Counterfeit Versions of Vital Medicines Prompt Vigilance
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The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator, has issued a warning to state regulators, healthcare professionals, and patients regarding the presence of counterfeit versions of two medicines—Defitalio, used for liver-related conditions, and Adcetris, employed in the treatment of a type of blood cancer. This caution follows an alert from the World Health Organization (WHO) regarding the circulation of falsified versions of these drugs in four countries, including India.
Defitalio is crucial for addressing a severe condition characterized by blocked vessels in the liver, while Adcetris plays a vital role in treating a specific type of blood cancer.
The CDSCO has urged state authorities to closely monitor the movement, sale, and distribution of these products in the market. They have also recommended thorough testing of medicine samples. Healthcare professionals are advised to prescribe these medications with caution and educate patients about reporting any adverse effects. Furthermore, individuals are encouraged to purchase these medicines exclusively from authorized stores.
Counterfeit versions of Defitalio for liver ailments were identified in India and Turkey. These falsified products were distributed outside of regulated and authorized channels, as per the alert.
Based on information provided by the WHO, the drug regulator noted that genuine Defitalio drugs are packaged in Germany and Austria. In contrast, the counterfeit versions falsely claim to be packaged in the UK and Ireland. Additionally, the stated expiration date is incorrect and does not align with the registered shelf life. Moreover, the product lacks marketing authorization in India and Turkey.
Counterfeit Adcetris injection 50mg has been detected in four countries, including India. These products are typically available at the patient level and are distributed through unregulated supply chains, primarily online. The falsified Adcetris has been discovered in both illicit and regulated supply chains, with the WHO identifying eight different batches of counterfeit products in circulation.
The use of falsified Defitalio could result in ineffective patient treatment, pose serious health risks due to its intravenous administration, and potentially be life-threatening in certain situations, as emphasized in the WHO alert, which was reiterated by the Indian drug controller.
These alerts come in the wake of a recent warning from the drug controller regarding Digene Gel, a medicine used for acid reflux and gastritis treatment. Abbott voluntarily recalled the product after some customers reported that the syrup was white in color, had a bitter taste, and emitted a pungent odor. The company reassured the availability of genuine Digene Gel in the market from its larger facility in Baddi, confirming the safety of tablet and stick pack variants.
