Delay in introducing new drugs regulator is hugely costly, pharma firm says
The government’s missing its April 1 deadline to introduce a new medicines regulator will cost the South African pharmaceuticals industry dearly, Pharma Dynamics CEO Erik Roos said in Wednesday. A plan to replace the Medicines Control Council (MCC) with the South African Health Products Regulatory Agency (Sahpra) has been in the pipeline since 2008. "The introduction of new generic molecules has long been postponed by the overwhelmed MCC, which has a backlog of between three and five years for registering generic medicines. "Delaying the launch by several more months could cost a company significantly and also wastes precious time in a product’s life. Most importantly, the postponement continues to hamstring SA’s ability to provide affordable, generic medication to its people, which it can ill afford given the already poor state of the health sector," Roos said. "Generic medicines are up to 80% cheaper than brand-name equivalents and are currently only used by 56% of the population....
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