NAFDAC Flags Meril Diagnostic Kits Over Audit Violations

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public notice regarding four diagnostic kits manufactured by Meril Diagnostics Pvt Ltd, India, after significant violations were observed during a World Health Organization (WHO) prequalification audit. NAFDAC's audit revealed that Meril Diagnostics was not operating in line with the required quality standards, raising concerns about the safety and quality of the medical devices.

Although these products are registered with NAFDAC, the marketing authorization holder, Kvath Int'l Ltd, confirmed that none of the devices have been imported into Nigeria due to the company's current non-operational status. NAFDAC has directed its zonal directors and state coordinators to conduct surveillance and remove the products from the market.

Healthcare professionals are advised to review their stock and report any suspected counterfeit or compromised products to the nearest NAFDAC office or via email. Recently, NAFDAC also withdrew counterfeit malaria medications circulating across the country.