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Ministry: Fake injections imported from unauthorized distributors, not available in local pharmacies

A Darzalex vial similar to those found with falsified batch numbers reported in Maldives.

Health Ministry has clarified that counterfeit batches of the cancer medication ‘Darzalex’ were identified among supplies imported from abroad through unauthorized distributors, and confirmed that the injections are not available in any local pharmacies.

Following the discovery, the World Health Organization (WHO) has issued a medical alert specifically addressing the Maldives and Mexico.

A media official from the Health Ministry told Sun that the counterfeit injections were never stocked or sold in Maldivian pharmacies. The official further stated that the Maldives was the first country to report the issue to the WHO, adding that identifying and reporting such a complex case independently demonstrates the strength of the country’s pharmaceutical testing and monitoring systems.

“These counterfeit injections were discovered among medications imported from overseas. They were not found in any local pharmacy and are not available for sale within the domestic market,” the official said.

The Maldives Food and Drug Authority (MFDA) initially identified the issue during May and June of this year.

According to the WHO report, the confirmed counterfeit batches of ‘Darzalex’ medication used in the treatment of multiple myeloma, a type of blood cancer, are batches MYS7381 and STV1K01. In relation to batch STV1K01 found in the Maldives, the MFDA detected visible particles or contaminants inside the vials.

The legitimate manufacturer of the drug, Janssen, has confirmed that the identified batches are not authentic products of the company.

The WHO has warned that the use of counterfeit medications can result in infections, worsening of the underlying condition, and potentially life-threatening outcomes. The organization also expressed concern about vulnerabilities in the international supply chain, noting that some hospitals had received the illicit products.

Authorities have urged the public and healthcare providers to obtain medicines only from authorized distributors and to report any suspicious products or information immediately to the MFDA or through the WHO Rapid Alert system.

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