India’s apex drug regulatory authority has flagged violations in the market for weight-loss drugs, issuing notices to entities for unauthorised sales, improper prescription practices, and deceptive marketing. The Central Drugs Standard Control Organisation (CDSCO) announced the crackdown on Tuesday, targeting online pharmacy warehouses, wholesalers, retailers, and slimming clinics as low-cost generic versions of blockbuster medications prepare to expand consumer access across the country.
CDSCO Targets Unauthorised Sales and Marketing Malpractices
The CDSCO audits and subsequent notices aim to curb illicit activities within the pharmaceutical supply chain as demand surges for high-profile treatments like semaglutide. According to the CDSCO, the enforcement actions respond directly to improper prescription practices and deceptive promotional strategies employed by various market participants. While the regulatory body did not disclose the exact number of entities that ultimately received notices or detail every specific infraction, the sweep covered 49 entities, including online distribution networks and specialized weight-loss clinics.
This intensified regulatory scrutiny arrives as India’s patent on semaglutide approaches expiration on March 20, paving the way for domestic manufacturers to introduce low-cost generic alternatives. Brand-name medications developed by Novo Nordisk, such as Ozempic and Wegovy, currently retail at significantly higher price points. Market data indicates that Ozempic costs between ₹8,800 and ₹11,000 per month, while Wegovy ranges from ₹10,800 to ₹16,000. In contrast, upcoming generic versions are projected to cost as little as ₹1,300 per month, drastically altering market accessibility.
Interpol Alert Triggers Surveillance of Counterfeit Batches
The regulatory tightening extends beyond domestic distribution issues. According to government communications reviewed by Mint, India’s drug regulator directed state authorities to increase supply chain surveillance after an Interpol intelligence alert flagged counterfeit semaglutide batches. The Central Bureau of Investigation (CBI) informed the CDSCO on July 7 regarding the alert, which originated in Austria. Austrian authorities identified counterfeit semaglutide products manufactured by Hilma Biocare, a European research and biotechnology firm that produces pharmacological substances.
Medical Experts Warn Against Unsupervised Use
Medical professionals have voiced strong concerns regarding patient safety amid the influx of both cheaper generics and illicit products in a nation grappling with high obesity rates. Ambrish Mithal, chairman of endocrinology at Max Healthcare hospital in New Delhi, emphasized the dangers of inadequate medical oversight, stating that unsupervised use prevents patients from recognizing or responding to adverse effects in time.
Under current regulations, the CDSCO permits semaglutide sales strictly against valid prescriptions issued by endocrinologists, internal medicine specialists, and, for specific conditions, cardiologists. However, retail chemists frequently fail to enforce these prescription requirements. Nikhil Tandon, a professor of endocrinology at the All India Institute of Medical Sciences in New Delhi, stressed that strict adherence to these governing conditions by doctors, pharmacists, and patients alike remains critical as market access broadens.
Anoop Misra, chairman of the Fortis Centre for Diabetes, Obesity and Cholesterol in New Delhi, described the government surveillance as timely, asserting that the primary focus moving forward must center on robust enforcement and heightened awareness campaigns directed at both medical practitioners and consumers.