Johannesburg - They may cost a fraction of the original price – but the question remains: are generic equivalents of popular medicines equal to and as effective as originator products?
Paul Anley, the chief executive of Pharma Dynamics, a private pharmaceutical company, firmly believes they are.
Speaking at a roundtable discussion held by the company on the pricing of medicine, trends in generic medicines and increases in chronic illness in the country, Anley said the fact that generic medicine was often incorrectly associated with being lower in quality because it is cheaper had, in the past, been a barrier for the industry.
“The reality is that there is no short cut for the registration of generic products. They pass the same high-quality requirements of originator products before they are allowed to be registered in the country.
“You are getting exactly the same thing. There has never been a clinical trial showing generics are less effective or of a lesser quality,” he said.
For the registration of a generic medicine by the regulatory Medicines Control Council (MCC), generic companies must conduct a bio-equivalence study to prove that the blood concentration of the active ingredient of the generic is comparable to the blood concentration of the originator’s medicine at any given time after taking the medicine until it has been eliminated from the body.
And despite seven out of the top 10 products released in the industry over the past 10 months being generic variations, and some medical aids implementing policies to encourage generics, Anley said the industry still faced some challenges.
“The massive backlog in the registration process for new products, which currently takes up to 40 months, is cited by the Department of Health as due to a lack of resources. This remains a major challenge for our industry.”
However, the formation of the SA Health Products Regulatory Authority – which will be responsible for speeding up the medicine registration process and will have more power than its predecessor, the MCC – was a positive development of the country’s generic medicines industry, Anley said. - The Star