African drug manufacturing
Enabling malaria drug supply by strengthening local manufacturing in Africa
African antimalarial manufacturing
Enabling malaria drug supply by strengthening local manufacturing in Africa
95% of malaria cases and deaths occur in Africa, and efforts to control the disease are stalling.1
Africa imports up to 61% of the packaged medicines2 and up to 80% of the pharmaceuticals it uses.3
The disruptions to global supply chains during the COVID-19 pandemic highlighted the need for a regionally sourced, quality-assured supply of antimalarials on the continent.
MMV has over 18 years of experience in supporting manufacturers to meet the World Health Organization’s (WHO) quality standards. Most recently, MMV has been working with three African pharmaceutical manufacturers towards WHO Prequalification, with one manufacturer in Kenya successfully prequalifying two antimalarials.4
The demand for malaria chemoprevention medicines is expected to grow, as WHO increases the range of eligible populations.
Producing quality medicines closer to patients who need them most will save lives and accelerate human and economic progress.
Africa’s overreliance on imports presents a continued obstacle to improving the health of its populations. African countries have underscored their intention to move towards greater self-sufficiency in the production of quality medicines and other therapies.
How is MMV supporting quality-assured antimalarial manufacturing?
Over the last 18 years, MMV has built a successful track record of helping pharmaceutical partners in Asia, North America, and Europe achieve regulatory approval or WHO Prequalification for their antimalarial products.
In line with its mission to promote equitable access to malaria medicines, Medicines for Malaria Venture (MMV) has been working in partnership with African manufacturers to support them to meet the World Health Organization’s (WHO) standards of Good Manufacturing Practice (GMP) and Prequalification,12 addressing a range of issues related to cost, packaging, distribution, continuity of supply, regional supply chain autonomy, training of healthcare workers and sustainability in many malaria-endemic countries.
So far, MMV’s work has focused on the following two countries:
- Kenya: MMV, with support from Unitaid, has been working with Kenyan manufacturer Universal Corporation Ltd (UCL) to produce WHO Prequalified SP for IPTp and SPAQ for SMC. In July 2022, UCL became the first African manufacturer to gain WHO prequalification for SP to prevent malaria in pregnant women. In October 2023, UCL received prequalification from WHO for SPAQ. UCL’s new status as a manufacturer of prequalified SP for IPTp and SPAQ has the potential to ensure that more African children and pregnant women will be protected from malaria. UCL is one of only five manufacturers in Africa to have received this quality certification for a medical product, doing so in partnership with India's Rena Exports Pvt Ltd., which it established a joint venture with in April 2015.
- Nigeria: In 2020, with funding from Unitaid, MMV started work with two pharma companies in Nigeria, Emzor and Swipha, to develop a quality-assured child-friendly, dispersible formulation of SP to protect women, children and infants from malaria. Swipha is expected to receive WHO pre-qualification for this product by the end of 2023.
Barriers to supply of malaria medicines in Africa
The production of quality-assured malaria drugs in Africa, the continent that accounts for 95% of global cases and deaths, falls short of demand. As a result, the continent is heavily reliant on importation of these essential medicines. A broad range of factors have impeded coverage with malaria prevention and treatment medicines in Africa. These include gaps in coordination, policy, regulations, human resources and service delivery.5 Deficits in the supply6 and quality7 of malaria medicines have persisted due to the following factors:
Few producers of quality-assured medicines: Africa imports up to 80% of its pharmaceutical needs.8 Of the 375 medicine producers in the region,9 only five manufacture drugs to WHO prequalification standards. The rest are constrained by underinvestment, infrastructure limitations, and regulatory challenges. A diversified, locally sourced supply base will help prevent the risk of stockouts and save more lives.
Procurement of quality-assured medicines is not prioritized: the supply of quality-assured drugs is often not guaranteed in malaria-endemic countries. It is important for governments to prioritize procurement of quality-assured antimalarials.
Supporting African pharmaceutical manufacturers to meet quality standards is therefore critical to safeguard the supply of quality antimalarial medicines in the region. This in turn, can boost uptake of lifesaving tools, meet the needs of Africa’s rapidly growing population and displace products of substandard or unknown quality. The production of quality-assured medicines in Africa will also help diversify sources of global medicine production.
MMV also works with international procurement and funding agencies to support the entry of these drugs into the market. This, in turn, has improved access to vital, quality-assured antimalarial therapies.
Why is antimalarial production in Africa important?
The COVID-19 pandemic shone a light on this problem, as supply-chain disruptions led to stockouts of many essential medicines, the impact going beyond the direct effect of the pandemic itself.10 Since then, many African countries have underscored their intention to move towards greater self-sufficiency in the production of quality medicines and other therapies.
Treatment: Fast access to malaria treatment is crucial to reduce the impact of this disease that can kill in a matter of hours. Artemisinin-based combination therapies (ACTs) are the mainstay of malaria treatment against the deadliest form of the parasite. A locally available, reliable source of ACTs, close to the patients who need them most, will save lives; this can also help displace products of substandard or unknown quality, which are known to contribute to resistance.
Prevention: Malaria chemoprevention involves administering antimalarial medicines to populations at heightened risk if infected. Over the past decade, the use of chemoprevention strategies has grown. In June 2022, WHO expanded its guidance to support the administration of sulfadoxine-pyrimethamine (SP)-based chemoprevention interventions to broader groups of people living in malaria-endemic areas in Africa: eligible populations now include infants aged 0-24 months, school-aged children and increasing numbers of pregnant women.11 Demand for this medicine is therefore expected to grow even more in the years to come.
Drivers of change: collaboration and an enabling environment
Read The Gaurdian's article on African drug manufacturing, published November 2023.
Title: Kenya manufacturer is first in Africa to get WHO approval for malaria drug
Pre-qualification seen as significant step towards self-sufficiency in healthcare in continent where more than 70% of drugs are imported'
Governments, regulators, funders and procurement agencies can support the creation of an enabling environment to accelerate impact.
Building an African pharmaceutical manufacturing sector that meets international quality standards will require pan-African and international collaboration and leadership bolstered by political will and far-sighted investors.13 It will also require guidance and commitment from normative bodies as well as private-sector cooperation.
MMV has worked closely with international stakeholders to ensure alignment and complementarity of this initiative with related strategies and activities. For instance, MMV and Africa CDC recently signed a Memorandum of Understanding to support strengthening of African pharmaceutical manufacturing capacity, in line with Africa CDC’s Strategic Plan for 2023-2027.
An enabling environment
Funders, governments, regional bodies, procurement agencies and health regulators have also shown commitment to Africa’s drive to make its own medicines. This is key for progress. For example, health regulators in Africa are working towards the regional harmonization of drug development and prequalification. In addition, Africa’s Continental Free Trade Area (AfCFTA) will create a large free trade area, develop regional value chains, and is expected to alleviate Africa’s reliance on external economies.14
It is essential that governments using domestic funds prioritize quality-approved sources of antimalarial medicines; for example, by procuring medicines from local manufacturers compliant with WHO GMP. Governments can also create a favorable and competitive environment for manufacturers of quality-approved essential medicines by removing import tariffs on the needed starting materials or by strengthening export rebates.
Conclusion: The rising tide lifts all boats
Achieving progress towards Universal Health Coverage is heavily dependent on access to affordable and high-quality essential medicines, vaccines and diagnostics. Local production should therefore be integrated as a key component of functional health systems. The regional manufacture and equitable distribution of antimalarial therapies and interventions will speed progress towards the elimination of malaria. As the capacity and skills of drug manufacturers grow, they will be able to leverage their experience with malaria medicines and expand into products for other diseases with increased collaboration from pan-African policymakers. The implementation and financing of these strategies are worthy of full global support.
1. World Malaria Report, 2022
2. World Economic Forum Report, AfCFTA: A New Era for Global Business and Investment in Africa
3. ‘How PEPFAR aims to spur medical manufacturing in Africa’. Devex Pro. December 2022
4. Universal Corporation Ltd (UCL) received WHO prequalification for sulfadoxine-pyrimethamine in August 2023 and sulfadoxine-pyrimethamine + amodiaquine (SPAQ) in October 2023
5. Roman et al. ‘Determinants of uptake of intermittent preventive treatment during pregnancy: a review.’ Malaria Journal. 2019; 18:372
6. Anne Fitzpatrick. “The impact of public health sector stockouts on private sector prices and access to healthcare: Evidence from the anti-malarial drug market.” Journal of Health Economics. January 2022
7. Walker et al. Are we doing enough to prevent poor-quality antimalarial medicines in the developing world? BMC Public Health. 2018
8. ‘How PEPFAR aims to spur medical manufacturing in Africa’. Devex Pro. December 2022
9. ‘Inside Africa’s Push to Make its Own Medicines’. International Finance Corporation. World Bank Group
10. ‘Inside Africa’s Push to Make its Own Medicines’. International Finance Corporation, World Bank Group
11. WHO Guidelines for Malaria, 2023
12. WHO Prequalification is a certification issued by the World Health Organization that ensures medicines adhere to global standards of quality, safety and efficacy. This is done by assessing the quality, safety and efficacy of medicinal products. Certifications for WHO Prequalification of pharmaceutical products and Good Manufacturing Practice (GMP) are an international endorsement of quality drugs
13. ‘Five ways to prepare for the next pandemic’. Nature. October 2022
14. ‘In Africa’s free trade area, investment in pharmaceuticals means impact and profit’. World Economic Forum. March 2023