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), also known as sinusoidal obstructive syndrome (SOS), in the context of haematopoietic stem-cell transplantation (HSCT) therapy. It is used for adults, adolescents, children, and infants over 1 month of age. VOD is a condition where the liver’s veins become obstructed, leading to impaired liver function.
Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General (India), issued a drug alert on September 6, directing all relevant authorities, including State and Union Territory drug controllers, CDSCO offices, and port authorities, to maintain strict vigilance over the movement, sale, and distribution of Defitelio in the market.
The directive also instructs officials to draw samples if the falsified product is found in the market and take necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules.
The falsified Defitelio product has been detected in India since April 2023 and in Turkiye (Turkey) since July 2023. These products have been supplied outside regulated and authorized channels, posing a significant threat to public health. WHO’s Global Surveillance and Monitoring System (GSMS) issued a medical product alert to highlight the detection of this product in WHO regions of Europe and SouthEast Asia due to the potential risk it poses to multiple countries and regions.
A notable distinction between the genuine and falsified products is in their packaging; the authentic Defitelio is packaged in German/Austrian packaging, while the falsified versions come in UK/Ireland packaging. The stated expiry date on the falsified products does not align with the registered shelf life, and the stated serial number does not match batch 20G20A. It’s important to note that Defitelio does not have marketing authorization in India or Turkey.
The use of falsified Defitelio can result in ineffective treatment and poses serious health risks, especially considering its intravenous administration. It could be life-threatening in some circumstances, warns Raghuvanshi in the alert.
Healthcare professionals are advised to prescribe Defitelio carefully and educate patients to report any adverse drug reactions (ADRs). Consumers and patients are urged to procure medical products only from authorized sources with proper purchase invoices.
The recent alerts from CDSCO highlight the importance of stringent regulatory measures and monitoring to ensure the safety and efficacy of pharmaceutical products in India, and to protect public health.