Three Indian drugmakers recall generic Ozempic over quality issues

The flood of low-cost copies of blockbuster diabetes and weight-loss drug semaglutide that transformed India's anti-obesity market has run into its first major credibility test.

Within months of the molecule going off patent and more than 50 generic versions hitting pharmacies, at least three Indian drugmakers have initiated product recalls or halted supplies over quality concerns, prompting specialists to demand far greater transparency from the industry.

The concerns surfaced after Hyderabad-based pharma giant Dr Reddy's Laboratories disclosed on Wednesday through an exchange filing that commercial supplies of its semaglutide would be delayed after certain batches were found to be "out of specification" because of an issue linked to the active pharmaceutical ingredient (API) used in the product.

The company said it was investigating the root cause and taking corrective measures, adding that there was "no impact on patient safety" or on its existing global regulatory filings.

Dr Reddy's semaglutide version is sold under the brand name



Obeda.

Similar recalls have also been initiated for Torrent Pharmaceuticals' Semalix and USV's Usema, according to industry sources.

The oral versions of semaglutide, belonging to a class of drugs called GLP-1-based therapy and developed by Danish drugmaker Novo Nordisk, had been available in India since 2022.

Last year, the weekly injectable versions of the drug, under brand names Ozempic and Wegovy were also launched in the country, months after US-based Eli Lilly launched its blockbuster GLP-1 based drug tirzepatide, branded as Mounjaro in India.

These drugs that work by mimicking gut hormones, have been hugely popular worldwide due to their mechanism of action that results in highly effective blood glucose control and dramatic weight-loss.

Despite their high costs, these medicines have also gained quick popularity in India and, since October last year, Mounjaro has been the country's top-selling medicine brand.

In March this year, the patent on semaglutide ended in India.