The Directorate General of Drug Administration (DGDA) has permanently “postponed” the production, distribution, sale and export of heartburn drug ranitidine after detecting carcinogenic ingredients in its raw materials.
The decision came over a month after the DGDA had imposed a temporary ban on September 29 on the import of the ingredients, production and sale amid global concerns over the presence of a probable carcinogen in the products.
Later, the DGDA sent the sample of raw ingredients, widely supplied by Indian companies Saraka Laboratories Ltd and SMS Life Science, to the World Health Organization (WHO) accredited laboratories for testing.
The result showed the existence of the carcinogen -- N-nitrosodimethylamine (NDMA) -- in the ingredients, according to a mass announcement published on Wednesday.
Based on the result, the DGDA permanently postponed production, distribution, sale and export of ranitidine, said it’s office.
“Postponing means no production, distribution and sale of ranitidine would be allowed from now on. Certification from standard labs would be required for further imports of such raw ingredients,” Sabrina Alam, superintendent of drugs at the DGDA, told The Daily Star.
Ranitidine, produced by almost every pharmaceutical company in the country, has annual sales of Tk 250 crore, officials said.
It is popular for reducing the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.
Experts say patients can consult doctors who would prescribe alternatives to ranitidine.
On September 13, both the US Food and Drug Administration and the European Medicines Agency published their decisions to review the presence of NDMA in medicines, including ranitidine, BBC reports.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies.
On September 19, the European Directorate for the Quality of Medicines suspended the certificate of suitability for Saraka Laboratories Ltd.
At the same time, Canada and France announced recalls of ranitidine products.