Background: Fixed Dose Combinations (FDCs) are products containing two or more active ingredients used for a particular indication, in a fixed ratio of doses. Today,there is a growing concern about the ever-growing list of irrational Fixed Dose Combinations (FDCs) which have flooded the pharmaceutical market in India. Such irrational use of antibiotic FDCs can rapidly give rise to resistant strains of organisms, increasing Adverse Drug Reactions and drug interactions which is a serious concern for the healthcare system. The present study is designed to fulfil the lacuna in the research regarding rational and irrational FDCs available in the Indian market.

Objectives: To analyse rational and irrational FDCs of antibacterial drugs and to create awareness about the extensive use of irrational FDCs among the prescribers.

Methodology: Data on FDCs available in the Indian market was collected from Current Index of Medical Specialities (CIMS) Jan-2022 and Drug Today Jan-Apr-2022.Their rationality was analysed based on their pharmacokinetic properties, pharmacodynamic activity, drug interactions and those listed in WHO Essential List Of Medicines and National List of Essential Medicines (NLEM).The number of companies producing such combinations were listed. A list of prohibited drugs which are still being circulated was also given.

Analysis and Results: A total of 86 combinations were listed, among which 42 combinations were rational and 44 combinations were irrational. The most common irrational FDC available is Ofloxacin+ Ornidazole, produced by 130 companies. A total of 15 FDCs were found banned but still being manufactured by several companies.

Conclusion: Many irrational FDCs are being supplied in the Indian market by different companies. Awareness about irrational FDCs, generated among prescribers through our study, will help to avoid the unnecessary risk of ADRs, drug resistance and financial burden on the patient. Hence, scrutiny and a strict review of the regulatory framework for FDC manufacturing and marketing is needed for the betterment of patient care in the country.

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