The drug authority has temporarily banned marketing and sales of heartburn drug Ranitidine tablets by two Indian pharmaceuticals — Saraca Laboratories Ltd and Dr Reddy's Laboratories. The government has also banned the production and marketing of Ranitidine tablets, mostly used to treat ulcers of the stomach, using the raw material from these two drugmakers, Director General of the Drug Administration MdMahbubur Rahman told Bangla Tribune on Sunday (Sept 29).
He said they sat down with pharmaceutical industry leaders and analysed the issue before taking the decision. The decision comes after GlaxoSmithKline Pharmaceuticals’ voluntary recall of Ranitidine tablets produced in India following an alleged detection of genotoxic nitrosamine NDMA by global and Indian regulatory authorities.
He said they sat down with pharmaceutical industry leaders and analysed the issue before taking the decision. “We temporarily banned the import out of concern,” said the drug administration chief. The move comes after GlaxoSmithKline (GSK) Pharmaceuticals’ voluntary recall of Ranitidine tablets produced in India following an alleged detection of genotoxic nitrosamine NDMA by global and Indian regulatory authorities.
GSK also decided to suspend release, distribution and supply of all doses of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations. Meanwhile, US retailer CVS has become the latest to suspend the sale of Ranitidine being investigated for links to cancer, reports the BBC.
It follows concern in several countries over the presence of impurities in Zantac and other ranitidine products. Canada and France have already announced Zantac recalls. The US and the European Union are investigating. Health authorities say there is no immediate risk, but patients have been advised to consult a doctor who can prescribe alternatives to ranitidine.
On Sept 13, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published their decisions to review the presence of N-nitrosodimethylamine (NDMA) in medicines containing the drug ranitidine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies.
NDMA is found in water and foods, including meats, dairy products, and vegetables, but is not expected to cause harm when ingested in very low levels, EMA say. Ranitidine products are used to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. They are available over-the-counter and on prescription.