Dark tale of local pharmaceutical firm, Universal Corporation Limited after Rwanda ban drug over safety concerns
Suspected dark operations at the controversial pharmaceutical firm operating on over 22 countries and with a Kenyan subsidiary located in Kikuyu, Kiambu county, Universal Corporation Limited has once again come to the fore raising concerns about the Rwanda Food and Drug Authority (RFDA) recalled and banned a specific batch of Fluconazole 200mg tablets imported from Kenya over quality and safety concerns.
This comes slightly a year after the firm was cited for exposing lives of HIV patients to danger over recalled ARV drugs believed to have compromised safety standards by the Pharmacy and Poisons Board (PPB).
And in the latest case flagged by the neighbouring Rwanda, RFDA, the regulatory body urged all stakeholders in the pharmaceutical supply chain, including importers, central medical stores, wholesalers, RMS branches, retailers, and public and private health facilities, to immediately halt the distribution of the affected Fluconazole tablets. The statement emphasized the importance of returning the identified batches to their respective suppliers for proper management.
“Rwanda FDA instructs all importers, central medical stores, wholesalers, RMS branches, retailers, public and private health facilities to stop the distribution of the above-mentioned batches of fluconazole 200mg tablets and return them to their suppliers for proper management.” The statement by RFDA read in part.
Curiously, despite the recall of the drug by the Rwandan government, the Kenyan government through the Ministry of Health headed by Cabinet Secretary Susan Nakhumicha is yet to issue any public notice regarding the same batch of Fluconazole tablets despite it being available in the shelves.
According to RFDA, four bulk batches of pink Fluconazole 200mg tablets imported into the country had a white discolouration.
RFDA directed importers and suppliers are supposed to report to RFDA within 10 days from today and as well issue the Health Ministry with quantities returned and final stocks on hand.
In November 2022, the Pharmacy and Poisons Board (PBP) recalled all Tenofovir/Lamivudine/Dolutegravir 300/300/500 mg (TLD) tablets, ARV drugs manufactured by Universal Corporation Limited believed to have compromised safety standards.
The said ARV drugs were packed in a white bottle stamped with the writings on the side.
“The drugs are in a white bottle with black writings on the side and the wordings ‘Universal Corporation Ltd’ (in blue). The recipients are being requested to return the drugs to the facilities.” PBP boss Dr. Fred Siyoi said.
The quality of the ARV drugs was questioned due to discoloration of the induction seal and the tablets changing colour as well as the bottle covers.
The ARV drugs were ordered by the Kenya Medical Supplies Authority (KEMSA) through the Universal Corporation Limited that is prequalified by the World Health Organisation (WHO) and paid by the global fund.
In this latest case, the swift and transparent response by RFDA underscores its commitment to ensuring the safety and efficacy of pharmaceutical products circulating in the country.
It said the decision to recall the Fluconazole tablets is in line with international best practices and serves as a precautionary measure to protect the health and well-being of the Rwandan population.
Fluconazole is commonly used to treat fungal infections and is an essential medication in healthcare settings.
Any compromise in its quality, as indicated by discolouration, raises serious concerns about the potential impact on patient health. The recall not only addresses the immediate issue of the affected batches but also demonstrates the RFDA’s dedication to maintaining high standards in the pharmaceutical sector.
Stakeholders in both Rwanda will be closely monitor the response from Kenya and the pharmaceutical company involved.
The incident highlights the interconnectedness of pharmaceutical markets in the region and the importance of rigorous quality control measures to safeguard public health.
The RFDA’s proactive approach serves as a model for effective regulatory oversight in the face of potential health risks, reinforcing the importance of collaboration between regulatory authorities, pharmaceutical companies, and healthcare providers to uphold the highest standards in drug safety and efficacy.
In 2020, Rwanda also recalled a Kenyan-made anti-fungal cream following complaints of poor packaging that damages its quality standard.
The regulator had said that Ketoconazole (Kenazole) Cream USP 2%w/w—used for the treatment of fungal and yeast infections—had been packaged poorly.
“Referring to the spontaneous reports from the clients, retail pharmacies and further investigation conducted by the Rwanda FDA, where Ketoconazole Cream 2% was found poorly packaged where it gets out of its package while in storage.” RFDA said.
Perviz Palu Dhanani is the Founder and Managing Director of Universal Corporation Limited.
