NHRC alarmed over the reported circulation of falsified liver drug Defitalio and cancer drug Adcetris: Issues notices to Union Health Secretary and the Drug Controller General of India



Press release

National Human Rights Commission

New Delhi, 13th September, 2023

NHRC alarmed over the reported circulation of falsified liver drug Defitalio and cancer drug Adcetris: Issues notices to Union Health Secretary and the Drug Controller General of India

The National Human Rights Commission, NHRC, India has taken suomotu cognizance of a media report that after the alert from the World Health Organization (WHO), the Central Drugs Standard Control Organization (CDSCO) has asked the state regulators, doctors and patients to remain vigilant about two medicines — liver drug Defitalio and cancer drug Adcetris as the falsified versions of these drugs are circulating in four countries, including India. Reportedly, the falsified versions of Adcetris injection 50mg, detected in four countries, including India are most often found to be available at the patient level and distributed in unregulated supply chains (mainly online).

The Commission has observed that the contents of the news report, if true, raise a serious issue of violation of human rights, which is a matter of concern. Accordingly, it has issued direct issuance of Notices to the Secretary, Union Ministry of Health & Family Welfare and the Drugs Controller General of India calling for a detailed report in the matter. The report should include the present status of the implementation of the relevant laws to check the supply and sale of the falsified versions of the life-saving drug including Defitalio and Adcetris, if any, as mentioned in the news report. The response is expected within four weeks.

According to the media report, carried on 11th September, 2023, the product does not have marketing authorisation in India and Turkey. However, the falsified versions of the liver medicine Defitalio were detected in India and Turkey, which were supplied outside of regulated and authorized channels.

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