Made in China


The FDA is set to open three offices in China, writes Clifford Coonanin Beijing

CHINA'S GROWING economic power in the past few years has been built on its exports of goods with relatively little added value. However, its future is built on sending high-quality products in sectors such as pharmaceuticals and biotech abroad. This means sub-standard drugs are bad business, and in China's growing health products market, the stakes are high.

A rash of product recalls from China has prompted the country's health authorities to consider something that for many years would have been politically impossible - allowing foreign agencies into the country to monitor its food and drug production.

Now regulators in Beijing have granted diplomatic approval for the US Food and Drug Administration (FDA) to open three inspection offices in China, in three cities: Beijing, Shanghai and Guangzhou.

The co-operation is significant. It's a sign of how China's growing openness is combining with its need to improve its international standing in the pharmaceutical business, and Chinese health authorities hope the offices will also increase China's own capacity to produce safe foods, drugs and medical devices. Thirteen employees would be assigned to work there.

The move is also a reaction by the FDA to criticism over its lack of overseas inspections after heparin, a widely used blood thinner, was contaminated and imported from China earlier this year. Heparin has been linked to more than 80 deaths in the United States.

Health and Human Services Secretary Mike Leavitt says that as well as the three Chinese offices, the US hopes to open two offices in Latin America and one in India by this autumn.

Chinese Foreign Ministry spokesman Liu Jianchao underlined the importance the Chinese government attached to introducing measures to tighten safety standards.

"We hold a positive attitude towards the co-operation with other countries on the food safety issue," Liu says.

In the case of heparin, the FDA found the drug was contaminated with a nutritional supplement that costs less, but mimics the real drug in routine tests for potency, which meant that it was not detected.

Investigators suspected that deliberate contamination may have taken place, but the FDA had not previously inspected the Chinese facility, and neither had Chinese drug safety regulators, because the plant was registered as a chemical factory.

In early June, the FDA requested an extra €175 million from the US Congress to help pay for more inspections. The additional funds will help the FDA set up new foreign offices, as well as pay for a system to help trace a product back to its origin, among other things. About one-third of all products imported to the US fall under FDA regulation.

The FDA has also signed agreements on third-country inspections, part of a broad effort to foster co-operation among US, European and Australian regulators. Officials are considering whether to limit production of certain "high-risk" medications to designated facilities that meet specified standards.

They also want to swap information more regularly on a wide range of drug development and safety issues.

The agreements signed under the deal incorporate the principles guiding a broad overhaul of US safety standards for imported products.

They include working with industry to establish standards, and not trying to inspect every product.

"We're working very closely with the government to create a new strategy," Leavitt says. "We see the office as not necessarily being just an inspection group."

Beijing has been under pressure to do something about consumer safety, after a series of scandals in the past couple of years did serious damage to the "Made in China" brand. Billions of euro worth of counterfeit and substandard goods, including snack bars, liquor, medicines and face creams, are produced every year in China and there are regular horror stories.

In one of the most highly publicised scandals, China revealed in 2004 that 13 babies had died from malnutrition in the eastern province of Anhui after being fed fake baby milk powder.

In July last year, Zheng Xiaoyu, formerly China's drug and food safety czar, was executed for corruption. With the reputation of the country's pharmaceutical exports at stake, it was no major surprise that retribution was quick and merciless.