The Drugs Controller of India has sounded a public health alert on ranitidine, after some drug regulators found it to contain a chemical compound which can cause cancer.
Ranitidine, an old, cheaply-priced medicine is commonly used to counter stomach acidity. It 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, V.G. Somani, who is under the Directorate General of Health Services, 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.
According to the directive, ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans.
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.