DGDA temporarily bans Ranitidine in Bangladesh

29 Sep, 2019
The Directorate General of Drug Administration (DGDA) temporary imposed a ban on import, production and sale of Ranitidine in Bangladesh.

DGDA took the decision suspecting that Ranitidine, the acid reflux drug, contains a cancer-causing impurity, an official of the drug administration said.

The decision came at a meeting of the drug administration with the representatives of Bangladesh Association of Pharmaceutical Industries (BAPI) held at the DGDA office this morning, he said.

It also decided to withdraw the drug from the market in the country, Sabrina Alam, drug super of DGDA, told The Daily Star.

Recently, the US Food and Drug Administration (FDA) claimed that it had found a cancer-causing impurity called N-nitrosodimethylanine (NDMA) in some products containing Ranitidine.

In a notice on September 13, the FDA said it has learned 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, it said.

On September 25, Economic Times, quoting AFP, reported that Indian authorities are closely monitoring the sale of heartburn drug Ranitidine after the US drug regulator claim.

Source: thedailystar.net