POST TIME: 30 September, 2019 12:43:48 AM / LAST MODIFIED: 2 October, 2019 11:57:08 AM
Drug admin bans Ranitidine for alleged link to cancer
Restricts import of raw materials from Indian Saraca Laboratories

Drug admin bans Ranitidine for alleged link to cancer

The Directorate General of Drug Administration yesterday 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 yesterday’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. We have also asked our drug manufacturers to test their drugs in accredited labs and send reports to us,” Rahman said.

The drug manufacturers will also withdraw Ranitidine tablets on their own initiative from the local markets, he added. “Representatives of drug manufacturers present at the meeting assured us that they will immediately withdraw ranitidine from the market”.

Rahman further said a circular in this regard will be published in national dailies while the drug administration will continue monitoring the situation.

Meanwhile, US retailer CVS Pharmacy has become the latest to suspend the sale of Ranitidine being investigated for links to cancer.

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.

Health authorities say there is no immediate risk, but patients have been advised to consult a doctor who can prescribe alternatives to ranitidine.

On Sept 13, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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. They are available over-the-counter and on prescription.