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Indian Supreme Court halts approval of new clinical trials until regulatory framework is set up

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5996 (Published 04 October 2013) Cite this as: BMJ 2013;347:f5996
  1. Sanjeet Bagcchi
  1. 1Kolkata

India’s Supreme Court has barred clinical trials of new drugs until a proper monitoring mechanism is put in place.1 The court made the decision on 30 September in response to a petition filed by an Indore and Pune based health activist group, Swasthya Adhikar Manch.2

The group said that the court had given the government 10 weeks to “come out with the actual implementation of the suggestions given by state government, National Human Rights Commission, petitioner and NGOs [non-governmental organisations] to strengthen the regulatory framework of clinical trials in the country.”3

Amulya Nidhi, a representative at the Swasthya Adhikar Manch, told the BMJ, “Between 3 July 2013 and 31 August 2013, 162 applications regarding global clinical trials including new chemical entities and …

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