Fight against substandard and falsified drugs must involve all stakeholders - expert

Pharmaceutical quality and health supply-chain specialist Wilson Chandomba in Mombasa on July 22 /BRIAN OTIENO

A fake batch of Postinor-2 (P2) tablets circulating in Kenya has exposed the growing challenge of protecting patients from substandard and falsified medical products.

Experts have warned that quality assurance must extend beyond the factory gate.

On August 14, the Pharmacy and Poisons Board 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 board said the fake product was visibly different from genuine tablets, with discrepancies noted in the batch printing method, patient information and sealing of the carton.

The alert is part of Kenya’s growing response to substandard and falsified medical products (SFMPs), highlighting a less visible aspect of patient safety—what happens to medicines between the manufacturer and the patient.

Pharmaceutical quality and health supply-chain specialist Wilson Chandomba said as Kenya strengthens regulatory coordination, surveillance and enforcement, the challenge should focus not only on detecting unsafe medicines after they enter the market but also on preventing them from reaching patients.

“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 Kenyan authorities to ensure quality standards are maintained throughout the supply chain until medicines reach patients.

The issue came as Africa’s push to manufacture more pharmaceutical products locally gains momentum, with the Intergovernmental Authority on Development (IGAD) taking the lead in the drive.

Chandomba said there was a strong link between expanding local pharmaceutical manufacturing and the fight against substandard and falsified medicines.

Producing medicines closer to African patients, he said, could strengthen health security, shorten supply chains and reduce dependence on external sources.

However, increased production must be accompanied by strong quality systems covering the entire journey from manufacture 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, an award-winning pharmaceutical quality and health supply-chain specialist, founded and is the managing consultant of CMCOMMS Supply Chain Quality Assurance.

He was part of 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.”

Chandomba said the fight against substandard and falsified medical products could 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, transporters, warehouses, wholesalers and health facilities.

Each actor, he said, has a role in maintaining 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 important for East Africa as the region expands local pharmaceutical manufacturing while strengthening cross-border trade.

Chandomba said increased manufacturing must ultimately translate into more quality-assured medicines reaching patients.

Kenya’s response also shows why enforcement alone cannot defeat falsified medicines, he said, arguing there is both a supply and a demand side to the problem.

“Supply reduction requires firm enforcement against illegal manufacture, importation and distribution, alongside secure procurement, traceability, qualified suppliers and logistics providers, and proper implementation of good storage and distribution practices,” he said.

Instant Analysis

The fake P2 alert exposes a wider weakness in Kenya’s pharmaceutical supply chain: protecting patients requires more than detecting counterfeit medicines after they reach the market. As Africa pushes to expand local drug manufacturing, quality assurance must extend from production and procurement to transport, storage and distribution. A medicine that leaves a compliant factory can still be compromised by poor handling, while counterfeit products can undermine confidence in legitimate manufacturers. The challenge therefore requires coordinated action by regulators, manufacturers, importers, logistics providers, wholesalers and health facilities. Stronger traceability, enforcement and supply-chain standards will be critical to ensuring medicines reaching patients are safe, genuine and effective.