Kenya faces a growing challenge of substandard and counterfeit medicines despite having a robust pharmaceutical industry, including guidelines for regulation sector players.
Substandard medicines are those that are licensed but do not meet quality specifications. In contrast, counterfeits are deliberately and fraudulently mislabelled as to their identity and/or source.
A study conducted by researchers at Bahir Dar University in Ethiopia shows continued demand for antibiotics and antimalarials in Kenya, driven by a high burden of infectious diseases, has created a lucrative market for counterfeiters.
According to the study, Kenya has the highest percentage of counterfeit and unregistered antibiotics and antimalarials at 17 percent, underscoring a significant risk to public health.
"Kenya had the highest percentage of counterfeit and substandard unregistered antibiotics and antimalarials at 17 percent, followed by Malawi at 10.7 percent. Amoxicillin is the most commonly reported substandard or counterfeit antibiotic. Other antibiotics such as ciprofloxacin and co-trimoxazole were also found to be substandard or counterfeit in Kenya,” the report states.
Of the 54 samples of amoxicillin and amoxicillin/clavulanic acid tested using Purposeful HPLC-UV, 37.7 percent were found to be substandard or counterfeit.
Of 60 samples of ibuprofen, amoxicillin/clavulanic acid, cetirizine, prednisolone, salbutamol, and zinc tested by convenience HPLC, 17 percent were identified as substandard or adulterated," it adds.
Antibiotics are drugs that treat infections by killing bacteria or inhibiting their growth. They are ineffective against viral infections such as the flu or common cold.
Antibiotics are used for conditions such as pneumonia, tuberculosis, urinary tract infections, and sepsis, and they help prevent infections during surgery and in patients with weakened immune systems.
Common types include penicillins, cephalosporins, macrolides, tetracyclines, and fluoroquinolones, which target various bacterial infections.
Antimalarials treat and prevent malaria, which is caused by Plasmodium parasites transmitted by mosquito bites. They are also used to cure certain autoimmune diseases.
Common antimalarial drugs include artemisinin-based combination therapies, chloroquine, quinine, mefloquine, and doxycycline, which are essential for malaria control.
Malaria, bacterial infections, and pneumonia remain major public health concerns, contributing to the widespread use of these medicines.
According to the World Health Organization (WHO), counterfeiters are taking advantage of the high demand for medicines by flooding the market with cheaper, fake alternatives, putting millions of lives at risk.
"The problem of counterfeit medicines in Kenya is growing and poses a serious threat to public health and well-being," said the WHO.
The WHO reports that, on average, one in 10 medicines in circulation in low- and middle-income countries (LMICs) is either substandard or counterfeit.
These medicines can lead to adverse health outcomes, treatment failure, development of resistance, and loss of confidence in the health system.
A 2018 survey by the National Quality Control Laboratories and the Pharmacy and Poisons Board (PPB) found that 12 percent of medicines marketed in Kenya were fraudulent or counterfeit.
Industry associations estimate that up to 30 percent of medicines in Kenya may be counterfeit, with a black market value of Sh15 billion.
The high prevalence of counterfeit medicines is also attributed to several factors, including weak or non-existent drug regulatory authorities, lack of regulation of exporters in free trade zones, and high profits associated with the trade.
Other contributing factors include small pharmaceutical industries, high demand for curative and preventive medicines, inflated prices, inefficient or weak cooperation among stakeholders at national, regional, and global levels, and the knowledge, attitudes, and practices of health professionals and community members towards substandard, falsified, unlicensed and unregistered medicines.
To address the counterfeit medicines crisis, the Pharmacy and Poisons Board (PPB) has strengthened its regulation of the pharmaceutical industry with a focus on preventing the circulation of counterfeit health products across the country.
The PPB and the Anti-Counterfeit Authority (ACA Kenya) signed a Memorandum of Understanding in 2024 to combat counterfeit medicines.
"This initiative is critical in addressing the challenges posed by technological advancements, porous borders, and limited resources within the authorities and represents a proactive approach to ensuring the integrity of healthcare products and technologies in Kenya," said Fred Siyoi, CEO of the PPB.
In addition, the regulatory body launched a crackdown in Nairobi County, resulting in the arrest of hundreds of people and the closure of unlicensed pharmacies and illegal pharmacies, actions aimed at sanitising the pharmaceutical sector by targeting fake pharmacists and illegal pharmaceutical outlets across the country.
"We are committed to ensuring that all medicines distributed in Kenya meet the required safety standards. These closures are necessary steps to remove dangerous counterfeit medicines from circulation and protect Kenyan consumers," the PPB said.
The PPB also introduced Pillscan, a near-infrared (NIR) technology tool designed to detect substandard and counterfeit medicines.
Joseph Okidi, a pharmacist in Nairobi, said there were several indicators to distinguish genuine medicines from counterfeits.
"Genuine medicines usually have clear, professional packaging with legible labels containing essential information such as the drug name, dosage, manufacturer details, and a serial number or QR code for verification.
Counterfeit medicines often come in poorly printed or inconsistent packaging with missing or incorrect labelling. Consumers should also inspect the medicine itself; genuine products tend to have a consistent shape, colour, and size, whereas counterfeits may have noticeable differences," said Dr Okidi.
He added that price is another telltale sign - fake drugs are often sold at significantly lower prices than their genuine counterparts.
"The problem of counterfeit medicines in Kenya is growing and poses a serious threat to public health. Consumers must remain vigilant when buying medicines," he stressed.
A common misconception is the difference between generic and counterfeit medicines. Dr Okidi clarified that generic medicines are legal, safe, and approved alternatives to branded medicines.
They contain the same active ingredients, strength, and dosage and go through the same regulatory processes as branded medicines.
Generics are often more affordable because they do not incur the same research and development costs as their branded counterparts.
"Generics are safe alternatives to branded medicines and are regulated by the authorities. Counterfeit medicines, on the other hand, are illegal, unsafe, and often put consumers at risk," he said.
