Drug Ingredients Get More Scrutiny

With an ever-larger proportion of the world’s pharmaceutical supply being produced in China, big pharma companies are steadily increasing their scrutiny of the drugs and drug ingredients they source from the country. To that end, Rx-360, a U.S.-based consortium of companies that share resources for monitoring the drug supply chain, is expanding into China.

The group took advantage of CPhI China, a major drug ingredient trade fair held in Shanghai last month, to hold its second formal meeting in China. Rx-360’s arrival in China is auspicious: The group was formed five years ago after tainted heparin made with raw materials from China caused the deaths of dozens in the U.S. Rx-360 wants to replicate in China many of the activities it conducts in other parts of the world.

“We don’t intend to make local companies feel excluded from this consortium,” Janice Berman, a Takeda Pharmaceutical executive who heads the Asia working group at Rx-360, said at the meeting. “We hope to share expertise with local companies and that those interested to join us will do so.”

Consortium members share among themselves information about trends and events that may affect the quality or integrity of the drug supply, as well as methods to deal with supply chain threats. They also share, on a voluntary basis, audit reports on pharmaceutical plants. In addition, Rx-360 performs plant audits when sponsored to do so by member companies. “Our core principle is that patient safety cannot be used as a competitive advantage,” Berman said.

It’s early days for Rx-360 in China. The group is still deciding what its priorities should be, according to Teresa Chen, a Shanghai-based quality audit manager for Boehringer Ingelheim who is coordinating the audit subteam for the consortium in China. But Rx-360 does intend to offer its program of consortium audits of manufacturing facilities. The group is now working with a third-party firm that will conduct them on its behalf, she said.

Although Rx-360 is dominated by major pharmaceutical companies, any firm that researches, produces, transports, or warehouses pharmaceuticals can join, Berman said. Regulatory agencies are welcome to participate as observers. In China, several local companies have expressed interest, she said. And encouragingly, a Shanghai-based official from the China State Food & Drug Administration spoke at a well-attended Rx-360 event at CPhI China.

But for the time being, most Chinese drug companies have probably not heard of Rx-360. Tommy Lin, director of business development and global licensing at HEC Group, a pharmaceutical manufacturer based in Dongguan, in southern China, admits that he is clueless about the group. The company might well join, Lin says, but that will depend on membership costs and the benefits HEC could derive from being a member.

Over the next few years, as Rx-360 gets more settled and better known in China, its members hope that it will expand across Asia, and in particular into India where many major producers of generic pharmaceuticals are based. But so far, Rx-360’s progress in India has been sluggish.

Guy Villax, head of the Portuguese active pharmaceutical ingredients maker Hovione and a member of Rx-360, tells C&EN that the group met with Indian drug industry leaders twice this year so far. But after that encouraging start, efforts to follow through with government officials in charge of pharmaceutical exports yielded no results.

“This lack of interest in the security of the supply chain by the country with the largest number of FDA-registered firms, and which claims to be the ‘pharmacy to the world,’ is, at the least, incomprehensible,” Villax says. China, so far, appears keener to polish its credentials as a reliable pharmaceutical source.