New requirements prescribed for clinical trials

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Three recent developments will affect future clinical trials in India.

Audio/video recording

The Drugs Controller General of India (DCGI) has issued an office order making audio/video recording of informed consent mandatory for new subject enrolments in all clinical trials in India, including global clinical trials. The order is effective from 19 November 2013.

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The business law digest is compiled by Nishith Desai Associates (NDA). NDA is a research-based international law firm with offices in Mumbai, New Delhi, Bangalore, Singapore, Silicon Valley and Munich. It specializes in strategic legal, regulatory and tax advice coupled with industry expertise in an integrated manner.

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