Gov't Flags Falsified Eye Drug in Kenyan Market

The Pharmacy and Poisons Board (PPB) has raised an alert over a falsified eye drug that has been detected in circulation in the Kenyan market.

In a statement on Monday, September 28, the regulator said the affected product is Lucentis (Ranibizumab) 0.3mg injection, bearing batch numbers 18862110 and 18802112 and falsely claiming to have been manufactured by Genentech.

"The Pharmacy and Poisons Board has detected a falsified Lucentis (Ranibizumab) 0.3mg injection batch numbers 18862110 and 18802112, misleadingly claiming to be manufactured by Genentech. This falsified product was found in circulation in the Kenyan market," the statement read.

PPB said a comparison between the suspected falsified product and the genuine product supplied by Novartis Overseas Investment AG revealed several differences.

The regulator noted that the product is labelled Lucentis, while the brand registered in Kenya is Patizra.

It also states 0.3mg on the label, whereas the registered product is labelled 10mg/mL.

Another difference identified was the packaging, with the suspected falsified product packed in a dark amber vial instead of the clear glass vial used for the genuine product.

The batch number, manufacturing date and expiry date on the suspected falsified product also did not match the details of the genuine product.

PPB warned that the falsified medicine could pose risks to patients because its contents and composition cannot be guaranteed.

"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," the statement added.

PPB urged healthcare professionals to remain vigilant and verify the authenticity of pharmaceutical stocks before dispensing them.

It further advised healthcare professionals to quarantine any products suspected to be falsified and report them to the relevant authorities.

Procurement agencies, hospitals, distributors, healthcare professionals and members of the public were also urged to immediately report any encounter with Lucentis (Ranibizumab) 0.3mg injection bearing batch numbers 18862110 and 18802112.

PPB directed all stakeholders within the supply chain to procure health products and technologies exclusively from Board-licensed manufacturers, importers, distributors and retailers, while maintaining appropriate records.

It warned that procuring medicines from unlicensed sources could endanger patients and amounts to a violation of the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya.

PPB said investigations into the falsified product had already led to an arrest as authorities sought to establish how the medicine entered and circulated in the country.

"The Board, in collaboration with the relevant Government investigative and enforcement agencies, has made significant progress in investigations, including the arrest of one (1) individual found in possession of the falsified product," the statement further read.

PPB said the investigation will now focus on tracing the source of the product, determining its point of entry into Kenya and establishing how widely it may have been distributed through the supply chain.

"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," the statement concluded.

This comes months after PPB responded to claims that 90 per cent of pharmacies in Nairobi were found selling illegal drugs.

In a statement on Saturday, July 4, the board's CEO, Ahmed Mohamed, clarified that the medicines examined in the study were legally imported under the parallel importation framework and were neither substandard nor unsafe for public use.

Addressing the report, Mohamed said the article's headline created a misleading impression about the status of the medicines that were assessed.

"The headline creates the impression that the medicinal products assessed were illegal, substandard, falsified or unsafe for patient use. This does not accurately reflect the findings of the study," the statement read.

Mohamed explained that the research was based on data collected between September 2023 and October 2024, meaning it did not reflect the current regulatory environment.

"The study was conducted between September 2023 and October 2024 and therefore reflects the regulatory environment that existed during that period," the statement added.

Mohamed also defended the parallel importation system, saying it is a legal mechanism established under the Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019 to improve access to medicines.

"Parallel importation is a lawful mechanism provided for under the Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019 to enhance the availability and affordability of medicines in Kenya," the statement noted.

Mohamed added that the medicines examined in the study had been approved under the existing legal framework and met internationally recognised manufacturing standards.

"The medicinal products assessed in the study were approved under this regulatory framework, manufactured by the original manufacturers in compliance with internationally recognised Good Manufacturing Practice standards, and were not found to be substandard, falsified or unsafe for patient use," the statement further read.