Drug regulator sounds health alert on antacid ranitidine
25 September 2019
The Central Drugs Standard Control Organisation (CDSCO), the country’s top drug regulator, has asked its state-level counterparts to get manufacturers to test anti-acidity drug ranitidine for possible presence of N-nitrosodimethylamine, a chemical compound that can cause cancer.
The directive comes after ranitidine was found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA has been classified by International Agency for Research on Cancer (IARC) as probably carcinogenic to humans.
Ranitidine is used for multiple indications in the country and is available in different formulations including tablets and injections. It is a prescription drug under Schedule H.
Drugs Controller of India VG Somani has issued a directive to all states alerting them on the possible risks of using anti-acidity drug ranitidine and asking them to ensure that drug manufacturers take measures to ensure patient safety.
The directive comes days after the US Food and Drug Administration (FDA) flagged low-level presence of carcinogenic substance in ranitidine, a low-priced medicine used commonly to counter stomach acidity.
The cancerous effect was noticed by the US FDA which has issued an alert. Companies manufacturing the formulation in India are expected to immediately stop production of ranitidine. Following the Drugs Controller’s directive, doctors would be advised by their medical associations to stop prescribing the medicine.
Some manufacturers like GlaxoSmithKline Pharmaceuticals have already responded by sending their ranitidine samples to laboratories for detection of possible NDMA presence in ranitidine.
“GSK is continuing investigations into the potential source of the NDMA. These investigations include continued engagement with GSK’s API suppliers, including Dr. Reddy’s (Laboratories Ltd) and Saraca Laboratories Limited," a spokesperson for the company said
JB Chemicals manufactures ranitidine under the brand name Rantac, while GSK Pharma manufactures the drug under Zinetac. Other brands are Sun Pharmaceuticals Ltd's Histac, Torrent Pharmaceuticals Ltd's Ranitin, Ajanta Pharma Ltd's Pepitran, among others.
Following the safety alert, Dr Reddy’s Laboratories has suspended all shipments of ranitidine products worldwide until the investigation outcome is available. While Dr Reddy’s does not sell the product in India, it sells both prescription and over-the-counter variants of rantidine in the US.