The Clinical Trials Toolkit has been designed by CDSA to provide guidance to researchers who are interested in conducting clinical trials in India. The purpose of the toolkit is to serve as an interactive roadmap and provide guidance and information on the various steps a researcher will need to keep in mind while planning a clinical trial in India.

The toolkit provides guidance on both academic and regulatory clinical trials. However, many of the steps are applicable to all types of research studies.

The toolkit has been adapted from the NIHR Clinical Trials Toolkit, and conceived considering the best practices in research in India and globally. It is in accordance with the Indian Drugs and Cosmetics Act, the New Drugs and Clinical Trials Rules, 2019 and the Good Clinical Practice Guidelines. Links to all relevant sites that provide information on existing guidelines and regulations have been provided wherever applicable. In the preparation of this toolkit, we have sought feedback from experts in different areas to try and ensure that the routemap is as comprehensive as possible and that the it is clear and easy to understand.

Recent Changes to the Toolkit

  • Notice issued by DCGI regarding the implementation of SUGAM online system for reporting of SAEs, can be accessed here. In addition, CDSCO has published a User Manual to help with navigating the SUGAM portal for SAE Reporting, which can be accessed here.
  • Updates to the Toolkit regarding Data Sharing in Clinical Trials, can be accessed here
  • COVID 19 Updates
  • On 19th March 2020, the Central Drugs Standard Control Organization, announced that in order to encourage the research and development of drug or vaccine for prevention or treatment of COVID-19, or in-vitro diagnostic kits for the diagnosis of COVID-19, will be processed on high priority. CDSCO shall also provide the required guidance for the regulatory pathway of such applications. Please refer to the circulars issued by the CDSCO, on the following links:
  • On 19th November 2019, the Indian Council of Medical Research (ICMR) released the National Guidelines for Gene Therapy Product Development and Clinical Trials.
  • On 12th September 2019, the Department of Health Research, Ministry of Health and Family Welfare (MoHFW) launched an online portal for the mandatory registration of Ethics Committees for Biomedical and Health Research involving human participants.
  • On 19th March 2019, MoHFW released the New Drugs and Clinical Trial Rules, 2019. The Clinical Trials Toolkit for India has been updated to reflect the New Drugs and Clinical Trial Rules, 2019.


We would welcome your feedback and suggestions on how we can improve the toolkit.

Please help to keep the toolkit up-to-date by reporting any out-of-date content or broken links.

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