DHAKA, Sept 29, 2019 (BSS) – Directorate General of Drug Administration has banned the import of raw material for making Ranitidine hydrochloride tablets from India.
The decision came after GlaxoSmithKline Pharmaceuticals’ voluntarily recalled Ranitidine tablets produced in India following an alleged detection of ‘genotoxic nitrosamine NDMA’ by global and Indian regulatory authorities, said a press release today.
It is temporarily banned because the United States Food and Drug Administration (USFDA) didn’t ban it nor did it make such recommendation. It was a voluntary recall by the company.
Directorate General of Drug Administration banned the import out of concern, said the release adding that they will continue monitoring the situation. The Drug Administration will also test samples of Ranitidine in accredited labs, it added.
GSK Pharma has also decided to suspend release, distribution and supply of all doses of ranitidine hydrochloride products to all markets.