After an alert issued by the World Health Organization (WHO), the Drug Controller General of India (DCGI) has instructed all state and union territory drug controllers to closely monitor the sale and distribution of counterfeit versions of two medicines: Defitelio, a liver medicine, and Adcetris, a cancer medicine (injection).
On September 5th, the DCGI stated that WHO had issued a safety alert regarding several counterfeit versions of Adcetris injections, each containing 50 milligrams, manufactured by the Tekeda Pharmaceuticals Limited in different countries, including India.
“These products are often available at the patient level and are distributed through irregular supply chains, primarily online. The identification of the products has been in both regulated and unregulated supply chains, sometimes even at the patient level,” said WHO. DCGI has indicated that at least eight different batch numbers of counterfeit versions are prevalent.
Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of Hodgkin’s lymphoma patients following the failure of autologous stem cell transplantation and for systemic anaplastic large-cell lymphoma.
On September 6th, DCGI issued another advisory, mentioning a safety alert by the United States FDA against a false product, Defitelio (Defibrotide) 80 milligrams/mL concentrate for infusion manufactured by Gentium SRL. DCGI said, “The counterfeit product has been found in India (April 2023) and Turkey (July 2023) and has been supplied outside the regular and legitimate supply channels.”
The actual manufacturer of Defitelio has confirmed that the product mentioned in the alert is indeed counterfeit. The United Nations health agency warned, “The use of counterfeit Defitelio may lead to ineffective treatment of patients and could pose additional serious health risks due to poor administration practices, and in some circumstances, it may be life-threatening.”
Following safety alerts for both products, DCGI has advised doctors and healthcare professionals to prescribe medicines with caution and educate their patients about reporting any adverse drug reactions (ADR).
DCGI has also instructed its officials to conduct surveillance on the market regarding the listed drug products, their sale, distribution, and stocks, in accordance with the provisions of the Drugs and Cosmetics Act and Rules.
For wholesalers and distributors, DCGI has stated that all affected products of active shelf life in the Goa facility manufactured under all batch numbers will be removed from distribution. On consumer and patient levels, the top drug regulator recommends that medical products should be sourced from legitimate sources only.