DCGI directs states, UTs to keep strict vigil on sale of falsified versions of drugs

Following the alerts issued by the World Health Organisation (WHO), 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, liver medication Defitelio and Takeda’s cancer drug Adcetris (injection).

The drug controller body has said that 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.

In another advisory, the DCGI referred to the safety alert issued by the WHO 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.

Following the safety alerts for both the products, the DCGI has advised doctors and healthcare professionals to carefully prescribe drugs and educate their patients for reporting any adverse drug reactions (ADRs).

The DCGI has 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.