DCGI asked manufacturers of Ranitidine API & formulations to verify their products and take appropriate measures to ensure patient safety after news of ranitidine contamination came in picture.
In the beginning of september month, USFDA reported that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. In USA, Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is also approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Dr. V.G. Somani Drugs Controller General (India) said in a notification to all zonal / sub zonal offices of CDSCO that, "It has been reported that some ranitidine medicines, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. The NDMA has been classified by International Agency for Research on Cancer (IARC) as probably carcinogenic to humans."
He further said, "in view of above, they were requested to communicate to the manufacturers of Ranitidine API & formulations under their jurisdiction to verify their products and take appropriate measures to ensure patient safety."
The drug Ranitidine are approved for multiple indications in India and available in various formulations including tablets, injections etc. The drug Ranitidine is a prescription drug included in Schedule H and it should be sold by retail only under prescription of Registered Medical Practitioner (RMP).
