Fixed dose combination (FDCâ??s) market recently faced a ban on 349 FDCâ??s due to unclear therapeutic rationality. The present study aims to assess the therapeutic rationality of FDCâ??s enlisted in CDSCO list 2020 approved in the last 5 years. List of 119 FDCâ??s approved in India from 2015-2020 by CDSCO was evaluated. In this assessment: WHO EML listing 2019, Efficacy of API, Efficacy of FDC, PKPD, Advantage of reduced dosing and Schedule of FDC was noted. In this evaluation we found that advantage of dose reduction was not offered by any FDC. There were 22.68% FDCâ??s that had chances of increased ADRs due to its API. 81.51% FDCâ??s were found to be rational, 17.65% semi-rational and 0.84% irrational. We reveal that 17.65% FDCâ??s approved in last five years were semi-rational and advantage of dose reduction was not offered by any FDC and 22.68% FDCâ??s had increased chances of ADRâ??s. Therefore, more stringent regulatory control is required by the CDSCO to ascertain therapeutic rationality.
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