ArticleHealth research policy and systems2025
Clinical trial registration in India: 12% of drug regulatory trials are not registered, as required by law.
Article in Health research policy and systems, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- A literature review and reflection on clinical trials: current challenges, future directions, and potential strategies to overcome practical barriers.AME clinical trials review · 2026Article
- Clinical trial registration in India: 12% of drug regulatory trials are not registered, as required by law.Health research policy and systems · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAmongst other things, the drug regulator, Central Drugs Standard Control Organization (CDSCO), is responsible for regulating clinical trials that underlie drug approvals in India. Since 2009, CDSCO has mandated that all regulatory clinical trials be registered with the Clinical Trials Registry - India (CTRI). In this study, we aimed to determine whether regulatory trials, for which CDSCO had given permission, were registered with CTRI as required. We also aimed to quantify missing CTRI records, if any.
methodsThis study involved regulatory trials, for which CDSCO permission letters were available. The permission letters, available as portable document format (PDF) files, were analysed to extract trial titles and protocol numbers. These data were then used to search the CTRI database, which was initially downloaded on 19 January 2024 and updated in August 2024, for matching records. The matches were confirmed by cross-referencing titles and protocol numbers, ignoring protocol version variations.
resultsOf the 381 trials examined, 335 (88%) had corresponding CTRI records, whereas 46 (12%) did not.
conclusionsThis study highlights that not all regulatory trials approved by CDSCO are registered with CTRI, despite legal requirements. The absence of a significant number of trials from CTRI raises concerns about transparency in the clinical trial enterprise in India. To improve trust and regulatory compliance, it is essential to establish explicit linkages between CDSCO and CTRI records to avoid the challenges of identifying matches. This study contributes to ongoing efforts to increase transparency and accountability in clinical trial registration in India.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.