Last Updated on September 14, 2023 by The Health Master
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.
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).
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.
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: