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Boosting drug supervision
2006-08-21
China Daily
Supervision is important to guarantee drug quality and drug administrators should not fail in their duties, says a signed article in Shanghai Securities News. An excerpt follows:
Seven deaths have been linked to a hazardous antibiotic injection, Clindamycin phosphate glucose injection produced by the Anhui Huayuan Worldbest Biology Pharmacy Co. Two months earlier, a fake injection produced by the Qiqihar No 2 Pharmaceutical Co, a privately-owned business in Northeast China's Heilongjiang Province, caused 11 deaths in China. These cases have greatly threatened public safety and the drug administrations were criticized for not performing their duties well.
Strict supervision is an important premise to urge pharmaceutical companies to enhance their quality control. Pursuing the maximum profits is the only goal of enterprises. Only when the supervisory departments perform their duties well to supervise the enterprises, they will emphasize on product quality to avoid risks.
Drug administrations were hard to absolve themselves from the blame in the above two cases,
The public knew more truth as the investigation deepened in the injection case. According to China Business newspaper, the fatal problems of infusion drugs normally relate to the impurities in the products. The State Food and Drug Administration only has restrictions on the total amount of the impurities during chromatogram test. But there is no standard about the specific varieties or quantity of the impurities. Also, there is no unified standard for antibiotics sterilization. Different pharmaceutical companies have different standards and techniques themselves. More importantly, infusion type of Clindamycin phosphate glucose has not been approved in other countries out of safety consideration, but China has issued certificates to it.
According to National People's Congress deputy Xu Ai'e, the total cost of drug approval is 48,000 yuan (US$5,900) and the minimum testing term was five years.
But at present, some new drugs were approved within a week or a month while the cost ranges from millions to tens of millions yuan. The corruption of a few officials was the reason why drug prices have skyrocketed and some drugs were of poor quality.
If related departments cannot shoulder their responsibilities, similar deadly cases may come up again.
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