NAIROBI, Kenya, Jan 1 — The Pharmacy and Poisons Board (PPB) has issued a public alert warning of falsified SIMULECT (basiliximab), a medication primarily used to prevent organ rejection following kidney transplants, after receiving an alert from the World Health Organization (WHO).
In a statement on Wednesday, the Board said the falsified product has been reported in Rwanda, Bulgaria and Türkiye, bearing a batch number SFYD2, which PPB clarified is not a valid batch number for genuine SIMULECT.
SIMULECT (basiliximab) is an immunosuppressive medicine administered by injection and is critical in reducing the risk of acute rejection in kidney transplant patients.
According to the regulator, the falsified product displays several discrepancies when compared to authentic SIMULECT packaging.
These include the use of the National Drug Code (NDC) 0078-0331-84, a code associated with medicines marketed in the United States, but which appears alongside other inconsistencies.
Among the identified irregularities, PPB said the falsified label lists the dosage unit in capital letters as “MG” instead of the standard “mg” used on the genuine product.
Additionally, while authentic SIMULECT packaging indicates the country of manufacture as “Product of France,” the falsified version lists it as “Product of Switzerland or France.”
“The falsified batch may contain incorrect, insufficient or harmful ingredients, and its quality, safety and efficacy cannot be guaranteed,” the Board warned, adding that use of the product poses a serious risk to patient safety and public health.
No confirmation on Kenya market
PPB noted that, to date, it has not detected or confirmed the presence of the falsified SIMULECT batch SFYD2 in the Kenyan market.
The alert has therefore been issued as a precautionary measure to heighten vigilance and prevent the potential entry of the product into the country’s pharmaceutical supply chain.
The Board urged procurement agencies, hospitals, distributors, pharmacists, pharmaceutical technologists and members of the public to remain alert and to report immediately any suspected encounter with the falsified medicine.
“All stakeholders are advised to procure health products and technologies exclusively from licensed manufacturers, importers, distributors and retailers,” PPB said, warning that sourcing medicines from unlicensed outlets endangers patients and violates the Pharmacy and Poisons Act.
PPB said it will work with relevant government investigative agencies to take firm regulatory and legal action against any individual or entity found to be involved in the distribution of falsified medicines.
Suspected falsified or substandard medicines can be reported through the PPB online reporting portal, USSD code *271#, the mPVERS mobile application, or via the official email and telephone contacts provided by the Board.
