Quality of generics in South Africa

Generics/Research | Posted 29/04/2013 post-comment0 Post your comment

A study of the quality of generic medicines in South Africa has shown large differences in the perception and the actual quality of generics [1].

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The study was carried out in 73 patients and 15 private and public healthcare providers in Cape Town, Durban and Johannesburg.  Data for patients was obtained from 12 focus group discussions and data for healthcare providers via semi-structured interviews.

South Africa introduced the National Medicines Policy in 1996 and has been encouraging the use of generics since 2000, when medicine prices became a critical issue.

In order to test actual quality 135 drugs (125 generics, 10 originator), which included paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43), the drugs were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British Pharmacopoeia (2005) and United States Pharmacopeia (2006).

All of the 135 drugs passed in vitro tests for quality. Patients and healthcare providers judged quality according to the effect of the drug on symptoms, while healthcare providers also judged quality based on their prior experience, manufacturers’ names and patients’ ability to pay.

The results of the study showed clear differences between perceptions of quality and the actual quality of the generics tested, with most patients being unfamiliar with generics.

The authors concluded that in order to improve access to affordable medicines healthcare providers’ and patients’ perceptions need to be addressed, as well as building trust in the agencies responsible for regulation of the quality and safety of medicines.

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1.  Patel A, Gauld R, Norris P, Rades T. Quality of generic medicines in South Africa: perceptions versus reality - a qualitative study. BMC Health Serv Res. 2012;12:297.

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