Oral Wegovy in India stalls as CDSCO experts ask Novo Nordisk for local data

India's drug regulator has not yet cleared the daily semaglutide tablet from Novo Nordisk, and the path for oral Wegovy in India now runs through fresh local evidence. When it met on 23 September, the Subject Expert Committee on Endocrinology and Metabolism withheld permission and asked the company for three sets of extra data, according to the committee recommendations reported by The South First. The same tablet is already authorised in the UK and the European Union. The committee set no deadline for the new material and gave no date for a second review.

What the CDSCO subject expert committee asked for

The Central Drugs Standard Control Organisation, or CDSCO, uses subject expert committees to examine applications before it decides on them. Here the panel reviewed a proposal from Novo Nordisk India to import and market semaglutide tablets in four strengths under the Wegovy brand. After what its minutes describe as detailed deliberation, the committee did not recommend approval and asked for more material "for further evaluation before the committee." That wording keeps the file open rather than closing it. The South First, which reported the committee recommendations, notes that nothing in them shows the tablets to be unsafe or ineffective. This is a request for data on a product that other regulators have already cleared, not a finding against the medicine itself.

The first request covers bioavailability and bioequivalence, shortened to BA/BE. The committee asked for any such study run in India on the proposed tablets, which it calls R2 formulations, and said that if none exists the company should run one in Indian participants. The second request is for Indian clinical trial data on the same tablets. The third asks for study results that justify or correlate the different amounts of the SNAC absorption enhancer across the four strengths. The first and third points are technical questions about how the tablet behaves in the body. The second is heavier for oral Wegovy in India, because a new clinical study in India would take far longer to plan, enrol and report than pulling existing files. The reported minutes do not say whether Novo Nordisk already holds Indian data.

Why SNAC and bioequivalence matter for a peptide pill

Semaglutide is a peptide, and a peptide swallowed as a plain tablet is largely broken down in the gut and poorly absorbed. Novo Nordisk pairs the drug with salcaprozate sodium, known as SNAC, which helps semaglutide survive the stomach and cross its lining into the blood. When SNAC levels differ from one strength to the next, a regulator can fairly ask whether each tablet delivers the exposure its strength implies. Bioavailability describes the share of a dose that ends up in the blood and the speed at which it gets there. Bioequivalence compares two versions of a product to see if they give closely matching drug levels over time. Both are routine tools, and they matter most when absorption depends on a helper ingredient rather than on the drug alone.

This is a request for data on a product that other regulators have already cleared, not a finding against the medicine itself.

Our coverage has already shown how sensitive oral semaglutide is to its recipe. Daewon Pharmaceutical reported that its DW5324 oral semaglutide candidate reached higher blood levels than Rybelsus in two small crossover studies, a reminder that formulation choices can move exposure a long way. The committee request reads in that light. It does not question semaglutide as a molecule, which Indian patients can already receive as the weekly Wegovy injection. It questions whether these specific tablets, with their varying SNAC content, have been shown to behave as expected in Indian participants. Whether global pharmacology studies will satisfy the panel, or whether new work is needed, is not clear. The South First report carries no response from Novo Nordisk on the three requests.

Where oral semaglutide stands outside India

Other regulators have moved faster. British approval for weight management came in June 2026, and a European Commission decision covering every EU member state followed a month later. According to Novo Nordisk, the tablet is already on sale in the US and the UAE. When it announced its July decision, the Commission pointed to the OASIS trials, where people on the highest tablet strength lost about 17% of body weight on average versus roughly 3% on placebo, with lifestyle support in both groups. Those figures are trial averages and do not predict any one person's result. In the US, demand came quickly: our report on Wegovy pill uptake covered a research letter finding that new starts on the tablet briefly passed the injection by March 2026.

India is not starting from zero. Novo Nordisk launched the injectable form of Wegovy there in June 2025 and framed the weekly shot as a long term obesity medicine, not a quick slimming aid. Indian approval for the injection also covers cutting the chance of serious heart events in adults who already have cardiovascular disease and carry excess weight. A tablet would offer the same active medicine as a daily dose, raised in steps, instead of a weekly injection. For our board, oral semaglutide remains approved and nothing changes for the molecule in its existing markets. The move is narrower: the Indian application stays filed, with its timing now tied to whatever evidence Novo Nordisk can supply and when the committee next lists it.

Torrent semaglutide trial and the Indian generic race

The same meeting handled a separate request from Torrent Pharmaceuticals. The company proposed a Phase 3 trial of semaglutide tablets in three lower strengths in adults with type 2 diabetes. As described in the minutes, the study is randomised, multicentric, double blind and double dummy, with an active control and parallel groups, and it will measure efficacy and safety. The committee recommended that permission be granted. The reported minutes do not name the active comparator, the number of patients or the length of treatment. This decision concerns a clinical trial in diabetes. It is not marketing permission for Torrent, and it does not cover weight loss, so it says nothing yet about whether a domestic tablet will reach Indian patients.

Still, the two decisions sit side by side for a reason. Torrent's trial is designed to produce exactly the kind of Indian clinical data the committee now wants from Novo Nordisk, though for a different use. The South First has separately reported that generic competition cut semaglutide prices in India after patent expiry, so the market Novo Nordisk hopes to enter with a tablet is already competitive on price. Other oral options are also advancing abroad, including Lilly's non peptide pill orforglipron, which drew a positive CHMP opinion in Europe; its Indian status was not part of this meeting. Every month that oral Wegovy in India waits for local data gives domestic rivals more time to build their own evidence.

Conclusion

Oral Wegovy in India is on hold, not refused. The CDSCO expert committee wants a local bioequivalence study, Indian clinical evidence and a rationale for SNAC levels across strengths, and it set no deadline. The first and third points may be answerable from existing work, while the second could take much longer if no Indian study exists. Any launch date should be treated as unknown until the committee lists the application again. This story is research and news context only, not medical advice.