Chinese drugmakers struggling to meet deadline

TAIYUAN - About 17 percent of China's axenic drug producers may fail to meet a deadline in qualifying for the country's new Good Manufacturing Practices for drugs, according to an official survey published on Thursday.

The State Food and Drug Administration survey shows that China has 4,462 production lines of axenic drugs in 1,319 enterprises, with only 23 percent of them intending to adapt to the new standard this month and 60 percent by the end of next year, the legal deadline.

The existing GMP 2010 entered into effect on March 1, 2011. After that point, all new drugs production units were required to meet the standards before being licensed.

In the meantime, existing drugs enterprises were offered two types of transitional period: the SFDA requested all manufacturers involved in axenic drugs to adapt to the new standard by the end of 2013, while all other drugs enterprises have until 2015 to upgrade their manufacturing procedure.

Axenic drugs refer to a particular type of pharmaceuticals including blood products, vaccines and injections.

Yin Li, head of the SFDA, said those unable to meet the deadline would face closure.

Quality control is crucial for drug safety, said Yin, adding that Chinese drugmakers also face problems with their small scale, lack of innovation and excessive competition.

A major drug safety scandal broke out in April, when a large amount of drug capsules were found to be made of industrial-level gelatin, which contains excessive levels of chromium.

The SFDA announced in May that 254 pharmaceutical enterprises, or 12.7 percent of all capsule makers in the country, were found to be producing unsafe drug capsules after a month-long inspection, with 5.8 percent of tested drugs found to contain excessive levels of chromium.