CDSCO raises alert on fake batch of DEFITELIO
New Delhi: Concerning the significant threat to public health posed by the falsified DEFITELIO (defibrotide sodium) 80 mg/ml concentrate for solution for infusion, Batch. No. 20G20A, Exp date 08/2024, manufactured by: Gentium Sri, identified in India, the Central Drugs Standard Control Organization has issued an advisory urging doctors and healthcare professionals to prescribe carefully and educate their patients to report any adverse drug reaction (ADR).
This warning came in line with the World Health Organisation (WHO) Medical Product Alert No. 7/2023, dated September 4, 2023, regarding the forged product DEFITELIO (DEFIBROTIDE), an 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Sri.
The alert mentioned that this forged item had been found in India (in April 2023) and Turkey (in July 2023) and was supplied outside of regulated and authorised channels.
DEFITELIO (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as a sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children, and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stop the liver from working correctly.
Considering the serious threat to public health presented by these falsified items and the risk posed to more than one Country and Region, the WHO GSMS (WHO Global Surveillance and Monitoring System) issued a Medical Product Alert to draw attention to the identification of this product in the WHO Regions of Europe and South East Asia.
In light of the foregoing, the genuine DEFITELIO maker confirmed that the product mentioned in the Alert is a fake.
Regarding this, the original manufacturer suggested that:
• Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.• The falsified products instead are in UK/lreland packaging.• The stated expiry date is falsified and does not comply with the registered shelf life.• The stated serial number is not associated with batch 20G20A.• DEFITELIO does not have marketing authorization in India and Tdrkiye.
Additionally, the alert highlighted the following risks caused by administering fake DEFITELIO:
"The use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances."
In light of the aforementioned, the Indian drug regulator CDSCO has issued the following warning to doctors and other healthcare providers, consumers, and patients, as well as to regulatory authorities (all state/UT drug controllers, all CDSCO zonal and sub-zonal offices, and all CDSCO port offices):
a. To Doctors and Healthcare Professionals: The doctors and healthcare professionals should carefully prescribe and educate their patients for reporting any ADRs.b. To consumers and patients: Be careful and only procure medical products from authorized sources with proper purchase Invoices.c. To Regulatory Authorities (All States/UTs Drugs Controllers and all Zonal and Sub-Zonal Offices of CDSCO, all Port Offices of CDSCO): Instruct your officers to keep a strict vigil on the movement, sale, distribution, and stock of the said drug products in the market, draw samples if said product lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.
