Kenya tightens war on fake drugs with a medicine tracking system

Pharmacy and Poisons Board CEO Ahmed Mohammed, during an interview in Nairobi on August 17, 2026. [Benard Orwongo, Standard]

When a patient walks into a pharmacy and buys a packet of medicine, the intention is simple: To treat or manage a health condition.

But what happens when that medicine is fake, substandard, illegally imported, or has been poorly stored?

The Pharmacy and Poisons Board (PPB) has adopted technology to help answer these questions in a move aimed at protecting patients from unsafe medicines.

As part of strengthening its existing regulatory controls, PPB is implementing authentication and track-and-trace technology to provide greater visibility of medicines across the supply chain; from manufacture or importation, through distribution, to the point of dispensing

Under the system, regulated products will progressively carry traceability information that enables PPB to verify their identity and follow their movement through the legitimate supply chain. This will strengthen the Board's ability to detect diversion, identify suspicious products and rapidly trace affected batches where a safety or quality concern arises

When a patient reports a problem, regulators can trace the medicine backwards through the supply chain and establish where it came from, allowing action to be taken, including a possible recall.

In an interview with The Standard, PPB Chief Executive Officer Ahmed Mohammed said the system is part of wider efforts to fight falsified and substandard medicines and illegal imports into the country.

“Our objective is to make the legitimate pharmaceutical supply chain increasingly difficult to penetrate with falsified, substandard or illegally supplied products. Traceability gives us an additional regulatory tool to verify products, follow their movement through the supply chain and intervene rapidly wherever a problem is detected,” said Dr Mohammed.

The need for such surveillance has been highlighted by the presence of falsified products in the market.

In a recent report, PPB flagged falsified products including antiretroviral drugs used to prevent HIV infection, Viagra, HIV rapid testing kits and blood thinners administered during dialysis.

According to the report released last month, substandard and falsified medical products can lead to treatment failure, contribute to antimicrobial resistance and undermine trust in the health system.

The PPB boss noted that patients do not need to be certain that a medicine is falsified before raising an alarm. Any suspicion should be reported directly to PPB.

“Once a complaint is received, regulators can begin tracing where the product was bought and how it entered the market,” explained the PPB boss.

“PPB does not rely solely on complaints. The Board conducts risk-based and active post-market surveillance, investigates product quality concerns and receives reports from healthcare professionals, patients and other stakeholders. Where a suspect product is identified, the Board traces its distribution pathway, secures samples where necessary and takes appropriate regulatory and enforcement action”.

Technology, however, is only one part of the changes being made by the regulator.

PPB has also been reviewing medicines already available in the Kenyan market to ensure they meet safety and quality requirements.

PPB has also undertaken a clean-up of the medicines register to ensure that products authorised for the Kenyan market have a current regulatory status. Products whose registrations had lapsed or had not been renewed were identified and are not eligible for continued importation or manufacture unless the applicable regulatory requirements are met

The aim, the Board says, is to ensure that products within the system are properly registered and can be verified as medicines that meet the required quality standards.

The regulator has also strengthened bioequivalence requirements, particularly for generic medicines.

Mohamed said the process helps establish whether a generic medicine performs comparably to the original brand.

The Board has also been working with local pharmaceutical manufacturers to strengthen their ability to produce quality medicines.

Local manufacturers have been trained on quality and safety measures, including process validation, as Kenya seeks to increase local production and reduce dependence on imported medicines.

“So far, we have 13 additional new local manufacturers at different stages of set up,  to manufacture medicines and medical products in the country,” said Mohammed.

Kenya still relies heavily on imported medicines and medical commodities, making the quality of products entering the country a major concern.

PPB says one of the biggest challenges remains illegal medicines entering the country.

Porous borders and limited human resources have made it difficult to monitor all points of entry.

The regulator has since deployed specialists to ports of entry to strengthen surveillance.

Inspectors are also being equipped with technology that can quickly test suspicious medicines.

“When a product is suspected to be falsified or substandard, it can be tested on the spot. If it fails the required checks, further investigations are conducted, including tracing the product back to its source,” said Mohamed.

Products confirmed to be falsified or unsafe are removed from the market and destroyed.

The Board also conducts active market surveys to identify unsafe products already circulating.

When genuine medicine becomes unsafe

But medicines do not have to be fake to pose a risk to patients.

A genuine medicine can lose its quality if it is poorly transported or stored.

PPB is therefore tightening requirements on how medicines are handled from the manufacturer to the patient.

Medicines must be transported and stored under the conditions recommended by the manufacturer.

For example, medicines that require refrigeration must be maintained at the required temperature throughout the supply chain.

The regulator is working with counties to inspect medicine storage facilities and has warned that premises that fail to meet the required standards could be closed.

The inspections are also being conducted in public health facilities across the country.

“The same quality standards apply throughout the supply chain, including public and private health facilities. Where storage conditions compromise the quality of medicines, the Board will require corrective action and, where necessary, take appropriate regulatory measures. Patient safety remains our overriding consideration,” warned Mohamed.

PPB says different medicines have different storage requirements and should be kept under the conditions specified by the manufacturer.

Poor storage can affect the quality of medicines even before their expiry date, making proper handling an important part of patient safety.

Expired medicines

Poor storage is not the only threat to the quality of medicines.

The regulator is also warning that expired medicines should never remain on pharmacy or hospital shelves.

Medicines have a defined shelf life, established through studies that determine how long they can maintain their required quality, safety and effectiveness.

There have been complaints of expired medicines being dispensed to patients in different parts of the country.

“Once a medicine reaches its expiry date, it must be removed from usable stock and must not be dispensed. Beyond the approved shelf life, the required quality, safety and performance of the product can no longer be assured,” said Mohammed.

Changing the role of pharmacists

The Board is also looking at how medicines are dispensed to patients.

It has developed good pharmacy practice guidelines aimed at improving the services patients receive when they visit pharmacies.

Pharmacists and other pharmaceutical professionals across the country are being trained to provide better advice to patients when dispensing medicines.

The Board says a pharmacy should not simply operate like an ordinary shop where a patient walks in and buys a product.

Instead, pharmacists should play a greater role in advising patients on the safe use of medicines.

More than 110,000 healthcare professionals, including doctors, nurses and clinical officers, have been trained to identify falsified and substandard medicines and report adverse reactions associated with medicines.

For years, PPB has also faced criticism over delays in approving medicines and conducting inspections, largely because of inadequate staffing.

Lack of adequate staffing has in the past affected inspections and active market surveys.

As a mitigation measure, 47 additional staff have been employed, with plans underway to onboard more staff and increase inspections across the country.

Mohamed said increased staffing is significant because Kenya has more than 10,000 regulated pharmaceutical premises, while pharmacies and pharmaceutical outlets are spread across the country.

The Board emphasises that detection of a defective product and its timely removal from the market is evidence of an active regulatory surveillance system. Where a safety or quality signal is identified, PPB assesses the risk, traces affected products and takes proportionate action, including recall or withdrawal where necessary.

For patients, the regulator's message is simple: "Medicines should be bought only from registered pharmacies and other authorised premises."

Kenyans are also encouraged to report any suspected falsified or substandard medicine to PPB by calling 0795743049 or reporting through