Mint Explainer: The trigger behind DGCI alert on Abbott’s Digene, Takeda's cancer jab
- DCGI has issued advisories to discontinue the use of Abbott's Digene Gel, a popular antacid medication, and Takeda's Adcetris Injection for cancer treatment, citing safety concerns
The Drugs Controller General of India (DCGI) is intensifying oversight to ensure safety and transparency. Recently, it issued advisories to discontinue the use of Abbott's Digene Gel, a popular antacid medication, and Takeda's Adcetris Injection for cancer treatment, citing safety concerns. Mint takes a closer look at the developments.
Why is Digene Gel on DCGI radar?
Following complaints of unpleasant taste and odour, the DCGI has warned doctors, pharmacists, and patients to cease using Diegene Gel, saying that it may pose safety risks leading to adverse effects. Manufactured at Abbott's Goa facility, Digene is an over-the-counter medication used for treating acidity and stomach-related issues.
How has Abbott India responded?
Abbott India has voluntarily recalled Digene gel manufactured at their Goa site following isolated customer complaints on taste and odour. The company said that there have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs, are not impacted, and Digene gel manufactured at other production sites is not affected and continues to be available in sufficient quantities to meet current demand.
Why is Takeda’s Adcetris Injection (Brentuximab Vedotin) under scrutiny?
The DCGI took action after the World Health Organization (WHO) alerted about the presence of counterfeit versions of Adcetris Injection 50mg (Brentuximab Vedotin) in India and three other countries. The WHO warned that the fake product is being distributed through unregulated supply chains.
What is Takeda Pharmaceuticals' response?
Takeda has clarified that India's Central Drugs Standard Control Organization (CDSCO) has issued an advisory against falsified Adcetris found in India. The company is authorized by DCGI to sell Adcetris in India and is distributing it through well-established supply chains. Takeda advises that Adcetris should only be procured from authorized distribution sources.
DCGI's advisory to medical community and state regulators
The DCGI has advised doctors to refrain from prescribing the flagged medications and to educate patients about potential adverse effects. Wholesalers and retailers have been directed to halt distribution and sales. State drug controllers have been advised to monitor the market closely for these products and to take action in accordance with the Drugs and Cosmetic Act and Rules.
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