PRE- AND POST-MARKETING CONTROL OF DRUG QUALITY AT THE NATIONAL HEALTH LABORATORY, BAMAKO-MALI

Abstract

Background and Objectives: In a world marked by the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, greater vigilance by pharmaceutical regulatory authorities is necessary. The National Health Laboratory (LNS), in accordance with its mission, takes samples throughout the country in order to ensure their quality control.

Methods: Samples were taken in certain regions and the district of Bamako and analyzed according to the standards of the United State Pharmacopoeia (USP), British Pharmacopoeia (BP) and International Pharmacopoeia (IP)by identification and assay methods. Products that do not meet the required specifications described by these pharmacopoeias are declared non-compliant.

Results: This allowed us to analyze a total of 617 samples with 11 cases of non-compliance for a rate of 2%. The causes of the non-conformities were due to the absence of an active ingredient, an under-dosage of the active ingredient and technical and regulatory defects.

Conclusion: After one year of activity, our results showed that out of a total of 617 drug samples collected and analyzed, 606 were compliant with a rate of 98% against 11 cases of non-compliance or 2% (p ≤ 0,05). The causes of the non-compliance were due to the absence of an active ingredient, an under-dosage of the active ingredient and technical and regulatory defects.

                   

Peer Review History:

Received: 5 October 2021; Revised: 11 November; Accepted: 13 December; Available online: 15 January 2022

Academic Editor: Dr. Asia Selman Abdullah, Pharmacy institute, University of Basrah, Iraq, asia_abdullah65@yahoo.com

Received file:                Reviewer's Comments:

Average Peer review marks at initial stage: 5.5/10

Average Peer review marks at publication stage: 7.0/10

Reviewers:

Dr. Govind Vyas, Compliance & Regulatory Officer Inva-Tech Pharmaceuticals LLC, New-Jersey, USA, govindvyas03@gmail.com

Dr. Muhammad Zahid Iqbal, AIMST University, Malaysia, drmmziqbal@gmail.com

Dr. Bilge Ahsen KARA, Ankara Gazi Mustafa Kemal Hospital, Turkey, ahsndkyc@gmail.com

Dr. Mohammad Bayan, Faculty of Pharmacy, Philadelphia University, P.O. Box: 1 Philadelphia University 19392 Jordan, mbayan01@qub.ac