Clinical Trial Registry of India (CTRI)

Definition, host & mandate

• Clinical Trials Registry – India (CTRI) — a free, online, publicly accessible record system (ctri.nic.in) for the prospective registration of clinical trials and related studies conducted in India.
• What a trial registry is — a publicly accessible database that records a defined minimum dataset of administrative and scientific information about a trial, ideally before the first participant is enrolled.
• Host / custodian — hosted, developed and maintained by the ICMR–National Institute for Research in Digital Health (NIRDH, formerly NIMS), a division of the Indian Council of Medical Research (ICMR).
• Origin & mandate — launched 20 July 2007 as a voluntary registry; registration was made mandatory by the DCGI with effect from 15 June 2009.
• Mission — ensure that all clinical trials in India are prospectively registered with full disclosure of the WHO-mandated dataset before the first participant is enrolled.
• Scope of registrable studies — broad — interventional trials of drugs, vaccines, devices, surgical/behavioural/educational interventions; bioavailability/bioequivalence (BA/BE) studies; observational/epidemiological and post-marketing surveillance studies.
• Terminology caution — CTRI "registration" means trial registration in a registry — distinct from the "pre-/post-registration" of pharmacology textbooks, which means product licensing / marketing authorisation. Do not conflate.