Trade in sub-standard drugs on the increase (Graphic Business)

TRADE in counterfeit and sub-standard drugs is said to be gradually overtaking trade in narcotics, because of the former’s low risk and high profitability which could generate an estimated $20 billion annually.
The phenomenon has affected the pharmaceutical industry in many countries including Ghana where recent study of anti-malarial and anti-tuberculosis drugs conducted by the World Health Organisation (WHO) revealed an alarming failure rate of the drugs due to their counterfeiting and sub-standard production.
The WHO study, which was conducted over the period 2008-2010, in collaboration with the US Pharmacopoeia (USP), involved other African countries, such as Ethiopia, Kenya, Tanzania, Zimbabwe, Cameroun and Nigeria.
According to a WHO definition, “a counterfeit medicine is a medicine which is deliberately 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.
Cases cited in the WHO study indicated that Amodiaquine Artesunate, which is the first line of treatment for malaria in Ghana, was found to have one of the highest failure rates, raising serious concerns among health professionals.
Although the report of the study is yet to be published, other studies have shown that some counterfeit and sub-standard drugs contained substantial amounts of powdered cassava, chalk powder and other substances that are injurious to human health.
When he presented some highlights of the WHO report at a lecture organised by the Ghana Academy of Arts and Sciences, in Accra recently, a former Vice-Chancellor of the University of Ghana, Prof Ivan Addae-Mensah said “Study after study is proving that there is a major problem in this country and the rest of West Africa and we need to tackle this as a team, not as individual professional bodies jockeying for recognition”.
Details of the study will be known early next year, by which time the report would have been published, but Prof Addae-Mensah shared with his audience some highlights of the report which were discussed at the 45th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Products last October, under his chairmanship.
He said the overall failure rate of 29 per cent for all the drug samples analysed was generally quite satisfactory but noted that where health was concerned, such a failure rate should raise concerns.
Ghana is said to have recorded the second highest failure rate of more than 60 per cent, coming after Nigeria with a more than 70 per cent failure rate, while Ethiopia recorded the lowest failure rate, having passed all the tests.
The problem was recently brought to the fore, when the Food and Drugs Board (FDB) identified some counterfeit and substandard anti-malarial drugs on the Ghanaian market and advised the public to be cautious when buying such drugs.
They include quinine sulfate, artesunate tablets and metakelfin tablets.
Additionally, some substandard chloroquine injections, which have not been registered by the Board, were also found on the market is spite of the fact that the use of Chloroquine as anti-malarial had been discontinued in Ghana since January 2005.
In its quest to safeguard the health of the consuming public, the FDB conducted periodic market surveillance on selected samples of medicinal products on the Ghanaian market for quality monitoring.
The counterfeit drugs were identified when samples of antimalarial 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 FDB to determine their quality status.
Speaking to the Daily Graphic, the Communications Manager of the FDB, Mr James Y. Lartey said the public needed to be on the look out for such unsafe drugs since many of them found their way to the Ghanaian market through unproved routes where custom officers could not arrest them.
He explained that laboratory analyses conducted by the FDB with the support of United States Pharmacopoeia and USAID revealed that samples of the anti-malarial medicines tested were either counterfeits or substandard, thereby compromising their quality, safety and efficacy.
The counterfeited antimalarial drugs with their respective batch numbers were Metakelfin tablets with batch number C827A, Metakelfin tablets with batch number E378A, Artesunate tablets with batch number 080504 and Quinine Suflate with batch number 30551Q.
The original manufacturers of Artesunate tablets and Metakelfin tablets are Guilin Pharmaceutical Company Limited, China , and Pharmacia & Upjohn under authority of Pfizer Inc., New York respectively yet some unscrupulous people, however, managed to imitate the original and package for sale to the public.
According to the FDB, during testing each of those two counterfeited products were found to be without some essential identifying features characteristic of the true/authentic products, therefore, conforming the laboratory findings.
Besides the counterfeit drugs, the FDB also identified a number of substandard medicines including Artilum-140 tablets with batch number RT923, Renovate tablets with batch number MH932, Malmed tablets with batch number M080218, Malmed tablets with batch number M090034, Co-Artesun tablets with batch number FS090301 and Acumal Junior Powder with batch number RA8001, all imported.
Other substandard drugs are Trafan tablets with batch numbers 0108J, 03, 26,24,02 which all locally manufactured.
Substandard Chloroquine injections, which have not been registered by the FDB but were found on the market despite the fact that the use of Chloroquine as anti-malarial has been discontinued in Ghana since January 2005 included Chloroquine phosphate injection with batch number 70901, Chloroquine injection 70805, Chloroquine injection O004125, and Chloroquine injection O71124.
Others are Chloroquine injection B. P 70901, Chloroquine injection 80414, Berova Chloroquine 071124 and Chloroquine injection O70905. The rest are Zoquit O070913, Chloroquine injection O80412, Berova injection 80412.
The 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 Food and Drugs Board…”
The Board has therefore directed the recall of those substandard antimalarial medicines from circulation by the respective manufacturers and importers and submit a complete product recall report to the Food and Drugs Board ten (10) days from the day of this publication.
It also advised the public not to patronise the specified batches of the counterfeited or substandard products and to report anyone found offering them for sale to the nearest FDB office.
As part of its responsibility as a regulatory body, the FDB also directed any wholesaler, pharmacy or licensed chemical shop that had in stock those medicines (with the specified batch numbers) to return them to the importer, distributor, manufacturer or to the FDB. It also directed the respective companies to immediately withdraw the products from the market in order not to endanger public health and safety.
Meanwhile, the FDB has indicated it was taking the necessary regulatory actions against the manufacturers/importers of those medicines.