GSK suspends ranitidine sale
A day after the Drug Controller General of India (DCGI) asked the state Food and Drug Administrations (FDAS) to verify the drug and formulation of ranitidine, British multinational drug major Glaxosmithkline Pharmaceuticals suspended supply of the drug to all markets, including India, as a precautionary measure. Other Indian drugmakers have also started testing their ranitidine products at various laboratories after the USFDA issued an advisory to health care professionals.
One of the most popular ranitidine brands in India is Zinetac, which has an annual sales of ~209 crore in the country’s ~688-crore ranitidine market.
“GSK has been contacted by regulatory authorities regarding the detection of genotoxic N-nitrosodimethylamine (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 GSK spokesperson said.
GSK manufactures ranitidine hydrochloride tablets 150 mg and 300 mg (Zinetac), using API from Saraca Laboratories and another supplier, SMS Lifesciences India, for supply to the Indian market. Subsequently, Saraca Laboratories was notified by the European Directorate for the Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended with immediate effect.
"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 they will not be released to the market while we await the test results," the GSK spokesperson added.