REGULATORY REASONS BEHIND THE BAN OF VARIOUS IRRATIONAL FIXED DOSE COMBINENT DRUGS

Medicines are an integral part of healthcare. More than one drug is frequently used for treatment of either single ailment or multiple comorbid conditions. Sometimes, two or more drugs are combined in a fixed ratio into a single dosage form, which is termed as fixed dose combinations (FDCs). The FDCs are justified when they demonstrate clear benefits in terms of (a) potentiating the therapeutic efficacy, (b) reducing the incidence of adverse effect of drugs, (c) having pharmacokinetic advantage, (d) better compliance by reducing the pill burden, (e) reducing dose of individual drugs, (f) decreasing development of resistance, and (g) cheaper than individual drug because of reduced cost from packaging to distribution. It is important that the above claims are adequately supported by scientific evidence.

Keywords:  Fixed Dose Combinations, Regulatory Reasons.