NAFDAC Raises Alarm Over WHO Notice on Meril Diagnostics Devices

The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers, patients, and the general public to a Notice of Concern (NOC) issued by the World Health Organisation (WHO) Prequalification Service regarding certain NAFDAC-registered medical devices manufactured by Meril Diagnostics Pvt. Ltd., India.

According to NAFDAC, the NOC followed significant violations observed during a WHO Prequalification (WHO-PQT) audit of the company’s manufacturing facility. The audit findings led to a declaration that the manufacturer was not operating in compliance with WHO requirements and applicable quality standards, raising concerns that the quality and safety of the affected medical devices cannot be guaranteed.

Despite the products having been 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 resulting from external policy changes.

NAFDAC emphasised that any of the listed products found within Nigeria would be deemed falsified, counterfeit, and fraudulently imported.

The agency reiterated its commitment to safeguarding public health, noting that it will intensify surveillance activities to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products in circulation across the country.

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 toll-free line 0800-162-3322 or by email to sf.alert@nafdac.gov.ng.