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.
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.
