DCGI asks ranitidine makers to ensure patient safetyOctober 1, 2019
The Drugs Controller of India alerted on ranitidine, a commonly used antacid drug, to have found to contain a chemical compound which can cause cancer.
Dr. V G Somani, Drugs Controller General of India has issued a directive to all states alerting them on ranitidine and asking them to ask all drug manufacturers to take measures to ensure patient safety, reported IANS.
According to the directive, ranitidine medicines 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.
The state drug controllers have been asked to communicate the manufacturers of ranitidine to verify their products and take appropriate action for public safety.
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