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New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee
Neelu Singh1, Nivedita J Madkaikar2, Partha M Gokhale3, Deven V Parmar4
1 Department of Clinical Research, Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India
2 Department of Clinical Development, Abbott Healthcare Private Limited, Mumbai, Maharashtra, India
3 Department of Medical, Boehringer Ingelheim India Private Limited, Mumbai, Maharashtra, India
4 Department of Clinical research and Development, Clinical R and D, Zydus Discovery DMCC, Dubai, UAE
Correspondence Address:
Mrs. Neelu Singh
Department of Clinical Research, Zydus Research Centre, Cadila Healthcare Limited, Survey No. 396/403, Sarkhej-Bavla, N. H. No. 8A, Moraiya, Ahmedabad - 382 213, Gujarat
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/picr.PICR_208_19
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The New drugs and Clinical trials rules 2019 (New rules) was introduced on 19th March 2019 by Government of India. New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA). This document is divided into different sections like definitions and applicable chapter & schedules for EC; changes related to registration of clinical studies and biomedical and health research; changes related to constitution, functions, proceedings, responsibility of EC for clinical trial; maintenance of records by EC; suspension and cancellation of registration of EC, post-trial access of drugs, changes and clarity related to academic clinical trials and role of ECs in compensation and medical management process. |
