China Takes Aim at Poor-Quality Drug Production

FiercePharma Manufacturing

January 7, 2014

China drug regulators have struggled to maintain high manufacturing standards within the country's burgeoning drug production industry. But after launching a drive against drug counterfeiters last year, they say they will focus this year on companies that are failing to make the grade.

The new program is part of a larger effort by the China Food and Drug Administration (FDA) to step up its oversight of a wide range of food and pharma manufacturing. The agency has been criticized for a number of drug and food scandals uncovered in the last few years. The new effort was announced last week by Zhang Yong, who heads China's FDA, the Shanghai Daily reports.

To supplement the actions, the National Health and Family Planning Commission will establish a public blacklisting effort to try to stop companies from using bribery to get their drugs into government health programs. The Wall Street Journal reported that companies blacklisted twice in a 5-year span will be banned for two years from selling in any province where authorities determine that bribery has been used to influence drug sales. It said companies can apply as usual to sell their products in other provinces. The program, slated to begin March 1, was announced last week and comes as GlaxoSmithKline ($GSK) and other Western drugmakers are being investigated for doing just that.

China has become a key link in the global pharma supply chain?mostly for its manufacturing of active pharmaceutical ingredients?but its oversight is generally considered lax. It is also often identified as central to the manufacture and distribution of counterfeit drugs. Authorities seem determined to try to shed both of those reputations with the new programs. Last month authorities reported rounding up 1,300 suspected counterfeiters and confiscating $362 million worth of fake drugs and raw materials.

But the country has promised before to crack down on rogue manufacturers. In 2008, China said it would get tough after raw heparin from there killed dozens of U.S. dialysis patients. The public furor also lit a fire under the U.S. FDA to pay more attention to foreign suppliers. The agency secured more money from Congress to put inspectors in countries that pose the greatest risks to the U.S. drug supply, but China for a year blocked visas for new inspectors. Vice President Joe Biden took the matter up during a trip there last year and secured a pledge to let the inspectors in. The FDA plans this fiscal year to add 10 drug and nine food inspectors to the staff of nine it already has in the country.

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