The Ministry of Food and Drug Safety (MFDS) has expressed its position on revoking the Good Manufacturing Practices (GMP) certificate for Hutecs Korea Pharmaceutical, urging the industry to remain vigilant against intentional GMP violations.
“GMP violations are not a problem unique to Korea. There are cases of GMP violations in developed countries,” said Kang Seok-yeon, director-general of the Drug Safety Bureau at the MFDS, meeting with journalists on Thursday. “However, we are worried about intentional GMP violations.”
On Wednesday, the ministry said it would proceed with revoking the GMP conformity decision for a large-scale formulation of Hutecs Korea Pharmaceutical’s content solids. The decision was made to revoke the GMP conformity decision for a wider range of formulations, including tablets, capsules, syrups, oral disintegrating tablets, and chewable tablets.
During an inspection in July, the company was found to have consistently manufactured six products, including Recutin Tablets, Roxacin Tablets, and Zalnagel Tablets, in violation of the license. The company arbitrarily manipulated the quantities of additives, both increasing and decreasing them. Furthermore, the company inaccurately documented in its manufacturing records, falsely claiming adherence to the licensed specifications.
“As this is the first case since the implementation of the GMP conformity revocation system in December 2022, we approached it cautiously, but the degree of violation in this case was serious,” Kang said. “It was painful, but we hope this will serve as an opportunity to manage GMP thoroughly.”
Kang noted that pharmaceutical companies must have wondered what the ministry would do in this case.
“They must have been alerted to see we made a firm decision,” he said. “We will not give the same punishment to all companies but will establish a public-private advisory system to determine punishments according to the degree of violation.”
Kang added that the ministry would consider the “stick” and the “carrot” as an incentive for the industry to comply with GMPs.
“There is a question of whether the stick alone will solve the problem. We need to strengthen GMP education for the private sector and companies,” he said. “The ministry’s drug design-based quality by design (QbD) is also a form of advanced GMP, so we will continue to present such a blueprint.”
Kang also commented on the timing of the eventual revocation of GMP conformity.
“(The process) is just beginning. The company has been notified, and there is a hearing process,” he said. “It’s not a permanent removal from the market. Item authorization will be maintained.”
Regarding the possibility of an administrative lawsuit with the company and the stay of execution, Kang said these are “matters for the court to decide.”
According to industry insiders, Hutecs Korea reportedly applied for a provisional injunction to suspend its execution later in the day.