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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) |
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