A comparison of the package inserts of originator brands and generic medicines registered by an international pharmaceutical company

Sing, Shaistha
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Over the past few years the usage of generic medicines has been increasing, mainly as a means to lower costs in the delivery of healthcare. But, the availability of generic medicines does come with its own set of potential problems which create doubt and a lack of confidence with the use of generic medicines. The package insert provided as a source of written information, accompanies a generic medicine. The originator medicine package insert is used as the primary source of information when compiling a generic medicine package insert hence it is easy to assume that the information provided in both package inserts would be the same. The South African Health Products Authority (SAHPRA) has the task of reviewing and approving the information that is presented in a generic medicine package insert. Previous research carried out has identified that there are significant differences in the information provided in package inserts of originator and generic medicines. This study was carried out to describe the differences noted in the package insert of generic medicines registered by an international pharmaceutical company in comparison to the information provided in the corresponding originator medicine package insert (PI) registered in South Africa. A textual analysis was used to compare the information presented in the PIs. The regulatory staff at generic pharmaceutical companies are responsible for compiling the package insert. A focus group discussion was conducted with the regulatory staff of a generic pharmaceutical company that is based in Johannesburg. The pharmaceutical company is one of the world’s leading generics and specialty pharmaceutical companies. Key findings from this study demonstrate that there are considerable differences between the information presented in the originator and generic medicine PIs. The differences noted can be attributed to the sources of information used by regulatory staff for the compilation of a generic medicine package insert as well as the health authority review process that is carried out prior to the approval of the package insert. The current system used by the health authority for the evaluation of generic medicine package inserts is flawed. Communication with the health authority is challenging and the lack of transparent processes contribute to a delay in the approval of generic medicine package inserts. The findings from this study indicate an urgent need to address the current South African registration system with respect to the labelling of generic medicines.
A research report submitted to the Faculty of Health Sciences, University of Witwatersrand, in partial fulfilment of the requirements for the Degree of Master of Science in Medicine (Pharmaceutical Affairs)
Sing, Shaistha, A comparison of the package inserts of originator brands and generic medicines registered by an international pharmaceutical company, University of the Witwatersrand, Johannesburg, <http://hdl.handle.net/10539/26667>