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China continues steps toward drug safety reform

By Kirsty Barnes , 31-Jul-2007

China continues to take steps toward drug safety reforms as it forges closer ties with US regulators and shuts down dodgy manufacturing plants.

The US Food and Drug Administration's (FDA) department of human Health Services (HHS) announced yesterday that it has set up a series of bilateral meetings with China in the coming months to tackle the pressing problems of the dubious safety of many food and drug imports from China.

 

 

 

"Our US regulatory agencies are concerned about what they see as an insufficient infrastructure across the board in China to assure the safety, quality and effectiveness of many products exported to the United States", HHS secretary Mike Leavitt said in a statement.

 

 

 

Yesterday HHS chief of staff went to Beijing on a fact-finding mission "to pave the way for us to open discussions on developing two Memoranda of Agreement (MOA) between our two governments, one on the safety of food and feed, and one on the safety of drugs and medical devices", said Leavitt.

 

 

 

"I am hopeful that we can achieve two, strong, action-oriented documents by December".

 

 

 

US food and drug regulators raised elevated concerns with China over the safety of its imports in May and requested "rapid action" over the establishment of better cooperation; better information; and establishment and enforcement of "regulations that we can understand, with which we agree and in which we feel confident".

 

 

The planned meetings are a follow-up to those discussions, said Leavitt.

 

 

 

The US is one of a number of countries that China has been working with to create a greater cooperation on product safety, Li Changjiang, head of the General Administration for Quality Supervision, Inspection and Quarantine, said in a news conference.

 

 

 

He also indicated that China was implementing stricter market access requirements for its manufacturing firms, as well as conducting spot checks on facilities and product quality.

 

 

 

The country is facing a mountainous task, with corruption, shoddy production and counterfeiting being widespread. Progress toward extensive reform will inevitably be slow.

 

 

 

Despite this, small victories are being won in the fight against pharma-industry crime. Late last week Chinese police arrested 15 members of a suspected counterfeit drug gang.

 

 

 

According to reports by China's Xinhua News Agency, the gang allegedly either bought fake drugs and repackaged them, or manufactured them, using materials such as water and starch.

 

 

 

Police seized counterfeit versions of 67 types of drugs produced by 53 companies, including 10,000 doses of rabies vaccine, 20,250 bottles of an injectable cardiovascular drug and 211 bottles of blood protein.

 

 

 

As part of the effort to clean up its act, China has also finally withdrawn the business license of the notorious Taixing Glycerin Factory and shut down all its premises.

 

 

 

It is alleged that the firm exported a product consisting of 15 per cent diethylene glycol (DEG) - a poison used in anti-freeze and as a solvent which can cause kidney failure - among other substances, and fraudulently passing it off as 99.5 per cent pure glycerin.

 

 

 

Glycerin is used as a sweetener in some medicines and Taixing's allegedly 'fraudulent glycerin' mixture ended up in medicines in Panama last year. Over 50 people were reported to have died as a result of taking cough syrup, antihistamine tablets, and calamine lotion contaminated with DEG.

 

 

 

Other facilities implicated in the production of unsafe consumable non-drug products were also shut down as part of the latest crackdown.

 

 

 

The Chinese authorities indicated that a legal investigation was now underway involving the companies and their managers although would give no further details.

 

 

 

If recent events in China are anything to go by, these managers should have grave cause for concern.

 

 

 

Zheng Xiaoyu, the former director of the country's State Food and Drug Administration (SFDA) was executed last month after being convicted of corruption in the drug approval process, which ultimately led to the death of Chinese citizens after substandard products reached the market.

 

 

 

Zheng's former colleague Cao Wenzhuan was also handed a similar fate although his death sentence has been suspended for two years and will be most likely commuted to life in prison.

 

 

 

Many other senior officials have or are also likely to receive lengthy jail terms as prosecutions continue.

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