The World Health Organization (WHO) has issued a global alert regarding a counterfeit batch of DEFITELIO (defibrotide) that has been detected in India and Turkey. The alert was issued on 6th September, 2023.
The global health agency warns that this falsified product poses significant risks to public health and has been supplied through unauthorized and unregulated channels.
In an official statement, the WHO stated, “This WHO Medical Product Alert refers to one falsified batch of DEFITELIO (defibrotide sodium). This falsified product has been detected in India and Turkey and was supplied outside of regulated and authorized channels.”
The genuine manufacturer of DEFITELIO has confirmed the authenticity of this alert, adding to the seriousness of the situation. The manufacturer has released a statement, saying, “Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging. The falsified product, on the other hand, comes in UK/Ireland packaging. The stated expiry date is falsified and does not comply with the registered shelf life. The stated serial number is not associated with batch 20G20A. Furthermore, this drug does not have marketing authorization in India and Turkey.”
DEFITELIO is a medication primarily used to treat a rare and severe condition known as hepatic veno-occlusive disease (VOD) in patients undergoing stem cell transplantation. The use of counterfeit drugs in such cases can lead to serious health complications and even fatalities.
The WHO’s alert comes as a warning to healthcare providers, pharmacies, and the public in India and Turkey to be vigilant and report any suspicious DEFITELIO products that do not conform to the genuine manufacturer’s description.
Counterfeit drugs pose a grave threat to global health, as they can contain incorrect ingredients or the wrong dosage, leading to ineffective treatment, adverse reactions, and potential harm to patients. These counterfeit products are often distributed through illicit channels, making it difficult for regulatory authorities to monitor and control their flow.
In light of these alarming developments, the DCGI has issued a series of directives to safeguard patient health:
- Medical Professionals’ Vigilance: Healthcare providers, including doctors and other medical professionals, have been instructed to exercise utmost caution to educate their patients about the risks associated with falsified versions and to promptly report any adverse drug reactions (ADRs).
- Consumer Caution: Consumers and patients are strongly advised to exercise caution and ensure that they procure medical products only from authorized sources with proper purchase invoices.
- Regulatory Vigilance: Regulatory authorities at the state and regional levels have been directed to maintain a stringent vigil on the movement, sale, distribution, and stock of these drugs in the market. They are empowered to draw samples for testing and initiate necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.