The pharmaceuticals Controller General of India (DCGI) has instructed the drug controllers of all states and union territories to maintain a rigorous vigil over the sale and distribution of fake versions of two pharmaceuticals in response to warnings given by the World Health Organisation (WHO).
DCGI has issued a warning against the liver drug Defitelio and the cancer medication Adcetris (injection) from Takeda, according to the news agency PTI.
In a warning on September 5, the DCGI stated that various counterfeit Adcetris injection 50 mg products made by Takeda Pharmaceutical Company Limited had been discovered in four different nations, 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.
Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, made by Gentium Srl, was a fraudulent product, according to a safety alert released by the WHO on September 6.
‘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 stated that the product mentioned in the notice is a fake and has been certified by the real producer of Defitelio.
‘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.
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