The National Agency for Food and Drugs Administration and Control, NAFDAC, has alerted the public to the sales and distribution of counterfeit Paludex tablets and suspensions across Nigeria.
In a statement on its X handle (formerly twitter), NAFDAC said that the Paludex Artemether/Lumefantrine tablets (80mg/480mg), were manufactured by Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout Emene- Enugu State.
It said that the counterfeit drugs were being marketed by MD Life Sciences Ltd, Emene Industrial Layout also in Enugu State.
The statement disclosed that NAFDAC also found in circulation, a Paludex (Artemether/Lumefantrine) dry powder for oral suspension (180mg/1080mg) for paediatric use.
According to the statement, the oral suspension is manufactured by Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout in Enugu and Ecomed Pharma Limited in Ogun State and marketed by MD Life Sciences Ltd.
NAFDAC said that the results of laboratory analysis on both products by a WHO-prequalified laboratory in Germany indicated zero per cent ‘Active Pharmaceutical Ingredient’ (API’s) in the products.
It said that the agency also sampled the same products and the reports of analysis confirmed zero per cent of API contents.
According to the statement, the products do not exist on NAFDAC registered product database and all NAFDAC registration numbers stated on the products are false.
It noted that genuine Artemether/Lumefantrine tablets or suspension was a combination of the two medications Artemether and Lumefantrine used to treat acute, uncomplicated malaria in adults and children.
“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,” it said.
NAFDAC said that all its zonal directors and state coordinators have been directed to carry out surveillance and mop up the fake products within their zones and states.
It also implored distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the products.
The agency said that all medical products must be obtained from authorised/licensed suppliers.
“The products’ authenticity and physical condition should be carefully checked.
“Anyone in possession of any of the above-mentioned products is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office.
The agency advised the public, especially those who have used any of the products to seek immediate medical advice from a qualified healthcare professional.
It also advised healthcare professionals and consumers to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
