US - Kenya health deal : How it will affect your medicine

the-star.co.ke · Feb 26, 2026 · Collected from GDELT

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Pharmacy and Poisons Board CEO Dr Ahmed Mohamed speaks to the Star / ENOS TECHE‘We rely on mature regulatory authorities like America’s FDA, but an applicant cannot simply bring an FDA certificate and get a licence. We follow the normal [review] process, but we do it much faster’‘Ultimately, the government is me and you; it is the responsibility of every Kenyan citizen to help police their health providers’If you are wondering how medicines reach you safely before they are sold in Kenyan pharmacies, or why some drugs take longer than others to enter the market, this interview is for you.The Star spoke with Dr Ahmed Mohamed, the chief executive officer of the Pharmacy and Poisons Board, to unpack the dynamics shaping the safety, quality and accessibility of medicines you use every day.He explained international regulatory partnerships, including the US-Kenya health cooperation framework, drug approval pathways, post-market surveillance and the fight against illegal pharmaceutical practices.The Star: You have recently taken over as CEO of the Pharmacy and Poisons Board. What direction are you taking the institution?Dr Ahmed Mohamed: First, I think it is important to clearly define the mandate of the Pharmacy and Poisons Board. We essentially serve as the watchdog for public health with regard to health products and technologies. Our mandate is built on three pillars: ensuring the safety, quality and effectiveness of every product.Recently, we have undertaken several strategic reforms aimed at strengthening our regulatory efficiency, transparency and public health protection. This involves significant modernisation of our digital regulatory platforms.Our current strategy is focused squarely on the patient rather than the commercial interests of the pharmaceutical industry, because that is the fundamental reason for our existence.In this process, we have expanded our human resource capacity and are operationalising our regional offices. We are devolving our services closer to the people so that citizens can easily access our offices, interact with our officers and report illegal practices, such as unauthorised premises or substandard products.It is often surprising to note that a doctor’s prescription is not the end of the process. If a patient takes a drug like paracetamol and it does not cure their headache as expected, they need to know what to do next. The patient is supposed to report this to our offices through our online platform or via their doctor or pharmacist. You do not need to be certain that a drug is bad; you only need to suspect it, and that is where we take over the investigation.Furthermore, we are strengthening our laboratories specifically for post-market surveillance. This means that once a product is registered and enters the market, we continue to follow up on its quality. We identify critical products, such as antibiotics or anti-hypertensive medicines, and sample them throughout the country for analysis in our lab.We typically conduct these reviews three to four times a year and share the reports with the public. Our laboratory now operates 24 hours a day to ensure continuous evaluation of product quality. Truthfully, the issue of substandard products in the market has gone down significantly of late.We are also supporting local manufacturers from a regulatory standpoint. The government’s intention is for Kenya to become a net exporter of health products rather than a net importer. To achieve this, we have established regulatory mechanisms to develop our local industry.Health products and technology are a matter of national security. We remember what happened during the Covid-19 pandemic, when countries locked down and exports ceased. The only way to prevent such a crisis in the future is to develop local capacity. We train manufacturers on good manufacturing practices and quality assurance, and fast-track the registration of their products.How many drug manufacturers are currently operating in the country?Currently, we have 31 manufacturers. However, because of the regulatory framework we have established, we are seeing about 10 new state-of-the-art facilities coming up.There is ongoing investment of about Sh100 billion in the pharmaceutical sector. These are new players, separate from the original 31, which demonstrates the growing confidence in our regulatory processes and the protection we offer to the industry.There is public anxiety whenever PPB recalls medicines. How should Kenyans understand recalls?It is important to understand that every industry has a recall process; it is not unique to the pharmaceutical sector. You see companies like Toyota recalling vehicles for brake issues worldwide. A recall is a vital process to ensure the safety of products already in the market.There are two types: Class One recalls are serious and involve products that may cause death or severe harm. We remove those immediately upon suspicion, sometimes based solely on visual appearance, and notify the media immediately.Then there are regular recalls, which involve smaller issues, such as a slight variance in the active ingredient. For example, if a drug is supposed to have 100 per cent of an active ingredient but is found to have 92 per cent, it is not necessarily a critical safety risk, but it affects efficacy. For us, the question is always whether the drug is effective. Recalls are a normal and good practice. The public should not fear when the Pharmacy and Poisons Board issues a recall; it means you have an active, proactive regulatory institution that is doing its work.How long does it typically take for medicine to be registered and brought to the Kenyan market, and what does that process involve?Internationally, it takes about two to five years to register a product. In Kenya, our service charter sets this at 24 months (two years).Drug registration involves many complex processes. For example, we require "bioequivalence" data for generic drugs to ensure they are therapeutically equivalent to the originator brand. If a company wants to manufacture a generic version of a drug like Augmentin, they must provide data proving that their version will have the same therapeutic effect.We also have to verify stability data to ensure a product remains safe for its claimed shelf life, and we must audit the manufacturing process. This includes qualifying the equipment used and validating the entire manufacturing process to ensure it complies with good manufacturing practices. It is not a matter of simply sitting and approving a file; it takes time. Our two-year timeline actually makes us one of the best and most efficient regulators in the world.The health agreement Kenya signed last year with the US says a drug approval by the Food and Drug Administration is enough for that product to enter the Kenyan market. Are we replacing PPB’s role here and turning it into a rubber stamp?We use a system called ‘reliance’, where we rely on mature regulatory authorities like the US FDA, the WHO prequalification system or the UK’s MHRA (Medicines and Healthcare products Regulatory Agency). This is primarily done for the benefit of the public health system, so that new molecules can reach Kenyan patients quickly.However, reliance does not mean we do not review the scientific documentation. It is strictly a fast-track mechanism. An applicant cannot simply bring an FDA certificate and get a licence; they must submit the entire dossier and every document they submitted to the FDA for our own assessment. We follow the normal process, but we do it much faster.At what maturity level is the PPB currently ranked by the WHO, and what have been the barriers to moving up?We are currently at Maturity Level 2, and we are moving towards Level 3. The most critical factor that delayed our move to Level 3 was human resources. We have an establishment requirement of almost 350 staff, but we have been operating with around 160, which is nearly a 50 per cent shortage. Fortunately, the Ministry of Health has been very supportive. Through a World Bank grant and Treasury approvals, we are now employing about 80 new people to close that gap.The higher the maturity level, the more confidence the public can have in the system. Level 4 represents "World-Listed Authorities", which are the top-tier trusted systems globally.There have been complaints regarding the five-year renewal of marketing authorisations. Is this process causing drug stockouts or blocking products?Legally, under the Pharmacy and Poisons Act (Cap 244), it is mandatory for products to be renewed every five years. If it is not renewed, the product is no longer licensed and cannot be on the market.We have been engaging stakeholders on this since 2022, but I think some took it for granted. We sat down with stakeholders and agreed on deadlines, moving the date four times. By the final cut-off of December 2025, 80 per cent of players had complied.For the remaining 20 per cent who did not submit, it is usually a commercial issue rather than a regulatory one. For example, a company may have an old molecule that is no longer profitable, or there may be over-representation in the market, say, more than 200 different brand names for the same paracetamol molecule. Companies may decide not to renew those.However, there is no crisis in availability. As a government, we prioritise accessibility, and we have pathways to deal with emergencies, such as issuing special permits for specific products based on a doctor’s prescription.What system gaps allow unlicensed chemists and rogue practitioners to flourish, and how is the board strengthening enforcement?The biggest problem is that some pharmacy practitioners lease their certificates to unauthorised persons. They claim in our system that a business belongs to them to get a licence, and then later claim they have "resigned" from their own business. They essentially open the shop and then disappear, leaving it in the hands of unqualified people.To d