Another Angle on Access to Medicines in South Africa

Following on from various recent media reports on the shortage of many essential medicines in South Africa, the Medicines Control Council recently announced that it will now allow for an expedited approval process for a change in supplier of an active pharmaceutical ingredient when sourced from a manufacturing site that has been prequalified by the World Health Organization.

It has been reported that several provinces in the country are experiencing critical shortages of various medications including: antibiotics‚ TB medication‚ anti-psychotics‚ antiretroviral medication for both adults and children‚ and drugs for high blood pressure‚ anxiety‚ depression, and pain.

As a result many patients therefore do not have access to the medicines they need.

The shortage of medicines in South Africa is said to be a result of a combination of factors, one of which is the availability of active pharmaceutical ingredients. However, concerns have also been raised about the effect of everyday logistical issues such as inaccurate forecasting and the poor payment history of certain provinces on the state of availability of certain medicines.

While it is widely expected that this announcement, and access to the WHO list of prequalified manufacturers, will speed up the approval process for a change in active ingredient manufacturer, it remains to be seen whether the global challenges faced with active pharmaceutical ingredient supply is responsible for the majority of shortages currently experienced in the country.

Date published: 2015/06/17
Author: Dirk Hanekom

Tags: product regulatory advice medicine health