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Year : 2022  |  Volume : 13  |  Issue : 3  |  Page : 129-131

Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019

Scientia Clinical Services, Pune, Maharashtra, India

Correspondence Address:
Dr. Ravindra Bhaskar Ghooi
E 516, The Island, Wakad, Pune - 411 057, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.picr_251_21

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The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.

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