Regulator DCGI cautions public against 2 falsified drugs following WHO alert

The Drugs Controller General of India (DCGI) has directed authorities across the states and Union Territories against the sale and distribution of falsified versions of two drugs. The action by the domestic drug regulator follows separate alerts issued by the World Health Organisation (WHO) against the falsified versions of liver medication Defitelio and cancer treatment injection Adcetris.

Ordering the state and UT drug controllers to keep a strict vigil on the movement, sale, distribution, and stocking of the drugs in the market, the regulator said the supplies of the falsified versions have been detected in the country through unregulated and unauthorised channels, and sometimes even available at the patient level. It also directed the authorities to draw samples from the market and initiate necessary action in accordance with the laws.

In an advisory, dated September 5, DCGI said falsified versions of Adcetris injection (50 mg), manufactured by Takeda Pharmaceutical Company, have been identified in four different countries including India. The drug Adcetris, or 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 a separate advisory, dated September 6, the regulator said falsified version of Defitelio (80 mg/ml), or defibrotide concentrate for solution for infusion, manufactured by Gentium Srl, has been detected in India in April 2023 and in Turkey in July 2023. The genuine manufacturer of Defitelio has confirmed that the product referenced in the alert is falsified, it added. 

The drug regulator has advised consumers and patients to be careful about the falsified products, and to make sure to collect the bill on any such purchase. The consumer should only procure the medical products from authorised sources with a proper purchase invoice, it added. 

According to the WHO, the use of the falsified version “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”. 

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