This article appeared in the June 2007 edition of INNSight

The China Syndrome – regulatory meltdown?

Readers with a long memory might remember the 1979 film entitled “The China Syndrome” which speculated about the possible meltdown of the core of an out of control nuclear reactor The suggestion was that if the core really did melt, it would be so hot as to melt its way through the earth’s core to emerge at China.

The film came to mind in the light of recent news about a real (non-nuclear) meltdown at the Chinese SFDA (State Food and Drug Administration) in May. While it is possible to make a light-hearted reference to the fictional film as an indicator to the nature of the events there, the subject of this meltdown was anything but light-hearted and is of a genuinely life-threatening nature.

For those who did not spot the news item, it was reported at the end of May that a Beijing court had sentenced to death the former director of China’s SFDA on charges of corruption.

The allegations against him included claims that Zheng Xiaoyu had taken more than $850,000 (€632,000) worth of bribes in the form of cash and gifts to inappropriately approve hundreds of drugs and medical devices during a three-year period from 2001 to 2003. The bribes apparently came from eight pharmaceutical companies and his misdeeds were determined to have caused the deaths of dozens of people who took fake and inferior products during his time in office.

Associated Press reported “In one instance, an antibiotic approved by Zheng’s agency killed at least 10 patients last year before it was taken off the market.” This really has become a matter of life and death; both for him and the unfortunate victims who took medicines that they presumed to be safe. The affair has done little to improve China’s image as a source of medicines, although credit must be given to the authorities that, somewhat belatedly, finally clamped down on his activities.

What is particularly unfortunate for the country’s image in this context is that, almost simultaneously, the EU released its latest statistics on seizures of counterfeit goods during 2006. As in previous years, it singled out China as the main source for counterfeit goods with over 80% of all articles seized coming from there although, with regard to medicines specifically, it noted that India does not have clean hands since that country was identified as the number one source for counterfeit medicines.

For those fascinated by statistics the report, which is available on http://www.eubusiness.com/Trade/1180620001.4/ noted “In particular medicines, widely on sale via the Internet, have shown a dramatic increase in seizures; 2.5 million items last year compared to 500,000 items in 2005.”

Returning to China specifically, the combination of the two items of news must be a blow to its attempts to follow India in becoming a major source of generic formulations to Western markets. Although supplies of Chinese APIs to the West have risen dramatically in recent years as they managed to increasingly undercut Indian competitors, formulations have always lagged behind.

This has been due to a combination of factors such as a shortage of fluent English speakers, a lack of transparency due to the political climate and questions about the ability of Chinese companies to reliably manufacture formulations to European or US GMP standards. These events will only have reinforced suspicions about local GMP supervision.

The SFDA is now trying to repair some of the damage and announced in response to the news that it would send 90 officials to carry out drug safety inspections in 15 provinces. There seems to now be a genuine effort to put things right but the Chinese authorities are going to have to not only put things right by proper enforcement but must also be seen to be doing so. This in turn will require a great deal more openness than they are normally comfortable with in their activities.

Chinese manufacturers want to be able to sell their formulations in the West and no doubt, their government would also like them to do so. The price of that is a system of GMP enforcement that is transparent and inspires confidence in Western buyers and authorities.

If you have any questions or comments

on this article, please do contact me.

peter@interpharm-consultancy.co.uk

www.interpharm-consultancy.co.uk