The Drugs Control General of India (DCGI) said that World Health Organization (WHO) has informed about a safety alert identified with multiple falsified versions of Adcetris Injection 50mg (Brentuximab Vedotin) manufactured by Takeda Pharmaceutical Company, identified in four different countries including India on September 6.
These products are most often available at patient level and distributed in the unregulated supply chains (mainly online), according to the DCGI. The products have been identified in both regulated and illicit supply chain, sometimes at patient levels as well. WHO has reported that there are at least eight different batch numbers of falsified version in circulation.
Adcetris (Brentuximab Vedotin) is used for treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma.
The regulator has instructed doctors and healthcare professionals to carefully prescribe and educate their patients for reporting of any ADRs (adverse drug reactions). Consumers and patients are advised to be careful and only procure the medical products from authorised sources with proper purchase invoice.
The regulator instructed officers under state and regional offices of the drugs controller to keep a strict vigil on the movement, sale, distribution, stock of the said drug products in the market, draw samples and initiate necessary action as per the provisions of Drugs and Cosmetics Act and Rules made thereunder.
"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 company spokesperson said in a statement in response to Moneycontrol."We strongly recommend that Adcetris should be procured from Takeda authorized distribution sources only," it said.
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