Many sub-Saharan African countries continue to face challenges in developing and implementing effective regulatory systems. Challenges such as poor inspection practices, ineffective licensing and product registration systems, inadequate access to quality control laboratories, weak pharmacovigilance and clinical trials have contributed to the proliferation of counterfeit drugs (substandard and falsified medicines) in the markets (1, 2).
Counterfeit and substandard drugs pose a serious threat to public health in Africa. They cause increased morbidity, higher treatment costs, and poor therapeutic outcomes. They also undermine the national health budget and erode the trust in medicines and the healthcare system. This problem is often underreported and requires urgent attention. The World Health Organisation (WHO) estimates that about 10% of medicines circulating worldwide and 25% in less developed countries are counterfeit. Africa and some parts of Asia are the most affected (3, 4). Africa’s main sources of drug import, the Chinese and Indian pharmaceutical industries have been classed as the major producers of counterfeit drugs (5).
Effective regulation of drugs requires a well-structured System which involves multisectoral collaboration and actions ranging from legal basis to quality evaluation and monitoring (6). WHO uses the ‘Global Benchmarking Tool’ for the evaluation of National Medicines Regulatory Authorities (NMRA) performance and to establish their levels of maturity and functionality in regulation (7). There are four maturity levels adopted from the International Standard ISO 9004, and they are reflections of how stable, integrated, and the extent of functioning of a regulatory system. In 2010, reports from WHO revealed that only 7% of 46 sub-Saharan African countries have moderately developed medicine regulatory capacity, 63% have minimal capacities, and 30% have National medicines regulatory authorities in place (8). There is no maturity level 4 NMRA operating in Africa. Nigeria, Ghana, South Africa and Tanzania are currently operating at maturity level 3 while the NMRA of Sierra Leone was classified using the WHO-self benchmarking tool in 2017 before the establishment of a quality management system, was classified at an overall maturity level of 1(9, 10), and for all functions.
One of the key functions of NMRAs is to evaluate the safety, effectiveness, and quality control data of new drugs before granting marketing approval (11). However, this process can be lengthy and inefficient, resulting in delays in patients’ access to affordable and essential medicines (12). Different regulatory authorities have varying requirements, structures, and processes for drug development, which makes it hard for pharmaceutical companies to develop drugs for simultaneous submission to all regulatory authorities (13, 14). In this Global competitive environment, reducing the time taken by a product to reach the market is a critical parameter; hence, the company's success relies on that. The South African NMRA typically receives about 4,700 applications annually but can only process around 2,550 per year (15). Before 2005 there was an equilibrium between the number of applications received and the registration certificates issued for medicines per year. However, from 2005 the number of applications submitted increased significantly whereas the number of certificates issued remained approximately the same (12).
There is a need to improve the regulatory capacity and performance of NMRAs in sub-Saharan Africa by implementing quality management systems (QMS) that can ensure consistent and transparent standards and procedures. QMS are defined as “coordinated activities to direct and control an organisation with regard to quality” (ISO 9000:2015) (16, 17). QMS can help NMRAs achieve their objectives by providing a framework for planning, implementing, monitoring, evaluating, and improving their processes (17). Effective and efficient regulation of medical products could provide an opportunity for investment in manufacturing, trade, and sale of pharmaceutical products, as well as an increase in research and development of new medical products and technologies. These yield social and economic benefits to the patients and communities. Building the regulatory capacity of medical products is also crucial for achieving Universal Health Coverage (UHC), the Africa Union (AU) Agenda 2063, and sustainable development goals (SDGs) on access to quality, safe, and efficacious health products.
The Pharmacy Board of Sierra Leone is the National Medicines Regulatory Authority and the first government institution in Sierra Leone to have certification for its quality management system (ISO 9001:2015) in 2019. It has vital departments, including Quality Assurance, Quality Control, Information, Drug Evaluation and registration, Inspection, Pharmacovigilance, and Clinical Clinical trials in Sierra Leone. This retrospective study provides information on the changes in quality improvement processes at the Pharmacy Board of Sierra Leone from 2016 to 2022 from identified counterfeit medicines and the status of the National regulatory system using the WHO Global benchmarking tool and internal and external audits reports by accredited lead auditors.