CHINA LEX PHARMA LAW NEWSLETTER
Vol. 1, No. 26 - November 23, 2000
TOPICS THIS ISSUE:
- Fake Medicine Destroyed in Shanghai
- Second OTC List Available Next Year
- SDA Pulls Drugs Containing PPA
- China Has Annual Increase of 1.2 Million Diabetes Patients
- China to Tighten Administration of Pharmaceutical Firms
Fake Medicine Destroyed in Shanghai
A batch of fake and shoddy medicine worth more than two million yuan was destroyed publicly on November 18.
The pharmaceuticals were destroyed at the founding ceremony of a special team put together to inspect fake and shoddy medicine in Shanghai.
The team is comprised 80 members and works under the Shanghai Medicine Supervision Administration.
(Source: Xinhua News Agency)
Second OTC List Available Next Year
The second OTC list will be released to the public by the first half of next year, after the completion of the preliminary selection and confirmation process.
The first OTC list was released in July 1999. The OTC selection process for the second list differs from the first in the following two aspects: (i) the second list directly divides the OTC Type A and OTC Type B drugs; and (ii) traditional medicines and medicines for local diseases both of which qualify under the national standards may be included on the list as well. Experts on Tibetan, Mongolia and Uigur medicines are invited to comment during the selection process.
(Source: China Pharma News)
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SDA Pulls Drugs Containing PPA
China's State Drug Administration (SDA) recently stopped the manufacture and sale of 15 different pharmaceuticals that contain phenylpropanolamine (PPA).
The banned pharmaceuticals include Contac Sustained-Release Capsules and Contac Maximum Strength Capsules, manufactured by Tianjin SmithKline & French Laboratories.
The impetus for the decision by SDA was a recently-published Yale Medical School study that found a correlation between PPA and strokes. SDA warned that ingestion of PPA-rich medicines could result in arrhythmia, hypertension, kidney failure and insomnia. The United States Food and Drug Administration (FDA) published a public health advisory on November 15 regarding drugs containing PPA. It is not known at this time when and under what circumstances the ban will be lifted.
(Source: China Daily)
China Has Annual Increase of 1.2 Million Diabetes Patients
China has 1.2 million new diabetes patients annually, with an increase of 3,000 daily, reported the Ministry of Health in Beijing on November 14.
November 14 is a significant date, "World Diabetes Day," and the theme this year was "you can grasp your health -- new millennium diabetes and lifestyle." An official from the Ministry of Health said that diabetes is closely related to having an unhealthy lifestyle, and information from that office released to the public focused on lifestyle change to combat the disease.
Diabetes and its related complications is ranked as one of the major health risks in China, following cancer and cardiovascular and cerebral diseases.
(Source: Xinhua News Agency)
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China to Tighten Administration of Pharmaceutical Firms
China will accelerate the reorganization of its pharmaceutical firms and eliminate redundant construction, Zheng Xiaoyu, director of the State Pharmaceutical Administration, said recently at a national pharmaceutical conference.
So far, most of the pharmaceutical firms in China are small or medium-size, and due to an insufficient capacity for technological innovation and poor management, 98 percent of the overall products are just imitations, according to the director.
Many firms have been producing the same drugs, which has inevitably caused structural redundancy in the pharmaceutical sector, and consequently, some firms manage to lower cost at the sacrifice of quality, said Zheng, adding that this in return has deteriorated the competitive power of this industry as a whole.
In order to eliminate the firms with inadequate technology and yield, China will continue to push the GMP system. Those that cannot meet the GMP standards are subject to being closed or suspended.
Zheng's words mirror the general position taken by SDA beginning last year that discouraged new production lines and manufacturing facilities that were in any way redundant with the existing capacities of the industry. At the same time, SDA introduced new regulations governing toll manufacturing, one alternative to new manufacturing facilities.
(Source: Xinhua News Agency)
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