Drug alert: DCGI issues alerts on two Falsified Drugs

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on December 31, 2023 by The Health Master

Drug alert

Drug alert: In a crucial move to protect public health, the Drugs Controller General of India (DCGI) has issued advisories to all states and Union territories, urging them to monitor the sale and distribution of counterfeit versions of two vital drugs:

Defitelio, a liver medication, and Adcetris, a cancer drug manufactured by Takeda.

These drug alerts come in the wake of warnings from the World Health Organization (WHO) regarding the presence of multiple falsified versions of these drugs in several countries, including India.

Concerns Raised by the DCGI

The DCGI’s advisory, dated September 5, highlights the alarming accessibility of these counterfeit products, particularly through unregulated online channels.

The falsified Adcetris injections, with at least eight different batch numbers in circulation, have been identified in both regulated and illicit supply chains.

This concerning trend necessitates immediate action to safeguard patient welfare.

Understanding Adcetris and Defitelio

1. Adcetris (Brentuximab Vedotin):

Indicated for patients with Hodgkin’s lymphoma post-autologous stem cell transplant and systemic anaplastic large cell lymphoma.

Targeted CD30-directed antibody-drug conjugate.

2. Defitelio (Defibrotide) 80 mg/ml:

Manufactured by Gentium Srl.

Detected in India (April 2023) and Turkiye (July 2023), distributed outside regulated channels.

The Genuine Risk with Counterfeit Defitelio

The WHO has verified that the counterfeit Defitelio poses a significant threat to patient safety.

Its intravenous administration, if falsified, could result in ineffective treatment and even life-threatening consequences.

It’s imperative to heed these warnings and ensure the authenticity of the medications we rely on.

DCGI’s Directives for Medical Professionals

The DCGI strongly advises healthcare providers to:

  • Prescribe medications with the utmost caution.
  • Educate patients about reporting any adverse drug reactions (ADRs).

Regulatory Measures

1. For State and Regional Offices:

Vigilantly monitor the movement, sale, and distribution of the mentioned drug products.

Conduct regular sampling and implement necessary actions in accordance with regulatory provisions.

2. For Consumers and Patients:

Only procure medical products from authorized sources, accompanied by a valid purchase invoice.

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