Pharmaceutical Bio Association Suspends Qualifications of Binex and Vibozon with Severe Disciplinary Action

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[Asia Economy Reporter Chunhee Lee] The Korea Pharmaceutical and Bio-Pharma Manufacturers Association recently imposed severe suspension penalties on Vynex and Vibozone Pharmaceutical, which were embroiled in controversy over unauthorized drug manufacturing.

The Pharmaceutical and Bio-Pharma Association announced on the 1st that it held the 2nd Ethics Committee meeting on the 31st of last month and reached a consensus to impose suspension penalties on Vynex and Vibozone Pharmaceutical.

Currently, following an administrative investigation by the Ministry of Food and Drug Safety, violations of the Pharmaceutical Affairs Act have been confirmed, including ▲arbitrary use of additives without approval for changes ▲falsified duplicate manufacturing records ▲no change in manufacturing methods ▲arbitrary increase or decrease in raw material usage.

The Ethics Committee of the Pharmaceutical and Bio-Pharma Association judged that these violations correspond to ‘acts against corporate social responsibility and ethics’ under the association’s articles of incorporation and ethics review standards. However, it took into consideration the Ministry of Food and Drug Safety’s view that the human harm is likely minimal. The suspension penalty ▲restricts all rights as member companies, including association-led education, voting rights, and collection of information and opinions on government policies, constituting a severe disciplinary action, according to the association.

The association plans to reconvene the Ethics Committee to determine the specific suspension period once the Ministry of Food and Drug Safety’s administrative sanctions and investigation results are released, and will proceed with follow-up approval procedures by submitting the disciplinary proposal to the chairman’s meeting and the board of directors.

An association official stated, "Apart from disciplinary measures against the two companies, we intend to establish fundamental solutions to reasonably improve drug quality management and generic contract manufacturing."