Compensation Issue in Clinical Trials Recent Indian Scenario
DOI:
https://doi.org/10.48165/Keywords:
Serious Adverse Events, Clinical Trial, Compensation,, Drug and Cosmetic ActAbstract
Hon’ble Supreme Court has shown its concern for protection of human rights of those who were the research participants for clinical trials and suffered either death or serious adverse events. These research participants had not given adequate compensation or no compensation at all. A Public Interest Litigation (PIL) has been filed in the Supreme Court of India in the year 2012 by a NGO, consequently a committee has been constituted by the Ministry of Health and family Welfare, government of India to look into the matter of compensation. Recently a formula to determine the quantum of compensation in the cases of clinical trial related Serious Adverse Events (SAEs) including deaths occurring during clinical trials have been evolved by a committee formed under the Drugs and Cosmetics Rules. This research paper deals with critical issue of compensation in clinical trial related SEAs including deaths of the research participants and initiative taken by the concern authorities including the directions given by the Supreme Court of India from time to time and provisions in the Drugs and Cosmetics (Amendment) Bill, 2013.
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References
Dhananjay Mahapatra.2644 died during clinical trials during 7 years. The Times of India, Oct, 2012
Hon'ble Mr. Justice R.M. Lodha, Hon'ble Mr. Justice Anil R. Dave. Swasthya Adhikar Manch, Indore & Anr. vs. Min. of Health & Family Welf. & Ors. WP (C) 33 of 2012, Order dated: 3rd January 2013, with W.P(C)No.79 of 2012, http://courtnic.nic.in/supremecourt/temp/wc%203312p.txt],
10.2012, 26.7.13
Ethical Guidelines for Biomedical Research on Human Participants Indian Council of Medical Research, New Delhi, 2006
The Drugs and Cosmetic (Amendment) Bill, 2013 (Bill No. LVIII of 2013)
The Indian Medical Council (Professional Conduct, Ethics & Etiquettes) Regulations, 2002, 7.22, CHAPTER 7: MISCONDUCT 6. Minutes of the meeting of the Ethics Committee held on 20th November, 2012 at 09:00 A.M. in the Council Office, Sector - 8, Pocket- 14, Dwarka, New Delhi – 77. Available at: http://www.mciindia.org/meetings/Ethics/2012/Minutes_20.11.2012. pdf
Pawan Kumar Bansal. Politicians who exposed malpractices in medical sector. Available at: http://www.merinews.com/article/politicians-who-exposed malpractices-in-medical
sector/15894017.shtml#sthash.ctMh8LEV.fHC3L1ZZ.dpuf
MP Chief Secy cites laws to not submit drug trials report. The Times of India, Feb 1, 2012: 11.
Unfair practices: Pharma cos fined €13bn in 4 years. The Times of India, July 16, 2012.
Safdrajung hospital case. Dainik Jagran, June, 1, 2013. 11. Rema Nagarajan. ‘Unethical’ clinical trial leaves 254 women dead. The Times of India, April 21, 2014: 2, 8.
Dhananjay Mahapatra. ‘Why no relief for those hit diversely by clinical trials?’. The Times of India, April 22, 2014: 8.
The Drugs and Cosmetics Rules have been amended vide GSR 53(E) dated 30-01-2013, Notification dated: 30.09.2013
The Drugs and Cosmetics Rules have been amended vide GSR 63(E) dated 30-01-2013, Notification dated: 30.09.2013
The Drugs and Cosmetics Rules have been amended vide GSR 572E) dated 30-01-2013, Notification dated: 30.09.2013
The Workmen’s Compensation Act, 1929
The Railway Accident and Untoward Incidence (Compensation) Rules, 1990.
Appendix XII of the Schedule Y to the Drug & Cosmetics Rules 1945 on 14th March, 2013.
