Ethics committee laws, penalty comparison across globe: a mandatory thought before accreditation process in India

Stuti Raibagkar, Falguni D. Majmudar, Devang A. Rana


To have a better quality of life and to fight with the diseases evolved the concept of clinical trials. A test of any new or existing drug on human being through different phases to check the efficacy and safety of the molecule is clinical trial. To cope up with the defects in drug system, India introduced Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules in 1945. Objective: To compare and contrast the different GCP guidelines and law suits, penalties, worldwide. We reviewed different internet databases and resources to find out the various penalties. The death occurring during clinical trials shook the pillars of credibility of clinical trials and led the government to make some regulatory provisions. The outcome is that now the ethics committee has to be accredited by a competent authority. This step led many problems for upcoming as well as the existing ethics committee and trial sites. The objective of the review article is to know the roles and responsibilities of different players of clinical trials i.e. the investigator, the sponsor and the ethics committee and to know the laws governing their responsibilities and the penalties affiliated to it. Since now the clinical trials in India are becoming more and more stricter there is a dire need to make aware the ethics committee members, sponsor and the investigator of their rights and duties towards one another and towards the patient/subject, so the tragedies in the clinical trials can be minimized. 


Accreditation, Clinical trial, Comparison, Ethics, Investigator, Penalties

Full Text:



Imran M, Najmi AK, Rashid MF, Tabrez S, Shah MA. Clinical research regulation in India-history, development, initiatives, challenges and controversies: still long way to go. J Pharm Bioallied Sci. 2013;5(1):2-9.

Papiya Bigoniya, Alok Shukla, Chandra Shekhar Singh. Present status of clinical trials in India: unfolding the truth. Pharma Review. New Delhi, India: KONGPOSH Publications Pvt. Ltd.; September-October 2010.

Dartmouth-Hitchcock. What are the penalties for failing to register? 2015. Available at:

Medline India. Good clinical practice guidelines, 2014. Available at:

ICMR. Guidelines, 2015. Available at:

WMA. WMA declaration of Helsinki - ethical principles for medical research involving human subjects, 2015. Available at:

Central Government Act. The Drugs and Cosmetics Rules, 1945, May 2011. Available at:

The Times of India. 49 babies die during clinical trials at AIIMS, 2015. Available at:

Pharmabiz. Clinical trials - commerce versus ethics, 2005. Available at:

Richard S. Saver. Medical research and intangible harm. Univ Cincinnati Law Rev. 2006;74:941-1012.

LII - Cornell University Law School. Cook County V. United States Ex Rel. Chandler (01-1572) 538 U.S. 119, 2003. Available at:

Dale Keiger, Sue De Pasquale, Naomi Shea. Trials & tribulation. The Johns Hopkins Magazine, 2002. Available at:

The Refusers. GlaxoSmithKline malpractice case in fatal vaccine clinical trial raises questions about trial standards - The Lancet, 2012. Available at:

Central Information Commission. Dr. Anand Rai vs. Ministry of Health and Family, June, 2011. Available at:

Internal Investigative Committee Membership. Report of internal investigation into the death of a volunteer research subject, 2001. Available at:

Pharmabiz. Clinical trials - commerce versus ethics, 2005. Available at:

Edward ABNEY, Barbara Allen, James Day, Robert Green, Delbert Jackson, James Pugh, et al. United States Court of Appeals, Sixth Circuit. Plaintiffs-Appellants, v. AMGEN, INC., Defendant-Appellee, March 2006. Available at:

Pharmaceutical News And Information. Vioxx Lawsuit: Vioxx Trial, 2008. Available at:

The Times of India. India a hotbed for clinical trials, 2007. Available at:

Charles Seife. Research misconduct identified by the US food and drug administration out of sight, out of mind, out of the peer-reviewed literature. JAMA Intern Med. 2015;175(4):567-577.

The Refusers. GlaxoSmithKline malpractice case in fatal vaccine clinical trial raises questions about trial standards - The Lancet, 2012. Available at:

Wikipedia. Abdullahi v. Pfizer, Inc., 2015. Available at:,_Inc.

Rutgers University School of Law. N.J. resources, 2012. Available at:

Wikipedia. Moore v. Regents of the University of California, 2014. Available at:

Targeted Individuals Canada. Cincinnati radiation experiments, 2011. Available at:

Randi Zlotnik Shaul. Reviewing the reviewers: the vague accountability of research ethics committees. Crit Care. 2002;6(2):121-2.

Randi Zlotnik Shaul, Shelley Birenbaum, Megan Evans. Legal liabilities in research: early lessons from North America. BMC Med Ethics. 2005;6:4.

Karen S. Thiel. Parental consent for children’s participation in biomedical research: the Ethical, Regulatory, and Judicial Framework of Grimes v. Kennedy Krieger Institute, Inc. J Health Care L. Pol’y. 2002;6:169.

Stephen F. Hanlon, Robyn S. Ethical issues in biomedical research: Diaz v. Hillsborough County Hospital Authority. JSTOR Hum Rights. 2003;30(2 Spring):16-8.

Micah R. Onixt, Robyn L. Sterling. Institutional review board liability for adverse outcomes. AMA J Ethics: Virtual Mentor. 2009 Apr;11(4):306-10.

Laura Lin, Bryan A. Liang. Wright v. Fred Hutchinson Cancer Center: maintaining patient and public trust in clinical research. AMA J Ethics: Virtual Mentor. 2004;6(11):41.

Lily Srivastava. Law and medicine. In: Lily Srivastava, eds. A Book. 2nd ed. New Delhi, India: Universal Law Publishing; 2013.

DLL Suite. Career reagent by four days to earn 4000 yuan for a living willing mice, 2012. Available at:

FBI. New Jersey Company pleads guilty to kickback and conspiracy charges and is sentenced to pay more than $22 million in criminal fines plus $2.4 million civil payment, 2009. Available at:

Katherine Fisher, Earlee Heath, Karo I. Loy. IN The United States District Court for the Northern District of Oklahoma, 2002. Available at:

Libcom. ‘Glaxo builds bonny babies!’ Unless you’re Argentinian, of course, 2012. Available at:

Central Information Commission. Mr. R. Rajendran vs. Directorate of General of Health, January 2012. Available at: