Counterfeit medicines in Kenya are policed by two separate agencies whose mandates overlap rather than divide cleanly, and a third agency is now waiting in the wings to absorb one of them. Anyone dealing with a suspected counterfeit or substandard medicine needs to understand not just what the Pharmacy and Poisons Board and the Anti-Counterfeit Authority can each do, but that the whole institutional map is mid-transition.

Two Regulators, Two Different Jobs

The Pharmacy and Poisons Board (PPB) is the medicines regulator: it registers pharmaceutical products, licenses pharmacies and pharmaceutical premises, and runs pharmacovigilance and post-market surveillance, including product recalls when a registered medicine turns out to be substandard or falsified. The Anti-Counterfeit Authority (ACA), created under the Anti-Counterfeit Act, 2008, has a broader consumer-goods mandate that includes medicines but is not limited to them: it investigates and prosecutes the manufacture, importation, and sale of counterfeit goods generally, working with agencies including the Kenya Revenue Authority, the Directorate of Criminal Investigations, and the Kenya Bureau of Standards. The two agencies signed a Memorandum of Understanding specifically to coordinate on counterfeit and illicit medicines, recognising that PPB’s regulatory registration function and ACA’s enforcement function needed a formal bridge rather than operating as two unconnected systems.

The Scale of the Problem, in PPB’s Own Numbers

PPB’s own reporting gives a concrete sense of what this enforcement actually looks like in practice. Between 2021 and 2025, the Board recorded 1,413 product quality complaints, coordinated 99 product recalls, received over 32,000 adverse drug reaction reports, and issued 18 public alerts on suspected falsified medicines; 13 falsified-product recalls have already been recorded in 2026 alone. Enforcement has intensified further with the closure of more than 200 non-compliant pharmaceutical premises alongside arrests and prosecutions, and PPB has announced a nationwide crackdown on illegal pharmacies, unlicensed medicine outlets, and licence-renting arrangements. A 2026 US Trade Representative Special 301 Report separately flagged Kenya as a significant transit and destination market for counterfeit goods generally, including fake medicines, noting that counterfeiters increasingly exploit express mail and courier networks in small consignments to evade detection, which is precisely the kind of gap that requires PPB and ACA to coordinate rather than work in silos.

The Enforcement Gap: Fragmentation Itself

The most persistent structural weakness is not a lack of legal power on either side, but the fragmentation between them and a third regulator, the Narcotic Drugs and Psychotropic Substances Board, that also touches medicines. A counterfeit medicine can trigger a PPB registration issue, an ACA counterfeiting investigation, and in some cases a narcotics enforcement question, depending on the product, and a business or complainant needs to know which door to knock on for which problem. Kenya’s own policy response acknowledges this: the government has been rolling out a National Product Catalogue, Drug Formularies, a National Logistics Management System, and track-and-trace systems specifically to close the visibility gap that lets counterfeit products move through the supply chain undetected between agencies.

A Bigger Change Already Under Way

The fragmentation problem is being addressed structurally, not just through better coordination. The Kenya Health Products and Technologies Regulatory Authority Bill, 2022 would create a single Kenya Health Products and Technologies Regulatory Authority (KHPTA) to absorb PPB’s functions along with the Narcotic Drugs and Psychotropic Substances Board’s, covering the entire lifecycle of medicines, medical devices, cosmetics, and other health products under one roof. The Bill passed the National Assembly in November 2024 and was forwarded to the Senate, where it remained at second reading as of early 2026. It has not been enacted, and PPB continues to operate exactly as before, including its July 2026 consultative engagement with Parliament’s Health Committee on strengthening pharmaceutical regulation. Anyone relying on this article’s description of PPB’s role should re-check the Bill’s status before assuming the current fragmented structure is still current, since a change here would be significant and the Bill has already cleared one full chamber.

What This Means in Practice

For a business bringing a counterfeit-medicine complaint, the practical routing today is: a product registration or quality concern about a specific medicine goes to PPB, a counterfeiting or trademark-infringement concern goes to the ACA, and matters involving both should be raised with both agencies given the coordination MoU between them, rather than assuming either agency alone has full authority to act. That routing will likely simplify once KHPTA is operational, but until then, the current two-agency, MoU-coordinated structure is what actually governs enforcement.

How We Can Help

Clay & Associates Advocates advises pharmaceutical businesses and rights holders on counterfeit medicine enforcement, PPB registration matters, and Anti-Counterfeit Act compliance. Our piece on patent protection for pharmaceuticals covers the related IP protection landscape this enforcement structure sits alongside. Contact our Intellectual Property practice to discuss a counterfeit medicine matter or PPB/ACA regulatory question.

Sources: Anti-Counterfeit Act, 2008; Pharmacy and Poisons Act, Cap 244; Kenya Health Products and Technologies Regulatory Authority Bill (National Assembly Bill No. 54 of 2022); Ministry of Health, Kenya Strengthens National Response Against Substandard and Falsified Medical Products; Anti-Counterfeit Authority, Safeguarding Public Health: ACA and PPB Unite Forces.

Frequently asked questions

Which agency handles a counterfeit medicine complaint in Kenya?
A product quality or registration concern goes to the Pharmacy and Poisons Board; a counterfeiting concern goes to the Anti-Counterfeit Authority; matters involving both should be raised with both, given the coordination MoU between them.

Will PPB be replaced?
A Bill to create a single Kenya Health Products and Technologies Regulatory Authority absorbing PPB’s functions passed the National Assembly in November 2024 and remains before the Senate; it has not yet been enacted, so PPB continues to operate as the current regulator.

How big is the counterfeit medicine problem in Kenya, based on official data?
PPB recorded 1,413 product quality complaints and coordinated 99 product recalls between 2021 and 2025, with 13 falsified-product recalls already recorded in 2026 alone.

Do PPB and the Anti-Counterfeit Authority coordinate with each other?
Yes. The two agencies signed a Memorandum of Understanding specifically to strengthen coordination on counterfeit and illicit medicines.