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.
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