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CDSCO warns about spurious medications in India after WHO issues an alert

Indian regulatory authority CDSCO (Central Drug Control Authority) issued a warning against a forged version of liver medication Defitelio (80 mg/ml defibrotide) and cancer medicine Adcetris injections (50 mg Brentuximab vedotin) marketed in the country after the World Health Organisation's (WHO’s) recent alert.

In their alert, WHO stated that the use of the fake version of Defitelio can cause inefficient treatment and other chronic side effects. Although the WHO has not received any reports regarding the adverse events, the safety and quality of the false products remain unknown.

According to a media report, WHO has spotted eight different batches of false Adcertis injections marketed in four countries, including India.

Defitelio medicine is used in severe veno-occlusive diseases in patients with hematopoietic stem cell transplantation, while Adcertis injections are used in the treatment of lymphomas (cancer-related to white blood cells).

In the statement, WHO said, "This WHO Medical Product Alert refers to one falsified batch of DEFITELIO (defibrotide sodium). This falsified product has been detected in India (April 2023) and Turkey (July 2023) and was supplied outside of regulated and authorised channels."

"The genuine manufacturer has advised that genuine Defiteio with lot 20G20A was packaged in German or Austrian packaging. The falsified products instead are in UK or Irish packaging. The stated expiration date is falsified and does not comply with the registered shelf life. The stated serial number is not associated with batch 20G20A. The drug does not have marketing authorization in India and Turkey, the WHO added.

Following the WHO warning, CDSCO released an alert and asked state authorities, physicians, and citizens to be cautioned about the false versions of Defitelio and Adcertis injections.

In the released statement, CDSCO commanded the state authority and said, "Instruct your office to keep a strict vigil on the movement, sale, distribution, and stock of the said drug products in the market, draw samples and initiate necessary action as per the provisions of the Drug and Cosmetic Act and rules made thereunder.

Previously, the CDSCO also issued a warning against Abbott’s Digene Gel. After consumers complained about the odour, taste, and colour of the product, the company voluntarily recalled the product manufactured in the Goa plant. However, the company assured that there is sufficient Digene medication on the market prepared in the Baddi plant and that it is completely safe.

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