NAFDAC Seizes Falsified Artemether/Lumefantrine Antimalarial in Kano

The National Agency for Food and Drug Administration and Control (NAFDAC) has seized a suspected falsified Artemether/Lumefantrine 80mg/480mg antimalarial medicine intercepted during routine post-market surveillance in Kano State. The product, purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India, was found to display a fake NAFDAC registration number that does not exist in the agency’s database. NAFDAC has classified the product as a Falsified Medical Product and warned healthcare professionals and the public against purchasing, supplying, or using it.

Me & You Pharma Takeaways

• NAFDAC seized a suspected falsified Artemether/Lumefantrine 80mg/480mg antimalarial in Kano State.
• The product was intercepted at the Coordinated Wholesale Centre (CWC), Kano, during routine surveillance.
• The NAFDAC registration number 02-3457 displayed on the product is fake and does not exist in NAFDAC’s registration database.
• The product does not declare a Marketing Authorisation Holder (MAH) on its label.
• NAFDAC has classified the product as a Falsified Medical Product.
• Consumers and healthcare professionals should avoid purchasing, supplying, or using the affected product and report suspected sales to NAFDAC.

What Happened?

NAFDAC officials intercepted a suspected falsified antimalarial medicine during routine post-market surveillance at the Coordinated Wholesale Centre in Kano State.

The product is labelled Artemether/Lumefantrine 80mg/480mg and purportedly identifies Bandaram Pharma Packleh Ltd (BPPL), India as its manufacturer. However, NAFDAC’s verification found that the registration number 02-3457 displayed on the product is not genuine and does not appear in the agency’s registration database.

The product, which carries Batch No. BP5203, a manufacturing date of October 2024, and an expiry date of September 2027, also does not identify a Marketing Authorisation Holder on its label.

NAFDAC has classified the product as falsified and advised the public not to use it.

Why It Matters To Your Health

Artemether/Lumefantrine is an antimalarial medicine used to treat malaria. Because malaria can become severe when effective treatment is delayed or inadequate, the circulation of falsified antimalarial medicines is a significant public health concern.

A falsified medicine may not contain the correct active ingredients, strength, or quality required for effective treatment. NAFDAC specifically warns that use of the affected product could result in treatment failure, worsening of malaria, and development of drug resistance.

The concern is particularly important in Nigeria, where malaria remains a major health problem and antimalarial medicines are frequently used. Taking a falsified product may give a patient the impression that they are receiving appropriate treatment while the infection continues to progress.

The fake NAFDAC registration number is also significant. A NAFDAC registration number is intended to indicate that a regulated product has gone through the agency’s registration process. In this case, verification showed that 02-3457 does not exist in NAFDAC’s registration database, raising a major authenticity concern.

What You Can Do

If you are buying or using antimalarial medicines:

• Avoid the affected Artemether/Lumefantrine 80mg/480mg, Batch BP5203 identified in the alert.
• Do not purchase medicines from unlicensed or unverified sellers.
• Buy antimalarial medicines from licensed pharmacies and authorised medicine suppliers.
• Check the product packaging, registration information, batch details, and other identifying information before purchase.
• If you already have the affected product, do not use it. Speak with a pharmacist or doctor about obtaining an appropriate replacement.
• If you have taken the product and your malaria symptoms persist or worsen, seek medical attention promptly.
• Report suspected falsified medicines to NAFDAC.

Understanding The Issue

Falsified medicines are products that deliberately misrepresent their identity, composition, or source. They can look similar to genuine medicines but may not contain what the label claims. This makes them particularly dangerous because patients may not realize that the treatment they are taking is not genuine.

In this case, NAFDAC intercepted the product during routine Post-Market Surveillance at the Coordinated Wholesale Centre in Kano State. Post-market surveillance allows regulators to monitor medicines after they have entered the supply chain and identify products that may pose risks to patients.

One of the major concerns identified was the NAFDAC registration number printed on the product. The number 02-3457 was verified by NAFDAC and found not to exist in its registration database. The product also failed to provide Marketing Authorisation Holder information on its label.

The product is labelled as Artemether/Lumefantrine 80mg/480mg, with Batch No. BP5203, a manufacturing date of October 2024, and an expiry date of September 2027. It purportedly lists Bandaram Pharma Packleh Ltd (BPPL), India, as the manufacturer. Based on NAFDAC’s findings, however, the product has been classified as a falsified medical product.

The presence of a fake registration number does not simply represent a labelling issue. It raises questions about whether the product has undergone the regulatory assessment required for medicines marketed in Nigeria. Patients should therefore not assume that a medicine is genuine simply because it displays a NAFDAC number on its packaging.

For malaria treatment, using the correct medicine is particularly important. If a falsified antimalarial does not provide effective treatment, the malaria infection may continue to progress. Delayed or ineffective treatment can increase the risk of complications, while inappropriate exposure to antimalarial medicines may also contribute to the broader problem of drug resistance.

Consumers should also avoid purchasing antimalarial medicines solely because they are cheaper or readily available from informal sellers. A legitimate source provides greater assurance that the product has entered the supply chain through an appropriate channel.

NAFDAC has advised healthcare professionals and members of the public to report suspected sales, distribution, or use of the affected product. The agency also stated that the alert will be uploaded to the World Health Organization Global Surveillance and Monitoring System (GSMS).

When To Speak With A Healthcare Professional

Speak with a pharmacist or doctor if:

• You have purchased or received the affected Artemether/Lumefantrine product.
• You are unsure whether an antimalarial medicine is genuine.
• Your malaria symptoms do not improve after treatment.
• Your symptoms become worse while taking an antimalarial.
• You experience unexpected side effects after taking the medicine.
• You need help choosing an appropriate antimalarial treatment.

Seek urgent medical care if malaria symptoms become severe or if you develop serious symptoms such as confusion, difficulty breathing, seizures, severe weakness, or loss of consciousness.

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Medical Disclaimer

This article is provided for general educational and informational purposes only and is based on information released by the National Agency for Food and Drug Administration and Control (NAFDAC)