The National Agency for Food and Drug Administration and Control (NAFDAC) has raised a critical public health alert following the detection of a counterfeit batch of Herceptin® 600mg/5ml (Trastuzumab Solution for Injection) in Ghana. The drug, a widely used treatment for HER2-positive breast cancer, was allegedly purchased in Nigeria and later presented by a patient at a hospital in Kumasi, Ghana.

NAFDAC disclosed this development in a warning published on its official website on Thursday, underscoring the serious risks posed by falsified medical products. The agency identified the counterfeit product as bearing batch number A8519, which does not match any legitimate batch manufactured or distributed by Roche, the original pharmaceutical company behind Herceptin.

Critical Breast Cancer Medication Now Targeted by Counterfeiters

Herceptin is a vital medication in the treatment of breast cancer, particularly for patients whose tumors test positive for the HER2 protein, a marker that often signals aggressive cancer growth. The drug may be used on its own or combined with other treatments, including aromatase inhibitors or chemotherapy agents such as paclitaxel or docetaxel.

Given its high demand and specialized usage, Herceptin is an attractive target for counterfeiters. NAFDAC warned that the presence of falsified Herceptin poses significant health risks, including the possibility of ineffective treatment, delayed cancer progression management, and increased mortality for patients who unknowingly receive a fake drug.

Key Features of the Counterfeit Product

According to NAFDAC, the fake Herceptin® 600mg/5ml injection can be distinguished through multiple inconsistencies in packaging and labeling. Among the red flags identified:

• Invalid batch number: A8519, which is not found in Roche’s production records.

• Packaging discrepancies: These include inconsistent fonts, label misalignments, and erroneous variable data on the outer packaging.

• Tamper-evident seal flaws: The counterfeit drug features seals that differ from those used on genuine Roche products, making them easier to breach or replicate.

NAFDAC has urged healthcare professionals, pharmacists, and patients to carefully inspect packaging before administration and report any suspicious products immediately.

Cross-Border Implications and Origin of Discovery

The alert was triggered after a patient in Ghana’s Ashanti Region presented the falsified drug at a medical facility. When Ghanaian authorities investigated its source, the patient claimed to have obtained the medication in Nigeria.

This revelation has raised alarm among public health regulators in both countries and has prompted calls for heightened surveillance at Nigeria’s pharmaceutical distribution points, especially in private hospitals, open drug markets, and unauthorized vendors.

While the counterfeit Herceptin has only been formally identified in Ghana, NAFDAC fears that similar batches may already be in circulation across Nigeria. Therefore, the agency has extended its alert nationwide to prevent further exposure and to mobilize pharmacies, oncologists, and hospitals to double-check their supplies.

Breast Cancer Burden and Medication Demand in Nigeria

Nigeria faces a growing burden of breast cancer, with recent reports showing that it is the most commonly diagnosed cancer among women in the country. According to recent cancer registries, over 22,000 women are diagnosed annually, and about 14,000 die from the disease, many due to late detection and poor access to effective treatment.

Trastuzumab (Herceptin) plays a central role in targeted therapy for HER2-positive cases. Unfortunately, its cost, limited supply, and restricted availability in rural areas make the market vulnerable to counterfeit alternatives. Fake medications, especially those used in oncology, not only fail to treat the disease but may also contribute to drug resistance and mislead physicians into abandoning effective regimens.

NAFDAC’s Call to Action and Verification Measures

In response to the incident, NAFDAC has reinforced its commitment to ensuring drug safety across Nigeria and called for public vigilance. The agency has directed stakeholders to take the following actions:

• Verify authenticity of Herceptin using manufacturer-approved codes and NAFDAC’s product verification services.

• Inspect packaging for errors in font, batch number, or tamper-evident seals.

• Report suspicious products to the nearest NAFDAC office or via its mobile platform.

• Avoid informal drug markets, which often serve as entry points for counterfeit drugs.

• Inform patients and medical professionals about the signs of counterfeiting and the risks of compromised medication.

NAFDAC also reiterated that only trained professionals should administer Herceptin and that patients should demand proof of authenticity before undergoing treatment with any oncology medication.

Industry-Wide Response and Regulatory Coordination

In light of the transnational implications of the case, NAFDAC has stated that it will intensify collaboration with Ghana’s Food and Drugs Authority (FDA) and other regional health agencies. This move aims to establish traceability, dismantle the distribution networks of counterfeiters, and prevent cross-border pharmaceutical crime.

NAFDAC is also reportedly coordinating with Roche to verify the origin of the falsified batch and support efforts to alert other countries that may be vulnerable to receiving similar counterfeit supplies.

Patient Safety and Pharmaceutical Integrity

Counterfeit drugs like this fake Herceptin undermine public trust in healthcare systems and threaten the progress made in cancer treatment. For a drug as vital as Trastuzumab, falsification not only places patients at risk but also burdens healthcare providers who may unknowingly administer ineffective therapy.

NAFDAC continues to urge medical professionals to be on high alert. Hospitals are encouraged to conduct internal audits of their oncology inventories and immediately isolate any suspicious medication.

Conclusion: Public Must Remain Vigilant

The circulation of a counterfeit version of Herceptin® 600mg/5ml in Ghana, allegedly sourced from Nigeria, underscores the urgent need for vigilance across the entire pharmaceutical supply chain. NAFDAC’s timely alert seeks to prevent a wider public health crisis by ensuring patients receive safe, effective medications and encouraging immediate reporting of any anomalies.

As Nigeria continues to battle rising cancer rates, ensuring the integrity of life-saving medications must remain a national priority. Every stakeholder—regulators, healthcare providers, pharmacists, and patients—must join forces to detect, report, and eliminate counterfeit drugs before they do irreversible harm.