April 25, 2006 22:13
Several Korean drug-testing labs stand accused of manipulating the test results of generic drugs. The government on Tuesday decided to re-investigate all generic drugs sold in Korea, which account for more than half or 3,907 of the total of 7,689 drugs available here, due to suspicions of large-scale testing fraud.
The Korea Food and Drug Administration said an investigation of 351 generics tested at 11 testing centers revealed that 10 drugs tested by four of them were approved based on manipulated so-called bioequivalence tests, which show that the efficacy of generics is on a par with the originals. The KFDA suspects that another 33 generics tested in nine labs also produced fake data, but further investigation is needed since the labs deny the charge.
Generics approved based on manipulated test results or suspected fake data account for 12 percent of all drugs the KFDA investigated. The investigation took a month after the watchdog was tipped off that some labs manipulated bioequivalence test results. The four labs already identified are run by LabFrontier, the School of Pharmacy of Sungkyunkwan University, BioCore, and the Korea Pharmaceutical Traders Association. The other nine under suspicion are run by the colleges of pharmacy of Kyung Hee University, Chonnam National University, Chungnam National University, Chung-Ang University and others.
The KFDA said the generics in question are not harmful to patients but their efficacy is in doubt. It ordered pharmaceutical companies to recall and destroy them. If other labs under investigation fail to offer clear explanations on the issue, the KFDA will cancel the approval it gave based on their test results and urge their makers to recall them voluntarily.
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