Pharmaceutical Quality Assurance of Diazepam Injection at the National Health Laboratory of Mali

Abstract

Objectives: In a world marked by the increase in chemoresistance leading to the adoption of therapeutic combinations, the advent of generic multi-source drugs, the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, a Greater vigilance by pharmaceutical regulatory authorities is needed. Drug Post-Marketing Surveillance (PMS) therefore plays an important role in detecting poor quality products on the market. Methods: The survey covered certain regions and certain points of sale. It aimed to assess the quality of Diazepam injection available on the market. The selection of drugs and geographic areas was made using risk-based sampling using the Drug Risk Assessment Tool (MedRS) developed by USP / PQM +. Results: A total of 44 samples were analyzed according to a risk-based protocol, of which 32 were compliant with a rate of 91% against 12 non-compliant or 9% (P≤0,05). Non-compliant drugs were mainly from the public sector. We also found that all samples were unregistered. Conclusion: The results clearly raise the issue of registration of drugs before their market authorization and the importance of continuous quality control and post-marketing drug analysis to ensure health and guarantee access to quality medicines for the health and well-being of populations.