Developmental Genotoxicology and genotoxicity testing guidelines: an overview on erythromycin genotoxicity

Despite the growing knowledge of genome and its integrity, it is hard to know which pharmaceuticals can harm its structure and functioning. Before a drug reach to the phase IV clinical trial it have to pass the genotoxicity tests. The micronucleus (MN), chromosomal aberration (CA) and Ames test are three main test batteries for genotoxicity recognized by the international conference on harmonization (ICH) Guidelines. As in case of macrolides antibiotics, they are the most harmful antibiotics among the other antibiotics. Erythromycin comes under this category and a prototype and most safe among macrolide antibiotic. It uses in long-term treatment so interaction with body occurs with a long time and, may cause different toxicities to the body including genotoxicity. A less number of works has done on Erythromycin genotoxicity testing. Some of them are recognized to have the genotoxic effect and some of them yet unknown. In this review the author has focused on genotoxicity testing in India for a new chemical entity (NCEs). This review also emphasized toxicity caused by Erythromycin and gave a hypothesis for mechanism of genotoxicity caused by Erythromycin.