The Central Drugs Standard Control Organization (CDSCO) has issued a safety alert regarding suspected counterfeit medication Defitelio (defibrotide) 80mg/mL concentrate for solution for infusion after discrepancies were found within the packaging and batch information.
The suspected counterfeit medication is labelled as Defitelio (defibrotide), batch 24GC01A with an expiry date of April 2027 (Medical Dialogues, 2026) (Arogya Legal, 2026).
The packaging states that it was manufactured by Patheon at their Ferentino site in Italy and licensed by Gentium S.r.l which is a subsidiary of Jazz Pharmaceuticals. However, the manufacturer has stated that this batch was never supplied to India. Defitelio does not have marketing authorisation in India, making the presence of the product in the Indian market a regulatory concern (Medical Dialogues, 2026) (Arogya Legal, 2026).
Healthcare professionals, distributors and patients have been advised to ensure they check the medication information and report suspected counterfeit stock to the relevant State or District Drugs Control Authorities or CDSCO.
According to the rapid alert notification, Gentium received an authenticity inquiry from India on September 21, 2026, concerning a product labelled as Defitelio 80 mg/mL, batch 24GC01A, with serial number 35118817455532 and an expiry date of April 2027.
A comparison of photographs of the suspect carton with an authentic reference sample revealed discrepancies in the text layout, font, artwork and overall presentation. Although the batch and serial numbers corresponded to a genuine batch of Defitelio, the packaging was identified as falsified. The notification also stated that a physical sample had not been received for laboratory testing at that time.
Defitelio contains defibrotide sodium and can be administered intravenously. It is used to treat severe hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome) due to haematopoietic stem cell transplant (HSCT).
This causes damage and blockage to the small blood vessels in the liver. This can lead to liver dysfunction and fluid retention and can affect multiple organs. Defibrotide acts on the vascular endothelium and helps to manage the blood clotting.
As this medication is used in patients who may be very ill, it is very important to ensure that it is genuine, high quality and administered appropriately.
Medicines can contain incorrect ingredients, incorrect strengths of the active ingredient and can be contaminated. This can cause serious issues for patients who may be very ill.
Delayed/inappropriate treatment – If the medicine does not contain the correct amount of active ingredient, the underlying issue will not be treated. This can cause severe liver damage and complications to multiple organs.
Contaminated – Medicines administered by injection can be contaminated due to poor manufacturing. This can cause patients to suffer from serious infections.
Unpredictable safety – The medicine may contain incorrect ingredients, strength and formulation. This can cause unexpected adverse effects. As defibrotide affects blood clotting, we cannot assume it is safe if it has not been authenticated.
Patients and carers should ensure they are receiving prescription medicines from an authorised source. Healthcare professionals and distributors should ensure they check that the medicine name, batch number, expiry date and packaging details are correct. If they suspect any counterfeit medicines they should report it to the relevant medicine authority.
This is not the first reported incident involving falsified Defitelio. On September 4, 2023, the World Health Organization (WHO) issued Medical Product Alert No. 7/2023 concerning falsified Defitelio batch 20G20A, which had been detected in India in April 2023 and Türkiye in July 2023. The earlier alert concerned a different batch and packaging discrepancies involving UK/Ireland packaging instead of the genuine German/Austrian packaging.
References:
U.S. Food and Drug Administration (FDA). (2016). Defitelio (defibrotide sodium) injection, for intravenous use: Prescribing Information. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114lbl.pdf
European Medicines Agency (EMA). (2023). Defitelio (defibrotide): Summary of product characteristics & European Public Assessment Report (EPAR). European Union. https://www.ema.europa.eu/en/medicines/human/EPAR/defitelio
American Society of Health-System Pharmacists (ASHP). (2024). Defibrotide Sodium Monograph. Drugs.com AHFS Therapeutic Classification. https://www.drugs.com/monograph/defibrotide.html
Central Drugs Standard Control Organization (CDSCO). (2026, October 26). Public Alert regarding falsified DEFITELIO (defibrotide) 80 mg/mL concentrate for solution for infusion (Batch No. 24GC01A). Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. https://cdsco.gov.in/
World Health Organization (WHO). (2023). Medical Product Alert N°7/2023: Falsified DEFITELIO (defibrotide sodium). World Health Organization Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. https://www.who.int/news/item/04-09-2023-medical-product-alert-n-7-2023-falsified-defitelio
World Health Organization (WHO). (2018). Substandard and falsified medical products. WHO Fact Sheets. https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
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