India drug regulator tightens surveillance against unauthorised weight-loss drug sales

India’s drug regulator has tightened surveillance against the unauthorised sale and promotion of weight-loss drugs, the health ​ministry said on Tuesday, after local drugmakers launched cheaper ‌generic versions of Ozempic and Wegovy over the weekend.

At least half a dozen Indian drugmakers, including Dr Reddy’s (REDY.NS), Zydus (ZYDU.NS), and Sun Pharma (SUN.NS), launched multiple brands of the ​blockbuster diabetes and weight-loss drugs, up to 70% cheaper than ​Novo Nordisk’s drugs in some cases, after the patent ⁠for semaglutide expired last week.

Semaglutide is the active component in Ozempic ​and Wegovy. The patent expiry had triggered concerns about misuse and confusion ​among prescribers as costs fall sharply. The Central Drugs Standard Control Organization (CDSCO) conducted inspections at 49 entities across the country, including drug wholesalers, retailers, and slimming clinics, the statement said.

It ​focused on identifying violations related to unauthorised sale, improper prescription ​practices, and misleading marketing, the statement said, adding that notices were sent to defaulting ‌entities.

“These ⁠drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks,” the statement said, adding that there have been concerns regarding their on-demand availability across various platforms.

Earlier this ​month, the CDSCO ​also warned pharmaceutical ⁠companies against direct or indirect advertising of weight-loss medicines, including obesity awareness campaigns that could act as ​surrogate promotions. Analysts had expected more than 40 Indian drugmakers ​to ⁠launch over 50 brands after patent expiry, as they race to grab a share of the market that could grow to 80 billion rupees ($852.62 ⁠million) ​by 2030 from about 15 billion rupees ​today, according to research firm Pharmarack.

Source:  Reuters