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India Tweaks Audio-Visual Norms For Trials

 
• By Anju Ghangurde

India has tweaked requirements around audio-visual recording of the informed consent process for clinical trials, relaxing the rules a little for HIV and leprosy drugs, but industry claims that the revised norms lack clarity on certain key aspects.

India has tweaked requirements around audio-visual recording of the informed consent process for clinical trials, relaxing the rules a little for HIV and leprosy drugs, but industry claims that the revised norms lack clarity on certain key aspects.

Details in a government notification mandate that audio-video recording of the informed consent process in case of "vulnerable" subjects in clinical trials of new chemical entities (NCEs) or new molecular entities (NMEs) including the procedure of providing information to the

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