NAFDAC flags four Meril diagnostic kits after WHO audit violations

The National Agency for Food and Drug Administration and Control has alerted Nigerians to a Notice of Concern issued by the World Health Organization’s Prequalification Service on four NAFDAC-registered diagnostic kits manufactured by Meril Diagnostics Pvt. Ltd in India.

This was disclosed in a public notice published on the agency’s website.

The Notice of Concern followed significant violations observed during a WHO Prequalification audit of Meril Diagnostics’ manufacturing facility.

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**What the agency said **

According to NAFDAC, the WHO audit found that the company was not operating in line with WHO requirements and applicable quality standards, raising concerns about the quality and safety of the affected medical devices.

The affected products, manufactured by Meril Diagnostics Pvt. Ltd and marketed in Nigeria by KVATH Int’l Ltd as the Marketing Authorization Holder, are:

• Meriscreen Malaria Pf / Pv Ag – NAFDAC Reg. No: A3-101135
• Meriscreen HIV 1-2 WB – NAFDAC Reg. No: A3-101136
• Meriscreen Malaria PF/PAN AG – NAFDAC Reg. No: A3-101137
• MERISCREEN Malaria Pf HRP-II Ag – NAFDAC Reg. No: A3-101118

Although the products were duly registered, NAFDAC stated that KVATH Int’l Ltd has confirmed that none of the listed devices has been imported into Nigeria due to the company’s current non-operational status following external policy changes.

• _“Although the products have been registered, the MAH (KVATH Int’l Ltd) has confirmed that they have not yet been imported into Nigeria due to the company’s current non-operational status following external policy changes. _
• “It is important to note that the above-mentioned products, if found in the country, will be considered falsified, counterfeit, and fraudulently imported,” the agency stated.

**More details **

NAFDAC directed all zonal directors and state coordinators to carry out surveillance and remove any of the listed products found in their jurisdictions.

• Distributors, retailers, healthcare professionals, and caregivers have been advised to exercise caution and refrain from distributing, selling, or using the listed diagnostic kits.
• The agency also stressed that all medical products should be sourced only from authorized or licensed suppliers, with careful checks on authenticity and physical condition before use.

Healthcare professionals have been asked to review stocks in hospitals, clinics, and pharmacies and report any suspected falsified or compromised products to the nearest NAFDAC office or call 0800-162-3322. Reports can also be sent via email to sf.alert@nafdac.gov.ng

**What you should know **

In a recent safety alert, NAFDAC recently directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.

• The agency also flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
• Another is on the circulation of falsified Dostinex 0.5mg tablets in Nigeria. The legitimate product is registered but not yet imported, while the fake batches, GG3470, LG8659, and GG2440 have no NAFDAC registration and may be unsafe

In one major operation in Lagos, NAFDAC intercepted counterfeit malaria medicines valued at over N1.2 billion hidden in a warehouse, with the fake drugs illegally imported and disguised as other goods before being seized by agency operatives.

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