PPB flags falsified eye drug circulating in Kenya, one person arrested
PPB warns of fake Lucentis eye injection in Kenyan market.
The Pharmacy and Poisons Board has uncovered fake batches of an eye medication called Lucentis (Ranibizumab) circulating in the Kenyan market, raising serious health and safety concerns for patients.
It is a drug that is administered by injection into the eye to treat retinal diseases that can cause loss of sight.
During surveillance, the PPB found Lucentis (Ranibizumab) labeled as approximately 0.3 milligrams with batch numbers 18862110 and 18802112.
The rogue people selling this drug also fabricated the name of the manufacturer as Genentech.
When PPB officials compared the suspected falsified product with the genuine product supplied by Novartis Overseas Investment AG, they found alarming discrepancies.
First, the product is labelled Lucentis, while the brand registered in Kenya by the Pharmacy and Poisons Board is called Patizra.
The dosing amount was also wrong. While the one found circulating in Kenya had 0.3 mg as the dosage, the registered product is labelled 10 mg/mL.
PPB said in a statement that the product is also packed in a dark amber vial, while the genuine product is packed in a clear glass vial.
The batch number, manufacturing date and expiry date also do not match the genuine product's details
“This batch of falsified Lucentis (Ranibizumab) 0.3mg injection may contain incorrect amounts of the active ingredient, no active ingredient at all, harmful contaminants, or undeclared substances, and therefore may not provide the intended therapeutic effect,” warned the PPB.
The PPB now advises healthcare professionals to remain vigilant, verify the authenticity of stocks before dispensing and to quarantine any suspected falsified products
They also warn procurement agencies, hospitals, distributors, all healthcare professionals, and members of the public to be alert and report immediately any encounter with the falsified Lucentis (Ranibizumab) 0.3mg injection batch numbers 18862110 and 18802112.
Moving forward, they ask anyone within the supply chain to procure Health Products and Technologies exclusively from Board licensed manufacturers, importers, distributors, and retailers, and maintain appropriate records.
“Procuring from unlicensed sources endangers patients and constitutes a violation of the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya,” says the PPB.
So far, PPB, in collaboration with the relevant Government investigative and enforcement agencies, has made significant progress in investigations of the rogue individuals, including the arrest of one person found in possession of the falsified product.
“Further investigations are ongoing to establish the source of the product, the point of entry into the country, and the extent of distribution within the supply chain. The Board will continue to take firm regulatory and legal action against all persons found to be involved in the manufacture, importation, distribution or supply of falsified health products and technologies,” they said in a statement.
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