Jurisdiction - India
Reports and Analysis
India – Notification On Compensation To Clinical Trial Subjects.

19 February, 2013


The Ministry of Health and Family Welfare (“MoHFW”), has notified the Drugs and Cosmetics (First Amendment) Rules, 2013 (“Amendment Rules”) on January 30, 2013 laying down the procedure to be followed for calculating compensation in case of injury or death during a clinical trial. The Amendment Rules follow the draft rules notified by the MoHFW in November 2011 to prescribe compensation for injury or death of clinical trial participants.


In terms of the Amendment Rules, made part of the Drugs and Cosmetics Rules, 1945 (“DC Rules”), the compensation for clinical trial related injury or death may be in the form of:


a. payment for medical management;

b. financial compensation for trial related injury;

c. financial compensation to nominee(s) of the subject, in the event of death of the subject; and                 

d. financial compensation for the child injured in-utero because of parent’s participation in the clinical trial.


The Amendment Rules lay down the instances, the occurrence of which would imply that the injury or death is related to clinical trial, and the subject or his/her nominee would be entitled to financial compensation. Such instances, inter alia, include violation of approved protocol, scientific misconduct or negligence by the Sponsor, adverse effect of the investigational product, and failure of the investigational product to provide intended therapeutic effect. Interestingly, the instances also include injury or death occurring in clinical trial due to the use of placebo and any clinical trial procedure involved in the study.


The Amendment Rules have, by amendment to the Schedule ‘Y’ of the DC Rules, prescribed for additional responsibilities of the Sponsors, Investigators and the Ethics Committees to cover cases pertaining to clinical trial related injuries and deaths. The Amendment Rules lay down that the Investigators have to notify the serious adverse events of death to the Licensing Authority, the Sponsor and the Ethics Committee within twenty four hours of their occurrence, and an independent Expert Committee constituted by the Licensing Authority should examine the cases and recommend the quantum of compensation in cases of death. Constitution of Expert Committee in cases of serious adverse events other than death appears optional for the Licensing Authority.


It is noteworthy that the Amendment Rules do not discuss quantum of the compensation to be paid to the clinical trial participants/their nominees, as the issue is expected to be addressed by the Central Drugs Standard Control Organization separately, following the public opinion and suggestions it solicited on the corresponding Guidelines issued on August 3, 2012 (reported in an earlier article).


The Amendment Rules are expected to evoke mixed responses from the industry, clinical trial professionals and the patient advocacy groups. 



For further information, please contact:


Alishan Naqvee, Partner, LexCounsel
Dhruv Manchanda, LexCounsel


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