“inspectors uncovered extensive regulatory failures during the raid, including what it described as the illegal importation of active pharmaceutical ingredients (APIs), inadequate sterile manufacturing conditions and the absence of proper analytical testing to confirm product quality, potency and purity.”

“Sahpra also raised the alarm over the absence of a pharmacovigilance system to monitor adverse drug reactions linked to the products, adding that it has already received reports of adverse events, including hospitalisations associated with some of the medicines under investigation.”