The Auditor-General has faulted the pharmaceutical regulator over its low staffing levels, even as audit findings show that the State agency has fallen short across virtually all its key performance targets, including licensing, product monitoring and drug safety.
An audit of operations and finances of Pharmacy and Poisons Board (PPB) revealed that the State body was understaffed by 46.6 percent, with 164 positions remaining unfilled despite management having received approval from the board to recruit.
In her audit report for the financial year ending June 2025, Auditor-General Nancy Gathungu noted that the regulator’s board had approved a staff establishment of 352 positions.
“However, only one hundred and eighty-eight (188) were in post, resulting in an understaffing of one hundred and sixty-four (164) positions,” said Ms Gathungu.
“In the circumstances, the effectiveness of the board with the existing staff deficits could not be confirmed,” she added. The PPB is the country’s statutory regulator for pharmacy practice, medicines and medical products, meaning it is responsible for ensuring that medicines sold and used in Kenya are safe, effective and properly handled.
Ms Gathungu also noted that the PPB had not been able to meet all of its key performance targets, an underperformance that may have been aggravated by persistent staff shortages.
On regulation of pharmaceutical premises and professionals, the PPB had set a target of 100 percent compliance but achieved only 85 percent. On pharmacovigilance —the monitoring of adverse drug reactions— the regulator planned a 20 percent increase but managed only a 12 percent improvement.
The board had targeted subjecting 1,200 samples to Post-Market Surveillance (PMS) but managed to test only 750, leaving a shortfall of 450 samples.
On overseas drug factory quality inspections, formally known as Foreign Good Manufacturing Practice (GMP) inspections, the target was 25 facilities, but only 10 were inspected during the period under review.
There was also a plan to train 200 officers, but only 10 were trained, translating to a dismal achievement rate of five percent.
The underperformance comes at a time when the country is grappling with unsafe medicines, including counterfeit drugs and the mushrooming of unregulated chemists, developments that put millions of patients at risk.
A previous report by Ms Gathungu’s office revealed that drugs worth more than Sh49 million were issued to public hospitals without undergoing mandatory quality testing in the 2023/24 financial year, increasing the likelihood that patients were exposed to substandard or unsafe medicines.
This means that thousands of patients seeking care in public hospitals across the country may have received untested medical drugs, in breach of national health and safety protocols.
In Kenya, the pharmaceutical black market is estimated at Sh15 billion, depriving the government of critical revenue needed for healthcare financing and effective regulatory enforcement.
The Pharmacy and Poisons Act mandates the National Quality Control Laboratory (NQCL) to examine and test drugs and any material or substance from which medicines may be manufactured, processed or treated. The laboratory is also responsible for ensuring quality control of drugs and medicinal substances.
The NQCL issues a certificate of analysis for every sample of drugs tested and approved for use in the country.
Despite these safeguards, substandard medicines are routinely recalled from the market. In 2023, for instance, counterfeit antibiotics and painkillers were seized from informal pharmacies in Nairobi, posing serious risks to consumers.
In December 2024, the PPB also quarantined cancer injections over quality concerns, highlighting weaknesses in quality assurance systems.
In April 2025, the regulator recalled several medicines, including paracetamol and Augmentin, due to colour changes, packaging errors or evidence of counterfeiting —failures that pose significant health risks to patients.
