REPORTS that most of the anti-malaria drugs sold in Lagos State, and perhaps in other parts of the country, were sub-standard may not be new; but they are worrisome nevertheless, against the backdrop of malaria being an endemic and major killer disease in Nigeria and Africa. It is not surprising that the world appears to be losing the war against this tropical disease.Researchers of the Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Lagos (UNILAG), revealed that about 84.6 per cent of anti-malaria drugs tested were substandard. The research, which covered 13 brands of Artesunate-amodiaquine combinations, also known as Artemisia Combination Therapy (ACT), retailed by pharmacies in the state failed to meet the United States Pharmacopeia (USP) specifications for one of the Active Pharmaceutical Ingredients (APIs). Yet, all the 13 brands of ACT tested carried the National Agency for Food, Drug Administration and Control (NAFDAC) registration numbers.This is not the first time such revelation is being made. Much earlier, Dr. Paul Newton and his colleagues from the Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration raised alarm over the proliferation of fake and poor quality anti-malaria drugs in Africa. It was an outcome of a research conducted between 2002 and 2010 on samples of suspect drugs from 11 African countries, including Ghana, Tanzania, Liberia, Sierra Leone, Nigeria, Kenya and Cameroon. Also, the World Health Organisation (WHO) reported that over 50 per cent of anti-malarial drugs marketed in Nigeria were counterfeits, thus reinforcing the finding of the UNILAG researchers.In response to this revelation, the President of Pharmaceutical Society of Nigeria (PSN), Azubuike Okwor, said the UNILAG study ''is a strong confirmation of our society''s long-held position that we need a new strategy in our fight against substandard and counterfeit medicines.' But the Director-General of NAFDAC, Paul Orhii defended the agency, affirming that the anti-malaria drugs approved by NAFDAC were not sub-standard. According to him, substandard anti-malaria drugs are more dangerous than counterfeit; and NAFDAC made sure that the drugs contain the right quantities of the active ingredients before approval. This explanation represents an attempt to exonerate the drug agency from blame. However, it is instructive that NAFDAC seal is not a guarantee of genuineness in our overtly corrupt environment. The reasonable grounds would be for the agency to challenge itself and other sister agencies to find effective ways of ensuring the quality of what Nigerians consume.The broad implication of this development is the danger that fake drugs pose to the lives and wellbeing of millions of people around the world, including Nigerians who live under the scourge of the malaria parasite. Experts are nearly unanimous on the point that fake and poor quality drugs raise the risk of treatment failures and resistant strains of the malaria parasite. Their findings show that counterfeits can contain a mixture of wrong active pharmaceutical ingredients that could alleviate the symptoms of malaria without curing it and with grave side effect. Indeed, Dr. Newton made the point that ''the enormous investment in the development, evaluation and deployment of anti-malarias is wasted if the medicine that patients actually take are, due to criminality or carelessness, of poor quality and do not cure.' He further stressed that malaria can be readily treated with the right drugs of good quality, but poor quality medicines, besides increasing mortality and morbidity, can exacerbate the economic and social impact of malaria on societies that are already poor.Malaria infects more than 200 million people each year and kills about 655,000, mostly children and pregnant women in Africa according to WHO data. An uncontrolled proliferation of fake and substandard drugs portrays immense danger for Nigeria and other African countries. The unpleasant truth is that Nigerians are involved in this trade in fake drugs, some of which are allegedly made in some Asian countries. Reportedly, in 2001, police in Guangzhou, China, arrested Nigerian and Chinese men for production of counterfeits of the anti-malaria halofantrine while production facilities for packaging materials for counterfeit anti-malarias were confiscated in Nigeria.Peddlers in fake and poor quality drugs are killing Nigerians, and attention must be riveted on effective preventive measures. This is a challenge to NAFDAC, Standards Organisation of Nigeria (SON) and the PSN among others. Notably, government policies over NAFDAC''s remit have been inconsistent. For example, in April 1996, the task force on the decongestion of ports directed that officials of NAFDAC and Standards Organisation of Nigeria should quit the ports and be invited when necessary. NAFDAC, Under Akunyili''s leadership had its right of inspection restored. Again, NAFDAC is off the ports. It is important to examine the import of this development on the war against counterfeit drugs as a way of ascertaining quality of imported drugs, particularly as the WHO and other research outputs suggest that the best way to counter the multi-billion dollar illicit drug industry is to position the regulatory agencies at the ports of entry. There may be need for an impact assessment to determine whether or not NAFDAC and such agencies as NDLEA and SON should return to the ports. Meanwhile, effective enforcement of existing laws should be intensified. And beyond government bureaucracies, inspectors should follow the products to the markets and retail outlets. Hospitals, both public and private, should ensure they dispense certified drugs and establish sample authentication facilities for counterfeit drug-free process, while Nigerians should be generally vigilant and report to the relevant enforcement agencies fake drug factories within their vicinity.
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