NAFDAC warns Nigerians against substandard Indian diagnostic kits

NIGERIA—Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has issued an urgent warning to healthcare providers and the general public, advising them to avoid using specific malaria and HIV diagnostic kits.

The alert follows the World Health Organisation (WHO) raising serious concerns about the quality and reliability of these medical devices.

NAFDAC released the public alert following a Notice of Concern from the WHO Prequalification service.

The notice followed WHO auditors’ discovery of significant violations at Meril Diagnostics Private Limited’s manufacturing facility in India.

The audit revealed that the company was not following WHO requirements or meeting the applicable quality standards expected for such critical medical products.

The WHO prequalification process serves as a globally recognized quality assurance mechanism.

This system evaluates medicines, vaccines, and diagnostic devices to confirm they meet international standards for safety, quality, and performance.

Nigeria, along with many other countries, depends heavily on WHO guidance when making procurement and regulatory decisions, particularly for essential public health tools used in disease diagnosis and treatment.

The agency emphasized that although it had previously registered the affected products for use in Nigeria, the WHO audit findings now mean their quality and safety cannot be guaranteed.

This uncertainty poses potential risks to patients who might use these diagnostic kits for detecting life-threatening conditions like malaria and HIV.

NAFDAC identified four specific medical devices subject to the WHO notice.

These include the 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).

Meril Diagnostics Private Limited manufactured all these products, while KVATH International Limited held the Marketing Authorisation for their distribution in Nigeria.

Despite their registered status, NAFDAC confirmed that none of these products have actually entered the Nigerian market.

The Marketing Authorisation Holder reported that the kits have not been imported into the country because the company is currently not operational due to external policy changes affecting its business operations.

However, NAFDAC issued a stern warning that if anyone discovers these products within Nigeria’s borders, authorities will classify them as falsified, counterfeit, and fraudulently imported.

The agency has instructed all its zonal directors and state coordinators to increase surveillance efforts and immediately remove any of these listed products from circulation if found.

NAFDAC reaffirmed its dedication to protecting public health and pledged to continue its surveillance activities.

The agency aims to ensure that all medicines, medical devices, and other regulated products circulating in Nigeria meet required standards for quality, safety, and effectiveness.

The agency called on distributors, retailers, healthcare professionals, and caregivers to exercise extreme caution.

NAFDAC specifically advised these groups to stop distributing, selling, or using the listed products immediately and to ensure they source all medical products only from authorized or licensed suppliers who comply with regulatory standards.