Uthman Ogunfolaji
The National Agency for Food and Drug Administration and Control has issued a nationwide alert warning healthcare providers and the public against the use of specific malaria and HIV diagnostic kits over serious quality concerns flagged by the World Health Organization.
In a public alert released on Tuesday, the agency said the WHO Prequalification Service (WHO-PQT) issued a Notice of Concern following the discovery of “significant violations” during an audit of the manufacturing facility of Meril Diagnostics Private Limited in India.
According to NAFDAC, findings from the audit showed that the manufacturer was not operating in line with WHO requirements and applicable quality standards, raising doubts about the safety, performance and reliability of the affected diagnostic devices.
Although the products were previously registered by NAFDAC, the agency stressed that their quality and safety could no longer be guaranteed in light of the WHO findings.
WHO prequalification is a globally recognised quality assurance mechanism used to assess medicines, vaccines and diagnostic devices to ensure they meet international benchmarks for safety, quality and performance.
Nigeria and several other countries rely heavily on the WHO’s guidance for procurement and regulatory decisions, particularly for critical public health commodities.
NAFDAC listed four diagnostic kits affected by the WHO notice. They include:
Meriscreen Malaria Pf/Pv Ag (Reg. No. A3-101135)
Meriscreen HIV 1-2 WB (Reg. No. A3-101136)
Meriscreen Malaria PF/PAN AG (Reg. No. A3-101137)
MERISCREEN Malaria Pf HRP-II Ag (Reg. No. A3-101118)
The products were manufactured by Meril Diagnostics Private Limited and marketed in Nigeria by KVATH International Limited, the Marketing Authorisation Holder.
Despite their registration status, NAFDAC disclosed that none of the affected kits had been imported into Nigeria.
The Marketing Authorisation Holder reportedly confirmed that the products have not entered the Nigerian market due to the company’s current non-operational status following external policy changes.
However, the agency warned that any of the listed products found within the country would be considered falsified, counterfeit and fraudulently imported.
NAFDAC said it has directed all zonal directors and state coordinators to heighten post-market surveillance and immediately remove any of the listed products from circulation if discovered.
The agency reiterated its commitment to safeguarding public health through continuous monitoring to ensure that only safe, effective and quality-assured medicines and medical devices remain in circulation.
NAFDAC urged distributors, retailers, healthcare professionals and caregivers to refrain from distributing, selling or using the listed products.
Healthcare providers were also advised to conduct immediate stock reviews in hospitals, clinics and pharmacies and report any suspected falsified or compromised products through the agency’s hotline (0800-162-3322) or via email at sf.alert@nafdac.gov.ng.
The agency further encouraged health professionals and patients to report any adverse events or side effects linked to medical products through its e-reporting platforms and the Med-Safety application available on Android and iOS devices.
The latest alert comes amid growing regulatory scrutiny of medical diagnostics in Nigeria’s health sector, as authorities seek to prevent substandard products from undermining efforts to combat malaria and HIV—two of the country’s leading public health challenges.
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