SA Health Products Regulatory Authority ‘understaffed and underfunded’

The register for the South African Health Products Regulatory Authority (SAHPRA) is outdated and sub-standard, its chief executive has admitted to Mail & Guardian.

It has a 16 000-product backlog dating back to 1995, according to Dr Boitumelo Semete, who said the shortcomings were “being addressed” after the register’s website went live last week to enable interaction with the public and the healthcare industry while SAHPRA deals with the “last vestiges” of the backlog, which Semete asserts will be “cleared by the end of the year”. 

This emerged after an alert Durbanite, Sharon Rina-Rose de Villiers, who suffers from chronic rheumatoid arthritis, experienced a severe reaction after having to change to a different brand of a schedule six medicine she takes.

De Villiers proved to be a “patient outlier” in personally registering her complaint, but the chairperson and chief executive of SAHPRA admitted to “dealing with huge backlogs” and confirmed that doctors regularly rely on the register when patients suffer severe adverse reactions.

A shocked and outraged De Villiers, who contacted M&G after being frustrated by SAHPRA’S responses, says the registration number of the alternative brand appeared not to exist.