Due to stric regulation for export, API industry got hurt

The EU adopted a new regulationconcerning the import of bulk drugs 2011/62/EU (62 orders ) in June 2011,which requires the manufacturer must approvide written declaration that provesevery batch product meet the EU GMP.This regulation is one of the mostinfluence export policy in domestic API industry.

Currently,the API annual export toEU amount in the pharmaceutical products is about 25%,so EU market is one ofthe most important markets.Therefore,the changes of EU import policy impactedon China's pharmaceutical export.

A raw material drug productionenterprises worker said that a considerable part of exported API is productedby chemical plants from the customs statistics.Because some chemical plantsdidn't observed the standard drug production and the cost production is reduced,so APIs qualities are not sure.The export of unqulified produts is not onlypertub the rules in the market,but also created the ssecurity risk and iscriticized by foreign countries.

In the past a long time,bulk drugsand especially intermediates are linked to chemical companies inextricably.In the pharmaceutical industry to promote GMP certification process,the nationaldrug regulatory authorities have tried to promote the raw material drugcompanies GMP certification.Due to limited regulatory authority,the chemicalcompanies didn't comply related certification and they still produced the APIs.It occupies part of the product cost advantage in international trade,which seriously impacted the APIs export.

By Ann