A National Department of Health statement last week that current drug shortages are partly because of stringent compliance standards from South African Health Products Regulatory Authority (SAHPRA) has been rejected by the regulator, reports The National.
The department had blamed local pharmaceutical manufacturers’ failure to comply with SAHPRA requirements as being among the reasons for the shortages, but the authority yesterday said several other issues were to blame.
Public hospitals and clinics are running short of critical medicines for conditions including hypertension, diabetes and severe mental illnesses, but SAHPRA communications manager Rodgers Baloyi said shortages could not be attributed to the regulator’s interventions alone.
“Shortages are multi-factorial and may arise from manufacturing constraints, global supply-chain disruptions, shortages of active ingredients and other operational challenges. Regulatory compliance interventions are not necessarily the sole cause of shortages,” he said.
Baloyi said SAHPRA regularly inspected pharmaceutical manufacturers to check whether they were meeting the required standards, and where deficiencies were identified, manufacturers were required to implement appropriate corrective and preventive actions.
However, the authority would not say which manufacturers had been found non-compliant, when the inspections took place or what specific shortcomings had been identified.
The shortage of psychiatric medication has been of particular concern, with the South African Society of Psychiatrists (SASOP) recently warning that essential drugs for treating mental illnesses were in short supply in Gauteng, KwaZulu-Natal, the Western Cape and Eastern Cape.
Professor Renier Coetzee, president of the Pharmaceutical Society of South Africa, has also raised concerns about the lack of reliable information on the extent of the shortages and whether promised supplies would arrive.
He added that local medicine manufacturing must also be a national priority.
“However, we must be realistic. Expanding local production will not resolve the immediate shortages. It requires sustained investment, appropriate infrastructure, regulatory capacity and long-term planning.”
Foster Mohale from the National Department of Health has previously told The National that shortages are due to various factors including geopolitical tensions and local manufacturers” non-compliance with SAHPRA regulatory requirements.
“The department has been actively engaging with suppliers and is procuring alternative medicines from other sources to minimise the impact on patients. Meanwhile, some patients may be temporarily switched to clinically appropriate alternative medicines for the same conditions until the supply constraints are resolved,” he said.
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