The 6-country study on fake and substandard malaria drugs published earlier this year was a definite warning and wake up call for strengthened and continued pharmaco-vigilance in Africa. Among 210 samples, 35% tested failed dissolution testing or measurement active pharmaceutical ingredient content against internationally acceptable standards.
Kenya is not relying on the results of such studies alone. “Officials from the Pharmacy and Poisons Board, a government regulatory body under the Medical Services Ministry, recently confiscated thousands of counterfeit Artemisinin-based malaria drugs in a shop in Nairobi. The company that manufactured the drugs was ordered to recall the entire batch,” according to IRIN News. Kenya has done its own research, and an officer from the Board told IRIN News that, “Our [government] study was much wider, we went to all eight provinces in Kenya, and took samples from all public, mission [religious] and private hospitals.” They found 16% of drugs to be substandard and feel that their study is more representative of the country.
That said, Board officials were aware that any level of substandard malaria drugs can undermine the confidence of the public. Ineffective customs control, lax enforcement of pharmaceutical regulations and light sentences for those caught help perpetuate the problem.
Hopefully with donor programs including GFATM, PMI and the World Bank Booster Program, antimalarial drugs in the public sector are of high quality. As the Global Fund says, “For any pharmaceutical products to be eligible for purchase with the Global Fund resources, its compliance with quality standards must be assured.”Â But in countries where a large portion of the population relies on the informal and private sector for health care, donors must rethink their methods for getting safe and effective medicines to the people.