ArticleJournal of clinical and diagnostic research : JCDR2016
Assessment of Rationality of Fixed Dose Combinations Approved in CDSCO List.
Article in Journal of clinical and diagnostic research : JCDR, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Assessment of knowledge, attitude and practice of fixed-dose combinations amongst attending physicians and residents: a cross-sectional evaluation.Drugs in context · 2024Article
- Pill Burden: A Major Barrier to HAART Adherence and Fixed Dose Combinations (FDCS) as its Solution - A Mini-Review.Current HIV research · 2024Review
- Physician's knowledge, attitude and practice of fixed drug combinations: Can we recognize the lacunae?Journal of family medicine and primary care · 2022Article
- The Development of Innovative Dosage Forms of the Fixed-Dose Combination of Active Pharmaceutical Ingredients.Pharmaceutics · 2022Review
- High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75 countries.PloS one · 2021Article
- Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study.Global health research and policy · 2017Article
- Herbal Fixed Dose Combinations in Nepal: Growing Concerns in a Developing Country.Journal of clinical and diagnostic research : JCDR · 2016Article
- Availability and rationality of fixed dose combinations available in Kaduna, Nigeria.Pharmacy practiceArticle
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3 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionFixed 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.
aimTo 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
methodsIn 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.
resultsOut 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).
conclusionWe 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.
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