Open AccessCurrent status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases
Author(s) -
Tushar B Nishandar,
Amit Ravindra Birajdar,
Nithya J Gogtay,
Urmila M Thatte
Publication year - 2019
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/picr.picr_93_18
Subject(s) - accreditation , medicine , clinical trial , audit , family medicine , institutional review board , control (management) , population , conflict of interest , business , accounting , political science , medical education , environmental health , management , finance , surgery , economics
The Prof. Ranjit Roy Chaudhury committee report recommended the accreditation of Institutional Ethics Committees (IECs). Rule 122DD of the Drugs and Cosmetics Act (and Rules) mandates that only registered ECs can accord approval for regulatory studies. We evaluated the current status of registered, reregistered, and accredited ECs in the country to assess the impact of both the recommendation and rule.