ABSTRACT

To accomplish the objective of expeditious approachability of new drugs for approval and to promote clinical research in par with developed countries clinical trials regulation, “New drug and clinical trials rules,2019” was notified by Union ministry of health and family welfare in official gazette on 19th march 2019 under GSR 227(E) after consultation with drug technical advisory board(DTAB).This rule replaced Part XA and Schedule Y of Drugs and Cosmetic Rules,1945 but license ,orders ,directions will continue to remain valid. This rule would apply to all new drugs, investigational drugs, bioequivalence and bioavailability study and ethics committee. This review highlights NDCT rules 2019 of India, expedited approval of clinical trials and BA/BE studies, which facilitated private business interests in the conduct of these trial in India. As a result, these will make India to be suitable center for conducting the trials, simultaneously increasing values of Indian regulation on global market. Keywords: Clinical Trial, Bioequivalence, Indian regulations
Publication date: 01/08/21

https://ijbpas.com/pdf/2021/August/MS_IJBPAS_2021_5598.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.8.5598