The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers, patients, and the public of the Notice of Concern (NOC) issued by the WHO Prequalification Service for some NAFDAC-registered medical devices manufactured by Meril Diagnostics Pvt. Ltd, India.
The NOC was issued following significant violations observed during the WHO Prequalification (WHO-PQT) audit of Meril Diagnostics Pvt. Ltd.’s manufacturing facility. This necessitated a declaration that the manufacturer was not operating in line with WHO requirements and applicable quality standards. Hence, the quality and safety of the medical devices are not guaranteed.
Product Details
The details of the affected medical devices manufactured by Meril Diagnostics Pvt. Ltd in India and marketed by KVATH Int’l Ltd (the Marketing Authorization Holder (MAH)) in Nigeria are as follows:
S/No | Application No. | Product name | NAFDAC Reg No |
1. | NF-MD-341983 | Meriscreen Malaria Pf / Pv Ag | A3-101135 |
2. | NF-MD-341813 | Meriscreen HIV 1-2 WB | A3-101136 |
3. | NF-MD-342022 | Meriscreen Malaria PF/PAN AG | A3-101137 |
4. | NF-MD-332483 | MERISCREEN Malaria Pf HRP-II Ag | A3-101118 |
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.
NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria.
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove any products found in their zones and states.
Distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance regarding the listed products and to refrain from distributing, selling, or using them. All medical products must be obtained from authorized or licensed suppliers. The authenticity and physical condition of these products should be carefully checked before use.
Healthcare professionals are advised to review stocks within hospitals, clinics, and pharmacy stores, report any suspected falsified or compromised products (medicines or medical devices) to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
