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India considers exempting from local drug trials medicines for life threatening diseases that have been approved abroad

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5583 (Published 10 September 2014) Cite this as: BMJ 2014;349:g5583
  1. Sanjeet Bagcchi
  1. 1Kolkata

The Indian government is considering exempting some important drugs, which have been approved in clinical trials abroad, from being tested in local clinical trials.

Media reports said that the government had decided to prepare a list of serious and life threatening diseases specifically relevant to India and to consider exempting new drugs for such diseases and ailments from local clinical trials if they have already been approved for marketing in developed countries such as the United States, the United Kingdom, …

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