China's drug regulator suspended the sale of 13 drugs using capsules allegedly made with excessive chromium levels, highlighting China's continued battle with food and drug safety as well as what analysts say are mounting cost pressures amid the government's health-care overhaul.
The State Food and Drug Administration said in a statement Sunday it asked local authorities in China to inspect drug-capsule manufacturers in their provinces. The statement named the 13 drugs under suspension, including 11 Chinese traditional herbal remedies and two antibiotics. All were made by Chinese pharmaceutical companies that purchased the capsules from small manufacturers in China's coastal Zhejiang province.
China's state-run China Central Television network reported Sunday that the toxic drug capsules had been made from industrial gelatin, which contains more of the chemical chromium than edible gelatin. Chromium can be carcinogenic with frequent exposure, according to the U.S. Centers for Disease Control and Prevention.
State media reported that the chromium came from leather scraps from manufacturers, which contains the chemical as part of the tanning process, used as a raw material. The state-run Xinhua news agency said police detained 22 people who allegedly produced and sold the capsules.
China is a major maker and exporter of drugs, but pharmaceutical analysts say it is unlikely the capsules have gone beyond China's borders. A spokeswoman said representatives from the China-based office of the U.S. Food and Drug Administration were unavailable for comment Monday.
Food and drug safety remain major issues in China, where food scandals —often driven by economic motives—frequently appear in the news. The government often launches campaigns to safeguard consumers by cracking down on harmful chemicals added to food, yet regulatory oversight remains a major problem.
While the majority of the nation's drug capsules are made in Zhejiang province, most multinational companies have tight sourcing restrictions and heavily monitor the manufacturers with whom they work. Capsules are used more often in China, while U.S. consumers typically use tablets.
Pfizer Inc., one of the numerous pharmaceutical companies that produces drugs in China, hasn't been affected, according to a company spokeswoman. Pfizer sources its capsules from a supplier in another province. A rigorous quality system to ensure that all materials that we source [including capsules] are in accordance with all applicable Pfizer as well as local and international regulatory standards in in place.
Analysts say that China's drug manufacturers are facing increasing price pressures in the country. The central government, which overhauled the country's health-care system over the past three years and extended national insurance to 95% of the population, has encouraged provincial governments to cut health-care costs and prices of so-called essential drugs, which include, among many, Chinese traditional medicines and antibiotics.
The vice governor of one of China's poorest provinces, Anhui, was promoted in 2010 to the national government as a vice director of the National Development and Reform Commission, the country's economic-planning agency, after cutting drug costs by 30%. The Anhui administrator was credited with creating a bidding system in which drug companies win hospital and pharmaceutical contracts by promising quality drugs at the lowest prices.
Since then, 16 other provinces have created similar bidding systems, putting pressures on many drug manufacturers to lower production costs. The lowest-price-wins model has set up a system in which manufacturers cannot profit. Many feel as though they have to cut corners on quality.
Cost pressure has also been created due to the country's once-a-decade leadership transition, which begins later this year. Many politicians, looking to curry favor with the central government in hopes of a promotion, have pushed harder for low prices. A pitch for quality will likely return later in the year, after party meetings in the fall set the future roster of leaders.
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