The Central Drugs Standard Control Organization (CDSCO) has issued a public notice warning about a suspected falsified batch of DEFITELIO (defibrotide) 80 mg/ml concentrate for solution for infusion, following a World Health Organization (WHO) alert.
According to the notice, WHO’s Market Surveillance and Control Regulation and Safety Department has reported that a medicinal product bearing the particulars of the suspected falsified batch may be available for sale and purchase in India.
The product is identified by batch number 24GC01A, with an expiry date of April 2027. The manufacturer is listed as Patheon, II Trav. sx Via Morolense, 5, 03013 Ferentino (FR), Italy, while the marketing authorisation holder is Gentium S.r.l., Piazza XX Settembre, 2, 22079 Villa Guardia (Como), Italy.
However, the manufacturer or its authorised agent has confirmed that the specified batch was never supplied to India.
Accordingly, CDSCO has directed that any product bearing these particulars found for sale or distribution in India must be reported immediately to the concerned State or District Drugs Control Authority and CDSCO at dci@nic.in for necessary action under the Drugs and Cosmetics Act, 1940, and the rules made thereunder.
Health Risks and Advisory
CDSCO has warned that the use of falsified DEFITELIO could result in ineffective treatment and pose serious health risks. Given that the product is administered intravenously, its use could be life-threatening in certain circumstances.
The regulator has advised doctors and healthcare professionals to prescribe medicines carefully and educate patients about reporting any adverse drug reactions (ADRs).
Patients and consumers have been advised to procure medicines only from authorised sources and ensure they receive proper purchase invoices.
CDSCO has also directed drug regulatory authorities across all States and Union Territories, along with its zonal and sub-zonal offices and port offices, to maintain strict vigilance over the movement, sale, distribution and stock of the suspected product. Officials have been instructed to draw samples if the product is found in the market and initiate appropriate action under the Drugs and Cosmetics Act, 1940, and the rules made thereunder.
DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease
(VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following
hematopoietic stem-cell transplantation (HSCT).
