Shawdesh Desk:

The two Indian companies that supply the raw material – Ranitidine hydrochloride – are Saraca Laboratories Limited and Dr Reddy’s Laboratories, according to a media release issued by the Directorate General of Drug Administration on Sunday.

Besides putting a temporary ban on production, sales and marketing of the drug with raw materials from the two Indian firms, the directorate asked the manufacturers to keep the drugs made from the raw materials of these sources quarantined.

Dr Reddy’s Laboratories already stopped supplying the raw material on Sept 22, according to the release.

There is no official account on how many Bangladeshi firms were using the two Indian firms’ raw materials to manufacture Ranitidine.

Ranitidine tablets, hugely popular in Bangladesh, are mostly used to treat ulcers of the stomach.

The directorate said it took the decisions after a meeting with representatives of the pharmaceutical industry following steps taken by pharmaceutical companies and drug authorities of other countries.

GlaxoSmithKline Pharmaceuticals has voluntarily recalled Ranitidine tablets produced with Saraca’s raw material following an alleged detection of N-nitrosodimethylamine (NDMA), which the US Food and Drug Administration says is a “probable human carcinogen”.

The release said European Directorate for the Quality of Medicines or EDQM suspended Saraca’s Certificate of Suitability.

The directorate said it would take the next steps in light of the measures taken by other countries.

Director General of the Drug Administration Major General Md Mahbubur Rahman told  “It’s a temporary ban because the USFDA didn’t ban it, nor did it recommend a ban on it. It was a voluntary recall by the company (GSK). We banned the import out of concerns.”

The authorities will continue monitoring the situation, he said and added other sources of import will remain unchanged.

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,” Maj Gen Mahbubur 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.

India’s Strides Pharma Science Ltd said on Friday it has halted sales of Ranitidine in the US market as it was conducting tests to identify possible cancer-causing impurities in the tablets.