India's weight-loss drug market is under regulatory scrutiny as the government documents 400 reports of adverse drug reactions (ADRs) potentially linked to semaglutide, according to government officials. The Indian Pharmacopoeia Commission (IPC) is currently evaluating these cases, including reports of gastrointestinal distress such as severe nausea and persistent vomiting, along with major dermatological issues. As reported by Mint, these reports have been collected since the drug's launch in India last year through dedicated state-level monitoring centres that report to the Centre.
The ongoing review could lead to tighter norms including label changes, safety warnings and stricter prescription rules. The Centre has already directed states to ensure this anti-obesity drug can be accessed only through prescription by endocrinologists, internal medicine specialists and cardiologists for some indications. According to Mint, several pharmaceutical companies including Sun Pharma, Zydus Lifesciences, Dr. Reddy's Laboratories, Mankind, Torrent, Glenmark, and Zydus Lifesciences have launched generic versions following patent expiry of innovators like Novo Nordisk and Eli Lilly in India.
Health experts report that almost half of people taking semaglutide develop well-documented side effects such as nausea, vomiting, or constipation. Dr. Ambrish Mithal, chairman of endocrinology at Max Superspeciality Hospital, noted that about 5% of Indian patients must discontinue the drug because they cannot tolerate gastrointestinal effects. However, Dr. Atul Gogia from Sir Ganga Ram Hospital estimates that 10-20% of patient population experience gastrointestinal side-effects, though he considers the ADR incidence low at less than 1% given the hundreds of thousands of patients using the drug.
India's obesity burden, combined with recent price cuts making semaglutide more accessible, is driving market growth. According to Grand View Research, the weight-loss drug market is projected to reach ₹347.5 million by 2035. The drug has been in global use for nearly a decade, debuting in 2017 with Ozempic for type-2 diabetes management and the dedicated weight-loss version Wegovy introduced in 2021. Industry leaders emphasize the need for close monitoring, with Mankind Pharma's Sheetal Arora stating that semaglutide should be initiated and monitored under qualified healthcare professional guidance.
