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), following alerts issued by the World Health Organisation (WHO). In an advisory on September 5, the DCGI said 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. On September 6, the DCGI issued another advisory, referring to a safety alert issued by the WHO on September 4 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.
They should also draw samples and initiate necessary action in accordance with the provisions of the Drugs and Cosmetics Act and the rules made thereunder, the DCGI said. For consumers and patients, the apex drug regulator has asked them to be careful and only procure the medical products from authorised sources with a proper purchase invoice. On August 31, the DCGI had issued an advisory alert against Abbott's antacid Digene gel, citing safety concerns as the United States-based drugmaker voluntarily recalled several batches of its Digene gel in India after the drug regulator raised an alert.
The DCGI had asked the consumers and patients to discontinue the use of Digene gel, which is manufactured at a Goa facility. As for wholesaler and distributors, the DCGI had said the impacted product, with all batch numbers, manufactured at the Goa facility within the active shelf life to be removed from distribution. Reacting to the development, Takeda Pharmaceutical Company Limited said Adcetris (injection) should be procured only from the authorised distribution sources.
"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 firm said in a statement.
It said falsified medical products pose a significant threat to public health and asserted that the firm 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".