China sets rules for excipient makers after scandal

A scandal over toxic drug capsules in China last year brought more unwanted attention to the gap between the country's place in the pharma ingredient world and the ability of its regulators to keep things on the up-and-up. China has since reorganized its drug-regulating agency and some of its rules but may still be unable to keep ahead of bad players there.

The country has created new licensing requirements for higher-risk excipients, reports an official explaining this week at the IPEC-Americas' ExcipientFest in Baltimore. The China Food and Drug Administration (CFDA)--the successor of the State Food and Drug Administration--based them on toxicity and dosage data, explained Dr. Sun Huimin of China's National Institute of Food and Drug Control. CFDA guidelines now also mandate that excipient manufacturers have clean rooms to prevent cross-contamination.

The issue in China is less with the requirements in place than the regulators' ability to make sure manufacturers are abiding by them, in-PharmaTechnologist reports that Meredith Ge, the former chairperson of IPEC, told the group. She said that the CFDA is looking to third-party audits and also relying on manufacturers to self-regulate.

Chinese APIs and other products have become an indispensable part of the global drug manufacturing supply chain and efforts to cut costs. But doing business there comes with risks. The FDA is expanding its efforts to inspect plants using new fees levied on makers of generic drugs. China has also broadened its effort, often stepping in to close problem operators after Western drugmakers have collected evidence against them.

Chinese authorities in April 2012 closed plants and made arrests after determining that illegal operations were pumping out capsules using industrial-grade gelatin derived from scrap leather. The leather had come from tanneries which used chromium in their processes. Seven people were sentenced to prison earlier this year following the crackdown, but not until after millions of the capsules had hit the market. 

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