Trial permission, Ethics Committee coordination and CTRI registration under the New Drugs and Clinical Trials Rules, 2019.
The New Drugs and Clinical Trials Rules, 2019 reorganised how trials are permitted and overseen in India, including defined timelines for CDSCO decisions and clearer obligations around compensation and Ethics Committee registration.
The sequence matters. Ethics Committee approval, CDSCO permission and registration with the Clinical Trials Registry – India each have their place, and enrolment must not begin before the required steps are complete. Getting that order wrong is one of the more expensive procedural mistakes available.
Trial permission applications, Ethics Committee submissions and coordination, CTRI registration, protocol and informed consent documentation, site readiness, and the records that stand up to inspection afterwards.
The NDCT Rules place real weight on informed consent, on compensation for trial-related injury, and on the Ethics Committee's continuing oversight rather than a single approval at the start. Treating these as filing exercises is how sponsors end up with findings that are difficult to remediate after the fact.
Tell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
Talk to our regulatory team