The drug authority in Bangladesh has banned “temporarily” the import of raw material for making Ranitidine hydrochloride tablets from India’s Saraca Laboratories Ltd.
The government has also banned the production and marketing of Ranitidine tablets, mostly used to treat ulcers of the stomach, using the raw material of Saraca, Director General of the Drug Administration Major General Md Mahbubur Rahman told bdnews24.com on Sunday.
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.
Rahman said they sat down with pharmaceutical industry leaders and analysed the issue before taking the decision.
“It’s a temporary ban because the USFDA didn’t ban it, nor did it recommend banning it. It was a voluntary recall by the company. We banned the import out of concern,” Rahman said, adding that they will continue monitoring the situation.
Other sources of import will remain unchanged, he said.
The drug administration will also test samples of Ranitidine tablets. “We’ll test the samples in an accredited laboratory. We have asked our drug manufacturers to test their drugs in accredited labs and send reports to us,” Rahman said.
GSK Pharma has also decided to suspend 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.