Alert on falsified versions of Adcetris Injection Brentuximab Vedotin Manufactured by M/s Takeda Pharmaceuticals Company Ltd

## Report on Falsified Versions of Adcetris Injection **1. Executive Summary:** This report analyzes a policy alert issued by the Central Drugs Standard Control Organization (CDSCO), Government of India, regarding falsified versions of Adcetris Injection (Brentuximab Vedotin) manufactured by Ms. Takeda Pharmaceutical Company Ltd. The alert was triggered by a World Health Organization (WHO) notification about the presence of these falsified products in multiple countries, including India. The core purpose of the alert is to protect patients and ensure the integrity of the drug supply chain by informing healthcare professionals, patients, and regulatory authorities about the falsified products and directing them to take necessary precautions and actions. Key findings highlight the involvement of unregulated supply chains, particularly online sources, and the identification of at least eight different batch numbers of falsified versions in circulation. **2. Introduction:** This report aims to provide a comprehensive overview of the CDSCO's policy alert regarding falsified Adcetris Injection (Brentuximab Vedotin), based solely on the information provided in the policy text. The report will outline the alert's objectives, rationale, key provisions, target audience, inferred implementation aspects, and expected outcomes. **3. Policy Overview:** * This is a new policy alert. * **Core Objective(s):** * To alert doctors and healthcare professionals to carefully prescribe Adcetris Injection and educate patients to report any Adverse Drug Reactions (ADRs). * To advise consumers and patients to procure medical products only from authorized sources with proper purchase invoices. * To instruct State/UT Drugs Controllers and CDSCO Zonal/Sub-Zonal Offices to maintain strict vigilance on the movement, sale, distribution, and stock of Adcetris Injection, draw samples, and take necessary action according to the Drugs and Cosmetics Act and Rules. **4. Background and Rationale:** The policy alert addresses the issue of falsified Adcetris Injection (Brentuximab Vedotin) identified in the supply chain. This problem poses a significant risk to patients, as these falsified products may not contain the correct active ingredient, may contain harmful substances, or may be present in incorrect dosages. The alert is a direct response to the WHO's notification regarding the identification of multiple falsified versions in circulation, highlighting the need for immediate action to prevent further distribution and protect public health. The text implies the falsified versions are prevalent in unregulated online supply chains and sometimes reach patients, necessitating a broad alert to all stakeholders. **5. Key Provisions / Changes:** This is a new policy alert. The key provisions outlined in the alert mandate the following actions: * **To Doctors and Healthcare Professionals:** Careful prescription and patient education regarding ADR reporting. * **To Consumers and Patients:** Procurement of medical products only from authorized sources with proper purchase invoices. * **To Regulatory Authorities (All States/UTs Drugs Controllers and CDSCO Zonal/Sub-Zonal Offices):** Strict vigilance on the movement, sale, distribution, and stock of Adcetris Injection, drawing samples, and initiating necessary actions as per the Drugs and Cosmetics Act and Rules. **6. Target Audience and Stakeholders:** The target audience and stakeholders directly affected by this policy alert include: * Doctors and Healthcare Professionals * Consumers and Patients using or potentially using Adcetris Injection * Regulatory Authorities: All States/UTs Drugs Controllers * CDSCO Zonal/Sub-Zonal Offices * All India Organization of Chemists and Druggists (AIOCD) **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** Central Drugs Standard Control Organization (CDSCO), State/UTs Drugs Controllers, and CDSCO Zonal/Sub-Zonal Offices. * **Timelines/Procedures:** The alert mandates immediate action by regulatory authorities, including strict vigilance, sample collection, and necessary action according to the Drugs and Cosmetics Act and Rules. There are no explicit timelines stated, but the urgency of the alert implies prompt implementation. The mention of AIOCD suggests collaboration for dissemination of information and monitoring. * The alert relies on existing regulatory frameworks (Drugs and Cosmetics Act and Rules) for enforcement. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes of this policy alert include: * Increased awareness among healthcare professionals and patients regarding the presence of falsified Adcetris Injection. * Reduced procurement of Adcetris Injection from unauthorized sources. * Enhanced vigilance and monitoring of the Adcetris Injection supply chain by regulatory authorities. * Detection and removal of falsified Adcetris Injection from the market. * Prevention of patient harm due to the use of falsified medication. * Increased reporting of ADRs, contributing to better pharmacovigilance. **9. Conclusion:** The CDSCO's policy alert regarding falsified Adcetris Injection (Brentuximab Vedotin) is a crucial measure to safeguard public health and ensure the integrity of the pharmaceutical supply chain. By alerting healthcare professionals, patients, and regulatory authorities, the alert aims to mitigate the risks associated with the use of these falsified products. The alert highlights the importance of procuring medications from authorized sources and maintaining strict vigilance to prevent the distribution of counterfeit drugs. This policy underscores the CDSCO's commitment to patient safety and its proactive approach to addressing potential threats to the drug supply.

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