Fixed Dose Combination Of Drugs: Are They Justified.

ABSTRACT

Abstracts Background:Fixed Dose Combinations (FDCs) are combinations of two or more active drugs in a single form. Prescribing FDCs has become a routine affair in medical practice. Combination drugs increase the compliance of patient to the treatment, decrease the pill burden, but may also lead to increase in the cost of the treatment and side effects. There has been increase in the irrational FDCs in the recent past. The rationality of a fixed dose combination is the most controversial and debated issue in today’s clinical practice. The eighteenth essential medicine list (EML) of WHO includes 25 FDCs while as the 2011 national list of essential medicines (NLEM) of India includes only18 FDCs. Contrary to this Indian market is flooded with FDCs, the scientific rationale for most of these remains unknown. In India, a fixed dose combination of drugs is considered a “NEW DRUG” and has to be approved by Drugs Controller General, India (DCGI). However, the Indian laws governing the approval and marketing of FDCs are not properly defined, the pharmaceutical manufactures take advantage of these loopholes and market combination that have no pharmacological rationale.