Recalls by Dr Reddy's, Torrent Put Spotlight on Quality Standards in India's Semaglutide Market

The recalls come just months after the expiry of Novo Nordisk's semaglutide patent in India, which triggered one of the country's largest generic drug launches and intensified competition in the diabetes and obesity treatment segment.

Semaglutide, a GLP-1 receptor agonist originally developed by Novo Nordisk, has been available in India in oral form since 2022. The company later launched its injectable brands Ozempic and Wegovy, while Eli Lilly entered the market with Mounjaro (tirzepatide). According to industry sources cited by India Today, Mounjaro has remained India's top-selling medicine brand since October 2025.

Following the patent expiry in March 2026, more than 50 generic semaglutide products approved by the Central Drugs Standard Control Organisation (CDSCO) entered the market from companies including Natco Pharma, Zydus Lifesciences, Alkem Laboratories, Sun Pharma, Glenmark Pharmaceuticals, Dr. Reddy's Laboratories, Torrent Pharmaceuticals and USV.

The launch of generic semaglutide significantly reduced treatment costs, with monthly therapy now ranging from around Rs 1,290 to Rs 8,000. Some multi-dose vial presentations have lowered the cost to nearly Rs 325 per weekly injection, making the therapy accessible to a larger patient population.

According to market estimates cited by India Today, India's GLP-1 therapy market is currently valued at approximately Rs 2,055 crore. While innovator brands accounted for 18% of units sold in June 2026, generic semaglutide products contributed the remaining 82%.

Dr. Reddy's recalled select batches of its semaglutide brand Obeda after certain batches were found to be "out of specification" due to an impurity associated with the active pharmaceutical ingredient (API). The company stated that there were no patient safety concerns or impact on its existing global regulatory filings, but commercial supplies would remain delayed until the issue is resolved.

Also Read: Dr Reddy's Delays Semaglutide Supply After API Quality Issue

The impurity was detected during production scale-up, prompting the company to halt manufacturing of new batches while it investigates the root cause. The company expects supply disruptions in India and Canada to continue until at least late October, although shipments already made to Canada remain unaffected, reports The Hindu.

Torrent Pharmaceuticals also initiated a voluntary precautionary recall of select batches of Semalix injection disposable pens (2 mg and 4 mg) manufactured by Dr. Reddy's Laboratories, following a product recall notification issued by the manufacturer for technical evaluation. The company stated that there is no risk to patients currently using the treatment and clarified that the recall is limited to the affected batches. Torrent also said that all its other semaglutide products, including Semalix tablets (3 mg, 7 mg and 14 mg), Sembolic tablets (3 mg, 7 mg and 14 mg), Semalix 8 mg injection, and Sembolic reusable injection, remain unaffected.

USV has similarly recalled batches of its semaglutide brand Usema, according to industry sources cited by India Today.

The recalls have renewed attention on manufacturing quality, particularly as peptide-based medicines require stringent controls over API quality and production consistency.

Reacting to the development, Mumbai-based diabetologist and metabolic disease specialist Dr Rajiv Kovil stressed the importance of greater transparency.

"The industry owes clinicians and patients a transparent explanation regarding the underlying technical issue, its clinical significance and whether any patient safety concerns exist," Dr Kovil told India Today.

He further stated that manufacturers should promptly communicate the reasons for recalls, affected batches and the recommended course of action to doctors, distributors and patients.

"If a company voluntarily recalls a product, it is important that the reason, the affected batches and the recommended action are communicated quickly and clearly to doctors, distributors and patients. Sometimes recalls are also part of quality assurance, but transparency is a must," Dr Kovil added.