GSK has decided to voluntarily recall its ranitidine medication sold in global markets including India as a precautionary action pending the outcome of ongoing tests and investigations globally. Business Today gathers that ranitidine is a Rs 200 crore brand in India and accounts for roughly 9 per cent of GSK pharma sales in India.
This move follows the US regulator's caution note issued on September 13 alerting patients and health care professionals that NDMA was found in samples of ranitidine. NDMA, the US regulator explained "is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests."
GSK spokesperson informs that the company has been contacted by the regulatory authorities of different countries, including India, 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."
A note issued by GSK says, subsequent to its decision, Saraca Laboratories, the company in India that supplies APIs for this, has been 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 manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Saraca Laboratories and another supplier, SMS Lifesciences India, for supply to Indian market.
As a precautionary action, GSK has decided to initiate voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Limited.
"The product manufactured using API from SMS will not be recalled from the market at this point of time. However, all such products will remain on hold and will not be released while we await test results," a note from the company says.
GSK, it says, "is continuing 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."