Critical Analysis of Cardiovascular and Central Nervous System Fixed Dose Combinations Available in Indian Market.
BACKGROUND
Fixed Dose Combinations (FDCs) are being increasingly used to improve compliance and achieve greater benefits of the two or more active ingredients given together than the corresponding individual drug components given separately.


OBJECTIVE
To analyse the rationality of Cardiovascular (CV) and Central Nervous System (CNS) FDCs available in Indian market.


METHODS
CVS and CNS FDCs, enlisted in Indian Drug Review, 2014, were analysed by a pretested validated eight point criteria tool. Each FDC was assessed for number of active pharmacological ingredients, approval by regulatory authority, listing in WHO Essential Medicine List. While efficacy, safety, pharmacokinetic, pharmacodynamic interactions and advantages of each FDC were analysed by literature search. The total score of the tool was 12 and score ≥7 was considered rational. FDCs were divided in four groups as per rationality and DCGI approval. ANOVA was used for statistical analysis and p<0.05 was considering statistically significant.


RESULTS
Out of 152 FDCs, 107 were CV and 45 belonged to CNS group and 40 had documented evidence of efficacy and safety. Majority of FDCs showed advantage of being convenient by reducing pill count and only 32 showed reducing adverse drug reactions. Out of 107 CV FDCs, 46 were rational and 61 were irrational with a mean rationality score of 6.72±2.82 (CI- 95 %, 3.90 - 9.54). While out of 45 CNS FDCs, 8 were rational and 37 were irrational with a mean rationality score of 6.22±2.08 (CI - 95 %, 4.14 - 8.30). A significant difference in mean rationality score of group A (DCGI approved + rational) was observed as compared to group B (DCGI approved + irrational) and group C (DCGI unapproved + rational) as compared to group D (DCGI unapproved + irrational) (p<0.05).


CONCLUSIONS
The absence of watertight pre-requisite, critical analysis of the scientific validity of the formulations and 'convenience' category has resulted into proliferation of irrational FDCs. This calls for strict regulatory approval process to avoid miserable FDC scenario in the country.
Resident, Department of Pharmacology, B. J. Medical College , Ahmedabad, Gujarat, India .
Krunal
K
Prajapati
Assistant Professor, Department of Pharmacology, B. J. Medical College , Ahmedabad, Gujarat, India .
Samidh
S
Shah
Professor and Head, Department of Pharmacology, B. J. Medical College , Ahmedabad, Gujarat, India .
Mira
M
Desai
Fixed dose combinations; Rationality; Regulatory approval