# India alerts over counterfeit Defitelio

> India's drug regulator warns of fake Defitelio posing health risks.
- Title: India alerts over counterfeit Defitelio · mint | Shortify
- Summary: India's drug regulator warns of fake Defitelio posing health risks. India's CDSCO issued an alert after WHO reported counterfeit Defitelio circulating in…
- Keywords: cdsco, defitelio, counterfeit, drug, india, health, adverse events, news, alerts, mint
- Source: mint — https://livemint.com/news/india/india-sounds-alert-over-counterfeit-defitelio-11793100174468.html
- Author: Priyanka Sharma
- Published: 2026-10-27T14:26:06+00:00
- Read time: 1 min
- Topics: cdsco, defitelio, who, counterfeit, drug, india, health, adverse events, news
## 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.
## Key takeaway

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.