Authority clarifies over fluconazole tables

DAR ES SALAAM: TANZANIA Medicines and Medical Devices Authority (TMDA) has clarified over the antifungal tablets- Fluconazole 200mg manufactured by the Kenyan company (Universal Corporation) following health concerns raised in Rwanda.

According to TMDA, on December 29 last year, it received a report from the Rwanda Food and Drug Authority (RFDA) on the presence of substandard Fluconazole 200mg tablets in its market manufactured by the Kenyan company.

The substandard medicine found with the following serial numbers: 5810315, 5810316, 5811390, and 5810022, and their expiry date is August 2025.

“TMDA would like to inform the public that it has not registered such tablets instead it has registered Fluconazole 150mg and 200mg capsule from the company” reads part of its statement.

It also said that it has not issued a permit for importing such medicine in the country, acknowledging the possibilities of illegal means for smuggling such medicines from unofficial boarders.

In addition, TMD noted that, the action taken by the RFDA was to comply with the World Health Organization’s (WHO) requirements to report the presence of substandard and counterfeit drugs, allowing other Drug Regulatory Authorities worldwide to take appropriate action if these versions are distributed in their countries.

The Tanzania Medicines and Medical Devices Authority (TMDA) is a government institution under the Ministry of Health established under Section 4(1) of the Medicines and Medical Devices Act, Chapter 219. The Authority is responsible for safeguarding public health by regulating the quality, safety, and efficacy of medicines, medical devices, and diagnostics.