NAFDAC raises alarm over fake anti-malarial medicine

The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm regarding the circulation of a fake antimalarial drug called Combiart Dispersible Tablet.

The agency announced this on its X handle on Thursday.

According to NAFDAC, the product is manufactured by Strides Arcolab Limited, an India-based company.

It said the product was discovered in both the Federal Capital Territory and Rivers State during surveillance activities conducted by its officials.

“The laboratory report of the analysis carried out on the product revealed that it contained Zero Active Pharmaceutical Ingredients. The product was also observed to have two different date markings,” it said.

The agency also said its database of registered products confirmed that the product licence has expired while the NAFDAC Registration Number on the product is wrong.

“The Artemether and Lumefantrine combination belongs to a group of medicines known as antimalarials. It treats malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to treat severe or complicated malaria,” it said.

The agency warned the public against using counterfeit or falsified medicines, noting that such products pose significant health risks because they do not meet regulatory standards.

It emphasised that such products often fail to effectively treat diseases or conditions that they are in and can lead to serious health consequences or death.

NAFDAC also said that the affected product has batch number 7225119 and a NAFDAC registration number A11-0299.

It said the manufacturing dates are June 2023 and February 2023, with expiry dates of May 2026 and June 2026.

The manufacturer’s name and address are Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore- 562 106, India.

“All NAFDAC zonal directors and state coordinators have been directed to surveillance and mop up the counterfeit products within the zones and states. Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid importing, distributing, selling, and using counterfeit products.

“All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

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“Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.

NAFDAC also urged healthcare professionals and patients to report adverse events or side effects related to the use of the product to the nearest NAFDAC office or through the E-reporting platforms available on the NAFDAC website, www.nafdac.gov.ng.

The public can also submit their complaints through the Med—safety application, which is available for download on Android and iOS stores, or simply send an email to pharmacovigilance@nafdac.gov.ng.