Mint Explainer: The trigger for DCGI alert on Abbott’s Digene, Takeda cancer jab
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.
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. 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. 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. 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.
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