The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a high-level warning regarding the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in Nigeria, highlighting significant public health risks.
In a statement released on Thursday via its official X handle, NAFDAC revealed that the counterfeit product was discovered during routine surveillance operations in the Federal Capital Territory (FCT) and Rivers State. Manufactured by Strides Arcolab Limited, based in India, the drug was found to contain no active pharmaceutical ingredients, rendering it ineffective for treating malaria.
The agency further reported discrepancies in the product’s labeling, including conflicting manufacturing dates—June 2023 and February 2023—and expiry dates listed as May 2026 and June 2026. In addition, the NAFDAC registration number displayed on the product was invalid, and its license had already expired, confirming its counterfeit nature.
Combiart, a combination of Artemether and Lumefantrine, is a well-established antimalarial medication commonly used to treat uncomplicated malaria. However, NAFDAC emphasized that counterfeit versions such as this one do not meet regulatory standards, posing severe health risks. These include the potential for ineffective treatment, worsened conditions, and even death due to the lack of active ingredients.
In response to this threat, NAFDAC has ordered its zonal directors and state coordinators to ramp up surveillance and remove any counterfeit stocks from circulation. The agency also issued a call for heightened vigilance among importers, distributors, retailers, and healthcare professionals to ensure that medical products are sourced only from licensed suppliers.
“Counterfeit medicines are a growing concern, and we urge all stakeholders to carefully verify the authenticity of drugs before use. Their safety, quality, and efficacy cannot be guaranteed when they fail to meet established regulatory standards,” NAFDAC stated.
Healthcare providers and the general public have been urged to report any suspicions of counterfeit or substandard medicines to NAFDAC’s offices nationwide. The agency reiterated its commitment to ensuring the safety of all medical products in Nigeria and safeguarding public health from the dangers posed by counterfeit drugs.
As counterfeit drugs continue to pose a serious threat to public health, NAFDAC’s latest alert serves as a crucial reminder of the ongoing battle to protect Nigerians from unsafe and ineffective medications.