The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over the circulation of “counterfeit” Paludex tablets and suspensions in Nigeria.
The agency said the drugs, labelled as Paludex (Artemether/Lumefantrine), are manufactured by Impact Pharmaceutical Ltd, and Ecomed Pharma Ltd, Enugu and marketed by MD Life Sciences Ltd, Enugu.
The statement said laboratory tests conducted by a WHO-prequalified laboratory in Germany and NAFDAC revealed that the products contain zero percent active pharmaceutical ingredient (API), rendering them ineffective and potentially harmful.
NAFDAC warned that the products are not on its registered database and all NAFDAC registration numbers stated on the products are false.
“Genuine Artemether/Lumefantrine tablets or suspension is a combination of the two medications Artemether and Lumefantrine used to treat acute, uncomplicated malaria in adults and children,” the statement reads.
“The illegal marketing of medicines or counterfeit medicines poses a great risk to the health of people; by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.
“Also, poor-quality pediatric formulations or medicines in general have the potential of causing treatment failure when the API content is below the prescribed dose.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified products within their zones and states.
“NAFDAC implores distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the products.
“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”
(The Cable)
