CDSCO raises alert on fake Lymphoma drug Adcetris Injection manufactured by Takeda Pharma

This advisory came in line with the World Health Organization (WHO) safety alert that identified multiple falsified versions of Adcetris Injection 50mg (Brentuximab Vedotin) manufactured by Takeda Pharmaceutical Company in four different countries, including India.

In accordance with the WHO safety alert, the regulatory authority has issued directives to medical practitioners and healthcare experts, emphasizing the importance of cautious prescription practices and patient education regarding the reporting of adverse drug reactions (ADRs). In parallel, consumers and patients have been urged to exercise vigilance by obtaining medical products exclusively from authorized sources and retaining proper purchase documentation.

Additionally, the regulatory body has directed officers operating under state and regional offices of the drugs controller to maintain rigorous oversight over the movement, sale, distribution, and stock of the aforementioned drug products within the market. They are tasked with collecting samples and initiating appropriate actions in accordance with the provisions outlined in the Drugs and Cosmetics Act, as well as the associated rules.

ADCETRIS (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma.

Brentuximab vedotin is composed of 3 parts: a chimeric human-murine IgG1 that selectively targets CD30, monomethyl auristatin E (MMAE), which is a microtubule-disrupting agent, and a protease-susceptible linker that links the antibody and MMAE. The IgG1 antibody enables Brentuximab vedotin to target tumor cells expressing CD30 on their surface. Following this Brentuximab vedotin enters the cell. Once inside, the linker is cleaved releasing MMAE which binds and disrupts the microtubule network.

The WHO notified that these products, ADCETRIS (Brentuximab Vedotin), are most often available at the patient level and distributed in unregulated supply chains (mainly online). The WHO further reported, "The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well."

The WHO further highlighted that there are at least 08 different batch numbers of falsified versions 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.

The following warning is given in light of the foregoing:

a) To doctors and Healthcare Professionals:

i. The doctors and healthcare professionals should carefully prescribe and educate their patients for reporting any ADRs.

(b) To consumers and patients:

i. To be careful and only procure the 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 a strict vigil on the movement, sale, distribution, and stock of the said drug products in the market, draw samples, and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.

Responding to the news, Takeda Pharma said in a statement,“ We would like to clarify that the Central Drugs Standard Control Organization has issued a general advisory cautioning against falsified versions of Adcetris Injection (Brentuximab vedotin) identified in India. Takeda has been authorized by the Drug Controller General of India to import, sell and distribute Adcetris in India, and we make it available to our patients here through well-established supply chain networks. We strongly recommend that Adcetris should be procured from Takeda authorized distribution sources only. Falsified medical products present a significant threat to public health. Takeda India is committed to safeguarding the integrity of its products and supporting the fight against falsified medicines in order to protect patient safety, which is our highest priority.”

Also Read:Drug Alert: 27 drug samples fail to clear CDSCO test, 1 declared spurious