ABSTRACT
Genotoxic effects such as deletions, breaks and rearrangements lead to cancer. Regions that are sensitive to breakage are referred to as fragile sites. Some chemicals induce fragile sites in chromosomal regions where oncogenes are present, which leads to potential carcinogenic effects. Hence, occupational exposure to some mixtures of pesticides is positively correlated with genotoxic damage in exposed individuals. DNA damage is not consistent and heterogeneous in crosswise population because individuals fluctuate in their capability to trigger or detoxify genotoxic substances, which results in unpredictability and inconsistency in the prevalence of cancer. This chapter presents a brief overview of the prevention of genotoxicity. The evolving directives and the rules regarding genotoxic impurities (GTIs) in active pharmaceutical ingredients (APIs) are presented, along with an integer of the prime equivalent pharmaceutical endeavour responses. Several conceptual and practical techniques for GTI control are presented in this chapter. Special cases that warrant additional interest including API starting materials and degradation products have been discussed. Finally, an attempt has been made to focus on potential role of regulatory developments.
