Background: The management of a disease or a health condition often requires more than one drug. Fixed Dose Combinations (FDCs) are pharmaceutical products containing two or more drugs in a single formulation. Fixed dose combinations have the advantage compared to single compound taken separately with respect to efficacy, safety and convenience but irrational combinations result in reduced efficacy and a high risk of adverse drug reactions. Pain is a common health concern affecting the general population and paracetamol is commonly used in the management of pain. This observational study was designed to evaluate the FDCs containing paracetamol in India. Materials and Methods: The brands of paracetamol FDCs marketed in India were selected from different printed and digital databases and analysed with the help of the Government of India websites and a scoring rubric. Results: The total FDC combinations containing paracetamol were 46. The class of drugs which were commonly combined with paracetamol were NSAIDs and opioid analgesics. More than 50% of paracetamol containing FDCs were found to be rational. Only 33% of paracetamol FDCs were approved by the Central Drug Standard Control Organisation (CDSCO) of India. Conclusion: The health care policymakers should take appropriate action on these irrational FDCs available in the market to achieve better safety and efficacy.
Keywords: Paracetamol, Fixed Dose Combinations, Rationality, NSAIDs, Government of India.
