Indian Journal of Pharmacy and Pharmacology
Official Publication of Innovative Education and Scientific Research Foundation
Official Publication of Innovative Education and Scientific Research Foundation
Print ISSN: 2393-9079
Online ISSN: 2393-9087
CODEN : IJPPTK
Indian Journal of Pharmacy and Pharmacology (IJPP) open access, peer-reviewed quarterly journal publishing since 2014 and is published under auspices of the Innovative Education and Scientific Research Foundation (IESRF), aim to uplift researchers, scholars, academicians, and professionals in all academic and scientific disciplines. IESRF is dedicated to the transfer of technology and research by publishing scientific journals, research content, providing professional’s membership, and conducting conferences, seminars, and award programs. With more...Short Communication
Author Details :
Volume : 10, Issue : 1, Year : 2023
Article Page : 45-49
https://doi.org/10.18231/j.ijpp.2023.012
Abstract
Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced side effects, (b) Pharmacokinetic disparity having peak efficacy at different time zone, (c) Chemical non compatibility leading to decreased shelf life, (d) Drug interactions due to common metabolizing pathways, and (e) limitations of dose titration of individual ingredients. As per Rule 122 E of Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs where the Central Drugs Standard Control Organization (CDSCO), ensures proper clinical data is submitted for the approval into the market. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) mentions the requirements for marketing approval of various types of FDCs.
Keywords: Fixed dose combinations (FDCs ), Patient Compliance, New Drug
How to cite : Chaudhry S, Fixed dose combinations in India- what a way to go!. Indian J Pharm Pharmacol 2023;10(1):45-49
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