Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
November 9, 2012 [Liberty Times reporters Zhong Lihua, Fang Zhixian, Huang Shuli, Yu Zhaofu, He Yuhua, Zhang Congqiu / Comprehensive Report]
GMP pharmaceutical companies, in an effort to cut costs, have collectively violated the law by outsourcing the packaging of "medications" to a "food" factory!
**To Save Costs, Six Pharmaceutical Companies Violate Laws Collectively**
A reader complaint revealed that six pharmaceutical companies—Shun Sheng, Nei Wai, Winston, Huang Jia, Yuan Zhou, and Century—contracted Shun Jie Biotechnology in Tainan to package their drugs. However, Shun Jie is a food factory with equipment that does not meet pharmaceutical standards. After receiving the tip in late September, the Health Ministry's Food and Drug Administration (TFDA), in collaboration with the Tainan District Prosecutors' Office, discovered at Shun Jie two types of drugs from Shun Sheng and one from Huang Jia, totaling approximately 25,400 pills, as well as 192,000 pills from Nei Wai. Authorities have ordered the recall of all 30 related drugs and advised patients taking these medications to discontinue use. However, the Supervision Alliance for Healthcare criticized the TFDA for delaying the warning for over a month, calling it a severe dereliction of duty.
The reader questioned why the supervising pharmacists at these GMP-certified pharmaceutical companies failed to fulfill their responsibilities, suggesting their licenses should be revoked and investigations launched into possible document forgery. They also demanded inquiries into how many other illegal pharmaceutical companies might be involved.
**Non-GMP Manufacturing Environment Treated as Substandard Drugs**
Li Mingxin, deputy head of the TFDA’s Risk Management Division, stated that GMP pharmaceutical companies must complete all production, manufacturing, and packaging processes in a GMP-compliant environment; otherwise, the drugs should be considered "substandard." Li explained that the companies outsourced aluminum foil blister packaging to Shun Jie for cost-saving reasons. Among the 30 drugs, nine—including Xibole, Cough Relief Capsules, Ouye Throat Lozenges, and Tongleshuang Enteric-Coated Tablets—are "over-the-counter" medications available at pharmacies after consultation, while the other 21 require a doctor’s prescription. So far, no adverse reaction reports have been filed for these drugs.
Li Mingxin noted that the violators have been fined NT$30,000 to NT$150,000 under the Pharmaceutical Affairs Act, with criminal liability under investigation by prosecutors. Additionally, Macro and Manhattan pharmaceutical companies outsourced packaging to Shun Sheng and Century, involving three more drugs, but only Shun Sheng and Century were penalized. The TFDA did not issue a public notice initially due to investigative confidentiality, only posting recall information on its website.
Supervision Alliance spokesperson Teng Xihua criticized the TFDA for quietly announcing the issue on its website, allowing uninformed patients to continue using the drugs. She questioned how the public could still trust government-guaranteed GMP standards and urged the TFDA to revoke the companies' licenses and strengthen inspections. However, Taiwan Pharmacist Association Chairman Li Shuping and Vice Chairman Lian Ruimeng argued that since the drugs were completed in pharmaceutical factories and only the aluminum foil packaging was outsourced, drug quality should not be affected.
**TFDA Criticized for Delayed Warning**
Shun Jie Vice President Lin Yishu emphasized that the company primarily handles packaging for health supplements. If pharmaceutical companies disguised drugs as health supplements for outsourcing, authorities should investigate the source.
Century Pharmaceuticals, which had violated GMP procedures twice before, committed a third offense this time. The New Taipei City Health Department stated it would impose heavier penalties. Century’s factory manager Wu Xuexiong explained that outsourcing packaging for low-volume drugs like stomach medicine and cold tablets was more cost-effective than investing in molds. Nei Wai Chemical’s special assistant Wang Qingzong said the drugs had already been sold to distributors before being repackaged and that distributors had been instructed to recall them.
Shun Sheng Pharmaceutical stated that its drug ingredients were legal and that the company lacked coating equipment, hence the outsourcing. Since coating machines cost NT$1–2 million and molds around NT$200,000 each, the company plans to handle packaging in-house moving forward.Source: http:/ / tw. news. yahoo. com/ gmp……ypes- recalled- 202614431. html
GMP Pharma Plant Recalls 30 Products Packaged by Food Factory
GMP pharmaceutical companies, in an effort to cut costs, have collectively violated the law by outsourcing the packaging of "medications" to a "food" factory!
**To Save Costs, Six Pharmaceutical Companies Violate Laws Collectively**
A reader complaint revealed that six pharmaceutical companies—Shun Sheng, Nei Wai, Winston, Huang Jia, Yuan Zhou, and Century—contracted Shun Jie Biotechnology in Tainan to package their drugs. However, Shun Jie is a food factory with equipment that does not meet pharmaceutical standards. After receiving the tip in late September, the Health Ministry's Food and Drug Administration (TFDA), in collaboration with the Tainan District Prosecutors' Office, discovered at Shun Jie two types of drugs from Shun Sheng and one from Huang Jia, totaling approximately 25,400 pills, as well as 192,000 pills from Nei Wai. Authorities have ordered the recall of all 30 related drugs and advised patients taking these medications to discontinue use. However, the Supervision Alliance for Healthcare criticized the TFDA for delaying the warning for over a month, calling it a severe dereliction of duty.
The reader questioned why the supervising pharmacists at these GMP-certified pharmaceutical companies failed to fulfill their responsibilities, suggesting their licenses should be revoked and investigations launched into possible document forgery. They also demanded inquiries into how many other illegal pharmaceutical companies might be involved.
**Non-GMP Manufacturing Environment Treated as Substandard Drugs**
Li Mingxin, deputy head of the TFDA’s Risk Management Division, stated that GMP pharmaceutical companies must complete all production, manufacturing, and packaging processes in a GMP-compliant environment; otherwise, the drugs should be considered "substandard." Li explained that the companies outsourced aluminum foil blister packaging to Shun Jie for cost-saving reasons. Among the 30 drugs, nine—including Xibole, Cough Relief Capsules, Ouye Throat Lozenges, and Tongleshuang Enteric-Coated Tablets—are "over-the-counter" medications available at pharmacies after consultation, while the other 21 require a doctor’s prescription. So far, no adverse reaction reports have been filed for these drugs.
Li Mingxin noted that the violators have been fined NT$30,000 to NT$150,000 under the Pharmaceutical Affairs Act, with criminal liability under investigation by prosecutors. Additionally, Macro and Manhattan pharmaceutical companies outsourced packaging to Shun Sheng and Century, involving three more drugs, but only Shun Sheng and Century were penalized. The TFDA did not issue a public notice initially due to investigative confidentiality, only posting recall information on its website.
Supervision Alliance spokesperson Teng Xihua criticized the TFDA for quietly announcing the issue on its website, allowing uninformed patients to continue using the drugs. She questioned how the public could still trust government-guaranteed GMP standards and urged the TFDA to revoke the companies' licenses and strengthen inspections. However, Taiwan Pharmacist Association Chairman Li Shuping and Vice Chairman Lian Ruimeng argued that since the drugs were completed in pharmaceutical factories and only the aluminum foil packaging was outsourced, drug quality should not be affected.
**TFDA Criticized for Delayed Warning**
Shun Jie Vice President Lin Yishu emphasized that the company primarily handles packaging for health supplements. If pharmaceutical companies disguised drugs as health supplements for outsourcing, authorities should investigate the source.
Century Pharmaceuticals, which had violated GMP procedures twice before, committed a third offense this time. The New Taipei City Health Department stated it would impose heavier penalties. Century’s factory manager Wu Xuexiong explained that outsourcing packaging for low-volume drugs like stomach medicine and cold tablets was more cost-effective than investing in molds. Nei Wai Chemical’s special assistant Wang Qingzong said the drugs had already been sold to distributors before being repackaged and that distributors had been instructed to recall them.
Shun Sheng Pharmaceutical stated that its drug ingredients were legal and that the company lacked coating equipment, hence the outsourcing. Since coating machines cost NT$1–2 million and molds around NT$200,000 each, the company plans to handle packaging in-house moving forward.Source: http:/ / tw. news. yahoo. com/ gmp……ypes- recalled- 202614431. html