NAFDAC issues warning on counterfeit malaria drug
NAFDAC
Abdullateef Fowewe
The National Agency for Food and Drug Administration and Control has raised the alarm over the distribution of counterfeit Combiart Dispersible Tablet 20/120mg in Nigeria, warning of significant public health risks.
The fake medication,
falsely labeled as a product of Strides Arcolab Limited in India, was uncovered during surveillance operations by NAFDAC’s Post-Marketing Surveillance Directorate in the Federal Capital Territory and Rivers State.
To ensure global surveillance and coordinated action against the counterfeit medicine, and as part of its global responsibility, NAFDAC confirmed that the issue would be uploaded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) to strengthen international efforts against counterfeit medicines.
The move, it said, underlines the potential cross-border implications of the counterfeit Combiart tablet and the urgent need for a coordinated response.
NAFDAC gave the details of the medicine as Brand Name: Combiart Dispersible Tablet 20/120mg.
Generic Name: Artemether + Lumefantrine 20/120mg Dispersible Tablet.
Batch No: 7225119.
NAFDAC Reg No: A11-0299.
Manufacturing Date: June 2023 and Feb 2023.
Expiry Date: May 2026 and June 2026.
Manufacturer’s Name and Address: Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore- 562 106, India.
This was made known in a statement, by the agency through its X (formally Twitter).
It disclosed that laboratory analysis of the product revealed it contained no active pharmaceutical ingredients, rendering it ineffective against malaria, the condition it is designed to treat.
Further investigations by NAFDAC uncovered significant discrepancies in the product’s labelling, including two different manufacturing and expiry dates and an invalid NAFDAC registration number.
The agency also confirmed that the product license had expired, further disqualifying it from legitimate distribution.
It noted that Combiart, a combination of Artemether and Lumefantrine, is a well-known antimalarial medicine used to treat uncomplicated malaria.
However, according to the agency, the counterfeit version circulating in Nigeria not only fails to treat malaria but poses grave health risks, the agency noted, warning that counterfeit medicines can lead to treatment failure, worsening of medical conditions, and, in severe cases, death.
To address the situation, NAFDAC said it has directed all zonal directors and State coordinators to intensify surveillance and remove counterfeit products from circulation.
However, importers, distributors, and retailers have been urged to verify the authenticity of their medical supplies and ensure they source products only from authorised suppliers.
Healthcare professionals, caregivers, and the general public are also advised to remain vigilant and report any suspicious products to NAFDAC immediately.
Urging the public to exercise caution and prioritize safety by obtaining medical products only from verified sources, the agency said reports of substandard or falsified medicines can be submitted via NAFDAC’s hotline at 0800-162-3322or by email at sf.alert@nafdac.gov.ng.
Additionally, it said healthcare professionals and consumers can report adverse drug reactions or side effects through NAFDAC’s Med-Safety app or the e-reporting platform available on the agency’s website.
