India’s drug regulator alerts doctors and patients about fake liver, cancer drugs

Following alarming warnings from the World Health Organisation (WHO), the Drugs Controller General of India (DCGI) has issued a directive to all states and union territories urging a strict monitoring of the sale and distribution of two crucial drugs, Defitelio for liver treatment and Adcetris for cancer.

A CD30-directed antibody-drug combination called Adcetris (Brentuximab Vedotin) is used to treat systemic anaplastic large cell lymphoma and Hodgkin’s lymphoma in individuals who have not responded to autologous stem cell transplantation.

World Health Organistaion’s (WHO) report-

“This WHO Medical Product Alert refers to one falsified batch of DEFITELIO (defibrotide sodium). This falsified product has been detected in India (April 2023) and Türkiye (July 2023) and was supplied outside of regulated and authorized channels,” the WHO warning stated.

The medication is approved for the management of severe hepatic veno-occlusive disease (VOD), sometimes referred to as sinusoidal obstructive syndrome (SOS), in haematopoietic stem-cell transplantation (HSCT) therapy. It is recommended for use by adults, young adults, kids, and infants older than one month. In VOD, the liver’s veins get obstructed, which prevents the organ from functioning properly.

Drugs Controller General of India stated-

“These fake products are predominantly found at the patient level and are distributed through unregulated supply chains, primarily online. They have been identified in both regulated and illicit supply chains, occasionally even reaching patients directly. The WHO has reported the presence of at least eight different batch numbers of these counterfeit versions in circulation,” The DCGI emphasised this in their letter to state drug enforcement officials.

The Defitelio product’s original maker has confirmed that the item listed in the alert is in reality a fake

“The use of counterfeit Defitelio may render the treatment ineffective and could pose serious health risks due to its intravenous administration, potentially leading to life-threatening consequences in some instances,” warned the United Nations’ (UN) health agency.

The DCGI has strongly recommended doctors and healthcare providers to use caution when administering these medications and to inform their patients about reporting any adverse drug reactions (ADRs) in response to these safety alerts for both medicines.

Additionally, the DCGI has asked state and local regulatory agencies to give its employees precise instructions about market movement, sales, distribution, and stock of the aforementioned drug goods. In accordance with the terms of the Drugs and Cosmetics Act and the rules adopted under it, these authorities are likewise requested to gather samples and take the required steps.

The DCGI had earlier issued an advisory alert on August 31 outlining safety concerns with respect to Abbott’s antacid Digene gel. As a result of the drug regulator’s caution, Abbott voluntarily recalled certain lots of its Digene gel in India. Digene gel, which is made in a Goa facility, should no longer be used, consumers and patients were informed.

The DCGI directed wholesalers and distributors to cease distribution of all impacted items, regardless of batch numbers, produced at the Goa factory and still within their active shelf life.

Takeda Pharmaceutical Company Limited emphasised that Adcetris (injection) should only be purchased from authorised distribution channels in reaction to these developments.

“We would like to clarify that the Central Drugs Standard Control Organisation has issued a general advisory cautioning against falsified versions of Adcetris Injection (Brentuximab vedotin) identified in India. Takeda has been authorised by the Drug Controller General of India to import, sell and distribute Adcetris in India, and we make it available to our patients here through well-established supply chain networks. We strongly recommend that Adcetris should be procured from Takeda authorised distribution sources only,” The organisation stressed in a statement.

All medications and other medical supplies should be purchased from reputable and approved vendors, WHO advised that in the event that anyone has any knowledge regarding the production or supply of these items, they should notify WHO at [email protected].

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