Assessment of Rationality of Fixed Dose Combinations Approved in CDSCO List
Introduction: Fixed Dose Combination (FDC) is highly popular in the Indian pharmaceutical market and has been particularly flourishing in the last few years. Though rationality status is not clear, the pharmaceutical industry has been manufacturing and marketing FDCs. Aim: To assess rationality...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JCDR Research and Publications Private Limited
2016-04-01
|
| Series: | Journal of Clinical and Diagnostic Research |
| Subjects: | |
| Online Access: | https://jcdr.net/articles/PDF/7691/17856_CE[Ra1]_F(GH)_PF1(Ro_Om)_PFA(AK)_PF2(PAG).pdf |
| Summary: | Introduction: Fixed Dose Combination (FDC) is highly popular
in the Indian pharmaceutical market and has been particularly
flourishing in the last few years. Though rationality status is not
clear, the pharmaceutical industry has been manufacturing and
marketing FDCs.
Aim: To assess rationality of FDCs enlisted in CDSCO list and
marketing in India according to pharmacokinetic (FD) and
pharmacodynamic (FD) reasoning and WHO rationality criteria.
Materials and Methods: In this study, 264 FDCs marketed in
India from 2009 to 2014 from CDSCO list 2014 were included.
Assessment was done on the basis of following parameters: 1)
Year and system of FDC; 2) Dosage form; 3) Number of Active
Pharmacological Ingredient (API); 4) Schedule of FDC; 5) The
presence of the FDC and its ingredients in the WHO Essential
Medicine List 2013 and National Essential Medicine List, India
2011; 6) FD and PK parameters of APIs of combination; 7)
PK and PD interaction; 8) Safety parameters of ingredients in
combination. Descriptive statistics in terms of frequency counts
and percentages were used for variables.
Results: Out of total 264 FDCs selected, maximum number
of combinations (112) were approved in 2010. System wise
selection showed 51 (19.31%) FDCs were from cardiovascular
system followed by 46 (17.42%) from pain/musculoskeletal
system. Oral dosage form was found to be maximum with 200
(75.75%) combinations. According to schedules, 154 (58.33%)
combinations were categorized under schedule H. There were
210 (79.54%) FDCs that had two API which was found to be
maximum, whereas, only 3 (1.13%) combinations had 5 API. We
could find possible PK and PD interactions in between API of
10 (3.78%) and 73 (27.65%) combinations respectively on basis
of standard textbooks and references. Similarly dose reduction
in API was seen in 58 (21.96%) FDCs. There were 123 (46.59%)
FDCs had chances of increased ADRs due to its API. Out of
264 combinations, 52 combinations were rational (6-9), 75
combinations were semi-rational (3-<6) and 137 combinations
were found to be irrational (0<3).
Conclusion: We could reveal that majority of combinations
approved in last six years were found to be semi-rational and
irrational. It is important to carry out detailed study in this area
to establish the fact and increase rationality of combinations. |
|---|---|
| ISSN: | 2249-782X 0973-709X |