Regulatory Affairs
NAFDAC Seizes Falsified Artemether/Lumefantrine in Kano, Warns Against Use
NAFDAC has seized a falsified Artemether/Lumefantrine 80mg/480mg product in Kano after finding that its NAFDAC registration number was fake. The Agency has advised healthcare professionals and the public to avoid the product.
The National Agency for Food and Drug Administration and Control (NAFDAC) has seized a suspected falsified antimalarial medicine, Artemether/Lumefantrine 80mg/480mg, during routine post-market surveillance at the Coordinated Wholesale Centre (CWC) in Kano State.
The product was labelled as being manufactured by Bandaram Pharma Packleh Ltd (BPPL), India. According to NAFDAC, verification showed that the NAFDAC registration number displayed on the product, 02-3457, is fake and does not exist in the Agency's registration database. The product label also did not provide information on the Marketing Authorisation Holder (MAH).
NAFDAC has classified the product as a Falsified (F) Medical Product and advised healthcare providers, importers, distributors, retailers, Patent and Proprietary Medicine Vendors (PPMVs) and members of the public to avoid purchasing, selling, supplying or using it.
Product details
The affected product is identified as:
- Product: Artemether/Lumefantrine 80mg/480mg tablets
- Purported manufacturer: Bandaram Pharma Packleh Ltd (BPPL), India
- Purported manufacturer address: Plot No. 1 & 2, Number 13, Mirgila, Nagar, India
- NAFDAC registration number: 02-3457 — identified by NAFDAC as fake
- Batch number: BP5203
- Manufacturing date: October 2024
- Expiry date: September 2027
- Marketing Authorisation Holder: Not stated on the product label
The finding highlights the importance of post-market surveillance in identifying medicines that may enter the supply chain despite lacking valid regulatory registration.
Why the alert matters
Artemether/Lumefantrine is an artemisinin-based combination medicine used in the treatment of malaria. When a medicine intended to treat malaria is falsified or otherwise fails to meet required quality standards, patients may not receive the treatment they need.
The World Health Organization (WHO) notes that substandard and falsified medical products can result in treatment failure and worsening of disease, while ineffective antimicrobial medicines can also contribute to antimicrobial resistance.
WHO also identifies antimalarials among the medical products frequently reported in connection with substandard and falsified medicines.
For healthcare professionals, this makes vigilance throughout the medicines supply chain particularly important, from procurement and distribution to dispensing and patient use.
What NAFDAC is advising
NAFDAC has advised healthcare professionals and members of the public to exercise caution and avoid the purchase, sale, supply or use of the affected product.
The Agency recommends obtaining medicines only through authorised and licensed suppliers and checking the authenticity of medicines before purchase and use. Anyone who suspects that the affected product is being sold, distributed or used is advised to report it to the nearest NAFDAC office.
WHO similarly advises consumers to obtain medicines from trusted, licensed outlets and to seek advice from a pharmacist, doctor or other healthcare professional when they suspect that a medicine may be falsified.
How to report suspected falsified medicines
NAFDAC advises healthcare professionals and consumers to report suspected substandard and falsified medicines or medical devices to the nearest NAFDAC office.
Reports can also be made through:
NAFDAC toll-free line: 0800-162-3322
Email: sf.alert@nafdac.gov.ng
Adverse events or suspected side effects associated with medicines or medical devices can be reported through NAFDAC's pharmacovigilance channels, including its electronic reporting platforms, the Med Safety application, the nearest NAFDAC office or:
Email: pharmacovigilance@nafdac.gov.ng
NAFDAC also provides its Reforms Unit for complaints through 09097630506 and 09097630507, or reforms@nafdac.gov.ng.
The Agency stated that the alert would also be uploaded to the WHO Global Surveillance and Monitoring System (GSMS), which supports international information-sharing on substandard and falsified medical products. WHO describes the GSMS as a mechanism for detecting, reporting and responding to such products globally.
The seizure in Kano serves as a reminder that medicine safety does not end with regulatory approval. Continued surveillance, responsible procurement and prompt reporting remain important safeguards against falsified medicines entering the hands of patients.