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: 20 November 2021; Revised: 18 December; Accepted: 31 December, Available online: 15 January 2022 Academic Editor: Dr. Asia Selman Abdullah, Pharmacy institute, University of Basrah, Iraq, asia_abdullah65@yahoo.com UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. 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 Similar Articles: ASSESSMENT OF COMMUNITY PHARMACIST AWARENESS ON ADVERSE DRUG REACTION (ADR) AND PHARMACOVIGILANCE REPORTING SYSTEM IN KHARTOUM LOCALITY, SUDAN THE EFFICIENCY OF INEFFICIENCY: MEDICINE DISTRIBUTION IN SUDAN