The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public alert about the circulation of counterfeit Combiart Dispersible Tablets (20/120mg) in Nigeria. The agency disclosed this via a post on its X handle on Thursday, warning about the health risks associated with the counterfeit product.
According to NAFDAC, the tablets, manufactured by Strides Arcolab Limited in India, were discovered in the Federal Capital Territory (FCT) and Rivers State during surveillance by the Post Marketing Surveillance Directorate. Laboratory analysis of the product revealed that it contained no active pharmaceutical ingredients, rendering it ineffective for treating malaria.
Key Findings
The counterfeit product was found to have irregularities, including two different date markings: manufacturing dates of June 2023 and February 2023, and expiry dates of May 2026 and June 2026. NAFDAC also confirmed that the product’s licence had expired and the registration number on the packaging was incorrect.
The product batch number was identified as 7225119, and the NAFDAC registration number was listed as A11-0299. The manufacturer’s details were stated as:
Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore (562 106), India.
Health Risks
Combiart is a combination of Artemether and Lumefantrine, used to treat uncomplicated malaria caused by mosquito bites. However, the counterfeit version poses severe health risks as it fails to meet regulatory standards.
NAFDAC highlighted that counterfeit medicines can lead to treatment failure, worsening health conditions, and potentially fatal consequences.
NAFDAC’s Action Plan
NAFDAC has directed all zonal directors and state coordinators to conduct widespread surveillance and remove the counterfeit product from circulation. The agency urged importers, distributors, retailers, and healthcare professionals to remain vigilant and ensure all medical products are sourced from authorized suppliers.
The public is advised to thoroughly check the authenticity and physical condition of medicines before purchase and use.
Reporting and Safety Measures
NAFDAC has called on healthcare professionals and the public to report any suspicious medicines or adverse drug reactions through the following channels:
- Hotline: 0800-162-3322
- Email: sf.alert@nafdac.gov.ng
- Med-Safety App: Available on Android and iOS
- NAFDAC e-reporting platform: Accessible on the agency’s website
- Email for adverse event reporting: pharmacovigilance@nafdac.gov.ng
Additionally, the alert will be shared with the World Health Organization’s Global Surveillance and Monitoring System to raise global awareness of the issue.
NAFDAC’s Advisory
NAFDAC reiterated that all medical products should be obtained from licensed suppliers to ensure their quality, safety, and efficacy. The agency continues to prioritize public health by intensifying its efforts to identify and eliminate counterfeit products from Nigeria’s supply chain.
