https://en.bharatpedia.org/w/index.php?action=history&feed=atom&title=Swasthya_Adhikar_Manch_v._Union_of_IndiaSwasthya Adhikar Manch v. Union of India - Revision history2026-08-19T01:06:19ZRevision history for this page on the wikiMediaWiki 1.43.6https://en.bharatpedia.org/w/index.php?title=Swasthya_Adhikar_Manch_v._Union_of_India&diff=269303&oldid=prev->Semanticz0 at 22:42, 9 May 20212021-05-09T22:42:53Z<p></p>
<p><b>New page</b></p><div>{{DISPLAYTITLE:''Swasthya Adhikar Manch v. Union of India''}}<br />
{{Short description|an Indian public interest writ petition filed before the Supreme Court of India and decided in 2013}}<br />
{{Infobox court case<br />
|name = Swasthya Adhikar Manch {{Abbr|v.|versus}} Union of India<br />
|court = [[Supreme Court of India]]<br />
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|full name = Swasthya Adhikar Manch and {{Abbr|Ors.|Others}} versus Union of India {{Abbr|&|and}} {{Abbr|Ors.|Others}}.<br />
|date decided = {{start date and age|2013|10|21|df=yes}}<ref>{{cite web |url=https://www.legitquest.com/case/swasthya-adhikar-manch-and-ors-v-union-of-india-uoi-and-ors/184c8a |title=Swasthya Adhikar Manch and Ors v. Union of India (UOI) and Ors}}</ref><br />
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'''''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.<br />
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One of the complaints was enrolling [[research participants]] without proper informed consent.<ref>{{cite journal |last1=Roy Chaudhury |first1=R. |last2=Mehta |first2=D. |title=Regulatory developments in the conduct of clinical trials in India |journal=Global Health, Epidemiology and Genomics |date=2016 |volume=1 |pages=e4 |doi=10.1017/gheg.2015.5|pmid=29868198 |pmc=5870412 |doi-access=free }}</ref><br />
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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.<ref name="Shukla 2013">{{cite web |last1=Shukla |first1=Anay |last2=Baxi |first2=Khushboo |title=Clinical Trials on Trial |url=http://www.nishithdesai.com/information/research-and-articles/nda-hotline/nda-hotline-single-view/newsid/1603/html/1.html?no_cache=1 |website=Nishith Desai Associates |date=20 January 2013}}</ref><br />
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Various regulatory changes followed the ruling.<ref name="Chatterjee 2013">{{cite journal |last1=Chatterjee |first1=S |title=Regulatory changes in conduct of clinical trials: a need for review. |journal=Indian Journal of Pharmacology |date=2013 |volume=45 |issue=4 |pages=323–4 |doi=10.4103/0253-7613.114990 |pmid=24014903|pmc=3757596 }}</ref><br />
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Any company seeking approval to do clinical trials has to report the risks and benefits to patients for the research.<ref>{{cite journal |last1=Kay |first1=M. |title=Indian Supreme Court demands clarity on clinical trial approvals |journal=BMJ |date=3 July 2014 |volume=349 |pages=g4383 |doi=10.1136/bmj.g4383|pmid=24994706 |s2cid=37807701 }}</ref><br />
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As a result of the ruling in 2014 India published new requirements for clinical trials.<ref>{{cite journal |last1=Bagcchi |first1=S. |title=India issues new requirements for clinical trial approval |journal=BMJ |date=15 September 2014 |volume=349 |pages=g5648 |doi=10.1136/bmj.g5648|pmid=25223241 |s2cid=41507151 }}</ref><br />
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The Supreme Court reprimanded an organization for not compensating victims who were injured.<ref>{{cite web |last1=Pandey |first1=Kundan |title=Drug trials: SC pulls up Centre for not compensating victims who suffered severe adverse effects |url=https://www.downtoearth.org.in/news/drug-trials-sc-pulls-up-centre-for-not-compensating-victims-who-suffered-severe-adverse-effects-44114 |website=www.downtoearth.org.in |language=en |date=17 August 2015}}</ref><br />
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==References==<br />
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==External links==<br />
*https://www.legitquest.com/case/swasthya-adhikar-manch-and-ors-v-union-of-india-uoi-and-ors/184c8a<br />
{{Clinical trials in India|state=expanded}}<br />
[[Category:Supreme Court of India cases]]<br />
[[Category:2013 in case law]]<br />
[[Category:2013 in Indian politics]]<br />
[[Category:2013 in health]]</div>->Semanticz0