The Ministry of Food and Drug Safety said it has imposed an administrative penalty on Jaytech Biogen, a drug importer, for failing to report the serial numbers or the supply list of imported medicines, including sex hormone agents.

According to the government’s pharmaceutical information disclosure system, the food and drug safety ministry fined the company 3.9 million won, a penalty equivalent to a one-month suspension of drug sales, on Aug. 12.

When reporting the supply list of drugs to the authorities, Jaytech Biogen omitted the serial numbers of the supplied drugs or the report of shipping from July to December.

The five drugs not reported to the regulator were Jenasteron Injection (ingredient: testosterone enanthate), Estradiol-Depot Injection 10mg (estradiol valerate), Taiyu Progesterone Inj. (progesterone), PMS-Nystatin Syrup (nystatin), and EK Epalrestat Tab. 50mg (epalrestat).

Under the Pharmaceutical Affairs Act, all drug suppliers must report the supply details to the food and drug safety ministry when selling drugs to medical institutions, pharmacies, drug wholesalers, and sellers of household medicines.

Except for quasi-drugs and raw materials for medicines, all finished pharmaceutical products, including imported drugs, must be reported to the regulator. Drug importers should label medications with serial numbers and report the supply list when shipping them.

A drug supplier failing to do so will receive a one-month drug sales suspension for the first violation. A company with a second violation could face a nullification of drug approval.

Out of the five suspended drugs, Jenasteron Injection, Estradiol-Depot Injection 10mg, and Taiyu Progesterone Inj. are sex hormone agents. Jenasteron, a male hormone, and Estradiol-Depot Injection 10mg, a female one, need special attention because the U.S. FDA labeled them “Grade X,” banning pregnant women from taking them.

Jaytech Biogen said the omission of the supply report was merely a mistake by its employee.

“It was a simple omission. The person in charge had too much work to do and delayed the report of the supply list. There is no safety problem,” an official at Jaytech Biogen said.

However, the Health Insurance Review and Assessment Service (HIRA) said the omission of serial numbers of supplied drugs could make it difficult to identify the distribution of medicines if the authorities have to order an emergency recall of a drug.

kch@docdocdoc.co.kr

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