the fifth approval for the pill, after the United States, the United Kingdom, the United Arab Emirates and Bahrain. Novo Nordisk said the pill was on sale in the United States, the United Kingdom and the United Arab Emirates, and that it planned launches in more countries in the second half of 2026. In India, the company launched injectable Wegovy in June 2025, according to The South First, which first reported the committee decision.

Approval and launch are separate steps, so a country can authorise a medicine months before it reaches pharmacies. India also differs from Europe on supply. Key semaglutide patents have lapsed in India, and generic injectable versions are already competing on price there, a shift covered in our story on semaglutide copies arriving as patents end. A branded oral product would enter a market where the active ingredient is no longer exclusive to Novo Nordisk. That context does not appear in the minutes. It does help explain why Indian firms are now filing their own oral semaglutide trials, as the same meeting showed.

Other decisions from the same meeting

The committee recommended permission for three phase 3 trials of petrelintide sponsored by Roche Products India. Petrelintide is an investigational amylin analogue that Roche licensed from Zealand Pharma. Two of the three approvals carry conditions. Every participant must have an eye fundus examination at screening, with results no more than one month old, and all sites must follow common procedures for managing low blood sugar episodes. The panel also cleared Torrent Pharmaceuticals to run a phase 3 trial of oral semaglutide tablets in adults with type 2 diabetes. That trial is randomised, double blind and compared against an active drug. It concerns diabetes care, not weight loss, and it does not grant Torrent marketing rights.

Two other items involved GLP 1 drugs. Virchow Biotech received a recommendation to manufacture and market a liraglutide injection for blood sugar control in adults with type 2 diabetes, based on a phase 3 comparison with Victoza, on condition that it runs a phase 4 study. LevimLifetech was cleared to run a phase 1 and 3 study of a proposed semaglutide biosimilar against Ozempic in type 2 diabetes. That clearance requires a drug safety monitoring board and an interim safety report to CDSCO at week 13. Expert committee recommendations go to the national drugs controller, who makes the final call. The minutes do not say when Novo Nordisk's file will return to the committee.

Conclusion

The CDSCO Wegovy pill review is paused, not closed. India's expert panel wants local absorption and clinical data and a clear account of SNAC levels before it advises on the tablet. The minutes do not say when the company will reply. Meanwhile the same panel cleared Roche's petrelintide trials and several Indian semaglutide studies, a sign that local GLP 1 activity keeps moving while the branded pill waits.