Innovator Medicines Versus Generic Medicine Package Inserts Safety Amendments, the Reality in South Africa

Abstract

Availability of clinically relevant and unbiased medicine information goes a long way in promoting rational use of medicines. The package insert (PI) is one of the sources of information utilised by healthcare professionals for accessing relevant medicine information such as indications, contra-indications and special precautions (Singh, Mohan, Kumar, & Gupta,2016). It is important that the PI contains updated safety information. The safety information in the PIs of the innovator and generic medicines are expected to be the similar since they contain the same active ingredients. Generic medicines have the same efficacy and safety as innovator medicines and are considered bioequivalent. Generic medicines are interchangeable with innovator medicines.