A fake batch of Postinor-2 (P2) emergency contraceptive tablets circulating in Kenya has exposed the growing challenge of protecting patients from substandard and falsified medical products.
Experts say quality assurance must extend beyond the factory gate, warning that medicines can be compromised at different stages of the supply chain before reaching patients.
On August 14, the Pharmacy and Poisons Board (PPB) warned the public about a counterfeit batch of P2 tablets identified by batch number T34197R, which falsely claimed to have been manufactured by Gedeon Richter PLC.
The regulator said the counterfeit product was visibly different from genuine tablets, with discrepancies noted in the batch-printing method, patient information and carton sealing.
The alert highlights a less visible but critical aspect of patient safety—what happens to medicines between the manufacturer and the patient.
Pharmaceutical quality and health supply-chain specialist Wilson Chandomba said Kenya’s efforts to strengthen regulatory coordination, surveillance and enforcement must also focus on preventing unsafe medicines from reaching patients in the first place.
“The bigger question for Kenya and the region is: how can countries prevent unsafe products from reaching patients in the first place?” he said.
Chandomba urged authorities to ensure quality standards are maintained throughout the pharmaceutical supply chain until medicines reach patients.
Local manufacturing
The concerns come as Africa accelerates efforts to increase local pharmaceutical manufacturing, with the Intergovernmental Authority on Development (IGAD) taking a leading role in the drive.
Chandomba said expanding local pharmaceutical production and combating substandard and falsified medicines are closely linked.
Producing medicines closer to African patients, he said, could strengthen health security, shorten supply chains and reduce dependence on external sources.
However, he warned that increased production must be accompanied by strong quality systems covering the entire journey from manufacturing to distribution.
“A locally manufactured medicine can still lose quality if it is poorly transported or stored. Equally, the reputation of legitimate African manufacturers can be damaged when their products are falsified,” he said.
Chandomba is an award-winning pharmaceutical quality and health supply-chain specialist and the founder and managing consultant of CMCOMMS Supply Chain Quality Assurance.
He participated in the IGAD and East, Central and Southern Africa Health Community (ECSA-HC) Community of Practice on Local Manufacturing of Health Products and Technologies conference held in Mombasa in July.
CMCOMMS was recognised at the 2026 Africa Supply Chain Excellence Awards (ASCEA) in the Humanitarian and Health Supply Chain Management category for its work on “implementation assurance for pharmaceutical quality systems and health supply chains.”
Quality can be lost after manufacture
Chandomba said the fight against substandard and falsified medical products can no longer remain a conversation limited to regulators, pharmacists and public-health specialists.
Medicines move through complex commercial supply chains involving manufacturers, procurement organisations, freight forwarders, airlines, ports, customs authorities, transporters, warehouses, wholesalers and health facilities.
Each actor, he said, has a responsibility to maintain the integrity of medicines.
“A genuine product can leave a compliant manufacturer meeting its required specifications and subsequently lose quality because of poor transportation, inappropriate storage, temperature excursions or failures in distribution,” he said.
“Quality assurance, therefore, cannot end at the factory gate. Although quality is not created in the supply chain, it can be lost there.”
The challenge is particularly significant in East Africa as countries expand local pharmaceutical manufacturing while strengthening cross-border trade.
Chandomba said increased manufacturing must ultimately translate into more quality-assured medicines reaching patients.
Enforcement and traceability
Kenya’s response to falsified medicines also demonstrates why enforcement alone cannot eliminate the problem, he said, noting that the challenge has both supply and demand dimensions.
On the supply side, Chandomba said authorities must strengthen enforcement against illegal manufacturing, importation and distribution while ensuring secure procurement, traceability, qualified suppliers and logistics providers.
He also called for proper implementation of good storage and distribution practices throughout the pharmaceutical supply chain.
The fake P2 alert therefore exposes a wider weakness that extends beyond counterfeit medicines themselves.
Protecting patients requires more than detecting falsified products after they enter the market. As Africa expands local pharmaceutical manufacturing, quality assurance must extend from production and procurement to transportation, storage and distribution.
A medicine that leaves a compliant factory can still be compromised by poor handling, while counterfeit products can undermine public confidence in legitimate manufacturers.
The challenge will require coordinated action from regulators, manufacturers, importers, logistics providers, wholesalers and health facilities.
Stronger traceability, enforcement and supply-chain standards will be critical to ensuring that medicines reaching patients are safe, genuine and effective.
