As Africa accelerates efforts to strengthen local pharmaceutical manufacturing, the conversation is increasingly moving from ambition to execution.
Ahead of AfriSummit 2026, we spoke with Arjun Mohindra, Chief Operations Officer at Dawa Life Sciences, to hear an African manufacturer’s perspective on what needs to change, the role of regulatory reliance and harmonisation, and why closer dialogue between industry and regulators matters for the continent’s pharmaceutical manufacturing ambitions.
Question 1: What will it take for African pharmaceutical manufacturers to compete successfully on quality, scale and affordability?
The honest answer is that quality is the part of this equation Africa has already solved — Dawa alone runs three GMP facilities to a standard that clears UNICEF, USAID and Mission Pharma procurement, and thirty-plus of Kenya’s registered manufacturers are proving the same thing every day. What determines whether that quality translates into competitiveness is scale and cost structure, and both are fixable rather than fundamental.
On scale, the fastest and cheapest capacity available isn’t a new plant — it’s the idle half of the ones already built (utilization sits below 50% across many of Kenya’s manufacturers). Unlocking it means demand-side measures first: procurement preferences that reward real manufacturers over import traders, advance market commitments, and reliable payment terms so cash flow doesn’t strangle capacity that already exists. Layered on top of that, regional harmonization — EAC joint assessments, the AMA Treaty now at 32 ratifications — turns nine fragmented national markets into one investable region, which is the single biggest multiplier on plant utilization there is.
On affordability, the cost structure today actively works against local producers: roughly 95% of APIs are imported, and duties on packaging and other essential inputs add an estimated 8–12% to local production costs while finished imported medicines enter largely free of equivalent charges. Extending the exemptions already applied to APIs to cover packaging and GMP infrastructure, investing in regional API and bioequivalence testing capacity, and channeling the blended DFI finance that’s already on the table (World Bank, Afreximbank, AfDB, IFC) toward bankable local expansion closes that gap without asking anyone to compromise on quality. Put simply: the capability exists — competitiveness is an environmental problem, not a capability problem.
Question 2: What regulatory change would make it easier for African manufacturers to expand across multiple countries?
The single highest-leverage change is mutual recognition — reliance — so that one quality dossier, assessed once by a trusted authority, opens multiple markets instead of requiring a separate registration battle with its own dossier, fees and timeline in every country. Today that duplication is one of the quiet reasons capacities sits idle: no East African plant can be globally competitive serving one national market at a time.
The good news is the machinery for this already exists — it doesn’t need to be invented, only used faster and more consistently. The EAC’s Medicines Regulatory Harmonization initiative has already proven the joint-assessment model works, visibly cutting approval timelines. The African Medicines Agency Treaty has been in force since 2021 and is now in its 2026–2030 Expansion phase, with 32 AU member states having ratified it. And the WHO–AMA Framework Agreement signed in May 2026 formally aligns global and continental harmonization efforts. What’s missing isn’t policy architecture — it’s speed and consistency of adoption at national level: regulators accepting each other’s decisions rather than re-reviewing what a trusted partner has already cleared.
Two things would accelerate that adoption. First, sustained investment in regulatory science capacity — assessor recruitment, digital submissions, stable career paths — since reliance only works as fast as the authorities implementing it can move, and industry has offered to co-fund that training. Second, pushing national authorities like Kenya’s PPB toward WHO Maturity Level 3, because a WHO-listed authority’s approvals carry currency that other regulators are willing to rely on — turning one country’s regulatory maturity into a credential the whole region can use. Tie that to AfCFTA and the logic completes itself: a harmonized regulatory layer is what turns free trade on paper into pharmaceutical trade in practice.
Question 3: As an African manufacturer, what value does AfriSummit bring by creating direct dialogue between industry and regulators?
The value is that it collapses the distance between a policy being written and a policy being workable. Most of what industry knows about ground-level friction — that a “6-month priority review” commitment routinely takes longer in practice, that bioequivalence studies cost $80,000–200,000 and quietly exclude local generics, that packaging duties add 8–12% to local costs while finished imports enter free — normally reaches regulators through position papers, consultation windows and formal submissions. That’s slow, and it’s easy for nuance to get lost in translation. A forum like AfriSummit puts the people who feel that friction and the people who can fix it in the same room, at the same time, without an intermediary — which changes both the speed and the honesty of the conversation.
There’s already proof this works when it happens. At the continental level, the EAC’s joint-assessment model, the AMA Treaty’s momentum to 32 ratifications, and the WHO–AMA Framework Agreement all came out of sustained, direct institutional dialogue rather than parallel national efforts that later needed reconciling.
For a manufacturer specifically, there are three concrete things a platform like this delivers that a written submission can’t. First, it lets industry make its harder asks — calibrated import measures, procurement preference, reserved-product lists — in the same breath as its safeguards (verified capacity, phased notice periods, annual review), so regulators hear the conditionality live rather than reading “protectionism” into a paper request. Second, it creates public accountability: a commitment like “Dawa commits its plants, its people and its quality systems — we ask regulators to commit the operating environment,” made on stage in front of PPB, FKPM, AMA and peer manufacturers, is harder to walk back from than a private submission, for everyone in the exchange. Third, it’s where the practical matchmaking happens — DFI financing conversations, EAC and AMA technical-committee volunteers, mentorship between established and emerging manufacturers — the kind of connective work that a strategy document can call for but can’t convene.
So, the real value isn’t the dialogue itself — regulators and industry always find some way to talk. It’s that AfriSummit makes that dialogue direct, public and reciprocal, which is precisely the ingredient the deck’s own closing lesson points to: progress comes from phased, funded, politically backed collaboration with industry at the table from day one, not from consultation after the decisions are already made.
For African pharmaceutical manufacturing to reach its full potential, capacity alone will not be enough. The operating environment around manufacturers, from regulation and procurement to financing, market access and regional harmonization will be equally important.
These are among the conversations that will continue at AfriSummit 2026, bringing regulators, manufacturers and industry stakeholders together in Nairobi to examine how stronger regulatory systems and closer collaboration can support sustainable pharmaceutical growth across Africa.
AfriSummit 2026
28 September – 2 October 2026
Emara Ole-Sereni Hotel, Nairobi, Kenya