Chinese medicine tablet enterprises GMP certificate recovery nearly 80% of the industry is facing strong supervision
Last Update: 2021-02-05
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Chinese medicine enterprises represented by Chinese medicine tablets have become the central area for the recovery of the GMP certificate of pharmaceutical products, and are becoming more and more intense. "Flying inspection" is the direct cause, complaints report is indispensable, and the use of GMP norms of Chinese medicine "earth-ocean combination" seems to be the crux of the problem. But on the whole, under the background of industrialization and industrialization, small and medium-sized Chinese medicine enterprises are more like meeting their own destiny.
Chinese medicine enterprises into a "flying inspection
On June 3, the State Administration of Food and Drug Administration ("CFDA") issued the 2015 Annual Drug Inspection Report.
report, a total of 59 enterprises received "flying tests" in 2015, of which 60% were Related to Chinese medicine, compared with 35. And chemical raw materials, biochemicals, chemical preparations, blood products add up to 4 items, a total of 24.
problems found in the "flying test" are also concentrated in Chinese medicine enterprises. Among them, there are 4 major problems in Chinese medicine tablets. Such as: tickets, illegal purchase of Chinese medicine tablets label sales and forged production records, out-of-factory black nests, Chinese medicine purchase and product factory can not guarantee full inspection.
the inspection of Ginkgo biloba extract and Ginkgo biloba preparations, there are also problems such as unauthorized change of process and falsification of record documents.
fact, Chinese medicine enterprises are not only the focus of spontaneous, unconventional flight inspection characterized by the drug supervision department, but also the focus of routine inspection such as GMP tracking inspection.
high-intensity inspection corresponds to a very high problem rate.
21st century economic reporters combined with the CFDA issued the "2015 GMP certificate recovery statistics" and the statistics released by the pharmaceutical network, made a finishing and verification. Of the 144 certificates found to have been recovered by 140 enterprises, the proportion of Chinese medicine enterprises was about 80%, to 115.
, there were 82 Chinese medicine tablets, accounting for 56.9%, and 33 pharmaceutical enterprises were among the sterile preparation enterprises. As early as 2014, Chinese medicine enterprises have become the focus of supervision, the number of certificates recovered that year was 20, accounting for 40% of the total number of withdrawals.
Guoguang, chief analyst at Southwest Securities' pharmaceutical team, believes that chinese medicine's non-compliance with heavy metal pollution is more serious than that of chemicals. Shi Lichen, founder of The Beijing Dingchen Medical Management Consulting Center, said that There have been problems such as storage, transportation, artificial pollution of heavy metal agricultural chemicals, irregular production of Chinese medicine tablets and unlicinsted production.
role of system design can not be ignored. According to the operating practice of flight inspection, the area where there are more problems in the previous year will be the focus of the next year's monitoring object, which also makes it difficult for the key monitoring object to get out of trouble in a short period of time.
addition, the new 2015 flight inspection rules added the "complaint report" this path, for a time, fierce competition and the problem is more common Chinese medicine enterprises in this way, fierce "tearing each other."
Wei (ad), a Chinese medicine tablet business owner in Anguo City, Hebei Province, disagrees with the views of pharmaceutical experts, who believe that it is difficult to meet international GMP standards with Chinese medicine.
Where do Chinese medicine drinking tablet enterprises go from
Chinese medicine drink tablets are Chinese medicine after the theory of Chinese medicine, Chinese medicine preparation methods, after processing, can be directly used in the clinical Chinese medicine.
, an enterprise owner in Anguo City, Lao Wei, was fined for buying Chinese medicine tablets from a pharmaceutical farmer for label sales, but fortunately there is no certificate to be recycled "nightmare". His friend Lao Guo, who is also a Chinese medicine tablet business owner, is not so lucky. The reporter called Lao Guo, the other side was discouraged, said he had left the industry, do not want to say more.
reporter also called the 2015 certificate was recovered in Anguo City Wanlian Chinese medicine tablets company, the other side said he was a former sales manager of Wanlian, has been away for a year. According to the announcement, Wanlian's GMP certificate was withdrawn in June 2015 and has not been returned.
Old Wei as a business owner and old Chinese medicine told reporters that small Chinese medicine drinking tablets enterprises are suffering from "the disaster of extinction", the reason is that the reality of the production of Chinese medicine and standards are far from. Lao Wei said that the "standard" refers to the "People's Republic of China Pharmacopoeia" has included about 1000 kinds of Chinese medicine. According to the Drug Administration Law, drug production shall be based on the drug standards and process standards prescribed by the State.
Zhu Guoguang and Shi Lichen agree that the problem is small businesses, not standards.
" is precisely because the state on the cultivation of Chinese herbal medicine, production, acquisition, warehousing, transportation and other links did not set standards, will let the law-making operators drill holes. "Slichen believes that the state should continue to strengthen the development of standards for the supply chain of Chinese herbal medicines.
Zhu Guoguang said that large-scale, centralized production is the future development trend of Chinese medicine enterprises. Strong supervision can effectively enhance industrial concentration, which is undoubtedly beneficial in terms of industrial development. Standards, the survival of the fittest is the most fair and conducive to society, the law of the market.
February 2016, the State Council issued the Outline of the Strategic Plan for the Development of Traditional Chinese Medicine (the "Plan"), which calls for "improving the technical level and economies of scale of the Chinese medicine manufacturing industry" and "building a high-quality product standard system for the whole chain of the Chinese medicine industry".
on the strong supervision facing Chinese medicine enterprises, Wang Wei, executive vice president of the China Over-the-counter Drug Association, said, "Regulatory authorities are based on strict prevention of drug harm incidents, improve the safety and effectiveness of public drug use as the starting point." Wang
also believes that the scale and industrialization of Chinese medicine is inevitable, but he thinks that the characteristics of Chinese medicine itself can not be ignored.
Because of a variety of reasons, it is difficult for hospitals to obtain high-quality Chinese medicine tablets on the market, the old Chinese medicine spread among the "Chinese medicine will be destroyed in Chinese medicine" argument, is because many famous Chinese medicine prescriptions of the benefits of the party in the hospital can not find qualified Chinese medicine tablets to dispedul.
" scale, industrialization is the general trend, but management must be in place, regulators in the implementation of supervision, the quality of drugs, efficacy and human health in the first place," Wang Wei said, in order to healthy development of the industry, high standards, strict requirements are necessary. (China Economic Network)
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