CDSCO issues alert on Falsified Versions of Adcetris Injection


The Drugs Control General of India (DCGI) has issued a safety alert in response to information from the World Health Organization (WHO) regarding multiple falsified versions of Adcetris Injection 50mg (Brentuximab Vedotin). This alert was issued on 5th September, 2023.

These counterfeit drugs, manufactured by Takeda Pharmaceutical Company, have been identified in four different countries, including India.

These counterfeit Adcetris Injections have become a cause for concern as they are most commonly found at the patient level and have infiltrated both regulated and unregulated supply chains, primarily online. WHO reports that at least eight different batch numbers of these falsified versions are currently in circulation.

Notably, Adcetris (Brentuximab Vedotin) is used in the treatment of patients with Hodgkin lymphoma after the failure of autologous stem cell transplant and in cases of systemic anaplastic large cell lymphoma.

In light of these alarming developments, the DCGI has issued a series of directives to safeguard patient health:

  1. Medical Professionals’ Vigilance: Healthcare providers, including doctors and other medical professionals, have been instructed to exercise utmost caution when prescribing Adcetris. They are urged to educate their patients about the risks associated with falsified versions and to promptly report any adverse drug reactions (ADRs).
  2. Consumer Caution: Consumers and patients are strongly advised to exercise caution and ensure that they procure medical products, especially Adcetris Injections, only from authorized sources with proper purchase invoices.
  3. Regulatory Vigilance: Regulatory authorities at the state and regional levels have been directed to maintain a stringent vigil on the movement, sale, distribution, and stock of Adcetris products in the market. They are empowered to draw samples for testing and initiate necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.

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