Audit reveals staffing crisis as drug regulator misses key safety targets

Audit reveals staffing crisis as drug regulator misses key safety targets
Auditor-General Nancy Gathungu. PHOTO/HANDOUT
In Summary

The PPB oversees the regulation of medicines, medical products, and pharmacy services, ensuring that drugs sold and administered in Kenya are safe, effective, and properly handled.

The Pharmacy and Poisons Board (PPB), Kenya’s official agency tasked with regulating medicines and pharmacy practice, has fallen short of critical safety and operational goals, a recent audit has revealed.

The Auditor-General’s report highlights that the board is operating with almost half its approved workforce vacant, a shortfall that may be hampering its ability to safeguard public health.

In the financial year ending June 2025, Auditor-General Nancy Gathungu noted that the board had approved a staffing plan 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,” she said. She added: “In the circumstances, the effectiveness of the board with the existing staff deficits could not be confirmed.”

The PPB oversees the regulation of medicines, medical products, and pharmacy services, ensuring that drugs sold and administered in Kenya are safe, effective, and properly handled.

The audit report shows that the regulator has underperformed in almost all its key targets, a situation that may have been worsened by persistent staff shortages.

On compliance with regulations for pharmaceutical premises and professionals, the board aimed for full adherence but achieved only 85 percent. Pharmacovigilance, which tracks adverse drug reactions, was set to increase by 20 percent but improved by just 12 percent.

Post-Market Surveillance of medicines also fell short, with only 750 of the planned 1,200 samples tested. Similarly, only 10 foreign drug factories were inspected against a target of 25 under the Good Manufacturing Practice (GMP) standards.

Training of staff was another area of concern. While the board intended to train 200 officers, only 10 underwent training, representing just five percent of the target.

These gaps come amid growing public health risks, including the spread of counterfeit drugs and unregulated chemists, which endanger millions of patients across the country.

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