Wednesday, October 4, 2023

DGCI warns states against falsified versions of critical drugs

Drugs Controller General of India (DCGI) has issued a directive to all states and union territories, urging a stringent monitoring of the sale and distribution of counterfeit versions of two critical drugs, Defitelio for liver treatment and Adcetris for cancer, following alarming alerts from the World Health Organization (WHO).

In an advisory released on September 5, DCGI highlighted that the WHO had issued a safety alert identifying multiple counterfeit versions of Adcetris injection 50 mg, manufactured by Takeda Pharmaceutical Company Limited, in four different countries, including India.

“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. WHO has reported the presence of at least eight different batch numbers of these counterfeit versions in circulation,” DCGI highlighted to state drug controllers.

Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate used for the treatment of Hodgkin’s lymphoma in patients who have not responded to autologous stem cell transplants and systemic anaplastic large cell lymphoma. DCGI issued a subsequent advisory, referencing a safety alert issued by WHO on September 4 regarding falsified Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Srl.

“The presence of this counterfeit product has been confirmed in India (April 2023) and Turkiye (July 2023), and it was supplied through unregulated and unauthorised channels,” as stated by WHO. The genuine manufacturer of Defitelio has corroborated that the product mentioned in the alert is indeed falsified.

“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,” cautioned the health body of UN.

In this regard, DCGI has strongly advised doctors and healthcare professionals to exercise caution when prescribing these drugs and to educate their patients about reporting any adverse drug reactions (ADRs).
Additionally, the DCGI has requested state and regional regulatory offices to instruct their officers to maintain strict vigilance over the movement, sale, distribution, and stock of the mentioned drug products in the market. These authorities are also urged to collect samples and initiate necessary actions in accordance with the provisions of the Drugs and Cosmetics Act and the rules enacted under it.

To consumers and patients, the apex drug regulator has issued a warning, urging them to exercise caution and purchase medical products only from authorised sources, with proper purchase invoices.

On August 31, the DCGI had previously issued an advisory alert regarding Abbott’s antacid Digene gel, citing safety concerns. This came as Abbott voluntarily recalled multiple batches of its Digene gel in India after the drug regulator raised an alert. Consumers and patients were advised to discontinue the use of Digene gel, which is manufactured at a Goa facility.

In relation to wholesalers and distributors, the DCGI directed that all impacted products, irrespective of batch numbers, manufactured at the Goa facility and within their active shelf life, be immediately removed from distribution.

In response to these developments, Takeda Pharmaceutical Company Limited stressed that Adcetris (injection) should be procured exclusively from 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 emphasised in a statement.



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