Pharmas face closure if they fail to meet Beijing’s new regulations; Most drug makers who passed the new regulation are now facing idle capacity because their capacity had been enhanced to meet standards

January 26, 2014 Leave a comment

Pharmas face closure if they fail to meet Beijing’s new regulations

Staff Reporter

2014-01-23

Drug manufacturers in China that have not passed new regulations under the Good Manufacturing Practice for Pharmaceutical Products (GMP) will face closure until they pass the verification process devised by the new GMP regulations, according to the China Food and Drug Administration.

Chinese pharmaceuticals can be divided into two categories — sterile medical products and non-sterile medical products.

The administration stated that all the sterile drugs manufactured by existing drug manufacturers had to meet the requirements of the new version of GMP before the end of 2013.

As of Dec. 31, 2013, the number of sterile drug producers was pegged at 1,319, with 796 passing the new GMP regulation and 523 trying to meet the new requirements or waiting to be merged with other companies.

The administration stated that those who have not met the requirements of the new GMP regulation could continue operating after they pass, but those who fail to pass the exam would be closed or merged, according to the Shanghai-based Economic Observer.

Most drug makers who passed the new regulation are now facing idle capacity because their capacity had been enhanced to meet standards, said a worker at China Shineway Pharmaceutical Group.

For drug producers, trying to meet the new GMP regulation is exerting mounting pressure as a result of idle capacity, bank loans, development for new drugs and capital flow.

Non-sterile medical products, on the other hand, have to meet the requirements of the new GMP by the end of 2015, said the report.

As of Oct. 2013, only 778 out of the total 3,839 non-sterile drug manufacturers passed the verification process.

An official at the China Association of Pharmaceutical Commerce said that at least 1,000 non-sterile medical producers have to be shut down or merged with other firms after the deadline passes in 2015.

Market observers are of the view that China’s pharmaceutical industry should be controlled by large pharmaceutical firms, which could help enhance quality, improve competitiveness and internationalization.

Filed under Macro Trends

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