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Industry specific-Medical Central Ministry of Environment, Forest & Climate change Drugs and Cosmetics Act, 1940

WHO Alert on falsified DEFITELIO (DEFIBROTIDE) 80 mg/ml concentrate for solution for infusion, B. No. 20G20A, Exp date 08/2024 mfg by: Gentium Srl and identified in India

06-Sep-2023 | File No. Enforc-11015(12)/1/2023-eoffice (Computer No. 115)

Central Drugs Standard Control Organization has issued an Alert Notification regarding a WHO Alert concerning falsified DEFITELIO (DEFIBROTIDE) 80 mg/ml concentrate for a solution for infusion, Batch No. 20G20A, with an expiry date of 08/2024, manufactured by Gentium Srl and identified in India.

According to the Notification, the World Health Organization (WHO) released Medical Product Alert No. 7/2023 on 04.09.2023, regarding the falsified product DEFITELIO (DEFIBROTIDE) 80 mg/ml concentrate for solution for infusion, Batch No. 20G20A, with an expiry date of 08/2024, manufactured by Gentium Srl. This falsified product was detected in India in April 2023 and in Turkey in July 2023, and it was supplied through unauthorized channels.

Due to the significant public health threat posed by these falsified products and the risks associated with their use in multiple countries and regions, the WHO Global Surveillance and Monitoring System (GSMS) issued a Medical Product Alert to report its detection in the WHO Regions of Europe and South East Asia.

DEFITELIO does not have marketing authorization in India and Turkey.

Risks associated with falsified DEFITELIO include ineffective treatment of patients and other serious health risks due to its intravenous administration, which could be life-threatening in some cases.

The following advisory is provided:

a. To Doctors and Healthcare Professionals: Doctors and healthcare professionals should prescribe with caution and educate patients to report any adverse drug reactions (ADRs).

b. To Consumers and Patients: Exercise caution 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 closely monitor the movement, sale, distribution, and stock of the mentioned drug products in the market.

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