301 Views Posted on 12-Nov-2010 under Health

The Food and Drugs Board (FDB) has directed the recall of substandard anti-malarial medicines from circulation by the respective manufacturers and importers and to submit a recall report within 10 days.

In a statement in Accra on Monday signed by the Chief Executive, Dr Stephen Opuni, the Board said: "This practice of selling counterfeit or substandard medicines is in contravention of section 12 of the Food and Drugs Law, PNDC Law 305B and its subsequent amendment Act 523, 1996, which states that: "Where a standard has been prescribed for any drug ., any person who labels, packages, sells or advertises any substance in such a manner that it is likely to be mistaken for that drug . commits an offence .."

"Additionally, section 18 of the Food and Drugs Law states categorically that; "No person shall manufacture, prepare, sell, supply, export or import into Ghana any drug, cosmetic, medical device or household chemical unless the article has been registered with the FDB ..". The statement asked the general public not to patronize the specified batches of those products and to report anyone found offering them for sale to the nearest FDB office. It also asked any wholesalers, pharmacy or licensed chemical shops that had in stock those medicines (with the specified batch numbers) to immediately return them to the importer, distributor, manufacturer or to the FDB.

The statement said the FDB had authorized the respective companies to immediately withdraw the products from the market in order not to endanger public health and safety while taking the necessary regulatory actions against the manufacturers and importers of those medicines. "Information from the general public on persons suspected to be in any practice possible of endangering public health and safety to FDB's mandate is most welcomed through 0244337235, 0244337245 or 0244385086," it added.

The statement said the FDB in its quest to safeguard the health of the consuming public, conducted periodic market surveillance on selected samples of medicinal products on the Ghanaian market for quality monitoring.

Recently, samples of anti-malarial drugs were picked from both public and private hospitals, retail pharmacies, licensed chemical shops and wholesale facilities across the country by officers in respective zonal offices of the DFB to determine their quality status. Laboratory analyses conducted by the FDB with the support of United States Pharmacopoeia and USAID revealed that samples of the anti-malarial medicine tested were either counterfeits or substandard, therefore compromising their quality, safety and efficacy. According to the WHO definition, "a counterfeit medicine is a medicine which is deliberate ly and fraudulently mislabelled with respect to identity and or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, without active ingredients, with insufficient active ingredients or with fake packaging whereas a substandard product is one found to be short of the required quality standards. Both counterfeits and substandard medicine are unfit for use.

It named some of the counterfeited anti-malarial drugs with their respective batch numbers as METAKELFIN TABLETS, ARTESUNATE TABLETS and QUININE SULFATE.

The original manufacturers of Artesunate tablets and Metakelfin tablets are Guilin Pharmaceutical Company Limited, China, and Pharmacia & Upjohn under authority of Pfizer, New York respectively. However, some unscrupulous people managed to package those counterfeit anti-malarial medicines to look similar to the original ones.

Each of the counterfeited products were found to be without some essential identifying features characteristic of the true or authentic products, therefore conforming the laboratory findings. Additionally, some substandard Chloroquine injections, which had not been registered by the FDB, were also found on the market despite the fact that the use of Chloroquine as anti-malarial had been discontinued in Ghana since January 2005. "The FDB has directed the zonal offices of the FDB to ensure the immediate removal of these counterfeit products from the retail shops involved and also from circulation", the statement added.