DGCI issues alert on falsified versions of 2 drugs for cancer, liver ailment
The DCGI has advised doctors and healthcare professionals to carefully prescribe drugs and educate their patients for reporting any adverse drug reactions (ADRs).
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NEW DELHI: The Drugs Controller 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 used for liver ailments and cancer, 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 cancer drug 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.
On September 6, the DCGI issued another advisory, referring to a safety alert issued by the WHO on September 4 for falsified liver medication 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, adding: “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.
The DCGI has advised doctors and healthcare professionals to carefully prescribe drugs and educate their patients for reporting any adverse drug reactions (ADRs).
It also asked the State and regional regulatory offices to instruct their officers to keep a strict vigil on the movement, sale, distribution and stock of the mentioned drug products in the market.
They should also draw samples and initiate necessary action in accordance with the provisions of the Drugs and Cosmetics Act and the rules made thereunder.
For consumers and patients, the apex drug regulator has asked them to be careful and only procure medical products from authorised sources with a proper purchase invoice.