Bangladesh bans Ranitidine

Companies asked to recall it by Nov 20

Manzur H Maswood | Published: 19:20, Nov 14,2019 | Updated: 19:44, Nov 15,2019

 
 

Department of Drug Administration

The government on Thursday permanently  banned production, marketing and sales of popular acidity drug ranitidine.

Ranitidine with any brand name has been  banned for ever by the Drug Administration in   a public notice.

The Drug Administration asked the pharmaceutical companies to recall ranitidine under any brand name by November 20.

‘The patients should take other acidity medicines,’ Drug Administration director general Major General Mahbubur Rahman told New Age.

The decision was taken after lab tests conducted by the Drug Administration found cancer causing substance in ranitidine, produced and sold in Bangladesh, in excessively high quantities, he said.

The Drug Administration sent the samples of the ranitidine in the World Health Organization accredited laboratory in Singapore which confirmed the carcinogen called NDMA, Mahbub told New Age.

In mid-September, drug manufacturers across the world began recalling the popular acidity medicine after the US Food and Drug Administration had confirmed that ranitidine contained carcinogen.

On September 29, the Bangladesh government imposed temporary ban on select ranitidine brands which  were produced using raw materials imported from Saraca Laboratories Limited of India.

‘Now onwards , all the brands of ranitidine produced in Bangladesh will be under the purview of the ban,’ Mahbub said.

He said that the Drug Administration had collected samples of all the brands in Bangladesh and got them tested by the  Singapore lab and found excessive level of NDMA in them.

He said almost 99 per cent of the drug producers in Bangladesh import raw materials from two Indian farms Saraca Laboratories Limited and SMS Life Science Ltd for ranitidine.

‘The tests were done on ranitidine produced using  the raw materials of the two Indian companies,’ Mahbub said.

Ranitidine, an over-the-counter drug, is popular in Bangladesh. Over 100 drug makers produce the generic drug with different brand names.

As an OTC drug, it is used to lower the quantity of acid produced in the stomach. It is also used to prevent and relieve heartburns  associated with acid ingestion and sour stomach.

As a prescription drug, it has multiple uses, including treatment and prevention of ulcers in the stomach and intestines and treatment of gastro-esophageal reflux disease or GERD.

Bangabandhu Sheikh Mujib Medical University pharmacology professor Sayedur Rahman told New Age that when any drug was manufactured, any harmful substance might get into it in the process.

When NDMA, being a carcinogen, is found in any medicine, they are usually withdrawn, he said.

The pharmacologist said that Bangladesh had no labs to test or  to detect NDMA or other harmful substances in medicines.

‘Our regulator [the Drug Administration] has to have the capability to detect such substances in the medicines, or else, recall of a particular drug would not yield much benefit,’ Sayedur said.

Cheap raw materials are used in drug manufacturing in Bangladesh and possibility of such contamination is not unlikely, he lamented.

But, he said, neither the country’s regulator nor our drug manufactures tend to strengthen their capacity to detect harmful substances in medicines in order to provide good quality products.

There are alternatives to ranitidine for acidity, including omeprazole and esomeprazole.

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