(Govt bans import of Ranitidine raw materials from Indian company Saraca)
Staff Reporter,alokitobd::The Directorate General of Drug Administration on Sunday banned temporarily the import of raw materials of Ranitidine hydrochloride tablets in the country from Indian company Saraca Laboratories Ltd.
Also, the production and marketing of Ranitidine tablets, mostly used to treat stomach ulcers, using Saraca raw materials were banned following alleged detection of genotoxic nitrosamine NDMA (N-nitrosodimethylamine) that causes cancer. For the sake of public health, Bangladesh Association of Pharmaceutical Industries took the decisions at a meeting at Mohakhali in the capital, said Major General Md Mahbubur Rahman, Director General of the Drug Administration.
The decisions came after GlaxoSmithKline (GSK) Pharmaceuticals voluntary recalled Ranitidine tablets produced in India following an alleged detection of genotoxic nitrosamine NDMA by global and Indian regulatory authorities.
The British multinational pharmaceutical company headquartered in Brentford, London also decided to suspend release, distribution and supply of all doses of ranitidine hydrochloride products to all markets, including India, as a precautionary action until the outcome of ongoing tests and investigations are available.
After Sunday’s decision on import ban, the drug admin DG said apart from Saraca, raw materials of another Indian company — Dr. Reddy’s Laboratories – are already in the blacklist for import.
With the latest ban, no Bangladeshi pharmaceutical company can import raw materials from these two companies, he added, saying that currently 31 Bangladeshi pharmaceutical companies import raw materials of Ranitidine tablets from Saraca.
“We’ll test the samples in an accredited laboratory.