Quality concerns hit cheap Ozempic copies in India within months of blockbuster launch

Multiple semaglutide makers have recalled batches or delayed supplies over quality concerns in India. Doctors are seeking transparent explanations as generics now account for most sales in the market.

In Short

• Dr Reddy's delayed supplies after some batches failed specification checks
• Industry sources said Torrent and USV also initiated semaglutide recalls
• The patent expiry in March opened the gates for dozens of copies

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 manufacturers have initiated product recalls or halted supplies over quality concerns, prompting specialists to demand far greater transparency from the industry, India Today has learnt.

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 widely known semaglutide 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.

India Today has reached out to Dr Reddy’s, Torrent Pharma and USV for their comments. This copy will be updated if and when their replies are received.

Clinicians, meanwhile, said that multiple batches of an important medicine being recalled raises huge questions.

"The industry owes clinicians and patients a transparent explanation regarding the underlying technical issue, its clinical significance and whether any patient safety concerns exist,” Mumbai-based diabetologist and metabolic disease specialist Dr Rajiv Kovil told India Today.

The latest market estimates show that the market size of GLP-1-based therapies stands at Rs 2055 crore and while innovator brands commanded 18 percent of the units sold in June this year, 82 percent of the units sold were the generic versions of these medicines.

QUALITY QUESTIONS

The latest episode surfaces as India's pharma market has been grappling with quality-related issues following instances involving contaminated cough syrups supplied within the country and abroad, repeated charges of supplying low-quality drugs to markets with weak regulatory oversight and a new controversy surrounding fake oxytocin that was connected with several maternal deaths in Rajasthan.

The development also come barely months after the core semaglutide patent expired in India in March, triggering one of the biggest generic launches the country's pharmaceutical industry has seen in recent years.

More than 50 Central Drugs Standard Control Organisation (CDSCO)-approved generic versions quickly entered the market from companies including Natco Pharma, Zydus Lifesciences, Alkem Laboratories, Sun Pharma and Glenmark Pharmaceuticals, apart from Torrent, Dr Reddy's and USV.

Competition sharply lowered treatment costs, with monthly therapy ranging from about Rs 1,290 to Rs 8,000 and some multi-dose vial formats bringing the cost down to nearly Rs 325 per weekly injection.

The aggressive pricing dramatically expanded access to a medicine that had until recently remained beyond the reach of many Indian patients seeking treatment for diabetes and obesity.

But the recalls have exposed the challenges of rapidly scaling production of a complex injectable biologic-like peptide where manufacturing consistency and API quality are critical.

Dr Reddy's told stock exchanges that certain batches failed to meet specifications because of an issue associated with the API. While the company stressed there were no patient safety concerns, it said commercial supplies would remain delayed until the problem is resolved.

For physicians, however, the issue goes beyond a single manufacturer.

"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," Dr Kovil said.

"Sometimes recalls are also part of quality assurance, but transparency is a must."

MARKET STEADIES

Ironically, quality concerns have emerged just as India's anti-obesity market appears to be settling into a more sustainable growth phase.

According to pharmaceutical market tracker Pharmatrac, the launch of generic semaglutide significantly expanded the size of the obesity market, but the initial surge in prescriptions has now plateaued.

While consumption of generic semaglutide had witnessed exponential growth immediately after launch, that rapid expansion has begun to stabilise.

The report also notes that innovator brands continue to post steady month-on-month growth, reflecting a loyal prescriber base and continued onboarding of eligible patients despite the influx of lower-priced alternatives.

That makes confidence in product quality even more critical as doctors decide which brands to prescribe in an increasingly crowded market.

“For India's generic drug industry, the episode also serves as an early reminder that success in the high-growth obesity segment will depend not only on competitive pricing but also on consistently meeting stringent quality standards,” said a pharmaceutical market analyst.

As dozens of companies compete for a share of one of the world's fastest-growing therapy markets, manufacturing reliability may prove to be as important as affordability, the analyst added.

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