To provide guidance to applicants and reviewers of applications, for approval of clinical trials and marketing (import, manufacture, sale) of investigational new drugs (IND) and new drugs (ND) in the country, the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly developed a 'Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India'.

This handbook is developed to increase efficiency and quality of review and highlights regulatory, administrative, and scientific review processes that should be followed by applicants and reviewers of new drugs/ clinical trials. It emphasizes the critical elements of pharmaceutical, preclinical, toxicological, clinical and prescribing information data to be submitted. It focuses on evaluation of the application for risk vis a vis benefit, innovation vis a vis existing therapies, unmet medical need, ethical aspects of patient safety and India specific concerns.

Developing of this handbook is significant as 'Make in India', Skill development and Universal health coverage initiatives of government of India have provided opportunities and incentives for new drug development in India. The Governing Council of ICMR in its meeting held on 16th January 2016, emphasized importance of clinical trials in new drug development. Approval for clinical trials and import, manufacture and sale of new drugs is granted by the COSCO, assisted by critical appraisal from subject expert committees and evaluation by ICMR.  In view of the increase in new drug development, it was felt that there is need to enhance capacity for regulatory review of clinical trials in the country.

The handbook will be dynamic and will undergo revisions in line with developments and changes in regulations. It will be available on ICMR and COSCO websites and form the backbone of the capacity building workshops for subject experts who review applications for clinical trials of new drugs.