The Nationwide Company for Meals and Drug Administration and Management (NAFDAC) has issued a public alert warning Nigerians concerning the circulation of a counterfeit batch of Artemether/Lumefantrine tablets, falsely branded as Aflotin 20/120, within the Nigerian market.
In accordance with the company on its official X account, the invention was made following a report by Ajanta Pharma Restricted, a pharmaceutical firm based mostly in Mumbai, India, which is the real producer of the unique product.
The corporate knowledgeable the company {that a} falsified model of its anti-malarial remedy had surfaced in Nigeria, bearing the batch quantity PA2128L.Ajanta Pharma reportedly clarified that this particular batch was initially manufactured in December 2018 and expired in November 2020 beneath the model Combisunate 20/120 with a pack dimension of 30 x 24 tablets. Nevertheless, the falsified model is being bought beneath the title Aflotin 20/120mg, repackaged in a distinct format (1 x 18 tablets).
The corporate additional defined that the counterfeit product did not match its permitted packaging requirements. “The overprinted matter on the falsified tablets didn’t align with Ajanta’s printing fashion, and the carton’s art work was inconsistent with our permitted design,” the corporate acknowledged.
Ajanta Pharma confirmed that it had not manufactured the Aflotin 20/120mg bearing Batch No: PA2128L and that the product at the moment in circulation with that batch quantity is counterfeit, based mostly on its investigation.
NAFDAC emphasised the well being dangers posed by counterfeit medicines, stating that such merchandise could not adjust to regulatory requirements, placing shoppers vulnerable to ineffective therapy and extreme well being penalties, together with demise.
In accordance with NAFDAC, the real Aflotin 20/120 is a mixture remedy of Artemether (20mg) and Lumefantrine (120mg), used to deal with uncomplicated malaria brought on by the Plasmodium falciparum parasite.
The company reported that the counterfeit model in circulation is labelled with a producing date of April 2023 and an expiry date of March 2026. The packaging falsely attributes manufacturing to Ajanta Pharma Restricted, with its acknowledged deal with in Mumbai, India.
In response to the alert, NAFDAC has directed all zonal administrators and state coordinators to accentuate surveillance efforts and take away any counterfeit merchandise discovered inside their jurisdictions.
The company additionally urged distributors, retailers, healthcare professionals, and caregivers to train warning and be certain that all medical merchandise are sourced from authorised and licensed suppliers.
NAFDAC suggested healthcare suppliers and shoppers to report any suspicious or substandard medicines to the closest NAFDAC workplace or via its e-reporting platforms. Stories of opposed drug reactions or uncomfortable side effects are additionally inspired via the identical channels.
