EVALUATION AND REGULATORY STATUS OF THE BANNED COMBINATION OF PCM & ACECLOFENAC
Abstract
The fixed-dose combination (FDC) of Paracetamol (PCM) and Aceclofenac has beewn widely used for pain and inflammatory conditions. However, scientific evaluation has raised concerns regarding its safety, pharmacological redundancy, and risk of adverse effects. Studies indicate that combining PCM with Aceclofenac offers no significant therapeutic advantage over individual drugs. Moreover, the combination increases the risk of hepatotoxicity and gastrointestinal complications. Regulatory bodies in India, including the Drugs Technical Advisory Board (DTAB), reviewed its risk–benefit profile. Based on evidence, the Government of India banned this FDC citing lack of rationality and heightened safety risks. The ban aligns with global regulatory standards emphasizing rational drug therapy. This evaluation highlights the importance of scientific scrutiny for FDCs to ensure public health safety
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References
British National Formulary (BNF 41) British medical association: London. 2001.
• European Pharmacopoeia, 4th ed., Council of Europe, Strasbourg cedex: France. 2002
. • British Pharmacopoeia, Vol. – I, Her Majesty’s Stationary office: London. 2002.
• Maheshwari RK, Chaturvedi SC, Jain NK. Analysis of aceclofenac in tablets using hydrotropic solublisation technique. Indian Drugs. 2006; 43(6)
. • Hasan Y, Abdel-Elkawy M, Elzeany BE, Wagieh NE. Stability indicating methods for the determination of aceclofenac. Farmaco. 2003; 58(2): 91 – 99.
• Srinivasan KK, Shirwaikar A., Joseph A., Jacob S., Prabu SL. Simultaneous estimation of aceclofenac and paracetamol in solid dosage form by ultraviolet spectrophotometry. Indian Drugs. 2006; 43(2)
• Shanmugam S., Cednil Kumar A., Vetrichelvan T., Manavalan R., Venkappyya D., Pandey VP. Spectrophotometric method for estimation of aceclofenac in tablets. Indian Drugs. 2005; 42(2): 106 – 107.
• Mahaparale PR, Sangshetti JN, Kuchekar BS. Simultaneous spectroscopic estimation of aceclofenac and paracetamol in tablet dosage form. Indian J. Pharm. Sci. 2007
• Dooley M, Spencer CM, Dunn CJ. Aceclofenac: a reappraisal of its use in the management of pain and rheumatic disease. Drugs. 2001.
• Atchison JW, Herndon CM, Rusie E. NSAIDs for musculoskeletal pain management: current perspectives and novel strategies to improve safety. J Manag Care Pharm. 2013.
• Moore N, Pollack C, Butkerait P. Adverse drug reactions and drug-drug interactions with over-the-counter NSAIDs. Ther Clin Risk Manag. 2015
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