The Drugs Controller General of India (DCGI) has directed drug controllers of all states and Union Territories to strictly monitor the sale and distribution of counterfeit versions of two drugs, liver drug Defitelio and Takeda’s cancer drug Adcetris (injection). warnings issued by the World Health Organization (WHO).
In an advisory on September 5, the DCGI said the WHO has issued a safety alert, identifying multiple counterfeit versions of Adcetris injection 50 mg, manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries, including India.
“These products are usually available at the patient level and are distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes also at patient level. WHO has reported that there are at least eight different batch numbers of counterfeit versions in circulation,” the DCGI said in a communication to state drug controllers.
Adcetris (Brentuximab Vedotin) is a CD30-targeted antibody-drug conjugate indicated for the treatment of patients with Hodgkin’s lymphoma after failure of autologous stem cell transplantation 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 the counterfeit product Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Srl.
“This counterfeit product was detected in India (April 2023) and Turkiye (July 2023) and was supplied outside regulated and authorized channels,” the WHO said.
It says that the real manufacturer of Defitelio has confirmed that the product referenced in the warning is counterfeit.
“The use of adulterated Defitelio will result in ineffective treatment of patients and may pose other serious health risks due to its intravenous administration and may be life-threatening in some circumstances,” the United Nations (UN) health agency said.
In response to the safety warnings for both products, the DCGI has advised doctors and healthcare professionals to prescribe medications carefully and educate their patients on reporting any side effects.
The DCGI has also asked the state and regional regulatory authorities to instruct their officials to strictly monitor the movement, sale, distribution and stock of the said drugs in the market.
They must also take samples and take necessary action in accordance with the provisions of the Drugs and Cosmetics Act and rules made under it, the DCGI said.
For consumers and patients, the apex drug regulator has asked them to be cautious and purchase the medical products only from authorized sources with a correct purchase invoice.
On August 31, the DCGI had issued an advisory warning against Abbott’s antacid Digene gel, citing safety concerns as the US-based drugmaker voluntarily recalled several batches of its Digene gel in India after the drug regulator issued a warning had warned.
The DCGI had asked consumers and patients to stop using Digene gel, which is manufactured at a factory in Goa.
As far as wholesalers and distributors are concerned, the DCGI had said that the affected product, with all batch numbers, manufactured at the Goa plant within the active shelf life, would be withdrawn from distribution.
Commenting on the development, Takeda Pharmaceutical Company Limited said that Adcetris (injection) should be obtained only from its authorized distribution sources.
“We would like to clarify that the Central Drugs Standard Control Organization has issued a general advisory warning against counterfeit versions of Adcetris Injection (Brentuximab vedotin) found in India.
“Takeda is authorized 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 established supply chain networks. We strongly recommend that Adcetris be purchased from a Takeda only authorized distribution sources,” the company said in a statement.
It said counterfeit medical products pose a significant threat to public health and asserted that the company is committed to protecting the integrity of its products and supporting the fight against counterfeit medicines to protect patient safety, “which is our top priority “.
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