The Acting Head of the Laboratory Services at the Food and Drugs Board (FDB), Mr. Eric Karikari Boateng, has taken a swipe at some newspaper publications that the FDB has “banned” some 22 drugs.
According to him the drugs have not been banned as being speculated, but instead manufacturers have been asked to recall the products.
“The products have not been banned, they have been recalled, the press release was clear. It is a product recall not a ban, that is, the marketing authorization of the product has not been redrawn,” he stressed.
The Acting Head of the Laboratory Services at the FDB explained that; “When you say ban, then it means the marketing authorization, the registration of the product has cancelled and therefore you cannot put the product on the market again. But when you say recall, normally in manufacturing the regulatory authority can allow the manufacturer to recall that product, that does not meet the specifications and standards according to which the product was registered and put on the market.”
“Using (the word) ban is totally incorrect, I repeat it is totally incorrect and I wonder why they said ban because a recall is a recall and it’s normal in pharmaceutical business” he iterated.
Mr. Eric Karikari Boateng was categorical that the recall of the 22 drugs does not mean they are fake, but rather its quality falls short of standards.
The Food and Drugs Board (FDB), yesterday called for the withdrawal of 22 anti-malarial drugs from the Ghanaian market due to their quality and risk to the health of the general public.
The affected drugs and their batch numbers are Artrine Tablet, 370402; Malar-2 Forte Tablets. 0101H; Dan mether Tablets; 005, Lomart Forte Tablets, Lf. 121; GSUNATE 24 KIT, Kf-03;GSUNATE 24 Kit, GO-02; Gsunate 100 Kit, GO-1;Amonate 400, 7005 and camosunate plus Adult Tablets, 704019.
The rest are Amonate-400; Palidar Tablets,051 Mo2792;Malafan Tablets,, 005, Meladoxine Tablets ; MD/92927;Maladrid Tablets,7007; Donaxine Tablets, 0705922; SP. Dox Tablets, SP-04; SP-Dox Tablets, SP.01; Damarich Tablets, ME 18-342 and Malareich Tablets, 47055.
In June 2008, the FDB detected defective Coartem tablets which were withdrawn because they were found to contain no active ingredient which fights malaria. In September, fake Augmentin tablets with similar defects were also withdrawn.
The Board says 170 anti-malarial drugs were sampled before the 22 were found to be defective because they did not meet FDB’s specifications and standards.
Speaking to Kwami Sefa-Kayi on PEACEFM’s “Kokrokoo”, he impressed upon the need for the general public to be wary and look out for the batch numbers of the listed drugs.
“Unfortunately, I don’t know why people don’t look at it, before any product is put on the market it has to have a batch number, date of manufacturing, date of expiry and the name of the manufacturer. It is a regulatory requirement which has to be met. In manufacturing, these things do happen, even in normal life things do happen that is why when you are buying a product you need to check the batch numbers,” Mr. Boateng cautioned.
He added that; “the particular batches, the batches that have been stated there, they are not supposed to be on the market, the manufacturer is supposed to redraw or recall those products from the market…the manufacturer has the batch numbers of the products, they know where they distributed those products, so they will have to provide that data to the FDB to ensure that all the products are recalled,” he said.
Source: Alex Ofei/Peacefmonline/Ghana
We have 28 guests and no members online