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Dr.Bettina Lavanya Magdaline .S*, Dr.Vasanthi.C, and Dr.Darling Chellathai


Objective: Fixed Drug Combination is the combination of two different drugs in a single pharmaceutical formulations. Rational FDC’S of two drugs can be advantageous, as it is convenient in Dose Scheduling, Patient Compliance, Enhanced Effect, Minimisation of Side effects. The disadvantages are the pharmacokinetics characteristics of two drugs may not match and dose of any component may not be independently adjusted. The identification of adverse effect of particular component is difficult. FDC are widely prescribed in India for various therapeutic targets. We undertook this study to analyse the FDC commonly prescribed in India and to find out any FDC that donot comply with the 1WHO list and 2NLEM (National List of Essential Medicines) 2011. Methodology: We collected the data of the widely prescribed FDC using CIMS,CIMS Asia.com, Indian drug review, Local hospital drug Formulary. We analysed the data comparing with the FDC in the WHO list and NLEM. Results: From the analysis of the data we found that around 70 FDC do not comply with the criteria developed by essential medical list of WHO or NLEM of India or both. Out of the 70, 23 were with antibiotics, 20 with analgesics and remaining with sedatives, antihistamines and vitamin preparation. Conclusion: Hence we claim the FDC are valuable therapy and also widely prescribed and they need to be developed based on the rationality of pharmacokinetic and pharmacodynamic parameters and clinical studies are needed to evaluate the safety and efficacy.

Keywords: FDC – Fixed Drug Combination.

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