Title: ‘Clinical Trial’ or ‘Critical Trial’ – A Scientific Affront on Human Rights

Authors: Dr Madhuri Irene, Moparty Hamsika

 DOI:  http://dx.doi.org/10.18535/jmscr/v4i8.03

Abstract

Change is the law of life, Law always supports changes for development and prosperity. Science is the inevitable tool for achieving progress in human civilization. The relationship of science and law is as old as the creation, the modern tendencies of human life and human attitudes Vis-a-Vis the technical development often lead to miscalculations and over enthusiastic estimations.

The fact is that both science and Law are the two sides of human life and they always move hand in hand for happy human life. Genetical Engineering, Cloning, Stem cell therapy and Clinical Trials etc., have been few of modern perplexities.

Traditionally Clinical Trials are associated more with serving the humanity, as a trend to understand disease patterns and seeking solutions for the dreadful diseases in the terms of better diagnostics. But in the recent times through Clinical Trials on humans, have created great alarm as it has been directly impacting on Human Rights philosophy.

This write-up intends to sketch a general sweep on the issues of Clinical Trials which have consumed many lives in the process of the Experiments and procedures by the scientific researches and the pharmaceutical sector.

Key Words: Clinical Trials, The Drug Controller General of India (DCGI), Drugs Technical Advisory Board (DTAB), The Central Ethical Committee of ICMR on Human Research.

References

 

1.      http://www.business-standard.com/article/pti-stories/only-45-of-2-868-clinical-trial-deaths-compensated-since-2005-113030500403_1.htm l

2.      http://www.thehindu.com/sci-tech/health/policy-and-issues/post-stringent-norms-clinical-trials-in-india-plummet/article4639976.ece 

3.      Swadhin Mondal& Dinesh Abrol, Clinical trials industry in India: A Systematic Review - ISID - isid.org.in/pdf/WP179.pdf

4.      courtesy of Cancer.gov.

5.      http://www.centerwatch.com/clinical-trials/overview.aspx

6.      www.centerwatch.com › Clinical Trials

7.      Data obtained from website of the Regulatory Authority i.e. Central Drugs Standard Control Organization (CDSCO) regarding DGCI Approval of clinical trials from 2007 till 2014 are noted for analysis

8.      Economic Times, 2013

9.      Jayaraman, 2004;  Singh. 2008; Bigoniya et al., 2010; Bajpai, 2013

10.  https://www.nlm.nih.gov/services/ctphases.html

11.  Economic Times, 2013

Corresponding Author

Dr Madhuri Irene

Assistant Professor, ICFAI Law School, IFHE, Hyderabad, Telangana

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