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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Alert on falsified versions of Adcetris Injection (Brentuximab Vedotin) manufactured by M/s. Takeda Pharmaceutical Company Ltd.

05-Sep-2023 | No. 42

Central Drugs Standard Control Organization has issued an Alert Notification concerning falsified versions of Adcetris Injection (Brentuximab Vedotin) manufactured by M/s. Takeda Pharmaceutical Company Ltd. According to the notification, the World Health Organization (WHO) has issued a safety alert regarding multiple falsified versions of Adcetris Injection 50mg (Brentuximab Vedotin) manufactured by M/s. Takeda Pharmaceutical Company Ltd. These falsified products have been identified in four different countries, including India. They are primarily available at the patient level and distributed through unregulated supply chains, particularly online. These products have been found in both regulated and illicit supply chains, and sometimes even at the patient level. The WHO has reported the presence of at least 08 different batch numbers of the falsified version in circulation, namely Batch No. 11980412 ED: 04/2024, 12188747 ED: 01/2025, 12188749 ED: 01/2025, 12200242 ED: 01/2025, 12202389 ED: 01/2025, 12203322 ED: 01/2025, 12310404 ED: 09/2025, and 512053 ED: 11/2024. ADCETRIS (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin lymphoma after the failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma. Based on this information, the following advisory is provided: a) To doctors and Healthcare Professionals: i. Doctors and healthcare professionals should carefully prescribe and educate their patients for reporting any Adverse Drug Reactions (ADRs). b) To consumers and patients: i. 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): i. Instruct your officers to keep strict vigilance on the movement, sale, distribution, and stock of the said drug products in the market.

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