The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to healthcare providers and the general public regarding specific malaria and HIV diagnostic kits, citing concerns about their quality that were raised by the World Health Organisation (WHO).
In an announcement made on Tuesday, NAFDAC stated that a Notice of Concern (NOC) was released by the WHO Prequalification service (WHO-PQT) after discovering "serious violations" during an audit of Meril Diagnostics Private Limited's manufacturing facility in India.
The agency's audit results indicated that the manufacturer was not adhering to WHO's operational requirements and the necessary quality standards.
Although NAFDAC had previously given approval for the affected products, it underscored that the "safety and quality are not assured" in light of the findings from WHO.
WHO prequalification represents a globally accepted quality assurance mechanism that evaluates medicines, vaccines, and diagnostic devices to ensure they adhere to international safety, quality, and performance standards. Countries, including Nigeria, often rely on WHO recommendations for procurement and regulatory decisions related to vital public health products.
NAFDAC identified four medical devices affected by the WHO notice: Meriscreen Malaria Pf/Pv Ag (registration number A3-101135), Meriscreen HIV 1-2 WB (registration number A3-101136), Meriscreen Malaria PF/PAN AG (registration number A3-101137), and MERISCREEN Malaria Pf HRP-II Ag (registration number A3-101118). These kits are produced by Meril Diagnostics Private Limited and marketed in Nigeria by KVATH International Limited, the Marketing Authorisation Holder (MAH).
Despite being registered, NAFDAC confirmed that the suspected products have not been imported into Nigeria. The MAH has indicated that the kits have not reached Nigerian shores due to the company's current non-operational status stemming from changes in external policies.
The agency warned that if any of these products are found within Nigeria, they will be classified as counterfeit, falsified, and illegally imported. NAFDAC has instructed all zonal directors and state coordinators to heighten surveillance and remove these products from circulation.
NAFDAC reiterated its commitment to safeguarding public health and will continue monitoring activities to ensure that the quality, safety, and efficacy of medicines and medical devices available in Nigeria are maintained.
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