Kenya is facing a growing health crisis due to the proliferation of substandard and counterfeit medicines, despite having a well-established pharmaceutical industry and clear regulatory guidelines.
Substandard medicines are those that are officially registered but fail to meet required quality standards. Counterfeit drugs, on the other hand, are intentionally mislabelled to conceal their true identity or origin.
A recent study by Bahir Dar University in Ethiopia has revealed that Kenya currently leads in the circulation of counterfeit and unregistered antibiotics and antimalarials, with the prevalence rate standing at seventeen percent. The high demand for these medications—driven by widespread infectious diseases such as malaria and pneumonia—has made the country a hotspot for pharmaceutical fraud.
“Kenya recorded the highest share of counterfeit and unregistered antibiotics and antimalarials at seventeen percent, followed by Malawi at 10.7 percent,” the researchers noted. Amoxicillin emerged as the most commonly counterfeited antibiotic, with other drugs like ciprofloxacin and co-trimoxazole also flagged.
The report further detailed that of 54 amoxicillin and amoxicillin/clavulanic acid samples analyzed through HPLC-UV testing, nearly thirty-eight percent failed to meet the required standards. Additionally, seventeen percent of 60 other samples—including ibuprofen, cetirizine, prednisolone, and zinc—were found to be substandard or adulterated.
Antibiotics are vital for treating bacterial infections like tuberculosis, pneumonia, and urinary tract infections. They are also crucial during surgeries and for protecting patients with weakened immune systems. Antimalarials, meanwhile, are essential for preventing and treating malaria—a disease still prevalent in Kenya—and are sometimes used in managing autoimmune conditions.
The World Health Organization (WHO) has raised the alarm, warning that counterfeiters are exploiting the persistent demand for essential medicines by pushing fake versions into the market, endangering millions of lives.
“The spread of counterfeit drugs in Kenya is alarming and poses a serious health threat,” said WHO, which estimates that one in every ten medicines in low- and middle-income countries is either fake or substandard. Such drugs can cause treatment failure, promote antibiotic resistance, and reduce public trust in healthcare systems.
Locally, a 2018 assessment by the National Quality Control Laboratories and the Pharmacy and Poisons Board (PPB) showed that twelve percent of drugs in the Kenyan market were counterfeit or fraudulent. Industry groups estimate the figure could be as high as thirty percent, representing a black-market trade worth approximately Sh15 billion.
The rise of counterfeit drugs has been attributed to multiple factors including weak regulatory enforcement, high profit margins in the illicit trade, lack of monitoring in free trade zones, inflated drug prices, and inadequate coordination among stakeholders at national and regional levels. In some cases, poor awareness among health workers and the public has also fueled the problem.
In an effort to counter this threat, the PPB has ramped up its regulatory efforts and partnered with the Anti-Counterfeit Authority (ACA). In 2024, the two agencies signed a Memorandum of Understanding aimed at enhancing the fight against fake pharmaceuticals.
“This partnership is a crucial step in addressing the challenges posed by porous borders, evolving technology, and limited resources,” said PPB CEO Fred Siyoi. “It reflects a proactive approach to safeguarding the integrity of health products and technologies in Kenya.”
As part of its crackdown, the PPB recently conducted a major enforcement operation in Nairobi, leading to numerous arrests and the shutdown of illegal and unlicensed pharmacies. These efforts are part of a broader campaign to cleanse the pharmaceutical industry and protect public health.