The Ministry of Food and Drug Safety has revoked the license of Hugel and Pharma Research Bio's botulinum toxin (BTX) products for selling their products in the domestic market without winning the governmental shipment approval.
The governmental shipment approval is a system that obligates the makers of medical products to acquire the government’s quality checks, such as tests and document reviews, before selling them at the domestic market. Except for some export-only pharmaceuticals, all products for local use must win approval. It is illegal to sell export products in the domestic market without approval.
The BTX products that have lost their license involve four types of Hugel's Botulax products – Botulax Inj. Botulax Inj. 50, Botulax Inj. 150, and Botulax Inj. 200 – and two types of Pharma Research Bio's products – ReNTOX Inj. 100 and ReNTOX Inj. 200.
Two of Pharma Research Bio's products are also subject to a six-month suspension of all manufacturing operations as the export-only products were sold in Korea.
"We ordered Hugel and Pharma Research Bio to recall and discard the BTX products in circulation and asked medical institutions stockpiling the drugs to cooperate with the recall," the ministry said. "The government will continue to do our best to provide safe medicines by cracking down on and punishing acts that threaten public health."
The ministry's action is intertwined with the long-standing practice of the BTX industry.
Korean BTX companies, including Hugel and Pharma Research Bio, have been using wholesalers to export products to countries where they have not received product approval, including China, and the wholesalers have secretly exported Korean BTX products through private couriers.
The recent problem arises from a controversy over whether the quantity handed over to wholesalers is considered domestic sale or export.
Korean BTX makers argue that handing over products to wholesalers does not require approval from the regulatory authorities as they are for export purposes.
However, the ministry stressed that although the export products do not require the government’s shipment approval, the quantity delivered to wholesalers should be regarded as domestic sales.
The ministry's announcement faced immediate backlash from the two companies.
Hugel reiterated its position through a statement on Thursday that the products in question were produced and sold for export, not subject to winning the shipment approval.
"The safety and effectiveness of botulinum products have never been a problem during the shipment approval process throughout the past decade," the company said. "We had no reasons to avoid or circumvent the shipment approval process intentionally, only following the ministry’s guidance stating that export products do not require a shipment approval."
Unfortunately, the ministry interpreted the regulations differently from judicial precedents, adhering to its position, the company added.
Hugel stressed that it plans to immediately apply for the cancellation and temporary suspension of the ministry's administrative order to revoke the product approval of Botulax.
Pharma Research Bio said that the company would also apply for the cancellation and temporary suspension of the ministry's order, saying it was due to unreasonable legal interpretation.
"The cancellation of licenses of products legally exported following the Ministry of Food and Drug Safety standards is incomprehensible," a company official said. "We will take legal action, including applying for the suspension of its execution."