An audit has revealed that medical drugs were distributed to public hospitals without proof of mandatory quality testing in the financial year ending June 2025, marking a second successive year of such uncertainty.
The Office of the Auditor-General said that medical drugs worth Sh86.6 million were circulated to public hospitals without proof of quality testing in the period under review, an escalation from the previous year when consignments worth Sh49.6million were flagged for a similar anomaly.
However, the audit did not indicate what share of all distributed medicines lacked proof of testing.
The Auditor-General, Nancy Gathungu, again implicated the State Department for Public Health and Professional Standards, citing it for the same lapse in two consecutive audit cycles without any corrective measures being taken after the issue was first raised.
Ms Gathungu found that the department had procured and supplied the medical products to hospitals ‘without evidence of testing’, contrary to Section 35D(1)(c) of the Pharmacy and Poisons Act 2012.
This law stipulates that the National Quality Control Laboratory (NQCL) must test all locally manufactured and imported medicines on behalf of the government before they are distributed for use.
‘In the circumstances, management was in breach of the law,’ the report stated.
The NQCL is the official government medicines-testing laboratory. Established under the Pharmacy and Poisons Act, the NQCL verifies that medicines meet the required standards of quality, safety and efficacy before they reach patients by testing their identity, strength, purity, stability and possible contamination.
The Auditor-General did not conclude that the medicines were unsafe, counterfeit, or substandard. However, without documented evidence that the legally required testing had been carried out, there is no official confirmation that the medicines complied with statutory quality requirements before being supplied to hospitals.
The finding comes at a time of growing concern over medicine quality in Kenya.
A 2024 study that analysed Kenya’s national pharmacovigilance database identified 2,767 reports of suspected poor-quality medicines between 2014 and 2021. More than half of these reports involved confirmed quality defects, while 41.6 per cent were related to suspected therapeutic failure.