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The Clinical Trials Registry-India (CTRI)

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April 18, 2023

Why in news?

The speedy approval of Covid-19 vaccines during the SARS-CoV-2 pandemic have raised questions regarding the transparency of the clinical trials and the safety and efficacy of the vaccines.

What is the Clinical Trials Registry-India (CTRI)?

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

  • CTRI is a free and online public record system for registration of clinical trials conducted in India.
  • It is hosted at the Indian Council of Medical Research's National Institute of Medical Statistics.
  • Initially it was launched on a voluntary basis in 2007.
  • In 2009, the Drugs Controller General of India (DCGI) mandated all trials to be registered in the CTRI.
  • CTRI is one of 17 public trial registries under the International Clinical Trials Registry Portal.
  • It is one of the 18 primary registries recognized by the World Health Organization (WHO).
  • Submission of Ethics approval and DCGI approval is essential for trial registration in the CTRI.

What trials should be registered under the CTRI?

  • Any trial involving human participants, of any intervention such as
    • Drugs,
    • Surgical procedures,
    • Preventive measures,
    • Lifestyle modifications,
    • Devices,
    • Educational / behavioral treatment
    • Rehabilitation strategies
    • Trials in the purview of AYUSH

What are the problems with CTRI?

  • Missing data - The record of enrollment with CTRI are inconsistent with only 281 of 606 (46%) trials being registered.
  • Classification - Classification of type of study is not defined in CTRI resulted in over 1,000 categories within the registry.
  • Optional - Classification of study is kept optional by CTRI leading to a large number of trials not providing this information.
  • Variations in names & organisations - Wrong spelling or different surnames can hinder the process of identifying this important individual.
  • Misleading information - Wrong data about whether a trial is registered prospectively or retrospectively can be classified as misleading information.

What can be done?

  • Unregistered – Trials, even though they have an India component, registered in other registries such as US, breaking the mandatory registration.
  • CTRI doesn’t have the power to make a trialist register but the Central Drugs Standard Control Organisation (CDSCO), can do so.
  • WHO regulations - Adhering to the WHO requirements can improve the registration of trials. Currently, India ranks 11 out of 18 registries.
  • Permanent body - Make it a permanent activity with staff on a 5-year contract.
  • Currently, the registry is a non-permanent activity of the ICMR with a ‘temporary’ staff of 15 years.

Other measures

  • Registration of trials accurately
  • Improving its inner workings for CTRI
  • Bringing all the documentation in one platform
  • Allow public access to the registry

Quick facts

International Clinical Trials Registry Platform (ICTRP)

  • ICTRP facilitates the prospective registration of the WHO Trial Registration Data Set on all clinical trials and the public accessibility of that information.
  • It is recognized as a primary registry by the World Health Organization.
  • The CTRI is one of 17 public trial registries under the International Clinical Trials Registry Portal.
  • In total it recognizes 18 registries with the registry of the U.S., ClinicalTrials.gov (CT.gov), which is recognized only as a data provider.

Central Drugs Standard Control Organization (CDSCO)

  • The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority (NRA) of India.
  • It is under Directorate General of Health Services, Ministry of Health & Family Welfare.
  • Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization.
  • CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories.
  • CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
  • The functions of CDSCO includes
    • Approval of new drugs and clinical trials,
    • Import registration and licensing of drugs,
    • License approving of blood banks, vaccines and r-DNA products,
    • Banning of drugs and cosmetics,
    • Grant of test license and personal license for drugs export,
    • Testing of new drugs.



  1. The Hindu│CTRI
  2. CDSCO│About CDSCO
  3. CTRI│About CTRI
  4. ICTRP│About ICTRP
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