In the wake of a controversy over unsafe capsules in China, the State Food and Drug Administration may blacklist some pharmaceutical manufacturers. The move is seen as an effort to restore a degree of public confidence after the SFDA conducted a month-long probe and found that 254 pharmaceutical companies, or 12.7 percent of all capsule makers, turned out capsules containing unsafe levels of chromium (back story).
The investigation, however, was begun only after local media uncovered the problem. And so the SFDA is floating the blacklist proposal and soliciting public comments until next Wednesday, according to China Daily. The blacklist will contain companies and people that "severely" violate safety rules in manufacturing and selling medicine and medical equipment (here is the SFDA statement).
Those who make or sell fake or substandard medicine, forge materials to apply for licenses, and produce medical equipment without credentials may be put on the list, according to the proposal. The blacklist will be made available through government websites and media releases. The SFDA will be in charge of monitoring behavior as supervisors will be tasked with inspecting companies on the list more often and demanding periodic quality management reports.
The idea is to ensure drug safety, deter violations and build a system to track drugmakers, the China Daily writes. One expert believes this may work. "If blacklisted, a company will lose its reputation and that will deal a heavy blow to sales. The cost of violating the rules will increase significantly," Sun Zhongshi of the National Rational Drug Use Monitoring System, which operates under the Ministry of Health, tells the paper. "It's important to determine a period of validity for the blacklist. Those who continue with their bad practices should be expelled from the trade forever."
So far, Chinese authorities have investigated 236 capsule makers and ordered 42 to halt production, closed down 84 production lines, revoked production licenses of seven companies and referred 13 to the police. Of the 11,561 batches of drugs tested, 5.8 percent were found to contain excessive levels of chromium, according to the SFDA (here is SFDA statement on its investigation).
Meanwhile, one manufacturer confessed to distributing capsules with high levels of chromium, but maintains steps are being taken to avoid a repeat. Biostar Pharmaceuticals acknowledged that the SFDA found excessive chromium levels in samples of 1.2 million capsules its Xin Aoxing Oleanolic Acid Capsule, an over-the-counter treatment for hepatitis B. Its own examination then found the same thing in samples from another batch containing 2.7 million capsules.
How did this happen? Biostar blamed the initial problem on a former employee who last year bought 4 million capsules from an unapproved supplier. The former manager was fired last August, although Biostar acknowledged that tests were not conducted, the drugmaker maintains testing was not required at the time. The drugmaker is now testing all capsules purchased since last June and has additional testing equipment and quality-control procedures in place. Biostar adds its capsules now come from food-grade gel.
"We intend to announce the results of this self-administered inspection in middle of June, when Xianyang SFDA, in turn, reviews and approves the conclusions of our inspection," Biostar ceo Ronghua Wang says in a statement. "...While we believe that our quality control and purchasing practices are adequately suited to address our needs, we have been and remain fully committed to complying with all applicable SFDA directives as well as bolstering our internal quality assurance measures. We have invested in additional testing equipment, and increased the frequency and depth of our self-administered inspections of our inventory and supplies."