Controversy Extends from Cold Medicine to Antidiarrheal Drugs
Oh Yu-kyung "Discovered in MFDS Preliminary Investigation"
MFDS "Efforts Beyond Investigation to Improve Quality"
Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, is speaking at a press briefing for reporters covering the Ministry held on the afternoon of the 28th in Jongno-gu, Seoul. [Photo by Ministry of Food and Drug Safety]
The Ministry of Food and Drug Safety (MFDS) has launched a high-intensity investigation to raise awareness about pouch-type medicines, commonly known as "squeezable medicines," which are preferred for their convenience in medication. Following a proactive investigation that uncovered quality issues with antidiarrheal drugs, the MFDS has declared a stringent policy to conduct "proactive random inspections" if further problems arise.
At a press briefing held on the 28th, MFDS Commissioner Oh Yu-kyung stated, "The MFDS will conduct proactive random inspections on formulations that may have blind spots in safety management or require caution," adding, "We aim to play a role in raising awareness within the industry."
This statement comes amid recent quality controversies primarily involving pouch-type medicines. The MFDS recently ordered a recall of the product with manufacturing number '23084' of Potagel (active ingredient Dioctahedral Smectite), an antidiarrheal pouch produced by Daewon Pharmaceutical, due to concerns over microbial limit exceedance and quality nonconformity. Subsequently, Daewon Pharmaceutical initiated a voluntary recall of 30 products with manufacturing numbers produced around the same period.
Moreover, this is not the first time pouch-type medicines have faced issues. In May, two children's cold medicines containing acetaminophen?Daewon Pharmaceutical's 'Col Daewon Kids Pen Syrup' and Dong-A Pharmaceutical's 'Champ Syrup'?were embroiled in quality controversies. Notably, Daewon Pharmaceutical faced quality issues again within just half a year. At that time, Col Daewon Kids experienced a 'phase separation' phenomenon where the medicine's active ingredients and syrup additives separated, while Champ Syrup showed browning and, following consumer complaints, was found to contain fungi such as yeast and mold beyond permissible levels, leading to a recall.
However, both products were assessed to pose no actual harm to consumers. Nevertheless, Daewon Pharmaceutical re-released the product with adjusted additive quantities to prevent phase separation, and Dong-A Pharmaceutical also resumed production after quality improvement procedures, including adding preservatives and heat treatment processes and changing sweeteners.
The MFDS emphasized that the proactive measures taken in the Potagel case resulted from the continuation of such situations. Commissioner Oh explained, "Because pouch-type cold medicines have had particularly many issues, the MFDS conducted investigations across several categories," adding, "Potagel was identified in our investigation, leading to the measures taken." Kang Seok-yeon, Director of the MFDS Drug Safety Bureau, added, "We conducted collection inspections focusing on products that appeared to have potential risks after evaluating their hazard levels."
Furthermore, the MFDS stressed that it will not stop at inspections but will also lead the industry toward quality improvement. Director Kang said, "We are striving to ensure the supply of excellent products through various education, guidance, and supervision related to Good Manufacturing Practice (GMP)," adding, "We will establish the upgraded GMP, 'Quality by Design (QbD),' to fundamentally improve mistakes related to GMP."
Meanwhile, as Potagel has maintained the number one market share in the antidiarrheal sector as a bestseller, some companies are expected to benefit from this controversy. Previously, Daewoong Pharmaceutical dominated the antidiarrheal market with annual outpatient prescriptions worth around 10 billion KRW through 'Smecta,' which contains the same active ingredient as Potagel. However, since 2021, Daewoong Pharmaceutical has been unable to produce Smecta after failing to receive the core ingredient supply from the original developer, allowing Potagel to rapidly capture the market. Daewoong Pharmaceutical has since reintroduced 'Stabic,' containing the same ingredient, to regain market share but has yet to restore its former glory. However, with Potagel expected to resume supply around mid-next month, it is anticipated that Stabic may recover its market share during this gap.
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