Quick-change: China puts oversight burden on drugmakers

Hot off a scandal in which gelatinmakers that feed the drug capsule industry were found to be using industrial, not food-grade, product, China is imposing new rules on drug manufacturers to audit excipient suppliers.

The difficulties with the new guidelines, in-Pharma Technologist points out, is that they go into effect in October, there was only a four-day window to make comments and the explanation of the proposed rules currently exist only in Chinese.

The draft excipient guidelines from the State Food and Drug Administration (SFDA) put the responsibility on drugmakers to audit and monitor the quality of excipient suppliers, the publication says, but do not give details on how that is supposed to happen. It also comes as the government intends to bum up the number of excipients that can be used in drug manufacturing to 381 from 130 by 2015.

In the last several months, China has closed dozens of gelatin- and capsulemakers and even arrested some players after it discovered many were drumming cheap scrap leather into their gelatin. In May, Chinese drugmaker Biostar Pharmaceuticals acknowledged that it had to destroy about 5 million capsules after tests by it and the SFDA determined they had been made with subgrade ingredients and some were contaminated with chromium.

On this side of the world, the FDA has been putting new rules on drugmakers as well to monitor heparin suppliers after tainted products from China in 2008 led to patient deaths.

- read the in-Pharma Technologist story
- a link to the guidelines in Chinese