Industry group Rx-360 lays plans for expanding activities in China

The Rx-360 consortium, a voluntary industry group of sourcing and supply chain managers, is laying the groundwork for expanding its operations into China, as a first step to inviting participation throughout Asia, according to Asia Work Group co-leader, Janice Berman, VP, quality assurance at Takeda Pharmaceuticals USA. The first meeting, in Shanghai, brought together representatives of several multinational pharma companies, a handful of China manufacturers and suppliers, and a US FDA representative (but not, so far, representatives from the Chinese FDA, SFDA).

The tentative plan, says Berman, is to set up work groups paralleling activities that have been going on in the US for several years: shared resources for supplier audits; supply chain security generally, and membership solicitations. A schedule of biennial meetings is being planned; the next meeting should be in April or May, says Berman.

RX-360’s mission statement is 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.” It was organized in the aftermath of the heparin scandal in 2008, when contaminated raw heparin ultimately showed up in finished product sold around the world, resulting in the deaths of over 100 Americans. With a letter of permission from the US Federal Trade Commission, member companies have been allowed to share processes and results from audits of their contract suppliers and others; another effort resulted in white papers and guidance on counterfeit prevention.

The supply-chain integrity issue in Asia is arguably as bad as it has ever been. Reuters reported in mid-December that the Chinese government had arrested 1,300 involved in various counterfeit medicine schemes within China, and Xinhua, the Chinese news agency, reported that a government office of intellectual property theft is cracking down on online sales of counterfeit medicines and other products.

The Rx-360 consortium maintains an office in Washington; current members include 87 manufacturers, suppliers and associations.