ETUDE RETROSPECTIVE DU CONTROLE DE QUALITE DES MEDICAMENTS AU LABORATOIRE NATIONAL DE LA SANTE, BAMAKO DE 2012 A 2019

In Africa, a number of factors contribute to the proliferation of counterfeit medicines: lack and inadequacy of technical personnel and qualified structures to control the quality of medicines, corruption, absence or weakness of national pharmaceutical regulatory authorities. The objective of this work is to develop the quality profile of drugs analyzed at the National Health Laboratory (LNS) in Bamako, Mali from 2012 to 2019.Our methodology was based on a retrospective collection of data from analytical certificates during our study period. Analytical techniques were based on pharmacopoeial methods, manufacturer methods and validated internal monographs.Thus, out of 4032 samples received and then analyzed, 3771 were compliant, i.e. a rate of 94%, and 261 were non-compliant, i.e. a rate of 6%. Non-compliance mainly affected the family of antibiotics with a rate of 22.22% followed by antiseptics 19.2%. The causes of non-compliance were due to underdosage of active ingredient or the absence of active ingredient.Greater vigilance and collaboration from national drug regulatory authorities is needed to make good quality, safe and effective drugs available to the population.