Auditor flags Sh49 million worth of untested drugs in public hospitals

Auditor-General Nancy Gathungu disclosed that the Health Ministry released drugs worth Sh49.6 million to hospitals in the 2023/24 financial year without submitting them for the required safety and quality checks.
Thousands of patients seeking treatment in public hospitals across the country may have been exposed to potentially unsafe medication due to the distribution of untested drugs in violation of national health regulations, a new audit has revealed.
In her latest report, Auditor-General Nancy Gathungu disclosed that the Health Ministry released drugs worth Sh49.6 million to hospitals in the 2023/24 financial year without submitting them for the required safety and quality checks.
This occurred despite the legal requirement for all medical products to be tested by the National Quality Control Laboratory (NQCL) before being released for use.
The audit, which reviewed the operations of the State Department for Public Health and Professional Standards for the year ending June 30, 2024, found that the failure to test the drugs before distribution contravened Section 35D(1)(c) of the Pharmacy and Poisons Act, 2012.
“This was contrary to Section 35D(1)(c) of the Pharmacy and Poisons Act 2012, which requires the NQCL to test all locally manufactured and imported drugs or medicinal substances on behalf of the government to ensure compliance with established rules. Therefore, management was in breach of the law,” stated the audit.
The audit report revealed that while the ministry spent Sh5.14 billion on goods and services in the financial year under review, part of this included drugs distributed to health facilities without any documentation confirming they had been tested for safety or effectiveness.
The NQCL is mandated to examine and test drugs, including materials used in their manufacture or processing. It also issues a certificate of analysis for every drug sample approved for use, which acts as proof that a product meets safety standards.
By bypassing this process, the ministry risked exposing patients to poor-quality or substandard drugs, which pose serious health risks.
In Kenya, all medical products are regulated by the Pharmacy and Poisons Board (PPB), which ensures their safety, quality, and efficacy.
The law prohibits the sale and distribution of untested or substandard drugs, and the country has in the past taken action to recall medicines that fail to meet the required standards.
For instance, in 2023, counterfeit antibiotics and painkillers were confiscated in unlicensed pharmacies in Nairobi.
The Auditor-General’s report raises concerns about lapses in oversight by both the Health Ministry and the NQCL, institutions tasked with protecting public health through strict adherence to medicine safety standards.