GSK recalls Zinetac amid concerns over cancer-causing contam
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Pharmaceutical firm GSK on Wednesday said it was voluntarily recalling several batches of its popular acidity medicine ‘Zinetac’ as a “precautionary” measure while regulators around the world investigated the drug, known as ranitidine, for potential cancer-causing contaminants. This includes recalls of batches of its brand from the Indian market, the firm said.

Ranitidine, a medicine that decreases stomach acid production, had a market size of Rs 688.6 crore in India and Zinetac was the second largest brand in this segment as of August 2019, according to AIOCD Awacs PharmaTrac.

Other popular ranitidine brands sold here include Aciloc by Cadila Pharmaceuticals, Rantac and Rantac-OD by JB Chemicals, Zydus Cadila’s R-Loc and Torrent Pharmaceuticals’ Ranitin. It is unclear whether the other firms are considering similar measures. GSK’s announcement comes on the heels of a letter by India’s apex drug regulator, the Drug Controller General of India (DCGI), to state regulators asking them to direct manufacturers of ranitidine’s active ingredients to “verify their products” and “take appropriate measures”.

The issue was first flagged earlier this month by the US Food and Drug Administration (US FDA), which stated in a release on September 13 that some ranitidine medicines contained “low levels” of an environmental contaminant known as ‘NDMA’. This contaminant, found in water and foods, is the same impurity the US regulator was investigating in blood pressure drugs valsartan and losartan last year.

While the US FDA had called for recalls of batches of valsartan and losartan due to “unacceptable” levels of NDMA, it has not raised a similar alarm over the NDMA content in ranitidine, which it is still investigating. Yet, GSK and Dr Reddy’s Laboratories have announced a voluntary suspension of sales of their ranitidine brand and active pharmaceutical ingredient, respectively.

“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,” stated a GSK spokesperson.

At the same, GSK plans to keep “all such products” on hold, which means they will not be released to the market while the company awaits the 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.”

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