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The market size for Ranitidine brand in India is estimated to be about $98 million
UK-based pharma GlaxoSmithKline Pharmaceuticals Ltd (GSK) has announced it is recalling the antacid drug Ranitidine from India, after the drug regulatory authority 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.
The US Food and Drug Administration (FDA) on September 13 had issued a safety alert citing the low-level presence of NDMA or N-Niteosodimethylamine, a known carcinogen, in ranitidine.
Following the flagging of the product by the US regulator, the Drug Controller General of India asked its state-level counterparts to get manufacturers to test the antacid for the impurity.
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 GSK, Zydus Cadila, Dr Reddy’s, JB Chemicals, Cadila Pharma and Sun Pharmaceuticals sell over 180 generic versions of the drug.
The market size for Ranitidine brand in India is estimated to be about $98 million.
GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API (Active Pharmaceutical Ingredient) from Hyderabad-based Saraca Laboratories and another supplier, SMS Lifesciences India Ltd, for supply to the Indian market.
Saraca Laboratories was recently 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.
“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,” the company spokesperson said.
GSK, however, clarified that the ranitidine product manufactured using API from SMS Lifesciences will not be recalled from the market at this point of time.
“All such products will remain on hold and they will not be released to the market till they receive test results,” the company said.
“GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers,” the company statement said.