Hugel says will fight Drug Ministry on botulinum toxin case

T
he Ministry of Food and Drug Safety said Wednesday it will revoke licenses of six botulinum toxin products manufactured by Hugel and Pharma Research Bio for failing to obtain due authorization.

Hugel, South Korea’s leading botulinum toxin products maker, however, said it would fight the ministry’s move, saying their products, produced for overseas sales, were not subject to the regulation.

Under the Drug Ministry’s order, the six botulinum toxin products -- two types of Pharma Research Bio’s ReNTox and four types of Hugel’s Botulax -- are to be immediately recalled from the local market and seized for destruction.

The ministry has also ordered an operations suspension of six months for Pharma Research Bio, as the ministry found the company sold its botulinum toxin products in the local market without proper approval for domestic sales.

In South Korea, under the Pharmaceutical Affairs Act companies should seek lot release certificates for biologic products in order to sell them on the domestic market.

The Drug Ministry raised the same issue with Hugel’s products, but the firm claimed its products were for overseas sales only and did not require lot release certificates.

Hugel said it plans to file a lawsuit against the Drug Ministry and ask the court to suspend the ministry’s order.

For many years, it has been a common business practice that botulinum toxin products makers sold their products in overseas markets without a lot release certificate.

It has been quite recent that the Drug Ministry started to illegalize the business practices of shipping products without the certificate.

Last year, the Drug Ministry revoked licenses for five botulinum toxin products of Medytox after finding the company had exported products to China without the certificate.


By Shim Woo-hyun (ws@heraldcorp.com)