The Directorate General of Drug Administration (DGDA) has suspended the production, distribution, sale and export of heartburn drug Ranitidine after detecting carcinogenic ingredients in its raw materials.
Ranitidine with any brand name has been banned for ever by the Drug Administration in a public notice. The Drug Administration also asked the pharmaceutical companies to recall ranitidine under any brand name by November 20.
The decision was taken after lab tests conducted by the Drug Administration found cancer causing substance in ranitidine, produced and sold in Bangladesh, in excessively high quantities.
The Drug Administration sent the samples of the ranitidine in the World Health Organization accredited laboratory in Singapore which confirmed the carcinogen called NDMA.
Earlier in mid-September, drug manufacturers across the world began recalling the popular acidity medicine after the US Food and Drug Administration had confirmed that ranitidine contained carcinogen.
On September 29, the Bangladesh government imposed temporary ban on selected ranitidine brands which were produced using raw materials imported from Saraca Laboratories Limited of India.
Almost 99 percent of the drug producers in Bangladesh import raw materials from two Indian farms Saraca Laboratories Limited and SMS Life Science Ltd for ranitidine.
Ranitidine, an over-the-counter drug, is quite popular in Bangladesh. The drug has been produced by almost every pharmaceutical company in the country with different brand names, has annual sales of Tk 250 crore.
As an OTC drug, it is used to lower the quantity of acid produced in the stomach. It is also used to prevent and relieve heartburns associated with acid ingestion and sour stomach. As a prescription drug, it has multiple uses, including treatment and prevention of ulcers in the stomach and intestines and treatment of gastro-esophageal reflux disease or GERD.
There are alternatives to ranitidine for acidity, including omeprazole and esomeprazole.