MUMBAI: The market leader of popular
antacid medicine
ranitidine in India,
GSK, said it has initiated a recall of its
Zinetac tablets (150mg and 300mg), from pharmacies and retail outlets across the country.
Expand
The recall follows a directive by Drugs Controller General of India (
DCGI) to state regulators and pharma companies on September 24, to verify the safety of the widely-sold anatacid and take measures to ensure patients’ safety, as reported by TOI.
GSK manufactures ranitidine using API (active pharmaceutical ingredient) from Saraca Laboratories and SMS Lifesciences India, for supply in the Indian market. The voluntary recall will cover the tablets which use raw materials from Hyderabad-based Saraca Laboratories. However, the product manufactured using API from SMS will not be recalled at this point of time.
Saraca was notified by the European Directorate for Quality of Medicines (EDQM) that its certificate of suitability for ranitidine hydrochloride has been suspended with immediate effect.
A GSK official told TOI, “The company has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NDMA in ranitidine products. Based on the information 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.
He also said that all such products (from SMS) will remain on hold and they will not be released to the market while till the results of the tests are available.
Details regarding the quantity of drug being recalled, and lots were not immediately available, but it would be significant.
Expand
Ranitidine is a popular antacid, with sales around Rs 700 crore in India. Zinetac (GSK), Aciloc (Cadila Pharma) and Rantac (JB Chemicals) are the top brands. Other companies including JB Chemicals have sent the drug samples to laboratories for investigation, and are waiting for the test results.
The DCGI move comes in the wake of an USFDA investigation for the presence of human carcinogen, NDMA, in ranitidine. The USFDA lainched a probe after a US-based online pharmacy raised the flag about cancer-causing impurities beyond permissible levels in certain ranitidine samples.