GSK to recall Ranitidine from India after regulator alert

NEW DELHI: British drugmaker GlaxoSmithKline on Wednesday said it is recalling heartburn drug Ranitidine from India, a day after the country’s drug regulator asked pharma companies to check their products for carcinogen.“As a precautionary action, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Ltd,” a GSK spokesperson said in a statement.Earlier this month, the US FDA had raised a global alarm over the presence of a probable cancer causing substance—NDMA or N-Niteosodimethylamine—in some Ranitidine medicines.GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Hyderabad-based Saraca Laboratories and another supplier, SMS Lifesciences India Ltd, for supply to the Indian market.Subsequently, Saraca Laboratories was notified by the European Directorate for the Quality of Medicines (EDQM) that its certificate of suitability for Ranitidine Hydrochloride has been suspended with immediate effect.GSK has been contacted by the Indian drug regulatory authority regarding the detection of genotoxic nitrosamine NDMA in Ranitidine products.“Based on the information received and correspondence with regulatory authorities, GSK made the decision to suspend the release, distribution and supply of all dose forms of Ranitidine Hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations,” added the spokesperson, clarifying that the product manufactured using API from SMS Lifesciences will not be recalled from the market at this point of time. However, all such products will remain on hold and they will not be released to the market till they receive test results.“GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” the spokesperson further said.Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organisation’s Model List of Essential Medicines. In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s and Sun Pharmaceuticals sell over 180 versions of the drug.The market size for Ranitidine brand in India is Rs 688.6 crore, as per data shared by AIOCD PharmaTrac.

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