The Pharmacy and Poisons Board (PPB) has warned that falsified Lucentis (Ranibizumab) 0.3mg injections bearing batch numbers 18862110 and 18802112 have been detected in the Kenyan market.
Lucentis (Ranibizumab) 0.3mg is administered by injection into the eye to treat diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema, conditions that can affect vision.
The medicine is also used for other retinal conditions at different doses.
The PPB’s alert was issued by Chief Executive Officer Dr Ahmed I. Mohamed on September 24.
Details of the falsified product
The regulator said the products falsely claim to have been manufactured by Genentech and were identified through its post-marketing surveillance activities.
A comparison with genuine Lucentis supplied by Novartis Overseas Investment AG revealed several differences that the Board said indicate the affected products are falsified.
The suspected products are labelled Lucentis, while the registered brand in Kenya is Patizra.
The label also indicates a strength of 0.3mg, compared with the registered product, which is labelled 10mg/mL.
The packaging also differs. The suspected falsified product is contained in a dark amber vial, while the genuine product is packaged in a clear glass vial.
The batch number, manufacturing date and expiry date also do not correspond with the genuine product’s details.
The Board warned that the falsified injections may contain incorrect amounts of the active ingredient, no active ingredient, harmful contaminants or undeclared substances.
It said the products may therefore fail to provide the intended therapeutic effect, raising concerns for patients who may receive them as part of treatment.
Advice for healthcare professionals
The PPB has advised healthcare professionals to verify the authenticity of their medicine stocks before dispensing them and to quarantine any products suspected to be falsified.
Hospitals, procurement agencies, distributors, healthcare professionals and members of the public have also been urged to report any encounter with Lucentis (Ranibizumab) 0.3mg injections bearing the two affected batch numbers.
The regulator has directed stakeholders in the pharmaceutical supply chain to procure health products and technologies only from Board-licensed manufacturers, importers, distributors and retailers, and to maintain proper procurement records.
The Board said sourcing medicines from unlicensed suppliers puts patients at risk and violates the Pharmacy and Poisons Act, Cap 244.
Investigations into the circulation of the falsified injections have already led to the arrest of one person who was found in possession of the product.
The PPB said it is working with government investigative and enforcement agencies to establish where the falsified medicine originated, how it entered Kenya and the extent to which it has been distributed within the supply chain.
Ongoing investigations and actions
The regulator said it would take regulatory and legal action against anyone found to have been involved in the manufacture, importation, distribution or supply of falsified health products.
Members of the public and healthcare professionals who encounter the affected products can report them through the PPB’s pharmacovigilance reporting channels, including its online portal, the mPvERS mobile application, pv@ppb.go.ke, pms@ppb.go.ke or telephone number 0795743049.
