Prescription for trouble: China about to dominate global drug market
markets. At a news conference this week, the deputy drug agency chief, Wu Zhen, called on countries to work together to ensure a safe global supply chain of medicines. “To solve the drug safety problems, we need international cooperation,” Wu said. “We hope to have … more cooperation and less finger-pointing.”
China dominates more than just antibiotics. U.S. regulators license 714 plants in China to produce ingredients for over-the-counter, generic, and prescription drugs for Americans. China has captured a major share of the global sales of many vitamins, antibiotics, enzymes, and painkillers. It makes a third of the world’s acetaminophen, an over-the-counter pain medication widely sold under the brand name Tylenol. Which brings up another possible scenario: “Just suppose you are taking some cholesterol drug, and its intermediates or active ingredients are made in China. Then there’s some conflict with Taiwan. Will your drug still be available?” asked Joe Acker, president of the Washington, D.C.-based Synthetic Organic Chemical Manufacturers’ Association. “The whole drug supply could be in jeopardy in these kinds of situations.”
Bayer, the German health-care giant, held patent protection until 2004 over the antibiotic known as ciprofloxacin, which it marketed as Cipro. That antibiotic now is mass-produced by generic firms, which get a key ingredient, dichloro fluorobenzene, from one of four Chinese companies or two Indian firms. The Chinese and Indian companies are all but exempt from oversight by the U.S. Food and Drug Administration (FDA). “Only 13 inspections were conducted in China in 2007,” Representative John Dingell (D-Michigan) said at a hearing on 1 November. “At this rate, it would take the FDA 55 years just to clear this backlog.” By giving China a virtual pass on FDA inspections, Acker said, Chinese firms get a cost savings of about 25 percent above American companies, which face unannounced on-site inspections at any time. Since European pharmaceutical companies also face tougher standards, they too have stopped producing some basic drug ingredients, ceding production to Chinese and Indian companies that face less scrutiny and have lower costs.
Outsiders say that Chinese drug plants run the gamut from First to Third World. “You will see some companies where you can eat off the floor. They are state-of-the-art,” said Acker, the U.S. trade group chief. “I hear other stories of places where people are making chemicals while wearing flip-flops.” The Chinese authorities and Chinese phrmaceutical companies do not allow foreigners to visit or examine plants, and the Chinese government takes foreign journalists to four Potemkin plants in which, as expected, everything looks modern and clean. Villax, the Portuguese executive who is a board member of the European Fine Chemicals Group, said that some Chinese pharmaceutical manufacturers were cutting corners and that unless enforcement tightened “people will die.” “It’s not low-cost labor that concerns us,” Villax said. “What we’re saying is there are a lot of people not playing by the rules, and not getting caught.”
