DCGI asks states to keep vigil on sale of falsified versions of 2 drugs following WHO alerts
Sep 10,2023
Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin's lymphoma after the failure of an autologous stem cell transplant and systemic anaplastic large cell lymphoma.
New Delhi The DrugsController General of India (DCGI) has directed the drugs controllers of all states and Union territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda's cancer drug Adcetris (injection), following alerts issued by the World Health Organisation (WHO). In an advisory on September 5, the DCGI said the WHO has issued a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India.
"These products are most often available at the patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation," the DCGI said in a communication to the state drugs controllers.
Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin's lymphoma after the failure of an autologous stem cell transplant and systemic anaplastic large cell lymphoma.
On September 6, the DCGI issued another advisory, referring to a safety alert issued by the WHO on September 4 for falsified product Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Srl.
"This falsified product has been detected in India (April 2023) and Turkiye (July 2023), and was supplied outside of regulated and authorised channels," the WHO said.
It said the genuine manufacturer of Defitelio has confirmed that the product referenced in the alert is falsified.
"The use of falsified Defitelio will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances," the health body of the United Nations (UN) said.
Source: The Economic Times.