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Wednesday, January 22, 2020

GSK recalls acidity tablet Zinetac amid concerns over cancer-causing contaminants

Zinetac medicine recalled: 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.

By: ENS Economic Bureau | New Delhi | Updated: September 26, 2019 3:13:09 pm
Zinetac recalled, zinetac tablet, zinetac acidity tablet, zinetac ban, zinetac tablet banned Zinetac recalled: US FDA in a release on Sept 13 said that some ranitidine medicines contained “low levels” of environmental contaminant ‘NDMA’.

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 voluntary suspension of sales of their ranitidine brand and active pharmaceutical ingredient, respectively.

This is a precaution as investigations into whether the contamination is harmful for patients are still ongoing. In the US this week, Sandoz voluntarily recalled “all quantities and lots” of its ranitidine capsules because of “confirmed contamination” with NDMA “above levels established by the FDA” in the product.

“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.

GSK’s Zinetac is manufactured using APIs by two Hyderabad-headquartered firms — Saraca Laboratories Ltd and SMS Lifesciences India Ltd. An API is the key ingredient that gives a medicine its therapeutic effect.

“Subsequently, Saraca Laboratories Ltd were notified by the European Directorate for the Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended with immediate effect,” stated GSK.

“Based on the information provided above and 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,” the spokesperson said, adding that Zinetac manufactured using API from SMS “will not be recalled from the market at this point of time.”

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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