The drug authority in Bangladesh has imposed a temporary ban on the import, production, and sale of Ranitidine tablets, produced with raw materials of two Indian companies – Saraca Laboratories Ltd, and Dr Reddy's Laboratories. Ranitidine tablets in Bangladesh are mostly made with raw materials from these two Indian companies.
The decision comes after GlaxoSmithKline Pharmaceuticals’ voluntary recall of Ranitidine tablets produced in India following an alleged detection of genotoxic nitrosamine NDMA by global, and Indian regulatory authorities.
As per the decision of Directorate General of Drug Administration (DGDA), taken during a meeting with pharmaceutical companies yesterday, the authorities have asked the medicine companies to test the range of N-nitrosodimethylamine in imported ranitidine hydrochloride in internationally accredited labs, and submit the Certificate of Analysis report to the authority.
The meeting also decided to fix the next course of action based on decisions by other regulatory authorities including the US Food and Drug Administration, European Medicines Agency, Health Canada, European Directorate for the Quality of Medicines, the Health Products Regulatory Authority, and Central Drugs Standard Control Organisation (CDSCO) of Bangladesh.
Ranitidine tablets are mostly used to treat ulcers of the stomach.
GSK also decided to suspend the release, distribution, and supply of all doses of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests, and investigations.
SM Shafiuzzaman, secretary general of the Bangladesh Association of Pharmaceuticals Industries told Dhaka Tribune that suspension on production, and sale of Ranitidine will continue until the test results come.
He also said they would voluntarily run some tests on these raw materials, and send them to the World Health Organization.
Concerns
Concerns rises after the US Food and Drug Administration (FDA) found N-nitrosodimethylamine (NDMA), a probable carcinogen in medicines which contain ranitidine.
In a statement issued on September 26, the FDA said: “These medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
Consumers taking OTC ranitidine, which is used to prevent, and relieve heartburn associated with acid ingestion, and sour stomach, may consider using other OTC products approved for their condition.”
Md Feroz Uddin Khan, managing director of Edruc Pharmaceuticals Company, told this correspondent that they did not receive any formal order from DGDA, but have already stopped producing this medicine.
“We estimated our financial loss, and it is no less than one to one and a half crore Taka. However, we cannot do anything if FDA says it is harmful,” he said.
As of yesterday, this correspondent found most pharmacists in the city were selling this drug. Most of the salesperson at the pharmacies said they are not aware about the FDA research findings.
Mohiuddin Ahmed Bhuiyan, professor of the department of pharmacy at Asia Pacific University, said: “Ranitidine is not an over the counter drug in Bangladesh, but people are still buying it without prescription.”
It is not just about Ranitidine, people need to stop having medicine without consulting with doctors, even if the symptoms do not seem serious, he said, people have a tendency of buying medicine without prescriptions.
Canada and France recall the products
US retailer CVS has become the latest to suspend the sale of Ranitidine. It follows concern in several countries over the presence of impurities in Zantac and other ranitidine products.
Canada and France have already announced Zantac recalls. The US and the European Union are investigating.
On Sept 13, both the FDA and the European Medicines Agency published their decisions to review the presence of N-nitrosodimethylamine (NDMA) in medicines containing the drug ranitidine.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies.
NDMA is found in water and foods, including meats, dairy products, and vegetables, but is not expected to cause harm when ingested in very low levels, EMA says.
Ranitidine products are used to reduce the production of stomach acid in patients with conditions such as heartburn, and stomach ulcers.
