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Efficacy &Pharmacovigilence &Treatment Bill Brieger | 17 Sep 2012 08:10 am

Prequalification of Malaria Medicines Needs to be Taken More Seriously

The Leadership newspaper in Nigeria reported on Sunday the launching of a new artemisinin-based combination therapy (ACT) drug knwon by the trade name ‘Artiquick.’  In order to ensure that it is not just another route to ‘profit-quick’, we looked into the WHO prequalification list to see if the Chinese company ArtePharm that makes the drug was listed.

Prequalification is based on a comprehensive evaluation of “the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites.” The resulting lists of malaria, TB, and HIV drugs and diagnostics is meant to guide various national and international health agencies in their procurement of medicines.

dscn7285sm.JPGThough not stated and often not practiced, it would be ideal if these lists also guided various drug regulatory agencies in malaria endemic countries. Although it is a somewhat arduous process to get prequalification, it is possible and necessary – two new medicines containing artesunate-mefloquine were just added in 12 September.

The prequalified list as of today contains 25 anti-malaria products from only 10 companies. ArtePharm is not among them.  Yet the manufacturer made it known that, “the   new  drug   which  has  proven  very  effective  since  early  this  year  when  it  underwent additional clinical trials, Nigeria can, thus, be very hopeful, on attaining the Millennium Development Goals (MDGs) target on malaria come 2015.”  In addition the manufacturer mentioned to the press that ACTs generally were recommended by WHO, implying that any ACT, including their own, was approved by WHO.

Finally the ArtePharm representative made it know that their product was tested and approved by Nigeria’s food and drug agency NAFDAC. NAFDAC does ensure that products contain the labeled ingredients in the labeled amounts and that the drug is safe to use. It is important in the fight against counterfeit drugs. But NAFDAC has approved hundreds of ACTs for sale and use in the country. Unlike WHO, NAFDAC and other national agencies do not have the reach to inspect the production processes at the root.

Hopefully ArtePharm will begin the journey of the prequalification process soonest, and that countries where it sells its product will also encourage that company and many others to take the responsible steps needed to ensure we have quality antimalarials that will actually eliminate disease and not just eliminate money from patients’ pockets.

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