About This Policy
Clinical Trials Liability Insurance protects companies and investigators against claims from trial participants who suffer harm during research. It is mandatory for clinical trials in India.
What's Covered
The policy covers legal liability for injury, illness, or death of trial participants arising from the administration or testing of drugs, medical devices, or other interventions as part of the approved clinical trial. It includes compensation payable as per DCGI guidelines, legal costs incurred in defending claims, and related medical expenses. Coverage is typically defined per subject, per trial, and per occurrence. Extensions are available for multi-site or multi-country trials.
Key Features
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Key Features
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Covers bodily injury, illness, or death of trial subjects, Includes compensation, medical expenses, and legal defence costs, Mandatory per DCGI (Drugs Controller General of India) for trials in India, Policy issued per trial protocol, site, and number of participants, Worldwide jurisdiction possible for multinational trials, Can be extended to cover ethics committee liability
Who Should Buy?
Pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), Hospitals, academic research institutions conducting trials, Principal Investigators (if not covered by sponsor)