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Banned drugs still on drug stores\\\' shelf

Shamsul Huda | Sunday, 25 May 2014



The Drug Administration (DA) last month banned five generic drugs for their 'harmful' effect on human life. But it has not recalled the drugs from the market in line with practice followed most countries, sources said.
The DA has asked the drug companies not to manufacture and market the drugs in question.
The DA in accordance with the recommendations made by the Adverse Drug Reaction Advisory Committee (ADRAC) banned the manufacture of drugs, namely, Pioglitazone, Rosiglitazone, Gatifloxacin (except eye drops), Tegaserod and Sibutramine in Bangladesh.
 Pioglitazone and Rosiglitazone are two anti-diabetic drugs. Pioglitazone is banned in Germany and France. But it is sold in the USA and other countries in Europe with risk warning. India too had banned the drug but it later lifted the ban.  Rosiglitazone is banned in most of Europe and the USA.
Gatifloxacin, is an anti-biotic drug, is banned in USA for health safety reasons. Tegaserod, used for treating irritated bowl syndrome (IBS), was banned in the USA in 2007. Sibutramine, used for treating the problem of obesity, is also banned in most countries.
 The banned generics under different brand names are available in the market as the drug authority has set no time limit for their use or recall from the market.
A source in the market said usually when a drug is banned, it is recalled from the market but in this case there is no recall and even there is no monitoring on the production and marketing of the banned products.
Salim Barami, director of the DGDA said, "We have written letters to the manufacturers of those five generics to stop their production and marketing. But there is no particular time limit about the already manufactured products or the raw materials that they have stocked."
He said usually after banning a drug, the products are recalled from the market but in this case it is not directed here.
Last month, the ADRAC in a meeting had suggested the drug authority to ban production and marketing of six generic drugs on the basis of necessary documents.
But the authority banned only five generics and left the decision pending in the case of  Flupenthixol-Melitracen as per demand made by the manufacturers.
The manufacturers said the Melitracen is used in many countries of the world. But in the ADRAC meeting, it was shown that the Melitracen's country of origin is not producing this drug and even India has banned this item.
According to a source in the drug office, the current market size of the Melitracen is more than Tk1.6 billion in the country and several leading companies are manufacturing the product under their own brand name.
When contacted, several physicians said, "We are yet to know about the decision on the ban of five generics in question."
They said information on harmful drugs should be available through the Bangladesh Medical Association and other channels.
A physician requesting not be named said all the six generics that were suggested for ban are harmful for health.
He said it is incredible to believe that despite knowing the adverse effects the authority did not recall the existing products in the market. Another one Melitracen is still in the market.
A senior official in the DGDA said, "We have banned import of raw materials for the five banned drugs but we are yet to cancel their registrations."
He said only the drug control committee can suggest for deregistration and it is likely to happen in the next meeting.