Following an alert by the World Health Organisation (WHO), the DCGI has asked the drug controllers of all States and Union Territories (UTs) to keep a vigil on the sale and distribution of falsified versions of Japanese drug major Takeda's cancer drug Adcetris injection 50 mg (brentuximab vedotin) in the country.
Adcetris is a CD30-directed antibody-drug conjugate indicated for treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma.
The Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi, in a drug alert issued on September 5, said that the WHO has informed about a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Ltd, identified in four different countries including India.
The WHO has reported that there are at least eight different batch numbers of falsified versions in circulation.
“These products are most often available at 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,” it said.
Based on the WHO's safety alert, the DCGI advised the State and regional regulatory offices to instruct their officers to keep a strict vigil on the movement, sale, distribution, stock of the mentioned drug products in the market. They should also draw samples and initiate necessary action as per the provisions of Drugs and Cosmetics Act and Rules made thereunder, added the DCGI.
Doctors and healthcare professionals have also been advised that they should carefully prescribe and educate their patients for reporting of any Adverse Drug Reactions (ADRs).
Takeda in a statement said, "Takeda has been 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 well-established supply chain networks.
We strongly recommend that Adcetris should be procured from Takeda authorized distribution sources only."