Quality problems of anti-tuberculosis Fixed-dose Combinations (FDCS) A way forward.

ABSTRACT

Fixed dose combinations (FDCs) of anti-tuberculosis drugs (Rifampicin, Isoniazid, Pyrazinamide and Ethambutol hydrochloride) have several advantages over loose combinations of these drugs. Hence, the use of FDCs in the short course chemotherapy of tuberculosis is being promoted internationally. However, these products are associated with quality problems such as loss of bio-availability of Rifampicin and instability of the drugs in the combination. Recent research in Indian laboratories has helped in identification of the major reasons behind these problems, which suggest that an entirely different approach is required to that currently being recommended by the world bodies. The purpose of this article is to briefly discuss the twin quality problems and to highlight the potential forward ways.