Quality control outcomes of pharmaceuticals and allied products analyzed in the Mission for Essential Drugs and Supplies (MEDS) laboratory: 2018-2020

Abstract

Quality control data was compiled for samples analyzed in the Mission for Essential Drugs and Supplies (MEDS) laboratory in the 2018-2020 period. During this interval, the laboratory received and processed 6,059 samples from Kenya and international sources. These samples comprised domestic (31.9%) and internationallymanufactured (67.0%) products while 1.1% were of undeclared origin. Analysis was performed using compendial and/or in-house specifications. The non-compliance rate was 8.0% consisting of 3.2 % local, 4.5% imports and 0.3% for samples of unknown origin. The top 20 drug classes with high failure rates were: environmental monitoring samples (100.0%), joint lubricants (50.0%), dialysis solutions (50.0%), microscopy stains (50.0%), herbal preparations (43.2%), nootropics (33.3%), solvents (33.3%), waters (32.0%), antiseptics/disinfectants (29.8%), medical devices (28.4%), hormones (23.7%), nutrient mixtures (20.9%), disease modifying antirheumatic drugs (20.0%), anti-incontinence drugs (16.7%), uterotonics (13.8%), vitamins (13.0%), anti-ulcer drugs (12.6%), vasopressor agents (12.5%), anthelmintics (12.2%) and hypolipidemics (10.8%). Full compliance was however, recorded with antiflatulants, digestive enzymes, antidiarrheals, prokinetics, anti-arrhythmics, anti-anginals, choleretics, antimycobacterials, anaesthetics, antimigraine drugs, bisphosphonates, antimyaesthenics thyroid/antithyroid drugs, erectile dysfunction drugs, ovulants, uricosurics, osmotic diuretics, vaginal lubricants, tocolytics, histaminics, lozenges, ear drops, detergents, radiopharmaceuticals, proteins, probiotics, acaricides, sterilization validation swabs and excipients. There was a significant increase in the overall non-compliance rate compared to the previous report for 2013-2017. These results add impetus towards the need for regulatory stringency to curb the occurrence of substandard and falsified products in the market.