KFDA To Ban 1000-plus Generic Drugs In New Blow To Korea's Domestic Pharmaceutical Companies, Potential Boost For Innovative Medicines
This article was originally published in PharmAsia News
Executive Summary
SEOUL - As regulators tighten checks for safety and effectiveness on South Korea's generic drugs, they have marked 1,226 products, or 58.5 percent of the 2,095 drugs examined, for elimination from the market
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SEOUL - As regulators tighten checks for safety and effectiveness on South Korea's generic drugs, they have marked 1,226 products, or 58.5 percent of the 2,095 drugs examined, for elimination from the market. The Korea Food & Drug Administration said these 1000-plus products are being banned because they were found to be less effective than claimed by the manufacturers, which are all local pharmaceutical companies. The clampdown is the result of evaluations conducted in 2007, and comes in the wake of rising public complaints about some local generic drugs, KFDA said. A KFDA official said that the products to be banned include both OTC and prescription medicines. The agency began testing generic drugs produced in Korea more than a decade ago. Of the 1,226 drugs subject to the ban, 1,212 were singled out for elimination after their producers failed to provide required data and documents; the other 14 generic products failed to pass KFDA data reviews. The drugs to be removed from the market include Daewoong's hyperlipemia product Simvastatine , which was determined to be less effective than claimed. Drugs manufactured by Dream Pharma, Samjin, Ilyang, Hyundai Pharm, Whanin, Skynewpharm, Sinil Pharm, Korea Meditech, Hanall, Research & Production Korea and Pharmaking have also been disqualified, KFDA said. Ilyang's antibiotic Cephradine also failed to meet regulatory standards. Due to comparatively high barriers, including steep investment costs, on the discovery and development of innovative pharmaceuticals, most Korean drug companies have instead focused on producing generic medicines. "The government's tightened surveillance of drugs is not good news for local generics-focused pharmaceutical companies," said Jung Cheol-won, spokesman for the Korea Pharmaceutical Manufacturers Association Jung also said that stronger government scrutiny of local generic products would ultimately help innovative drugs produced by multinational companies. A rising public preference for original drugs produced by international pharmaceutical companies, Jung said, combined with tighter KFDA controls on the overall market could eventually trigger a restructuring of the local pharmaceutical industry. Some companies producing generic versions of medicines could be eliminated from the market or acquired by stronger competitors, Jung said. Meanwhile, South Korean pharmaceutical outfits are jittery about the new Korea-US Free Trade Agreement, which they fear could lead to a flood of innovative medicines into South Korea (Also see "South Korea To Implement cGMPs On OTC Drugs To Prepare For U.S. Free Trade Agreement" - Scrip, 30 Dec, 2008.). That agreement is awaiting legislative approval in each country. - Peter Chang ([email protected]) |