Regulatory legal for foreign CROs and sponsors running trials in India.
India is a major destination for clinical research, and a foreign sponsor or contract research organisation can operate here, but every trial runs through the New Drugs and Clinical Trials Rules 2019, which govern approval, ethics-committee oversight, informed consent, compensation for trial-related injury, and the conduct of the study. The DCGI approval, the registered ethics committee, and the compensation framework are non-negotiable, and the rules impose timelines and accountability that a sponsor must build into the trial from the protocol stage.
The sensitivity of health data adds a DPDPA layer, because trial data is personal data and often sensitive, requiring lawful basis, security, and cross-border-transfer discipline. We manage the regulatory approvals and ethics-committee arrangements, structure the sponsor, CRO, site, and investigator contracts with clear allocation of the compensation and liability obligations, and build the health-data compliance so the trial is both regulatorily sound and data-protection compliant.
Managing DCGI and CDSCO approvals and the regulatory pathway under the New Drugs and Clinical Trials Rules 2019.
Structuring registered ethics-committee oversight and the informed-consent process the rules require.
Building the trial-injury compensation framework and allocating the obligation among sponsor, CRO, and site.
Drafting the sponsor, CRO, site, and investigator agreements with clear liability, indemnity, and IP allocation.
Building DPDPA-compliant handling of trial data, including lawful basis, security, and cross-border transfer.
Structuring the foreign sponsor or CRO entity and its FDI and FEMA position.
Yes, subject to the New Drugs and Clinical Trials Rules 2019. The trial needs DCGI approval, registered ethics-committee oversight, compliant informed consent, and a trial-injury compensation framework. These requirements must be built into the protocol and the contracts from the outset.
The rules impose a compensation obligation for trial-related injury or death, and the allocation among the sponsor, the CRO, and the site must be set out clearly in the contracts. This is a central commercial and legal issue in structuring an Indian trial.
Yes. Trial data is personal data and frequently sensitive health data, so the DPDPA applies to its collection, processing, security, and cross-border transfer. The trial must have a lawful basis and appropriate safeguards, in addition to the clinical-trial regulatory requirements.
No. No engagement is treated as accepted until conflicts, scope and terms are confirmed in writing. An initial discussion is confidential and is used only to understand the matter and assess fit.
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