Fake Antimalaria Drugs in Africa - who is watching
By: Judith Cobbina (WOMEC)
Thirty five percent of 153 anti-malaria drugs studied in six cities in Africa for efficacy and quality have failed both tests.
The studies conducted in Accra, Lagos, Kampala, Kigali, Nairobi and Dar es Salaam revealed that the drugs did not contain enough active ingredients or failed dissolution test while a third of the drugs contained only artemisinin.
This latest study confirms the problem of low quality anti- malaria drugs that Africa has over the years been battling with.
The report by Roger et al had it that not only were the drugs of low quality but some contained only artemisinin which the World Health Organization (WHO) has banned as a monotherapy in order to prevent resistance.
WHO in January 2006 issued new treatment guidelines recommending ACTs for the treatment of uncomplicated malaria and called for an end to the production and marketing of artemisinin monotherapies in order to protect these formulations against parasitic resistance.
Drug resistance and poor quality drugs are the major cause of treatment failures, long stay in hospitals and loss of man hours, economic loss, death and the high cost of treatment.
According to the report the high persistence of substandard drugs and clinically inappropriate artemisinin monotherapies risk patients’ safety, drug resistance and places the future of malaria treatment at risk globally.
The question is who is watching? Are there no rules and regulation regarding drug manufacturing internationally and locally? If there are, are they been implemented?
Most regulatory agencies in African countries only conduct safety tests on pharmaceutical products with little or no emphasis on efficacy testing. Efficacy testing can only be evaluated using thorough, standardized and controlled clinical evaluations or trials.
It is important that all drugs sent to Africa must undergo efficacy testing and this should not only be restricted to new generic drugs but also on a batch to batch analysis of safety and efficacy on all medicinal products before being imported or marketed in Africa.
This becomes necessary since different drugs from different continents have varying effects on people due to differences in body composition and climatic changes.
Malaria eradication in Africa is a major Millennium Development Goal (MDG) priority for health. The fight against the importation of poor quality drugs into Africa cannot be fought by Africans alone.
It is the responsibility of all local and international regulatory agencies to ensure that international and local directives, aimed at improving public health are monitored and implemented to the letter.