Examples
Worked examples
- Is an instance
A pharmaceutical sponsor running a Phase III trial in India registers it in CTRI before enrolling the first participant, receiving a CTRI/YYYY/MM/NNNNNN identifier.
- Is an instance
An Indian medical journal, following its editors' 2008 pledge, declines to publish results from a trial with no CTRI (or other WHO-recognized) registration.
Counter-examples
Looks similar, but isn't
- Not an instance
Registering a trial in CTRI only after enrollment has already begun -- CTRI does not accept retrospective registration; the requirement is specifically prospective.
- Not an instance
Treating CTRI registration as optional for trials seeking India's Central Drugs Standard Control Organisation (Drugs Controller General) approval -- it has been a regulatory requirement, not a best practice, since the New Drugs and Clinical Trials Rules, 2019.
Editorial commentary
CTRI, the Clinical Trials Registry – India, is India’s national public registry for clinical trials, launched on July 20, 2007. It is operated by the Indian Council of Medical Research (ICMR), hosted at ICMR’s National Institute for Research in Digital Health and Data Science (the former National Institute of Medical Statistics, NIMS), with initial funding jointly from the Department of Science and Technology, ICMR, and the World Health Organization.
Last verified August 25, 2026 against CTRI’s WHO ICTRP registry profile and CTRI’s own about/FAQ pages.
WHO ICTRP Primary Registry Status
CTRI is a designated Primary Registry within the WHO International Clinical Trials Registry Platform (ICTRP) network, alongside ClinicalTrials.gov, ISRCTN, ANZCTR, ChiCTR, and others. As a primary registry, CTRI’s data collection follows the WHO Trial Registration Data Set and ICMJE’s trial registration requirements, and its records feed automatically into the WHO’s global ICTRP search portal alongside every other primary registry’s data, without a trial needing to be separately registered with WHO itself.
Mandatory Registration: From Best Practice to Legal Requirement
CTRI registration began as a voluntary measure in 2007. India’s Central Drugs Standard Control Organisation (Drugs Controller General of India) made registration mandatory effective June 15, 2009. That requirement moved from regulatory order to statutory rule with the introduction of the New Drugs and Clinical Trials Rules, 2019, which formalized clinical trial registration as a legal condition rather than a Drugs Controller General policy alone. Following a 2018 review that found registration violations still occurring, CTRI reiterated the prospective-registration requirement to sponsors and investigators.
Registration must be prospective — completed before the first participant is enrolled. CTRI does not accept retrospective registration of trials that have already begun enrolling.
What Registration Requires
A CTRI application requires submission of both Ethics Committee approval and Drugs Controller General of India (DCGI) approval as a precondition of registration, alongside the standard WHO Trial Registration Data Set fields: intervention and comparator details, primary and secondary outcomes, eligibility criteria, target sample size, recruitment status, and sponsor/investigator information.
CTRI Identifier Format
A registered trial receives a permanent identifier in the format CTRI/YYYY/MM/NNNNNN — the four-digit registration year, the two-digit month, and a sequential number (for example, CTRI/2020/06/026192). The identifier does not change even if the trial’s status is later updated (completed, terminated, or withdrawn).
CTRI and Journal Publication (ICMJE)
The ICMJE’s 2004 recommendation that member journals only publish trials registered in a WHO-recognized primary registry has direct local enforcement in India: in February 2008, Indian medical journal editors pledged not to publish results from unregistered Indian trials, reinforcing CTRI’s role as the default registry Indian researchers use to satisfy that publication precondition.
CTRI vs. Other National Registries
CTRI plays the same structural role for India-based trials that ISRCTN plays for UK-sponsored trials or ChiCTR plays for China-based trials: a nationally-operated registry that independently satisfies WHO ICTRP and ICMJE requirements. A multi-country trial with Indian sites frequently registers in both CTRI and ClinicalTrials.gov (or another applicable registry) when it also has US-regulated sites, since each registry answers a different jurisdiction’s requirement — see CASRAI’s CDSCO clinical trial approval pathway guide for how CTRI registration fits into India’s broader regulatory-authorization process.
Why This Matters for Research Administration
For research administrators supporting India-based or India-inclusive multi-country trials, CTRI registration is a gating step that must be completed before enrollment, not a documentation task that can trail behind study start-up — unlike some registries where a short administrative grace period is tolerated in practice, CTRI’s prospective-registration rule is actively enforced by both the Drugs Controller General’s regulatory authority and Indian journals’ independent editorial policy.
Frequently Asked Questions
Is CTRI registration mandatory?
Yes. It has been mandatory since a June 15, 2009 order from India’s Drugs Controller General, and is now on a statutory footing under the New Drugs and Clinical Trials Rules, 2019.
Can a trial be registered in CTRI after enrollment has started?
No. CTRI requires prospective registration, completed before the first participant is enrolled.
Who operates CTRI?
The Indian Council of Medical Research (ICMR), hosted at ICMR’s National Institute for Research in Digital Health and Data Science.
Does CTRI registration satisfy ICMJE’s trial-registration requirement for publication?
Yes. CTRI is a WHO ICTRP primary registry, and ICMJE accepts registration with any WHO-recognized primary registry, not ClinicalTrials.gov specifically.
References
- WHO ICTRP, “Registry Profile: Clinical Trials Registry – India (CTRI)” (2023).
- Clinical Trials Registry – India, official site (ctri.nic.in): about and FAQ pages.
- New Drugs and Clinical Trials Rules, 2019, Government of India.
- Bhide et al., “How to Register a Clinical Trial in India?,” Indian Journal of Dermatology.
Also known as
Clinical Trials Registry - India · CTRI number
Machine-readable encodings
Use in your systems
<role vocab="credit"
vocab-identifier="https://casrai.org/dictionary/"
vocab-term="CTRI (Clinical Trials Registry – India)"
vocab-term-identifier="https://casrai.org/dictionary/term/ctri-clinical-trials-registry-india" />{
"@context": "https://schema.org",
"@type": "DefinedTerm",
"@id": "https://casrai.org/dictionary/term/ctri-clinical-trials-registry-india",
"name": "CTRI (Clinical Trials Registry - India)",
"identifier": "https://casrai.org/dictionary/term/ctri-clinical-trials-registry-india",
"description": "The Clinical Trials Registry - India (CTRI) is India's national clinical trial registry, established on July 20, 2007 and operated by the Indian Council of Medical Research (ICMR), currently hosted at ICMR's National Institute for Research in Digital Health and Data Science (formerly NIMS), and recognized as a WHO International Clinical Trials Registry Platform (ICTRP) primary registry. Registration is mandatory and must occur prospectively, before enrollment of the first participant; the requirement, initially a 2009 order from India's Drugs Controller General, was subsequently placed on a statutory footing by the New Drugs and Clinical Trials Rules, 2019.",
"inDefinedTermSet": "https://casrai.org/dictionary/domain/clinical-research#set",
"url": "https://casrai.org/dictionary/term/ctri-clinical-trials-registry-india",
"sameAs": [
"Clinical Trials Registry - India",
"CTRI number"
],
"license": "https://creativecommons.org/licenses/by/4.0/",
"publisher": {
"@id": "https://casrai.org/#organization"
},
"dateModified": "2026-08-25T05:40:18",
"inLanguage": "en"
}
