The primary conclusion has been reached in the Qiqihar No 2
Pharmaceutical Co fake drug case, which has so far claimed nine
lives.
According to the State Food and Drug Administration (SFDA), the
pharmaceutical company in Heilongjiang Province purchased 1 ton of
"propylene glycol" in September 2005 from a trader to use in the
production of Armillarisni A injections. But the "propylene glycol"
delivered by Wang was actually diglycol, a cheaper, toxic
industrial material.
The company failed to discover this problem before it made and
sold doses of the drug, which led to fatal kidney failure when it
was administered.
The circular published by the administration emphasized that the
pharmaceutical company had violated Good Manufacturing Practice
(GMP) regulations, the guidelines that pharmaceutical companies
must follow when producing medicine.
GMP is an independent management system concerning product
quality and safety. In China, these guidelines generally equal the
regulation of drug manufacturing and quality control.
Although China's Drug Administration Law only requires
enterprises to get attestation on a voluntary basis, the SFDA ruled
in 1999 that pharmaceutical companies without attestation could not
manufacture drugs after July 1, 2004. Officials explained that
although the number of companies reduced after attestation was made
compulsory, the production level and product quality still have
room for improvement.
Bai Huiliang, director of the SFDA Department of Drug Safety and
Inspection, acknowledged that companies' average attestation costs
exceeded 10 million yuan (US$1.25 million) each, including spending
on essential technological upgrading.
These massive costs have forced many old State-owned
pharmaceutical enterprises to reorganize in an effort to get the
money required for attestation. The Qiqihar No 2 Pharmaceutical Co
was reformed between 2003 and 2005, the peak time for reform
throughout the industry. It is said that the company invested 30
million yuan (US$3.75 million) to get attestation.
GMP has actually set detailed standards for all production and
management links. It emphasizes that enterprises should have
sufficiently qualified technical staff to conduct production and
quality management. These people should have a clear understanding
of their duties, know the rules of operation and receive necessary
training. According to SFDA officials, more than 500 inspection
teams have been sent to examine enterprises in recent years.
Objectively speaking, after investing so much money and making
such great efforts, the mistake made by Qiqihar No 2 Pharmaceutical
Co ought not to have happened if the company had really fulfilled
all the requirements of GMP.
But the tragedy did happen. The expensive GMP attestation
campaign did not produce the expected results.
Industry insiders once revealed the routes that could be taken
to ensure unqualified drug are not checked: not sending products
for examination on time, producing a special batch of quality
products for the examination when the normal products cannot meet
the national standards, and rewriting inspection reports.
At the same time, it is hard for administrative departments to
supervise companies' purchases of raw materials due to insufficient
financial and human resources. Provincial administrative
departments can only inspect enterprises once a year at the
most.
It is not realistic to expect administrative departments to
conduct all inspections of pharmaceutical manufacturers. A more
practical and possible way would be to allow intermediary
institutions to do the day-to-day attestation work, with
administrators just giving directions and making strict spot
checks. Then the limited personnel of administrative departments
can be freed from the heavy burden of its daily attestation work
and improve its efficiency.
The authorities have reflected on their past attestation
procedures. The SFDA issued a provisional regulation on random drug
tests on the same day it circulated the notice on the Qiqihar fake
drug case, requiring local administrative departments to conduct
random field inspections.
It is not too late to rectify the situation. But the authorities
should also consider how to ensure drug manufacturers strictly
follow the GMP of their own accord, rather than just doing so in a
perfunctory manner.
The author is a reporter with the South China Bureau of China
Business News.
(China Daily May 26, 2006)