Enhancing quality improvement and capacity building for African pharmaceutical manufacturers

The African continent has approximately 375 drug makers serving over 1.1 billion people. When one compares this figure to 10,500 drug manufacturers in India and 5,000 in China for a population of 1.4 billion each, it becomes quite apparent that there is significantly limited local manufacturing on the African continent. The consequence of this is long-standing, inequitable access to quality, safe, efficacious, and affordable medical products.

Along with the poor local manufacturing capacity of Africa’s pharmaceutical industry, there is also the challenge of weak compliance by local manufacturers with Good Manufacturing Practices (GMP). The conditions of many pharmaceutical companies in Africa are undesirable, with poor quality of both the individual production sites and the quality management systems. Only a few local manufacturers in Africa have reached international standards of quality, and only South Africa, Morocco, Kenya, and Uganda have pharmaceutical manufacturing companies with WHO-prequalified products.

The above factors, among others, drive the high prevalence of poor-quality medicines on the continent. Learning lessons from the COVID-19 pandemic on the need to build a resilient and self-reliant pharmaceutical industry in Africa, the last few years have seen concerted efforts being made to strengthen Africa’s local pharmaceutical manufacturing capacity to meet the needs of the continent. The Africa CDC has set an ambitious target to manufacture 60% of Africa’s routine vaccine needs by 2040.

Recent quality improvement and capacity building interventions in Africa’s pharmaceutical sector

A new determination to provide medicines locally has led to the development of various interventions and initiatives to support local pharmaceutical manufacturing on the continent. Two major interventions are:

· Establishment of the African Medicine Agency (AMA): Recently, 15 African Union (AU) member states ratified the treaty to create the AMA. As a continent-wide regulator, the AMA will complement national and regional efforts and optimize regulatory processes on the continent. It is predicted that rather than having to register the same medical product in different countries, local African pharma manufacturers would be able to deal with one assessment process and get one recommendation that could be used by all African countries to authorize the product nationally, thereby significantly reducing the time, money, and effort required for drug or product introduction.

· Introduction of African Pharmaceutical Technology Foundation: The African Development Bank has developed the African Pharmaceutical Technology Foundation (APTF) to strengthen Africa’s access to the technologies that support the manufacturing of medicines and vaccines. So far, African pharmaceutical companies do not have the scouting and negotiation capacity and bandwidth to engage with global pharmaceutical companies and thereby have been marginalized and left behind in complex global pharmaceutical innovations. The APTF aims to fill this critical gap by serving as a transparent intermediary, advancing and brokering the interests of Africa’s pharma sector with global pharmaceutical companies.

In addition to these continent-wide interventions, several African countries are also making progress in building their drug manufacturing capabilities. Leveraging strategic partnerships, African countries are developing tailor-made interventions to address challenges such as weak regulatory mechanisms, limited availability of financial and technical support, and poor quality management systems that impede their local pharma manufacturers.

Case-in-point: Nigerian pharmaceutical manufacturers’ quality improvement and capacity building programme

In line with the Nigerian presidential mandate to develop innovative yet contextual interventions to improve availability and access to quality medicines, Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD), in partnership with Bloom Public Health, through the World Bank-funded IMPACT Program, will support local pharmaceutical manufacturers in Nigeria with a Quality Improvement and Capacity Building Programme.

Read also: Good Manufacturing Practices (GMP) and its impact on pharmaceutical quality in Africa

This programme will support selected Nigerian pharmaceutical manufacturing companies in the attainment of Good Manufacturing Practices (GMP) and WHO Prequalification for their products. Bloom Public Health will provide full technical support for the selected companies, including accessing gaps in the companies’ technical capacities and quality management systems using internationally accepted regulatory standards and inspecting the corresponding manufacturing sites to ensure conformity with WHO Good Manufacturing Practices (GMP).

This WHO prequalification programme is poised to be the most significant pharmaceutical intervention in Nigeria in recent times and could unlock a plethora of opportunities for local pharmaceutical manufacturers in Nigeria. This includes opportunities for increased sales and market access, both locally and internationally, by conferring eligibility for international, donor-sponsored tenders for medicines; improved capacity to manufacture products for entry into stringently regulated markets; increased potential to compete successfully for contract manufacture for local markets; and faster registration.

The National Institute for Pharmaceutical Research and Development (NIPRD) and Bloom Public Health will be engaging critical pharma sector stakeholders in the program launch scheduled for April 28, 2023, in Lagos, Nigeria.

In conclusion, acknowledging the hindrances to quality medicines’ availability and accessibility on the continent, Africa has initiated developments to address the critical gaps in its pharma sector. African local manufacturers must leverage these opportunities to increase their capacity for local manufacturing and guarantee quality-assured products that secure the health and safety of the public, as well as position Africa as a global competitor.