Free medical management
For any injury during the trial, the sponsor provides free medical management for as long as the investigator considers it necessary, or until the injury is shown to be unrelated to the trial, whichever is earlier.
Rule 40(1)If a participant is injured or dies because of a clinical trial, Indian law requires the sponsor to provide free medical management and financial compensation. Here is how it works under the New Drugs and Clinical Trials Rules, 2019.
Rules 39 and 40 of the NDCT Rules, 2019 place the responsibility for medical care and compensation on the trial sponsor — not on the participant.
For any injury during the trial, the sponsor provides free medical management for as long as the investigator considers it necessary, or until the injury is shown to be unrelated to the trial, whichever is earlier.
Rule 40(1)Where permanent disability or any other injury occurs, the trial participant receives financial compensation from the sponsor.
Rule 39(2)Where a participant dies, financial compensation is paid to their legal heir by the sponsor.
Rule 39(1)Financial compensation is in addition to any expenses incurred on the participant’s medical management.
Rule 39(3)The quantum of compensation is fixed by formula. Because loss of life is the maximum injury possible, compensation for any other serious adverse event (SAE) cannot exceed what would have been paid in case of death.
| R | Participant at enrolment |
|---|---|
| 0.5 | Terminally ill (expected survival not more than 6 months) |
| 1.0 | High risk (expected survival 6–24 months) |
| 2.0 | Moderate risk |
| 3.0 | Mild risk |
| 4.0 | Healthy volunteer or no-risk participant |
For 100% disability, compensation is 90% of the amount that would have been paid in case of death.
For less than 100% disability, compensation is proportional to the actual percentage of disability suffered.
A congenital anomaly or birth defect in a baby may occur because one or both parents took part in a trial. This covers:
The amount is set so that, kept as a fixed deposit, it would earn monthly interest roughly equal to half the minimum wage of an unskilled worker in Delhi.
Compensation is linked to the number of days in hospital. Each day of hospitalisation is compensated at double the minimum daily wage.
The doubling recognises that hospitalisation causes more than the participant’s own wage loss — including inconvenience and the wage loss of an attendant.
See how the death and permanent-disability formulas work for a given age and risk category. This is for understanding only — the actual amount is decided by the Central Licencing Authority.
Does not apply where expected mortality is 90% or more within 30 days (fixed ₹2 lakh).
Every serious adverse event is reported and reviewed independently. For a trial-related death, the process runs as follows:
Investigator reports the SAE to the Central Licencing Authority, sponsor and Ethics Committee.
Sponsor and investigator forward their analysed reports to the Authority and head of the institution.
EC sends its report and opinion on compensation, per the Seventh Schedule formula.
An independent expert committee recommends the cause and quantum of compensation.
The Central Licencing Authority decides relatedness and the amount, by order.
The sponsor pays the compensation within 30 days of receiving the order.
For permanent disability or other injury, a similar process applies; the Authority may refer the case to an expert committee where necessary. If a sponsor fails to pay or provide medical management, the Authority can suspend or cancel the trial or restrict the sponsor from further trials.
If you have any concern about an injury or side effect during a trial, inform your study doctor or the Clinical Research Centre team immediately.
Summary prepared by the Clinical Research Centre, KG Hospital, from Rules 39–42 and the Seventh Schedule of the New Drugs and Clinical Trials Rules, 2019 (CDSCO, Government of India). It is for general information only and is not legal advice. Compensation in any individual case is determined by the Central Licencing Authority in accordance with the Rules.