Chinese companies now account for more than 50% of the global active pharmaceutical ingredient (API) market. It has more than 500 companies registered to sell in the U.S. and 10 times that many serving its own market. But many of those continue to struggle to meet international standards.
As an example, Bloomberg points to the fact that last year, Chinese authorities ordered about 700 Chinese firms to review pending drug applications and withdraw any that were false or incomplete in an effort to step up its drug quality oversight. About three-quarters of the applications were voluntarily withdrawn or rejected by China’s regulators, even though some of the drugs also were approved for sale in the U.S.
Several of the company’s explained the disparity to Bloomberg by saying that their products sold in China were tested by Chinese labs that provided faulty information while those sold in the U.S. were certified by research firms in North American companies and, as a result, are safe. It was a sentiment that echoed China's regulators.
“Drugs approved in the past are still being used, but there may not be accurate data to prove that their efficacy reached international levels,” Wu Zhen, vice minister of China’s FDA explained at a press conference about its oversight, Bloomberg reports.
Of course, the U.S. FDA is not relying on its Chinese counterparts to ensure drug safety. It has upped its own staff dedicated to plant inspections there and has recently posted a steady stream of warning letters issued to Chinese drugmakers.
Some of those are operators like Concept Products, a Tianjin, China-based company that the FDA found lacking in some of the most basic GMP standards. A warning letter said the company did not write up or follow any processes for holding each lot for sampling. It never got the OK from the quality control people before release, and also didn't do stability testing to determine how the APIs should be stored and their appropriate expiration dates. The company also did not have established procedures for regularly cleaning and maintaining equipment.
Two weeks ago, the FDA issued a warning letter for two facilities operated by Xinxiang Tuoxin Biochemicalin in Xinxiang City, Henan, China for dirty equipment, holes in the facility that allowed inspects into clean rooms and paint above API equipment that was chipping off the ceiling.
But some of the drugmakers that the FDA has cited, and that have had products banned from entry into the U.S., are large Chinese operations which supply some of the biggest western drug companies.
Those include Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical, which were slammed in warning letters for manipulating testing and turning in falsified batch test results on APIs.
Shanghai Desano works with GlaxoSmithKline’s ($GSK) HIV med speciality group, ViiV Healthcare. ViiV said it did a review after being told of the warning letter and determined it should not affect the supply of any of its medications.
It found similar issues at Chongqing Lummy Pharmaceutical, and those problems have spilled onto clients in the U.S. The FDA this year rescinded its approval of an ANDA for temozolomide capsules, a chemo drug, that had been issued to Philadelphia-based Lannett after figuring out that it had been approved after the FDA had banned the Chinese API supplier. Lannett has sued the FDA.
Despite the regulatory issues, Chinese companies continue to build business in the U.S. Bloomberg reports that China’s drug exports to the U.S. grew 4% last year.
- read the Bloomberg story
- here's the warning letter to Xinxiang Tuoxin Biochemicalin
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