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Indian Supreme Court demands clarity on clinical trial approvals

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4383 (Published 03 July 2014) Cite this as: BMJ 2014;349:g4383
  1. Meera Kay
  1. 1Bangalore

The Supreme Court of India has told the government that applicants seeking approval to conduct clinical trials must be asked to provide a risk-benefit assessment of the drug being investigated, its potential benefit to patients, and the advantages it offers over existing treatments.

The order was passed during the hearing of a petition1 filed by the non-governmental organisation Swasthya Adhikar Manch (Health Right Forum), which advocates issues related to health rights in India, seeking directions for the regulation of clinical trials involving new drugs and chemical entities.

The …

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