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India issues new requirements for clinical trial approval

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5648 (Published 15 September 2014) Cite this as: BMJ 2014;349:g5648
  1. Sanjeet Bagcchi
  1. 1Kolkata

The Indian government has issued an order with “immediate effect” to researchers, medical institutions, and drug companies about the criteria they must follow to win approval for clinical trials of new drugs.

The order from the drug controller general of India (DCGI), which was issued on 5 September,1 aimed to improve the regulation of clinical trials in the country. It stated that, for new trials to be approved, they must include information on an assessment of …

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