The comment below is in response to Editor-in-Chief Michelle Hoffman's December 2008 editorial, “A Tale of Two Pharmacetuical Industries.”
Reader H.Y. Guh writes:
Your recent article in Pharmaceutical Technology about two pharmaceutical industries, one for export and one for the domestic, in China is absolutely correct. Having been consulting in China over the past 7 years, however, I am in disagreement on the regulations by the Chinese government.
The State Drug and Food Administration (SFDA), a government agency in Beijing, regulates the pharmaceutical industry in a way similar to that of the FDA. As a matter of fact, the SFDA has literally copied US GMP practices and regulations for its use.
The sad part is inadequate enforcement due to rampant corruptions at all levels of the agency. During visits to my clients, I have observed personally how an inspection was conducted and managed. Furthermore, the market place is chaotic, “anything goes”, and full of bribery and kickbacks. Hospitals and medical professionals rely heavily on the “gray” drug income to maintain services and livelihood. For instance, a skilled surgeon makes a meager salary of about 3,000 Yuan (or US$450) a month, less than a college graduate of 2-3 year experience. The thin profit margins have made it economically impossible for pharmaceutical companies to follow GMP. For overseas markets of good margins, Chinese firms can afford to meet GMP requirements acceptable to the FDA or other foreign agencies.
As an overseas Chinese, I feel horrible about the poor pharmaceutical quality that Chinese people are getting. From a pragmatic standpoint, China lacks resources to manage all of its needs demanded by 1.3 billion citizens. Its leaders have to make tough choices. Drug quality unfortunately commands less priority when compared to food safety.
On the positive side, China is rapidly evolving and is moving toward an open society day by day. I hope in the not too distant future, the SFDA would attain adequate funding, strengthen enforcement and do away with the 2-tier system.
