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Year : 2022  |  Volume : 3  |  Issue : 3  |  Page : 211-218

Present status of department of health research registered ethics committees in india after implementation of new drugs and clinical trials rules 2019

1 Department of Pharmacology, Government Autonomous Medical College, Ratlam, Madhya Pradesh, India
2 Vice-Chairperson, Institutional Ethics Committee, Department of Pharmacology, Government Autonomous Medical College, Ratlam, Madhya Pradesh, India

Correspondence Address:
Dr. Neeraj Kumar Agrawal
Department of Pharmacology, Government Autonomous Medical College, Ratlam - 457 001, Madhya Pradesh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JME.JME_52_21

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Background: Under the New Drugs and Clinical Trials Rules -2019 that came into force on 14th September 2019, all Ethics Committees (ECs) reviewing biomedical and health research should register with the authority designated by the Central Government of India. Study Objective: We investigated the status of registration of ECs in the Department of Health Research (DHR) to date. Materials and Methods: The data collection was started on 1 April, 2021 and was last updated on 10 April, 2022. The ECs registered with DHR were extracted from NAITIK online portal. The ECs were segregated according to the state and Union territories, medical colleges, dental colleges, and hospital and research institutes. Results: Total of 836 registered ECs were uploaded on the DHR website to date. Out of which, 822 (98.32%) were Institutional and 14 (1.67%) were independent. Among total ECs, 518 (61.96%) were in hospitals and research institutes, 231 (27.63%) in medical colleges, and 73 (8.73%) in dental colleges. 76 (9.09%) got the final certificate after completion of a provisional period of two years. Among 606 medical colleges and 316 dental colleges, 38.11% and 23.10% of colleges had registered ECs respectively. Maharashtra has the highest number with 129 (15.43%) registered ECs whereas Gujarat is number one (53.33%) in terms of percent registered ECs in medical colleges of particular states. Conclusions: Timely registration of ECs should be encouraged by the concerned stakeholders and try to make a robust mechanism for bringing transparency, uniformity, and accountability to the ECs across the states.

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