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Spurious liver and cancer drugs in market, apex regulator warns states, doctors, patients

The country’s apex drug regulator, Central Drugs Standard Control Organisation (CDSCO), has asked state regulators, doctors and patients to remain vigilant about two medicines — liver drug Defitalio and cancer drug Adcetris — after the World Health Organization raised alert against falsified versions of them circulating in four countries, including India.

Defitalio is used for treatment of a serious condition where vessels in the liver are blocked, and Adcetris is used for the treatment of a type of blood cancer.

“Instruct your officers to keep strict vigil on the movement, sale and distribution of said products in the market,” the two alerts sent by CDSCO read, adding that samples of the medicines should be tested. The alerts urge healthcare professionals to prescribe the two medicines with caution and educate the patients about reporting any adverse events. It also asks people to purchase these medicines only from authorised stores.

The falsified versions of the liver medicine Defitalio were detected in India and Turkey. “This falsified product… was supplied outside of regulated and authorised channels,” as per the alert.

On the basis of the information provided by WHO, the drug regulator said the genuine drugs are packaged in Germany and Austria, whereas the falsified versions claim they were packaged in the UK and Ireland. “The stated expiry date is false and does not comply with the registered shelf life,” the alert said. Moreover, the product does not have marketing authorisation in India and Turkey.

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The falsified versions of Adcetris injection 50mg, the drug controller said, were detected in four countries, including India. “These products are most often available at patient level and distributed in the unregulated supply chains (mainly online),” the alert said. The falsified Adcetris has been discovered in the illicit as well as regulated supply chain. The WHO has detected eight different batches of falsified products in circulation.

“The use of falsified Defitelio will result in ineffective treatment of patients, may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances,” the WHO alert said, which was reiterated by the Indian drug controller.

These alerts come days after the drug controller issued a similar alert for Digene Gel, which its company Abbott voluntarily recalled after some customers reported the syrup to be white in colour, bitter in taste, and pungent in odour. The syrup used for treatment of acid reflux and gastritis is usually pink and sweet to taste. Only the syrups manufactured at its Goa facility were recalled, with the company assuring that there is enough Digene Gel available in the market supplied from its bigger facility at Baddi. The company also assured that the medicine in tablet and stick packs continue to be safe.

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