The Korean Pharmaceutical Association urged that the controversy over changing the active ingredient for the dyslipidemia treatment "Rosuzet," which erupted amid conflict between the major shareholder and the management of the Hanmi Pharmaceutical group, be reviewed with patient safety as the top priority, not business logic.
The Korean Pharmaceutical Association issued a statement on the 5th, saying, "Changing a drug's active ingredient is not simply a matter of switching suppliers or reducing expense; it is directly linked to public health and trust in medicines," and added, "It must be reviewed cautiously on the premise of sufficient scientific verification and a rigorous assessment by the regulator."
The association explained that even when the active ingredient is the same, differences in manufacturing environment, production process, quality control level, and impurity management systems can lead to variations in quality and safety. For this reason, it stressed that changing an ingredient is not merely a business judgment but an issue that can affect therapeutic efficacy and patient safety.
It also recalled the importance of ingredient management by citing the 2018 valsartan ingredient impurity incident. At the time, the detection of potentially carcinogenic substances in some overseas ingredients led to large-scale recalls and prescription changes, causing confusion for both the medical field and patients.
Earlier, Hanmi Pharmaceutical CEO Park Jae-hyun said Shin Dong-kuk, chair of Hanyang Precision Co. and the largest shareholder, improperly intervened in management, claiming he forcibly pushed to switch Rosuzet's ingredient to a China-made ingredient for reasons such as cost cutting.
On this, the association said, "The selection of drug ingredients and quality control is not a matter to be approached by the same standards as general business decisions by corporations," and added, "Because these are products dealing with the public's lives and health, the scientific judgment of experts, including quality-control managers and pharmacists, must be respected."
It also pointed out that if dependence on a particular country or supply chain increases, instability in the supply of medicines can occur due to changes in international conditions or production disruptions. This is because the active pharmaceutical ingredient industry is an important foundation for the stability of drug supply and for national health security.
The association asked Hanmi Pharmaceutical to transparently disclose information on the entire manufacturing process, including impurity management systems, on the premise of thorough quality and safety verification by the Ministery of Food and Drug Safety during the ingredient-change process, and to communicate sufficiently with the pharmacist community.
The association also said, "Medicines are not a mere target for expense cutting but a public asset directly linked to people's lives," adding, "We will continue efforts to ensure quality and safety so that the public can use medicines with confidence."