India’s apex drug regulatory authority has flagged violations in the country’s market for weight-loss drugs, sending notices to entities engaged in unauthorised sales, improper prescription practices, and deceptive marketing.

Audits and inspections of 49 entities — including online pharmacy warehouses, wholesalers, retailers, and slimming clinics — have led to notices being issued to “defaulting entities”, the Central Drugs Standard Control Organisation (CDSCO) said on Tuesday.

The actions are part of efforts to curb malpractices in the pharmaceutical supply chain, including unauthorised sales and misuse of weight-loss drugs, as low-cost generic versions of semaglutide from domestic manufacturers are set to expand access, the CDSCO said.

The CDSCO did not respond to queries on how many entities were issued notices or the specific nature of violations by those who received the notices.

Doctors have raised concerns about possible misuse of the drugs in a country with high obesity levels and poor adherence to prescription requirements by retail chemists.

“The risk comes from misuse or unsupervised use,” said Ambrish Mithal, chairman of endocrinology at Max Healthcare hospital in New Delhi. “If taken without proper evaluation and follow-up, patients may not recognise or respond to adverse effects in time.”

The CDSCO said semaglutide has been approved in India on the condition that it is sold only against prescriptions issued by endocrinologists or internal medicine specialists and, for certain conditions, by cardiologists.

Multiple drug makers in India have launched low-cost versions of Ozempic and Wegovy, both developed by Novo Nordisk, at prices that could cut treatment costs after the expiry of semaglutide’s patent in India on March 20.

Specialists say Ozempic costs around ₹8,800 to ₹11,000 per month, while Wegovy ranges from ₹10,800 to ₹16,000. Generic versions could cost as little as ₹1,300 per month.

As access expands with generics, experts say adherence to regulatory safeguards will be critical.

“The conditions governing how these drugs are prescribed, sold and used must be strictly followed by doctors, pharmacists, and patients alike,” said Nikhil Tandon, a professor of endocrinology at the All India Institute of Medical Sciences, New Delhi.

Experts say stronger enforcement and awareness will be key to ensuring appropriate use.

“The government’s intensified surveillance is timely,” said Anoop Misra, chairman of the Fortis Centre for Diabetes, Obesity and Cholesterol, New Delhi. “The priority should be stronger enforcement and better awareness among both doctors and patients.”