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39. Compensation in case of injury or death in clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug.
(1) Where any death of a trial subject occurs during a clinical trial or bioavailability or bioequivalence study, the legal heir of the trial subject shall be provided financial compensation by the sponsor or its representative, who has obtained permission to conduct the clinical trial or bioavailability or bioequivalence study, in accordance with the procedure specified in rule 42
(2) Where permanent disability or any other injury occurs to a trial subject during a clinical trial or bioavailability or bioequivalence study, the trial subject shall be provided financial compensation by the sponsor or its representative, who has obtained permission to conduct the clinical trial or bioavailability or bioequivalence study, in accordance with the procedure specified in rule 42.
(3) The financial compensation referred to in sub-rule (1) or sub-rule (2) shall be in addition to any expenses incurred on medical management of the trial subject.
(4) In the event of an injury, not being permanent in nature, the quantum of compensation shall be commensurate with the loss of wages of the subject as provided in the Seventh Schedule.
(5) The sponsor or its representative shall give an undertaking along with the application for clinical trial permission to the Central Licencing Authority to provide compensation in the case of clinical trial related injury or death for which subjects are entitled to compensation.
(6) Where the sponsor or its representative, who has obtained permission to conduct clinical trial or bioavailability or bioequivalence study, fails to provide financial compensation, as referred to in sub-rule (1) or sub-rule (2), the Central Licencing Authority shall, after affording an opportunity of being heard, by an order in writing, suspend or cancel the clinical trial or bioavailability or bioequivalence study or restrict the sponsor including its representative, who has obtained permission to conduct clinical trial or bioavailability or bioequivalence study, to conduct any further clinical trial or bioavailability or bioequivalence study or take any other action for such period as considered appropriate in the light of the facts and circumstances of the case.
40. Medical Management in clinical trial or bioavailability and bioequivalence study of new drug or investigational new drug._ (1) Where an injury occurs to any subject during clinical trial or bioavailability and bioequivalence study of a new drug or an investigational new drug, the sponsor, shall provide free medical management to such subject as long as required as per the opinion of investigator or till such time it is established that the injury is not related to the clinical trial or bioavailability or bioequivalence study, as the case may be, whichever is earlier.
(2) The responsibility for medical management as referred to in sub-rule (1), shall be discharged by the sponsor or the person who has obtained permission from the Central Licencing Authority.
(3) Where the sponsor or its representative, who has obtained permission to conduct clinical trial or bioavailability or bioequivalence study, fails to provide medical management, as referred to in sub-rule (1), the Central Licencing Authority shall after affording an opportunity of being heard, by an order in writing, suspend or cancel the clinical trial or bioavailability or bioequivalence study or restrict the sponsor including its representative, who has obtained permission to conduct clinical trial or bioavailability or bioequivalence study, to conduct any further clinical trial or bioavailability or bioequivalence study or take any other action for such period as considered appropriate in the light of the facts and circumstances of the case.
41. Consideration of injury or death or permanent disability to be related to clinical trial or bioavailability and bioequivalence study._ Any injury or death or permanent disability of a trial subject occurring during clinical trial or bioavailability or bioequivalence study due to any of the following reasons shall be considered as clinical trial or bioavailability or bioequivalence study related injury or death or permanent disability, namely:-
(a) adverse effect of the investigational product;
(b) violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator leading to serious adverse event;
(c) failure of investigational product to provide intended therapeutic effect where, the required standard care or rescue medication, though available, was not provided to the subject as per clinical trial protocol;
(d) not providing the required standard care, though available to the subject as per clinical trial protocol in the placebo controlled trial;
(e) adverse effects due to concomitant medication excluding standard care, necessitated as part of the approved protocol;
(f) adverse effect on a child in-utero because of the participation of the parent in the clinical trial;
(g) any clinical trial procedures involved in the study leading to serious adverse event.
42. Procedure for compensation in case of injury or death during clinical trial, bioavailability and bioequivalence study._ (1) The investigator shall report all serious adverse events to the Central Licencing Authority, the sponsor or its representative, who has obtained permission from the Central Licencing Authority for conduct of clinical trial or bioavailability or bioequivalence study, as the case may be, and the Ethics Committee that accorded approval to the study protocol, within twenty-four hours of their occurrence; and if the investigator fails to report any serious adverse event within the stipulated period, he shall have to furnish the reasons for delay to the satisfaction of the Central Licencing Authority along with the report of the serious adverse event.
(2) A case of serious adverse event of death shall be examined in the following manner, namely:-
(i) the Central Licencing Authority shall constitute an independent expert committee to examine the cases and make its recommendations to the said authority for arriving at the cause of death and quantum of compensation in case of clinical trial related death;
(ii) the sponsor or its representative and the investigator shall forward their reports on serious adverse event of death after due analysis to the Central Licencing Authority and the head of the institution where the clinical trial or bioavailability or bioequivalence study has been conducted within fourteen days of the knowledge of occurrence of serious adverse event of death;
(iii) the Ethics Committee for clinical trial shall forward its report on serious adverse event of death after due analysis along with its opinion on the financial compensation, if any, determined in accordance with the formula specified in the Seventh Schedule, to be paid by the said sponsor or its representative, who has obtained permission from the Central Licencing Authority for conduct of clinical trial or bioavailability or bioequivalence study, as the case may be, to the Central Licencing Authority within a period of thirty days of receiving the report of the serious adverse event of death from the investigator;
(iv) the Central Licencing Authority shall forward the report of the investigator, sponsor or its representative and the Ethics Committee to the Chairperson of the expert committee;
(v) the expert committee shall examine the report of serious adverse event of death and make its recommendations available to the Central Licencing Authority for the purpose of arriving at the cause of the serious adverse event of death within sixty days from the receipt of the report of the serious adverse event, and the expert committee while examining the event, may take into consideration, the reports of the investigator, sponsor or its representative and the Ethics Committee for clinical trial;
(vi) in case of clinical trial or the bioavailability or bioequivalence study related death, the expert committee shall also recommend the quantum of compensation, determined in accordance with the formula specified in the Seventh Schedule, to be paid by the sponsor or his representative who has obtained the permission to conduct the clinical trial or the bioavailability or bioequivalence study, as the case may be;
(vii) the Central Licencing Authority shall consider the recommendations of the expert committee and shall determine the cause of death with regards to the relatedness of the death to the clinical trial or the bioavailability or bioequivalence study, as the case may be;
(viii) in case of clinical trial or the bioavailability or bioequivalence study related death, the Central Licencing Authority shall, after considering the recommendations of the expert committee, by order, decide the quantum of compensation, determined as per the formula specified in the Seventh Schedule, to be paid by the sponsor or its representative and shall pass orders as deemed necessary within ninety days of the receipt of the report of the serious adverse event;
(ix) the sponsor or its representative shall pay the compensation in case the serious adverse event of death is related to clinical trial or the bioavailability or bioequivalence study, as specified in the order referred to in clause (viii) of the Central Licencing Authority within thirty days of the receipt of such order.
(3) Cases of serious adverse events of permanent disability or any other injury other than deaths shall be examined in the following manner, namely:_
(i) the sponsor or its representative, and the Investigator shall forward their reports on serious adverse event, after due analysis, to the Central Licencing Authority, chairperson of the Ethics Committee for clinical trial and head of the institution where the trial or bioavailability or bioequivalence study has been conducted within fourteen days of the reporting of serious adverse event;
(ii) the Ethics Committee for clinical trial shall forward its report on serious adverse event of permanent disability or any other injury other than deaths, as the case may be, after due analysis along with its opinion on the financial compensation, if any, determined in accordance with the formula specified in the Seventh Schedule, to be paid by the sponsor or its representative who has obtained permission to conduct clinical trial or the bioavailability or bioequivalence study, as the case may be, within thirty days of receiving the report of the serious adverse event;
(iii) the Central Licencing Authority shall determine the cause of the injury and pass order as specified in clause (iv), or may constitute an independent expert committee, wherever it considers necessary, to examine such serious adverse events of injury, and such independent expert committee shall recommend to the Central Licencing Authority for the purpose to arrive at the cause of the serious adverse event and also the quantum of compensation, as determined in accordance with formula as specified in the Seventh Schedule in case of clinical trial or bioavailability or bioequivalence study related injury, within a period of sixty days of receipt of the report of the serious adverse event;
(iv) in case of clinical trial or the bioavailability or bioequivalence study related injury, the Central Licencing Authority shall, by order, decide the quantum of compensation, determined in accordance with the formula specified in the Seventh Schedule, to be paid by the sponsor or his representative who has obtained the permission to conduct the clinical trial or the bioavailability or bioequivalence study, as the case may be, within a period of ninety days of receipt of the report of the serious adverse event;
(v) the sponsor or its representative, who has obtained permission to conduct the clinical trial or bioavailability or bioequivalence study, as the case may be, shall pay the compensation in case of clinical trial or bioavailability or bioequivalence study related injury, as specified in the order of the Central Licencing Authority referred to in clause (iv) within thirty days of receipt of such order.
43. Medical management and compensation for injury or death relating to biomedical and health research overseen by an Ethics Committee for biomedical and health research as referred to in Chapter IV._
Notwithstanding anything contained in these rules, medical management and compensation for injury or death relating to biomedical and health research, overseen by an Ethics Committee for clinical trials as referred to in Chapter IV, shall be in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants specified by the Indian Council of Medical Research from time to time.
SEVENTH SCHEDULE
(See rules 39, 40, and 42 )
FORMULAE TO DETERMINE THE QUANTUM OF COMPENSATION IN THE CASES OF CLINICAL TRIAL RELATED INJURY OR DEATH
Compensation = (B x F x R) / 99.37
Where,
B = Base amount (i.e. 8 lacs)
F = Factor depending on the age of the trial subject as per Annexure 1 (based on Workmen Compensation Act)
R = Risk Factor depending on the seriousness and severity of the disease, presence of co-morbidity and duration of disease of the trial subject at the time of enrolment in the clinical trial between a scale of 0.5 to 4 as under:
However, in case of patients whose expected mortality is 90% or more within 30 days, a fixed amount of Rs. 2 lacs should be given.
(i) A permanent disability: In case of SAE causing permanent disability to the trial subject, the quantum of compensation in case of 100% disability shall be 90% of the compensation which would have been due for payment to the nominee (s) in case of death of the trial subject. The quantum for less than 100% disability will be proportional to the actual percentage disability the trial subject has suffered.
Accordingly, following formula shall be applicable for determination of compensation:
Compensation = (C x D x 90) / (100 x 100)
Where:
D = Percentage disability the trial subject has suffered.
C = Quantum of Compensation which would have been due for payment to the trial subject’s nominees) in case of death of the trial subject.
(ii) Congenital anomaly or birth defect: The congenital anomaly or birth defect in a baby may occur due to participation of anyone or both the parent in clinical trial. Following situations may arise due to congenital anomaly or birth defect.
The compensation in such cases would be a lump sum amount such that if that amount is kept by way of fixed deposit or alike, it shall bring a monthly interest amount which is approximately equivalent to half of minimum wage of the unskilled worker (in Delhi). The quantum of compensation in such cases of SAE shall be half of the base amount as per formula for determining the compensation for SAE resulting into death.
In case of birth defect leading to sub-clause (c) and (d) of this clause to any child, the medical management as long as required shall be provided by the Sponsor or his representative which will be over and above the financial compensation.
(iii) Chronic life-threatening disease; and
(iv) Reversible SAE in case it is resolved.
In case of clinical trial related SAE causing life-threatening disease and reversible SAE in case it is resolved, the quantum of compensation would be linked to the number of days of hospitalisation of the trial subject. The compensation per day of hospitalization shall be equal to the wage loss. The wage loss per day shall be calculated based upon the minimum wage of the unskilled worker (in Delhi).
Since, in case of hospitalisation of any patient not only the patient loses his/her wage, there will be direct or indirect losses of various kind including inconvenience, wage loss of attendant, etc. The compensation per day of hospitalization in such case shall be double the minimum wage. Accordingly, following formula shall be applicable for determination of compensation:
Compensation = 2 X W X N.
Where,
W = Minimum wage per day of the unskilled worker (in Delhi)
N = Number of days of hospitalization
Annexure 1
Factor (F) for calculating the amount of compensation
| Age | Factor |
|---|---|
| Not more than… | |
| 16 | 228.54 |
| 17 | 227.49 |
| 18 | 226.38 |
| 19 | 225.22 |
| 20 | 224.00 |
| 21 | 222.71 |
| 22 | 221.37 |
| 23 | 219.95 |
| 24 | 218.47 |
| 25 | 216.91 |
| 26 | 215.28 |
| 27 | 213.57 |
| 28 | 211.79 |
| 29 | 209.92 |
| 30 | 207.98 |
| 31 | 205.95 |
| 32 | 203.85 |
| 33 | 201.66 |
| 34 | 199.40 |
| 35 | 197.06 |
| 36 | 194.64 |
| 37 | 192.14 |
| 38 | 189.56 |
| 39 | 186.90 |
| 40 | 184.17 |
| 41 | 181.37 |
| 42 | 178.49 |
| 43 | 175.54 |
| 44 | 172.52 |
| 45 | 169.44 |
| 46 | 166.29 |
| 47 | 163.07 |
| 48 | 159.80 |
| 49 | 156.47 |
| 50 | 153.09 |
| 51 | 149.67 |
| 52 | 146.20 |
| 53 | 142.68 |
| 54 | 139.13 |
| 55 | 135.56 |
| 56 | 131.95 |
| 57 | 128.33 |
| 58 | 124.70 |
| 59 | 121.05 |
| 60 | 117.41 |
| 61 | 113.77 |
| 62 | 110.14 |
| 63 | 106.52 |
| 64 | 102.93 |
| 65 or more
|
99.37 |