Regulator halts import of GSK’s asthma drug and imposes a fine

GlaxoSmithKline (GSK) received two administrative penalties from the Ministry of Food and Drug Safety (MFDS) on July 19.

The ministry imposed the penalties after GSK violated regulations by failing to report a change in the specifications of the main ingredient in a raw drug and confusing the drug’s manufacturing number and expiration date.

According to the MFDS, GSK has failed to report changes in the specifications of the main ingredient in the active pharmaceutical ingredient (API). Four items violated the rule. They are Seretide 100 Discus (fluticasone-salmeterol), Seretide 250 Discus, Seretide 500 Discus, and Flixotide Junior Evohaler 50 mcg (fluticasone propionate (micronized), all of which are specialty medications used to treat asthma.

MFDS imposed a fine of 52.2 million won ($37,680) on three items -- Seretide 100 Discus, Seretide 250 Discus, and Seretide 500 Discus. It also slapped a six-month import suspension on Flixotide Junior Evohaler 50mcg from Aug. 1, 2024, to Jan. 31, 2025.

The penalties were imposed under Article 42 of the Pharmaceutical Affairs Act and Article 8(1) of the Rules on the Safety of Pharmaceuticals and Other Drugs.

In addition, in the case of GSK's acne treatment Duacgel 5% (clindamycin phosphate-containing benzoyl peroxide), it was found that the manufacturing number and expiration date on the direct container of the drug were changed and imported and sold. Accordingly, the regular imposed a 15-day sales suspension from Aug. 1 to 15 on the item.

This action is based on Articles 56 (1) and 59 of the Pharmaceutical Affairs Act and Article 71 of the Rules on the Safety of Drugs and Pharmaceuticals.