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The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians regarding the presence of counterfeit Artemether/Lumefantrine tablets, misrepresented as Aflotin 20/120, in the Nigerian market.
The agency’s alert, shared via its official X account, follows a report from Ajanta Pharma Limited, a pharmaceutical firm based in Mumbai, India, which produces the authentic product.
Ajanta Pharma notified NAFDAC about the emergence of a falsified version of its anti-malarial drug in Nigeria, identified by the batch number PA2128L.
The company specified that this particular batch was originally manufactured in December 2018 and expired in November 2020, marketed under the name Combisunate 20/120 with a packaging of 30 x 24 tablets.
Conversely, the counterfeit version is being sold under the name Aflotin 20/120mg, repackaged in a different format (1 x 18 tablets).
Ajanta Pharma further highlighted that the counterfeit items do not conform to its approved packaging standards. “The overprinted information on the counterfeit tablets did not correspond with Ajanta’s printing style, and the carton artwork was inconsistent with our approved design,” the company remarked.
Ajanta Pharma confirmed that it did not produce the Aflotin 20/120mg with Batch No: PA2128L and affirmed that the circulating product with that batch number is counterfeit, based on its investigation.
NAFDAC underscored the health dangers associated with counterfeit medications, warning that such products may not meet regulatory standards, potentially exposing consumers to ineffective treatment and severe health risks, including death.
NAFDAC also highlighted that the genuine Aflotin 20/120 is a combination therapy of Artemether (20mg) and Lumefantrine (120mg) used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite.
The agency indicated that the counterfeit product in circulation is marked with a manufacturing date of April 2023 and an expiry date of March 2026, falsely indicating Ajanta Pharma Limited as the manufacturer, along with its address in Mumbai, India.
In light of the alert, NAFDAC has instructed all zonal directors and state coordinators to enhance surveillance activities and eliminate any counterfeit products discovered in their regions. The agency also called upon distributors, retailers, healthcare professionals, and caregivers to be vigilant and ensure that all medical products are sourced from authorized and licensed suppliers.
NAFDAC encouraged healthcare providers and consumers to report any suspicious or substandard medicines to the nearest NAFDAC office or via its e-reporting platforms. Additionally, reports of adverse drug reactions or side effects are welcome through the same channels.
