WHO found Defitelio, used for liver conditions, and Adcetris, a cancer drug manufactured by Takeda Pharmaceutical, being sold as counterfeit.
Defitelio, used for liver conditions, and Adcetris, a cancer drug manufactured by Takeda Pharmaceutical are found to be sold as counterfeit by WHO. (Supplied)
The Drugs Controller General of India (DCGI) has issued a directive to the drug control authorities in all states and Union Territories (UTs) to closely monitor the sale and distribution of counterfeit versions of two medications.
One is Defitelio, used for liver conditions, and the other is Adcetris, a cancer drug manufactured by Takeda Pharmaceutical.
This directive follows safety alerts issued by the World Health Organisation (WHO).
On 5 September, the DCGI issued an advisory stating that the WHO had issued a safety alert regarding multiple counterfeit versions of Takeda Pharmaceutical Company Limited’s Adcetris injection (50 mg). These counterfeit versions have been detected 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, also known as Brentuximab Vedotin, is a specialised antibody-drug conjugate that targets CD30 protein. It is prescribed for the treatment of two specific medical conditions: Hodgkin’s lymphoma in patients who have not responded to an autologous stem cell transplant, and systemic anaplastic large cell lymphoma.
Lymphoma is a type of cancer that affects the lymphatic system, which is a part of the body’s immune system, and it can manifest as either Hodgkin’s lymphoma or non-Hodgkin’s lymphoma.
Reacting to the development, Takeda Pharmaceutical Company Limited said Adcetris (the injection) should be procured only 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,” it said.
“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 added in its statement.
It said falsified medical products posed a significant threat to public health.
It asserted that it was 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”.
On 6 September, the DCGI released a subsequent advisory in response to a WHO safety alert of 4 September regarding counterfeit Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, which is produced 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 products, the DCGI has advised doctors and healthcare professionals to carefully prescribe drugs and educate their patients to report 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 procure medical products only from authorised sources with a proper purchase invoice.
On 31 August, the DCGI issued an advisory alert against Abbott’s antacid Digene gel, citing safety concerns.
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 wholesalers and distributors, the DCGI said the impacted product, with all batch numbers, manufactured at the Goa facility within the active shelf life to be removed from distribution.
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