Kenya Regulator Issues Alert Over Falsified Lucentis Eye Drug Found in Market

Kenya’s medicines regulator has issued an alert over a falsified eye medicine detected in circulation, warning that patients could face serious risks because the contents of the product cannot be guaranteed.

The Pharmacy and Poisons Board (PPB) said on Monday, September 28, that the affected medicine is labelled as Lucentis (Ranibizumab) 0.3mg injection and bears batch numbers 18862110 and 18802112.

According to the regulator, the product falsely claims 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,” the Board said.

The PPB said the suspected falsified medicine was found in circulation in the Kenyan market and warned members of the public and those working within the pharmaceutical supply chain to exercise caution.

Differences found in suspected fake medicine

The regulator said a comparison between the suspected falsified product and a genuine product supplied by Novartis Overseas Investment AG revealed a number of differences.

Among the discrepancies identified was the product name and strength displayed on the packaging.

While the suspected product is labelled Lucentis, the PPB said the brand registered in Kenya is Patizra.

The suspected medicine also carries a 0.3mg designation, whereas the registered product is labelled 10mg/mL, according to the regulator.

There were also differences in the physical packaging.

The PPB said the suspected falsified product was contained in a dark amber vial, unlike the genuine product, which is supplied in a clear glass vial.

The regulator further said the batch number, manufacturing date and expiry date appearing on the suspected product did not correspond with the details of the genuine medicine.

Warning over possible patient risks

The PPB said the authenticity and composition of the suspected medicine could not be established, raising concerns over its potential effect on patients.

“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 regulator warned.

The Board urged healthcare professionals to remain vigilant and verify the authenticity of medicines before dispensing pharmaceutical products.

It also directed professionals who encounter suspected falsified products to quarantine them and report them to the relevant authorities.

Procurement agencies, hospitals, distributors and other healthcare professionals, as well as members of the public, were specifically urged to report any encounter with the affected Lucentis product carrying batch numbers 18862110 or 18802112.

PPB calls for tighter checks across supply chain

The regulator directed stakeholders across the pharmaceutical supply chain to obtain health products and technologies only from manufacturers, importers, distributors and retailers licensed by the Board.

It also called for appropriate records to be maintained throughout the supply chain.

The PPB warned that obtaining medicines from unlicensed sources could put patients at risk and constitutes a violation of the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya.

The alert comes as authorities investigate how the suspected falsified medicine entered the Kenyan market and how widely it may have circulated.

One person arrested as investigation continues

The PPB said its investigation, conducted alongside government investigative and enforcement agencies, had already resulted in the arrest of one person allegedly found in possession of the falsified product.

“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 regulator said.

Investigators are now seeking to establish the source of the medicine, determine how it entered Kenya and establish the extent of its distribution within the supply chain.

The PPB said it would continue pursuing regulatory and legal action against individuals found to have been involved in the manufacture, importation, distribution or supply of falsified health products and technologies.

Alert follows earlier row over medicines in Nairobi pharmacies

The latest warning comes months after the PPB responded to claims concerning medicines examined in pharmacies in Nairobi.

In July, PPB chief executive Ahmed Mohamed rejected what he described as a misleading impression created by a report claiming that 90 per cent of Nairobi pharmacies were selling illegal drugs.

Mohamed said the medicines assessed in the study had been legally imported under Kenya’s parallel-importation framework and were not found to be substandard or unsafe for public use.

“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,” Mohamed said.

He also pointed out that the research covered a period between September 2023 and October 2024, meaning its findings reflected the regulatory environment during that period rather than necessarily describing the situation at the time of his July statement.

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

What is parallel importation?

Mohamed defended Kenya’s parallel-importation framework, describing it as a lawful mechanism intended to improve the availability and affordability of 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,” he said.

According to Mohamed, the medicines examined in the earlier study had been approved within the applicable regulatory framework and were manufactured by their original manufacturers in accordance with internationally recognised Good Manufacturing Practice standards.

He said the products assessed in that study were not found to be substandard, falsified or unsafe for patient use.

The two developments underline the distinction between medicines legally supplied through Kenya’s regulatory framework and products that the regulator identifies as falsified.

The PPB’s latest alert specifically concerns the Lucentis-labelled product bearing batch numbers 18862110 and 18802112, which the regulator says is falsified and is being investigated.

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