NAFDAC issues alert on WHO notice against Indian device manufacturer

NAFDAC issues alert on WHO notice against Indian device manufacturer

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 010/2026, notifying healthcare providers, patients and the general public of a Notice of Concern (NOC) issued by the World Health Organization (WHO) against Meril Diagnostics Pvt. Ltd, India.

According to NAFDAC, the NOC was issued by the WHO Prequalification Service following significant violations observed during a WHO Prequalification (WHO-PQT) audit of the manufacturing facility of Meril Diagnostics Pvt. Ltd. The audit findings indicated that the company was not operating in compliance with WHO requirements and applicable quality standards, raising concerns over the quality and safety of some of its medical devices registered in Nigeria.

Although the affected products were previously registered by NAFDAC, the Marketing Authorisation Holder (MAH), KVATH Int’l Ltd, has confirmed that the devices have not been imported into Nigeria. The company attributed this to its current non-operational status following external policy changes.

NAFDAC stressed that any of the listed products found within the country would be regarded as falsified, counterfeit and fraudulently imported.

The agency reaffirmed its commitment to protecting public health and said it would intensify post-market surveillance to ensure the quality, safety and efficacy of medicines, medical devices and other regulated products in circulation across Nigeria.

Healthcare professionals have been advised to review stocks in hospitals, clinics and pharmacies, and to report any suspected falsified or compromised medicines or medical devices to the nearest NAFDAC office. Reports can also be made via the agency’s toll-free line, 0800-162-3322, or by email at sf.alert@nafdac.gov.ng.

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