CDSCO Issues Alert on Falsified Defitelio; Urges Strict Vigilance on Distribution
The Central Drugs Standard Control Organisation (CDSCO), India's central drug regulator, has issued a directive to all states, Union Territories (UTs), and its various offices to closely monitor the sale and distribution of the falsified product Defitelio (defibrotide) 80 mg/ml, which is used as a concentrated solution for infusion. This action follows a recent alert from the World Health Organization (WHO) regarding this product, manufactured by the Italian pharmaceutical company Gentium Srl.This marks the second alert by CDSCO in a span of two days concerning falsified drugs in India, based on WHO communications. On September 5, CDSCO had issued a similar alert concerning falsified versions of Takeda's cancer drug Adcetris injection 50 mg (brentuximab vedotin) in the country.Defitelio is primarily indicated for the treatment of severe hepatic Veno-Occlusive Disease (VOD),…