Supreme Court blocks 157 clinical trials, says must follow new regime

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In March, the Centre had disclosed that at least 80 people had died due to illegal clinical trials in the last seven years. Reuters In March, the Centre had disclosed that at least 80 people had died due to illegal clinical trials in the last seven years. Reuters
SummaryOnly five trials were cleared from January 1-August 31 this year.

be considered by the government to ensure audio-video recording in all the cases even as the bench cautioned that any “laxity” or “inaction” by them would only delay the trials.

The court also said the contention that investigators, who inquire into cases of adverse events during and after such trials, were hired by the pharmaceutical companies and were paid by them was an “area of concern”. “If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically,” it said. Luthra concurred with the court and said the government would consider this suggestion.

In March, the Centre had disclosed that at least 80 people had died due to illegal clinical trials in the last seven years. It said there were 2,644 “serious adverse events” of deaths during clinical trials during 2005-2012. Of these, 80 have been attributed to clinical trials, while the other deaths could be due to terminal illnesses or other life-threatening diseases.

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