DCGI Issues Alert Regarding Falsified Medications: Adcetris and Defitelio

DCGI Issues Alert Regarding Falsified Medications: Adcetris and Defitelio. Image/NDTV

Global Concerns Prompt Indian Health Authorities to Act

The Drugs Controller General of India (DCGI) has issued alerts concerning the sale and distribution of falsified versions of two critical medications, Adcetris and Defitelio, following safety alerts from the World Health Organization (WHO). These actions aim to safeguard patient health and combat the distribution of counterfeit drugs.

Adcetris Safety Alert

Adcetris (Brentuximab Vedotin) is a vital cancer drug used in the treatment of conditions like Hodgkin’s lymphoma. The WHO identified multiple falsified versions of Adcetris injection 50 mg, manufactured by Takeda Pharmaceutical Company Limited, in several countries, including India. These counterfeit products are primarily available at the patient level and often distributed through unregulated supply chains, particularly online.

The DCGI advises healthcare professionals to exercise caution while prescribing medications and educate patients about reporting adverse drug reactions (ADRs). Regulatory authorities are instructed to monitor and control the distribution and stock of these counterfeit drugs, taking necessary actions under the Drugs and Cosmetics Act.

Defitelio Safety Alert

The second alert pertains to Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Srl. The WHO reported the presence of falsified Defitelio in India and Turkiye. The genuine manufacturer of Defitelio has confirmed the falsification. The use of falsified Defitelio can lead to ineffective treatment, posing serious health risks, particularly when administered intravenously.

Ensuring Patient Safety

The DCGI emphasizes that patients should procure medical products only from authorized sources, accompanied by proper purchase invoices. The import, sale, distribution, and stock of these counterfeit medications should be closely monitored and regulated by regulatory bodies.

Pharmaceutical companies like Takeda Pharmaceutical Company Limited stress the importance of procuring medications from authorized distribution sources to ensure patient safety. Falsified medical products pose significant threats to public health, and the industry is committed to protecting patient safety and maintaining the integrity of medications.

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