The Central Drugs Standard Control Organisation (CDSCO) on October 23, 2026, issued a Public Alert on Falsified Defitelio (Defibrotide) 80 mg/mL.
CDSCO has warned against the sale and distribution of falsified Defitelio (Defibrotide) 80 mg/mL concentrate for solution for infusion, bearing batch number 24GC01A and expiry date April 2027. The manufacturer confirmed that it never supplied the genuine batch to India, and the product does not have marketing authorisation in India.
Any product bearing these particulars found for sale or distribution in India shall be reported immediately to the concerned State/UT Drugs Control Authority and the relevant CDSCO office for necessary action under the Drugs and Cosmetics Act, 1940, and the rules made thereunder. Healthcare professionals and consumers have been advised to procure medicines only from authorised sources, as falsified products may result in ineffective treatment and serious health risks.
[Notification No. - Enforc-11013(11)/10/2026-eoffice]
