This archive report was first published on 9 January 2020.
Kenya's Decision on Port Efficiency May Increase Counterfeit Medicine Risk ¶
Kenya's regulations for greater port efficiency could increase the risk of counterfeit medicines in East Africa.
President Uhuru Kenyatta's decision to withdraw state agencies, including medical inspectors, from Mombasa Port could put the health of Kenyans and citizens of landlocked neighboring countries at risk.
On June 1, 2019, President Kenyatta ordered the Kenya Ports Authority (KPA) to stop inspecting cargo at the port, citing the need to accelerate cargo clearance.
However, this decision may compromise the vigilance of the Kenya Pharmacy and Poisons Board (PPB), Uganda's National Drug Authority (NDA), and the Rwanda Food and Drugs Authority, which previously worked together to inspect imported medicine at Mombasa Port.
The World Health Organization (WHO) issued an alert on fake Augmentin found in Kenya and Uganda in 2019, its second warning about the discovery of the falsified antibiotic in Africa.
Industry stakeholders believe that the withdrawal of state agencies from the port may lead to rising cases of fake medicine entering the country, as unlicensed importers may take advantage of the PPB's absence at the port.
However, the PPB claims that 99% of the medicine in the country is currently of good quality, and that there is no counterfeit medicine in Kenya.
But Dr. Anastasia Nyalita, chairperson of the Kenya Association of Pharmaceutical Industries, disagrees, stating that only established brands are reported in case of any problem, while those related to counterfeits sold to unlicensed pharmacies go unreported.
According to the NDA, 10% of the drug regimens in Uganda have substandard or counterfeit copies, which enter the country through porous borders, across Lake Victoria.
A silent majority believes that counterfeit medicine is a growing problem in the region, due to the presence of 'unregulated' or 'briefcase' importers who mainly use consolidated cargo.
Stakeholders question the capacity of the three state agencies mandated to carry out future inspections, including the Kenya Ports Authority (KPA), the Kenya Revenue Authority (KRA), and the Kenya Bureau of Standards (KEBS).
Dr. Nyalita explained that KEBS lacks capacity to carry out inspection analysis for pharmaceutical products and to ensure compliance by companies, which raises the cost of legitimately imported medicines and shortens the shelf life of products that reach the local market.
The latest Auditor-General report indicates that the Kenya Medical Supplies Agency had supplied expired drugs worth some US$1.50 million to the country's regional government hospitals by the end of 2018.
The WHO requires governments to establish strong national medicines regulatory authorities with a clear mission, a solid legal, technical, and financial foundation, and the capacity to exert effective market control and proper monitoring and evaluation.
