New Delhi: The Central Drugs Standard Control Organisation (CDSCO), has issued a public alert over a counterfeit batch of Defitelio, a drug used to treat a rare liver condition, identified in the country following a warning from the World Health Organization (WHO).

The product, Defitelio (defibrotide) bearing the batch number 24GCO1A was manufactured in Italy by Patheon for Gentium S.r.l., a wholly owned subsidiary of Nasdaq-listed Jazz Pharmaceuticals.

Defitelio does not have marketing approval in India and distribution agents have confirmed that the flagged batch was “never supplied to India”, however, the company received an inquiry, concerning the authenticity of a product purported to be Defitelio.

The genuine batch “24GCO1A” was packaged for the European market and distributed in Spain, Finland, Israel, Portugal, Sweden, Slovenia, Turkey, Uruguay and the UAE.

While the batch and serial numbers correspond to a genuine, legitimate batch, a comparative assessment of photographic images by the company revealed “multiple discrepancies in text layout, font, artwork, and overall presentation.”

Gentium is still working to obtain the product and confirm details about its source and disposition.

According to WHO, Jazz Global Safety Data- base has found no other reports associated with the affected batch and this is a single reported incidet.

The CDSCO in its alert has directed state and zonal officials to immediately report the product, warning that it may “pose serious health risks and prove life-threatening in certain circumstances.”

Meanwhile patients have been advised to procure the medicine only from authorized sources with proper purchase Invoice.

In the US, Defitelio is approved to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT).

Published On Oct 28, 2026 at 10:21 AM IST

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