Telangana DCA issues urgent advisory as generic semaglutide floods market

The Drugs Control Administration (DCA), Telangana on Tuesday issued a high-priority public advisory on the usage and safety of Semaglutide-based drugs that have flooded the market, following the landmark patent expiry of the drug.

The move comes as several Indian pharmaceutical giants including all the top drug manufacturers from Hyderabad launched affordable versions of the popular weight-loss and diabetes drug, triggering a huge public demand.

The TS DCA has expressed serious concern over the potential for misuse. With prices for Semaglutide formulations (vials and pre-filled pens) dropping significantly, the TSDCA warned the general public  that such drugs are ‘Prescription Only’ and must not be treated as over-the-counter (OTC) lifestyle supplements.

“The public is strongly advised not to self-medicate with Semaglutide for weight loss or any other purpose. The treatment must be conducted under the direct medical supervision of a Registered Medical Practitioner (RMP),” DCA advisory



said.

The advisory said that while Semaglutide is effective for Type-2 Diabetes and obesity management, it belongs to GLP-1 receptor agonist class, which could impact metabolic functions.

Improper use without a doctor’s evaluation of medical history and dosage can lead to acute pancreatitis, kidney injury, severe gastrointestinal reactions and even acute gall bladder disease, DCA said.

“The public is cautioned against buying from unregulated online platforms. Such products are frequently substandard, spurious, or unsafe. They should buy this medicine by producing a valid prescription,” DCA said.

The DCA has warned pharma companies from taking-up surrogate advertisements or any indirect promotion that could mislead consumers or encourage ‘off-label’ use of the product.

The TSDCA has urged the general public to report any instances of illegal sale or promotion of Semaglutide formulations directly to the Drugs Control Administration, Telangana.