Clinical Trials Registry – India (CTRI)

• Clinical Trials Registry – India (CTRI) is the government of India's official clinical trial registry.
• The National Institute of Medical Statistics of the Indian Council of Medical Research established the CTRI on 20 July 2007.
• Since 2009 the Central Drugs Standard Control Organization has mandated that anyone conducting clinical trials in India must preregister before enrolling any research participants.
• The CTRI requests all the information which the World Health Organization recommends for clinical trial registries.
• Additionally, the CTRI collects information specific to the circumstances of India, including

1. the address of the principal investigator,
2. the name of the ethics committee overseeing the trial and confirmation of their government registration;
3. proof of permission from the Drugs Controller General of India, the expected end date of the trial;
4. all study sites; and
5. the method of randomizing participants and the allocation concealment.

• The World Health Organization Registry for clinical trials helped make the Indian registry more effective.

Ayurveda Dataset on CTRI Portal

• Marking a significant step towards worldwide visibility for Ayurveda based clinical trials, the Ayurveda dataset on CTRI Portal will be launched online tomorrow by Ayush Minister Shri Kiren Rijiju.
• This Ayurveda Dataset of CTRI has been jointly developed by ICMR and CCRAS, Ministry of Ayush.
• The Minister will also launch four more Portals, all developed by the Central Council for Research in Ayurvedic Sciences (CCRAS).
• CTRI is a primary register of Clinical Trials under WHO’s International Clinical Trials Registry Platform (ICTRP) and creation of Ayurveda dataset in CTRI facilitates usages of Ayurveda terminologies to record clinical study meta data based on Ayurveda interventions. Until now the clinical trials in Ayurveda were dependent on terminology borrowed from modern medicine.
• The key feature of this digital platform is the provision of selection of the Ayurveda Health conditions from drop down of 3866 Ayurveda morbidity codes incorporated from the NAMASTE portal (a portal developed by the AYUSH Ministry) in which morbidity statistics pertaining to Ayurveda has been classified according to International Classification of Diseases standards.
• It means, now the information, results etc. of Ayurveda Clinical Trials will be available in Ayurvedic vocabulary in the clinical trials registry of India.

Why is the Clinical Registry important?

• Clinical trials are being done continuously in the world for new drug discovery, treatment of diseases etc.
• The problem is that the results of these tests are not publicly available and due to this there is a possibility of not having accurate information about the trials.
• In view of this, the World Health Organization made it mandatory to create an online registry of clinical trials.
• In India this work is being done through CTRI and this registry is also part of the World Health Organization registry.
• The four more portals that will also be launched tomorrow are AMAR, SAHI, e-MEDHA and RMIS. All of these are primarily developed by CCRAS while RMIS is a collaborative effort of ICMR and CCRAS.