Your rights in a clinical trial in India

Indian law protects people who take part in clinical trials.

Before you join

• The trial must be approved by an ethics committee
• It must be listed on CTRI, India's trial registry
• You must be told everything in a language you understand, then sign only if you agree

During the trial

• You can leave at any time, without giving a reason
• Leaving does not stop your usual care

If you are harmed

• The New Drugs and Clinical Trials Rules, 2019 provide medical care and compensation for trial-related injury

Sources

• CDSCO: New Drugs and Clinical Trials Rules, 2019
• Clinical Trials Registry – India (CTRI)