Brentford: British drugmaker GSK said it has no plans to reintroduce its once top-selling heartburn medication Zinetac (ranitidine) brand in India, despite the US court last week ruling that there is no sound scientific evidence to back the claims that the drug increases the risk of cancer.

GSK owns the trademarks Zinetac and Zantac for its ranitidine medications. It uses the Zantac trademark outside India.

“In 2017 and 2018, GSK made the business decision to discontinue making and selling ranitidine tablets,” a GSK spokesperson told ET. “Given the number of alternative products on the market today, and in line with the initial business decision in 2017, GSK has no plans to reintroduce ranitidine.”

The southern district of Florida dismissed all the Zantac federal Multi-District Litigation (MDL) in its ruling last week that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.

GSK, Sanofi, Boehringer Ingelheim and Pfizer are together facing about 50,000 lawsuits in the US with potential injury awards of tens of billions of dollars, as plaintiffs alleged that they developed cancers such as those of liver, bladder, pancreatic, esophageal and stomach after taking Zantac.

GSK discontinued Zinetac/Zantac 150 mg and 300 mg tablets globally in May 2020, following regulatory concerns over the presence of N-Nitrosodimethylamine (NDMA), a probable human carcinogen in the ranitidine active pharmaceutical ingredients. The company also sold its newly built manufacturing plant in Vemgal, Karnataka, established for the purpose of making ranitidine products, taking an impairment charge of about Rs 640 crore.

For years, Zinetac was a top-selling brand of GSK with sales of more than Rs 200 crore annually. But even as GSK exited, other ranitidine brands continue to be available in the Indian market.