POST TIME: 15 November, 2019 00:00 00 AM
Govt slaps ban on ranitidine

Govt slaps ban on ranitidine

The government yesterday imposed a ban on the import, production, and sale of heartburn drug Ranitidine, which is produced using ingredients sourced from two Indian firms. A public announcement to the effect was made by Mohammad Mahbubur Rahman, director general of the Directorate General of Drug Administration (DGDA). The decision comes more than a month after the DGDA’s announcement on September 29 of a temporary ban on the import of Ranitidine’s ingredients, as well as on the drug’s production and sale, amid global concerns over the presence of a possible carcinogen in the product. The raw materials of the two Indian suppliers—Saraka

Laboratories Limited and SMS Life Science—were examined in the World Health Organisation (WHO)-accredited laboratory under the DGDA.

The test revealed higher-than-normal levels of MDMA, a substance which is harmful to human health.

The decision to issue a temporary ban on Ranitidine was made after a research paper published by the United State’s Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on September 13 discovered the presence of N-Nitrosodimethylamine (NDMA) in Ranitidine. NDMA contains cancer-causing elements.

Following the test result, the DGDA suspended the production, distribution, sale, and export of the heartburn drug. Ranitidine is produced by nearly every pharmaceutical company in the country and generates annual sales revenue of Tk. 250 crore, a DGDA official said.

The popular drug helps reduce the production of stomach acid in patients who suffer from conditions like heartburn and stomach ulcers.

NDMA has been classified as a probable human carcinogen on the basis of animal studies. It is found in water and food, including meat, dairy products, and vegetables, but is not expected to cause harm when ingested in very low levels.

On September 19, the European Directorate for the Quality of Medicines (EDQM) suspended the certificate of suitability for Saraka Laboratories. Canada and France also announced recalls of Ranitidine at the same time.