NAFDAC has alerted Nigerians to a counterfeit Artemether/Lumefantrine malaria tablet, Aflotin 20/120, urging vigilance in the supply chain

The National Agency for Food and Drug Administration and Control (NAFDAC) on Tuesday issued a public alert regarding the circulation of a counterfeit Artemether/Lumefantrine malaria tablet identified under the brand name Aflotin 20/120 in Nigeria.

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NAFDAC, via its official Twitter handle, stated that the counterfeit product was discovered and promptly reported to the agency by the genuine manufacturer, Ajanta Pharma Limited, based in Mumbai, India.

According to NAFDAC’s statement, Ajanta Pharma’s investigation revealed that the counterfeited product bears the batch number PA2128L, which the genuine manufacturer had used in December 2018 for a different product, Combisunate 20/120 (Artemether 20mg/Lumefantrine 120mg Tablets), with an expiry date of November 2020 and a pack size of 30 x 24 tablets. The counterfeit version is being sold as Aflotin 20/120mg with a significantly different pack size of 1 x 18 tablets.

Furthermore, NAFDAC noted that the overprinting on the counterfeit packaging did not align with Ajanta Pharma’s established overprinting style.

Following a thorough investigation and examination of the suspect product, Ajanta Pharma confirmed to NAFDAC that the Aflotin 20/120mg with Batch No: PA2128L currently present in the Nigerian market is indeed counterfeit.

The agency clarified that the genuine Aflotin 20/120 tablet is a combination of Artemether and Lumefantrine (20mg/120mg), primarily indicated for the treatment of uncomplicated malaria caused by the Plasmodium falciparum parasite.

NAFDAC strongly emphasised the significant dangers posed by counterfeit medicines to public health. These substandard products do not adhere to stringent regulatory standards, meaning their safety, quality, and efficacy cannot be guaranteed.

The agency warned that the use of counterfeit medicines often leads to ineffective treatment of diseases, potentially resulting in severe health consequences, including fatalities.

In response to this alarming discovery, NAFDAC has instructed all its zonal directors and state coordinators to immediately initiate surveillance activities to identify and remove any counterfeit Aflotin 20/120 products found within their respective zones and states.

NAFDAC also issued a crucial advisory to distributors, retailers, healthcare professionals, and caregivers, urging them to exercise extreme caution and maintain heightened vigilance throughout the pharmaceutical supply chain.

This measure is essential to prevent the further distribution, sale, and use of these dangerous counterfeit products.The agency reiterated the importance of sourcing all medical products exclusively from authorised and licensed suppliers to ensure their authenticity and quality.