The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a warning to the public about the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in Nigeria.
The product, manufactured by Strides Arcolab Limited in India, was discovered in the FCT and Rivers State during surveillance activities conducted by NAFDAC officers.
According to laboratory reports, the counterfeit product contains zero active pharmaceutical ingredients (APIs) and has two different date markings.
The report stated: “The National Agency for Food and Drugs Administration and Control (NAFDAC) is writing to inform the public about the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in the country. The product is manufactured by Strides Arcolab Limited, based in India.
“This product was discovered in the FCT and Rivers State, during surveillance activities conducted by officers of the Post Marketing Surveillance Directorate of NAFDAC.”
Furthermore, NAFDAC said that its database of registered products confirmed that the product license has expired, and the NAFDAC Registration Number on it is incorrect.
The Combiart Dispersible Tablet 20/120mg is an antimalarial medication used to treat malaria, a red blood cell infection transmitted by mosquito bites.
“The Laboratory report of the analysis carried out on the product revealed that it contained Zero APIs. The product was also observed to have two different date markings. The NAFDAC database of registered products has confirmed that the product license has expired and the NAFDAC Registration Number on it is wrong and not for the product.
“COMBIART (Artemether + Lumefantrine 20/120mg) The Artemether and Lumefantrine combination belongs to a group of medicines known as antimalarials. It treats malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to treat severe or complicated malaria.”
However, the counterfeit version poses serious health risks, as it may not effectively treat the disease, leading to severe health consequences, including death.
NAFDAC has directed its zonal directors and state coordinators to conduct surveillance and mop up the counterfeit products.
The agency has also advised importers, distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of counterfeit products.
To ensure the authenticity and physical condition of medical products, NAFDAC recommends obtaining them from authorized/licensed suppliers.
The agency also encourages healthcare professionals and consumers to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office or through their website.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit products within the zones and states.
“Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of counterfeit products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
“Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng”
In addition, NAFDAC has implemented various strategies to curb the menace of substandard and falsified medicines, including enforcement of regulation and control of APIs, ensuring good manufacturing practices compliance, and deployment of cutting-edge monitoring technologies.
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