NAFDAC warns against malaria, HIV diagnostic kits over quality concerns

The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned healthcare providers and the public against the use of certain malaria and HIV diagnostic kits following quality concerns raised by the World Health Organisation (WHO).

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In a public alert issued on Tuesday, NAFDAC said the WHO Prequalification service (WHO-PQT) released a Notice of Concern (NOC) after identifying “significant violations” during an audit of the manufacturing facility of Meril Diagnostics Private Limited in India.

According to the agency, the audit findings showed that the manufacturer was not “operating in line with WHO requirements and applicable quality standards.”

Although NAFDAC previously registered the affected products, the agency stressed that their “quality and safety are not guaranteed” due to the WHO findings.

WHO prequalification is a globally recognised quality assurance mechanism that assesses medicines, vaccines and diagnostic devices to ensure they meet international standards of safety, quality and performance. Many countries, including Nigeria, rely on WHO guidance in procurement and regulatory decisions, particularly for critical public health tools.

Products affected

NAFDAC listed four medical devices affected by the WHO notice.

They are Meriscreen Malaria Pf/Pv Ag with registration number A3-101135; Meriscreen HIV 1-2 WB with registration number A3-101136; Meriscreen Malaria PF/PAN AG with registration number A3-101137; and MERISCREEN Malaria Pf HRP-II Ag with registration number A3-101118.

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The products were manufactured by Meril Diagnostics Private Limited and marketed in Nigeria by KVATH International Limited, the Marketing Authorisation Holder (MAH).

Despite their registration status, NAFDAC disclosed that the affected products have not been imported into Nigeria.

It added that the MAH confirmed that the kits “have not yet been imported into Nigeria due to the company’s current non-operational status following external policy changes.”

However, the agency warned that if any of the listed products are found within the country, they would be considered falsified, counterfeit, and fraudulently imported.

It added that it has directed all its zonal directors and state coordinators to intensify surveillance and remove any of the listed products from circulation.

“NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria,” the agency said.

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Advice to health workers, distributors

The agency urged distributors, retailers, healthcare professionals and caregivers to exercise caution.

They are advised “to refrain from distributing, selling, or using the listed products and to ensure that all medical products are sourced from authorised or licensed suppliers.”

It also asked health professionals to review stock levels in hospitals, clinics, and pharmacies and to report any suspected falsified or compromised products through its hotline at 0800-162-3322 or via email at [email protected].

The agency further encouraged healthcare professionals and patients to report adverse events or side effects linked to medical products or devices through the e-reporting platforms on the agency’s website, via the Med-safety application available on Android and iOS stores, or by email to [email protected].