The Drug Controller General of India (DCGI) has issued an alert on falsified versions of Adcetris injection that is prescribed to treat cancer. In a letter dated September 5, the drug regulator highlighted that the World Health Organization (WHO) has informed about a safety alert identified with multiple falsified versions of Adcetris injection 50 mg (Brentuximab Vedotin).
The drug, manufactured by Takeda Pharmaceuticals, is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin Lymphoma after failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma.
The letter, as seen by Financial Express.com, revealed that falsified versions of the drug has been identified in four different countries including India.
“These products are most often available at patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chain, sometimes at patient levels as well,” the letter revealed.
According to the drug regulator, WHO has reported that there are at least 8 different batch numbers of falsified versions in circulation.
In a statement shared over email, a spokesperson of Takeda Pharmaceuticals told Financial Express.com: “We would like to clarify that the Central Drugs Standard Control Organization has issued a general advisory cautioning against falsified versions of Adcetris Injection (Brentuximab vedotin) identified in India.”
The spokesperson also revealed that Takeda has been authorised by the Drug Controller General of India to import, sell and distribute Adcetris in India, and they make it available to the patients here through well-established supply chain networks.
“We strongly recommend that Adcetris should be procured from Takeda authorized distribution sources only. Falsified medical products present a significant threat to public health. Takeda India is committed to safeguarding the integrity of its products and supporting the fight against falsified medicines in order to protect patient safety, which is our highest priority,” the spokesperson told Financial Express.com.
It has advised doctors and patients to carefully prescribe and educate their patients to report any adverse drug reactions (ADRs). Additionally, it warned consumers to be careful and only procure the medical products from authorised sources with the proper purchase invoice.