Malaria is the second largest public health challenge (after HIV/AIDS) in Kenya with an estimated 34 000 children dying from the direct effects of infection each year. It accounts for over a third of all consultations in government clinics. The typical Kenyan child will use antimalarial drugs at least four times in a year. Economic losses due to malaria are also large. As matters of public policy to reduce morbidity and mortality due to malaria the medicines to which communities resort must be safe and effective and efforts to control malaria must complement and not contradict each other. But currently neither of these areas is successfully addressed due to a clear disconnect between antimalarial drug registration in Kenya and the national antimalarial drug policy. Three examples illustrate this problem. The first example albeit now an historical one is the registration of sulfamethoxypyridazine products for human use in the late 1990s at a time when the national antimalarial policy statedthat only sulfadoxine-pyrimethamine or sulmethoxypyrazinepyrimethamine (SP) drugs should be used as first-line antimalarial policy. Sulfamethoxypyridazine has been considered unsuitable for human use for some years (WHO 1991) and is now generally restricted to veterinary use only. There were at least seven sulfamethoxypyridazinepyrimethamine products in the Kenyan market in 1998 though these were later withdrawn following a report from the National Quality Control Laboratory. (excerpt)