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Preety Lachhiramka and Sujay Patil*


Background: A single dosage form having two or more active pharmacological ingredients is called a fixed dose combination (FDC). Justification and rationality is found with very few FDC’s. Fixed dose combinations have many advantages and disadvantages. A FDC can be rational or irrational depending on the WHO criteria for rationality. FDC play a crucial role in chronic disease treatment adherence with increased compliance. Rationality of a FDC has always been a debatable issue over the years. FDC need to be prescribed, if possible from WHO essential drug list or National Essential Medicine List of India. Sensitization of health care professionals at beginning of their career is very important to curb this problem from the root itself. Methods: It was a prospective observational study. Few random students were selected from 2nd year MBBS and were told to note down various FDC’s listed in CIMS, MIMS and Drug Bulletin. FDC were later analyzed for rationality based on WHO rationality criteria. Few of the most common FDC which were found irrational have been mentioned in our study explaining the basis for same. Results: Many FDC’s were scrutinized for rationality and irrational ones were mentioned explaining the reason for same. This denoted that marketing approval for a FDC is very lax and health care professionals are falling prey to unethical practice by pharmaceutical industries, by bribing doctors in form of various goodies. Assessment and vigilance of adverse drug reactions reported or caused by FDC’ needs to be done regularly. Conclusion: Most of the FDC’s which were found irrational in our study were explained. Pharmaceutical companies need to understand importance of rationality before they come up with such combinations. Rational drug combinations are always of immense help to the health care system and cost effective. Guidelines for manufacturing and sales of FDC need to be followed by the Pharmaceutical companies.

Keywords: rational, irrational, fixed drug combinations.

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