Swasthya Adhikar Manch v. Union of India

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Swasthya Adhikar Manch v. Union of India
Emblem of the Supreme Court of India.svg
Court Supreme Court of India
Full case name Swasthya Adhikar Manch and Ors. versus Union of India &Ors..
Decided21 October 2013;11 years ago (2013-10-21) [1]

Swasthya Adhikar Manch v. Union of India was a 2013 court case in which Swasthya Adhikar Manch requested additional government regulation in the management of clinical trials. The court found in favor of that organization and ordered regulation.

One of the complaints was enrolling research participants without proper informed consent. [2]

Results of the ruling include that contract research organizations must register with the government, trials must define how they will give compensation to research participants in case of injury, researchers must report guidelines for safe use of the study drugs in advance of beginning the trial, and there must be draft rules defining what conditions must be met before a trial begins. [3]

Various regulatory changes followed the ruling. [4]

Any company seeking approval to do clinical trials has to report the risks and benefits to patients for the research. [5]

As a result of the ruling in 2014 India published new requirements for clinical trials. [6]

The Supreme Court reprimanded an organization for not compensating victims who were injured. [7]

References

  1. ↑ "Swasthya Adhikar Manch and Ors v. Union of India (UOI) and Ors".
  2. ↑ Roy Chaudhury, R.; Mehta, D. (2016). "Regulatory developments in the conduct of clinical trials in India". Global Health, Epidemiology and Genomics. 1: e4. doi: 10.1017/gheg.2015.5 . PMC   5870412 . PMID   29868198.
  3. ↑ Shukla, Anay; Baxi, Khushboo (20 January 2013). "Clinical Trials on Trial". Nishith Desai Associates.
  4. ↑ Chatterjee, S (2013). "Regulatory changes in conduct of clinical trials: a need for review". Indian Journal of Pharmacology. 45 (4): 323–4. doi: 10.4103/0253-7613.114990 . PMC   3757596 . PMID   24014903.
  5. ↑ Kay, M. (3 July 2014). "Indian Supreme Court demands clarity on clinical trial approvals". BMJ. 349 g4383. doi:10.1136/bmj.g4383. PMID   24994706. S2CID   37807701.
  6. ↑ Bagcchi, S. (15 September 2014). "India issues new requirements for clinical trial approval". BMJ. 349 g5648. doi:10.1136/bmj.g5648. PMID   25223241. S2CID   41507151.
  7. ↑ Pandey, Kundan (17 August 2015). "Drug trials: SC pulls up Centre for not compensating victims who suffered severe adverse effects". www.downtoearth.org.in.
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