Fixed dose combinations in India- what a way to go!

Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular & diabetes, tropical malaria HIV and Cancer. FDCs useful conditions especially when multiple disorders often co-exist The advantages of the FDC basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment packaging activities. drawbacks (a) Pharmacodynamic mismatch between two ingredients, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced side effects, (b) Pharmacokinetic disparity peak at different time zone, (c) Chemical non compatibility decreased shelf life, (d) Drug interactions due common metabolizing pathways, (e) limitations titration individual ingredients. As per Rule 122 E Drugs Cosmetics Act 1940, New where Central Standard Control Organization (CDSCO), ensures proper clinical data is submitted for approval into market. Appendix VI Schedule Y (Drugs Rules 1945) mentions requirements marketing various types FDCs.