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India alerts over counterfeit Defitelio
India's drug regulator warns of fake Defitelio posing health risks.
In brief
India's drug regulator warns of fake Defitelio posing health risks. India's CDSCO issued an alert after WHO reported counterfeit Defitelio circulating in domestic supply chains, urging hospitals to report adverse events and consumers to verify purchase documents. Originally reported by mint.
CDSCO alerts on counterfeit Defitelio
India's Central Drugs Standard Control Organization issued an urgent regulatory alert after the World Health Organization warned of a counterfeit batch of Defitelio circulating in domestic supply chains.
“The WHO, through its market surveillance and control regulation and safety department, has informed that a suspected falsified medicinal product bearing the following particulars may be available for sale and purchase in India”
Counterfeit product details
The fake Defitelio cartons label Patheon's facility in Ferentino, Italy as the manufacturer and Gentium S.r.l., a subsidiary of Jazz Pharmaceuticals, as the marketing authorization holder.
“The packaging falsely identifies Patheon’s facility in Ferentino, Italy, as the manufacturer and Gentium S.r.l., a subsidiary of Jazz Pharmaceuticals, as the marketing authorization holder.”
Batch number and expiry
The counterfeit batch has a serial number 35118817455532, batch number 24GC01A, and expires in April 2027.
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Manufacturer denial
The manufacturer confirmed the batch was never supplied to India, despite the packaging falsely identifying Patheon's facility in Ferentino, Italy as the manufacturer.
“However, the manufacturer or its authorized agent has confirmed that the above-mentioned product batch was never supplied to India”
Health risks
Using counterfeit Defitelio can cause ineffective treatment and life-threatening risks for patients with severe hepatic veno-occlusive disease.
“The use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances”
Regulatory actions
Doctors and hospitals must report adverse events, while consumers should verify purchase documents to avoid counterfeit drugs.
“Doctors and hospitals have been directed to report any adverse events, while consumers have been advised to verify purchase documents.”
At a glance
India's CDSCO issued an alert after WHO reported counterfeit Defitelio circulating in domestic supply chains, urging hospitals to report adverse events and consumers to verify purchase documents.
