Swasthya Adhikar Manch v. Union of India
CourtSupreme Court of India
Full case nameSwasthya Adhikar Manch and Ors. versus Union of India & Ors..
Decided21 October 2013 (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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