CDSCO Issues Alert Over Suspected Falsified Defitelio
The regulator has warned that the product may be available for sale and purchase in the country and has called for immediate reporting and strict surveillance.
According to the alert, WHO, through its Market Surveillance and Control Regulation and Safety Department, informed the authorities that a suspected falsified medicinal product bearing the specified particulars may be available for sale and purchase in India.
The product is identified as DEFITELIO (defibrotide) 80 mg/mL concentrate for solution for infusion, carrying batch number 24GC01A, with an expiry date of 04/2027. The manufacturer is listed as Patheon, II Trav. sx Via Morolense, 5, 03013 Ferentino (FR), Italy, and the marketing authorisation holder as Gentium S.r.l., Piazza XX Settembre, 2, 22079 Villa Guardia (Como), Italy.
However, the manufacturer or its authorised agent has confirmed that the batch mentioned in the alert was never supplied to India.
Accordingly, CDSCO directed that any product bearing these particulars found being offered for sale or distribution in India should be reported immediately to the concerned State or District Drugs Control Authority, and to CDSCO through dci@nic.in, for necessary action under the Drugs and Cosmetics Act, 1940, and the Rules made thereunder.
On the associated risks, the regulator warned that the use of falsified Defitelio would result in ineffective treatment and may pose other serious health risks because of its intravenous administration. These risks could be life-threatening in some circumstances.
Based on these concerns, CDSCO issued an advisory to doctors and healthcare professionals, consumers and patients, and regulatory authorities.
Doctors and healthcare professionals have been advised to prescribe carefully and educate their patients about reporting any adverse drug reactions (ADRs).
Consumers and patients have been advised to exercise caution and procure medical products only from authorised sources with a proper purchase invoice.
For regulatory authorities, including all State/UT Drugs Controllers and all zonal, sub-zonal and port offices of CDSCO, the notice directs officers to maintain strict vigilance over the movement, sale, distribution and stocks of the product in the market. They have also been instructed to draw samples if the product is found in the market and initiate necessary action under the Drugs and Cosmetics Act, 1940, and the Rules made thereunder.
The public alert, signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), encloses a copy of the rapid alert notification received from WHO.
Copies were marked to all State/UT Drugs Controllers and the heads of CDSCO’s zonal, sub-zonal and port offices for information and necessary action. The All India Organization of Chemists and Druggists (AIOCD) was also sent the alert through aiocd@aiocd.com, with a request to circulate it to chemists’ and druggists’ associations across all States and Union Territories.
The alert was additionally marked to the Joint Secretary, Drugs Regulation Section, Ministry of Health and Family Welfare, Kartavya Bhawan-I, New Delhi, for information, and to the CDSCO-IT Cell for publication on the CDSCO website.
The enclosed Rapid Alert Notification of a Medicinal Product Falsification was issued by the Government of Upper Bavaria, Germany, and addressed to BfArM. Bearing reference number DE_BY_04/verified falsification/2026/963/1, it marks the falsification status as “verified.”
The notification identifies the product as Defitelio 80 mg/mL concentrate for solution for infusion, with the generic name defibrotide, intended for human use. The pack presentation is one carton containing 10 vials, and the marketing authorisation number is EU/1/13/878/001.
It records batch number 24GC01A and expiry 04/2027 as the particulars appearing on the counterfeit product, while the manufacturing date is listed as unavailable. Gentium S.r.l. is identified as the marketing authorisation holder and Patheon as the manufacturer.
Providing the background, the notification states that on September 21, 2026, Gentium received an authenticity inquiry from India concerning a product purported to be Defitelio 80 mg/mL, bearing batch number 24GC01A, serial number 35118817455532, and an expiry date of April 2027. It specifically notes that Defitelio does not have marketing authorisation in India.
A comparative assessment of photographs of the carton against an authentic retention sample revealed multiple discrepancies in the text layout, font, artwork and overall presentation. Although the batch and serial numbers corresponded to a genuine, legitimate batch of Defitelio, the packaging was described as clearly fraudulent.
Photographs included in the notification show a carton bearing product code 00368727004603, serial number 35118817455532, batch number 24GC01A, and expiry 04/2027. The photographed packaging is marked 200 mg/2.5 mL, indicates intravenous administration, and states that the carton contains 10 sterile single-patient-use vials.
The packaging also carries a distribution statement naming Jazz Pharmaceuticals, Inc., Palo Alto, CA 94304. Its composition panel states that each millilitre contains 80 mg of defibrotide, with each 2.5 mL vial containing 200 mg, and lists sodium citrate dihydrate, hydrochloric acid and sodium hydroxide for pH adjustment, and water for injections. These are details displayed on the packaging reproduced in the falsification notification.
Following its assessment, the marketing authorisation holder concluded that the incident represented an attempt to falsify the product.
The authentic batch 24GC01A was distributed to the United Arab Emirates, Cyprus, Spain, Finland, Israel, Portugal, Sweden, Slovenia, Turkey and Uruguay.
At the time of the notification, this was a single reported incident. The marketing authorisation holder had not received a physical sample for laboratory testing and was continuing efforts to obtain the product and confirm details about its source and disposition.
A search of the Jazz Global Safety Database found no other reports associated with the batch number. Based on the information then available, there was no evidence that other units were affected, and no product recall was being initiated at that time. The marketing authorisation holder’s investigation remained ongoing.
Regarding distribution, the notification states that the genuine batch 24GC01A, expiring in April 2027, was packaged for the European market, identified in the document as “FI/SE/IR,” while the product complaint originated from India.
The original 14-digit serial number displayed on the falsified product had been decommissioned at Movianto Netherlands on February 26, 2025, and shipped to Gen Ilac in Turkey on February 28, 2025.
As the action taken, the issuing authority recorded that the information had been referred to BfArM. The proposed action was for BfArM to forward the information to the authority in Italy.
To view the official notice, click the link below:
