The Directorate General of Drug Administration on Sunday imposed a temporary ban on the import of raw materials of heart-burn medicine Ranitidine from 2 Indian companies, and its production and sale in the country.
The decision came just weeks after a research paper published by the US Food and Drug Administration and European Medicines Agency on September 13 found the presence of N-Nitrosodimethylamine – which contains cancer causing elements – in Ranitidine.
Maj Gen Md Mahbubur Rahman, director general of the administration, told The Business Standard that after discussing the matter with leaders of Bangladesh Association of Pharmaceutical Industries, a temporary ban has been imposed on Ranitidine of Saraca Laboratories Limited and Dr Reddy's Laboratories.
"The local companies are not allowed to import Ranitidine raw materials from the 2 Indian companies in question," he said, adding no medicine made with the raw materials cannot be sold in the country.
Local pharmaceutical companies have been asked to stop marketing the medicine in Bangladesh and withdraw Ranitidine tablets already available in the market.
"The companies will collect samples of Ranitidine from the market and inform the drug administration if they find any harmful ingredients after testing those in their labs," Maj Gen Mahbubur added.
Then the drug administration will test the quality of Ranitidine tablets, he added.
According to a source at the drug administration, 31 local pharmaceutical companies import raw materials of Ranitidine from Saraca Laboratories Limited.
Meanwhile, on September 22, Dr Reddy's Laboratories suspended supply of its drug Ranitidine worldwide as a precautionary measure.
Therefore, in public interest, the ban has been imposed on the import of raw materials from the two companies, the source added.
A circular will be published in this regard on Monday.
According to the Bangladesh Association of Pharmaceutical Industries, the total sale of Ranitidine in the Bangladeshi market stood at Tk250 crore per month prior to the ban.