Drug watchdog to increase activities in China

The US-based RX-360, a global pharmaceutical industry consortium of volunteers protecting patient safety and enhancing supply-chain security, plans to increase its activities in China, which has become a major supplier for the global drug industry.

The Washington-based nonprofit organization was established in 2009 to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain.

"With globalization of distribution for both drug components and finished products, China has undoubtedly played an important role in the global pharmaceutical industry. The country has a large number of manufactures, supplying raw materials to the world," said Brian Johnson, chairman of RX-360, who is also the senior director of supply chain security at the drug company Pfizer. "How to ensure the security of sourcing and supply chain and increase the awareness in the country becomes very critical as with many problems that to date have yet to be resolved."

The group's work in China will parallel what it has been doing in the US and Europe for several years, such as raising awareness of issues that have an impact on the security and integrity of pharmaceutical products and sharing best practices through education It will also promote the efficient use of joint and shared audit programs to continue to improve the transparency of supply channels.

The group has also developed a series of tools and published white papers to help the industry and regulators address key areas of supply-chain security such as cargo theft, illegal product diversion, economically motivated adulteration, monitoring of drug shortages.

"Our goal is to work with local industries and regulators to further our mission in China," said Johnson, adding that this is also a step for RX-360 to invite more participation by local suppliers throughout Asian countries.

"Leading industry groups such as RX-360 will be very happy to share their expertise with local industries in combating security threats in our common supply chain. And I think these educational and best-practice sharing activities will benefit Chinese companies, especially those smaller ones," said William Pay, Greater China head of the global strategic sourcing office at Bayer Healthcare, which was a cofounding member of RX-360 consortium along with Pfizer, Takeda, Amgen , Eli Lily, Roche and others.

The group also stressed the need for cracking down on online sales of counterfeited drugs, which has become increasingly rampant in China.

In December last year, the Chinese government arrested more than 1,300 people involved in various counterfeit drugs sold on online.

Earlier this month, China's Food and Drug Administration warned about authenticity and quality of overseas drugs sold online, and said 75 percent of overseas generic anti-cancer drugs supplied by online agents are fake and ineffective.

Also this year, police from Central China's Henan province arrested 19 suspects for allegedly bogus medical devices, busting 13 marketing dens and seizing 48 medical devices originating from overseas waste.

"The online sales of counterfeit drugs now are a big issue for the whole pharmaceutical industry in securing supply chain safety. More efforts should be given to this section, and meanwhile, how to carry out effective supervision work is also important," said Rory Budihandojo, director of the Asia-Pacific audit center of excellence at Boehringer Ingelheim China, also a member of the group.

RX-360 was founded in the aftermath of the heparin scandal in 2008, when tainted raw heparin was found in finished products sold around the world, which led to the deaths of more than 100 Americans.

Since then, RX-360 member companies in the pharmaceutical industry began to share their information of supply-chain security and also established white papers and guidance on preventing counterfeits and exposing other forms of pharmaceutical crimes.

So far, the group has more than 80 members, including manufacturers, suppliers and industry associations. The group has set up an Asia Working Group run by Dr Zhijian Xiao, head of quality operations Asia Pacific of AstraZeneca.

wanghongyi@chinadaily.com.cn