Normalisation of Deviance and Medicines Regulation

Abstract

Normalisation of deviance is a sociology concept which describes a situation where an unchecked error or omission becomes standard practice. It has been used to describe the sequence of events leading to the Challenger and Columbia space shuttle explosions.

The exponentially uncontrolled deluge of Complementary Medicines onto the South African market could similarly be attributed to a decision in 2002 by the Medicines Control Council / Medicines Regulatory Affairs Cluster of the Department of Health to continue accepting administrative information for these medicines after the six month expiry date of the "Complementary Medicines Call-up".