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Objective: To analyse the rationality of various FDCs used in the treatment Diabetes Mellitus and to find out the irrational FDCs existing in Indian market. Material and Methods: Study Design: Analytical study. Data on FDC's available in the Indian market was collected from Current Index of Medical Specialities (CIMS) and Monthly Index of Medical Specialities (MIMS) and their rationality was analysed using a pretested tool based on FDCs listed in WHO essential list of medicines and National List of Essential Medicines (NLEM), others based on their pharmacodynamic activity, Pharmacokinetic parameters and significant drug interactions occurring due to API (Active pharmaceutical ingredients) contained within the product Result: A total of 18 combinations were analysed, among those 11 combinations were irrational. Conclusion: Predominantly irrational FDCs are being circulated in the Indian market hence through analyses by prescribers is needed before prescribing to patients in order to avoid ADR. This calls for a close scrutiny of marketed FDC's and educating prescribers to use them with great care and caution also indicates a serious review of regulatory framework for drug manufacturing and marketing.
KEYWORDS: Fixed Dose Combinations; Antidiabetics; Irrational.
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