Calf blood drugs stop production for rectification? General Administration of food and drug: subject to the notice of Internet

Source: China economic network, January 19, 2016, June 2015, CFDA (State Food and Drug Administration) reported that Wuhan Hualong Pharmaceutical Co., Ltd was withdrawn GMP certificate and recalled relevant products due to illegal production of calf blood deproteinized extract injection and forgery of all production records Six months later, the incident escalated again Recently, Netease announced that CFDA has stopped the production of domestic calf blood drugs, required the industry to rectify, and studied and formulated new industry standards It is understood that calf blood deproteinized extract, as a drug to improve cell energy metabolism, has been used clinically for many years It is a kind of drug with large amount of money in clinical use in China, and also the third pillar of nervous system drugs It is worth noting that at present, domestic calf blood drugs have occupied more than 99% of the domestic market share The analysis shows that if the domestic manufacturers stop production in an all-round way, it will undoubtedly lead to the shortage of drug market and affect patients' drug use The reporter of "daily economic news" yesterday (January 18) called a number of pharmaceutical companies that produce calf blood medicine to find out the situation, and found that many pharmaceutical companies have indeed stopped production at present, but nearly half of them said they are still in normal production, and there will be no supply and demand problems After verifying the situation, the CFDA information and Publicity Office said that no relevant information was found on the CFDA official website, and that the rumors "shall be subject to the notice on the Internet" In the 1960s, jaegerkh developed the calf blood egg free self extract The calf blood with a relative molecular weight of less than 6 × 10 was made by membrane filtration technology At present, China has approved the production of calf blood drugs, including calf blood (Deqing) deproteinized injection, Deproteinized Calf Blood Extract Eye Gel, Deproteinised Calf Serum Enteric Capsules, etc., involving 22 pharmaceutical companies, clinically used mainly in the brain and nervous system diseases, vascular diseases, radiation damage diseases, eye diseases and other fields The reporter of "daily economic news" noted that recently, Netease announced that CFDA has stopped the production of domestic calf blood drugs in an all-round way and required the industry to rectify after the Wuhan Hualong incident in June 2015 The raw materials of biochemical drugs are mostly from animal tissues, with complex ingredients, relatively high requirements for production process and quality control, and belong to high-risk drugs It is reasonable for CFDA to strictly control the quality " Pharmaceutical analyst Gan Xiang said According to the public data, after the Hualong incident in Wuhan, Changchun Changqing Pharmaceutical Group was put on file for investigation due to the incomplete animal quarantine certificate for the use of calf blood as raw material, the suspected forgery of production records and inspection records of individual batches of pharmaceutical enterprises, and Zhaoke Pharmaceutical Co., Ltd Hefei Co., Ltd for its unauthorized purchase of calf blood deproteinized extract intermediate products from Inner Mongolia strange biological technology In the second half of last year, the General Administration of food and Drug Administration conducted flight inspection on calf blood drug manufacturers one by one No matter Hualong, Changqing pharmaceutical and Zhaoke pharmaceutical, the problems reported are not accidental, which shows that there are some problems in this industry at least or more " A pharmaceutical industry source, who declined to be named, said that biochemical drugs are easy to catch up with raw materials According to the approved production process, the enterprise shall use the fresh calf blood or calf serum as the raw material in the GMP certified production workshop of the enterprise, after alcohol precipitation, centrifugation and concentration, make the calf blood concentrate, and then make the calf blood deproteinized extract injection through ultrafiltration, dialysis, filling and other steps Whether the blood is fresh or not and whether the blood is pure is hard to guarantee for some pharmaceutical companies " Said the person Market supply will be affected According to Netease report, CFDA, based on the information of previous flight inspection institute, domestic calf blood drug production has been suspended and disclosed 11 Companies involved include Xingqi ophthalmic, AoHong pharmaceutical, Changchun Tiancheng, Jilin kangnair, treasure island, white swan pharmaceutical, Shengtai biology, Dilong pharmaceutical, Jiangshi pharmaceutical, Wuhan Renfu and qingyutang pharmaceutical It is worth noting that many of the above pharmaceutical companies are subsidiaries of listed pharmaceutical companies, involving Fosun Pharmaceutical, Fu'an pharmaceutical, Tonghua Jinma, Harbin hi tech, humanwell pharmaceutical, Lishi pharmaceutical, treasure island, etc Yesterday, the reporter of "daily economic news" called the above-mentioned pharmaceutical companies respectively to find out the truth, and found that some of them had already stopped production "We haven't produced this medicine now I haven't received any notice as to when to reproduce it." Qingyutang staff said A dealer of Shengtai biology also told reporters that calf blood deproteinized extract injection is currently in a state of suspension, "because I heard that the State Food and drug administration has adjusted the production standard of the drug." In addition, relevant staff of ohong pharmaceutical and Wuhan humanwell also confirmed that the company had stopped production of the drug But there are exceptions The sales manager of Xingqi eye medicine in Chongqing confirmed to the reporter that Xingqi eye medicine's calf blood series products are still in normal production and have not been affected in any way; people related to treasure island and Jilin Cornell also expressed the same view to the reporter It is worth noting that, according to the data of minenet, in 2014, in the domestic sample hospital calf blood deproteinized extract market, avich accounted for only 0.4% of the market share, while domestic drugs accounted for more than 99% of the market share; in addition, according to 2014 According to the annual data, calf serum deproteinized drugs, ganglioside, oxiracetam, rat nerve growth factor and edaravone are among the top five drugs for nervous system, accounting for 40% of the market share Even if half of the pharmaceutical companies stop production now, the whole market supply will be affected " Ganxiang believes that calf blood drugs belong to auxiliary drugs, which are suitable for various symptoms, and the suspension of such drugs has a huge impact on the whole industry In this regard, the CFDA information and publicity office personnel, after verifying the situation, said to the reporter of the daily economic news that at present, CFDA has not made relevant notifications on the official website, and for relevant information, please refer to the notification on the Internet According to Shi lichen, head of Beijing Dingchen medical management consulting center, in 2015, ginkgo leaf incident and calf blood deproteinized extract injection incident broke out one after another, which shows that the state's regulation of extract is more and more strict, "whether it is plant extraction, animal extraction or mineral extraction, the state's regulation is indeed not perfect Now the state is increasingly strict in monitoring and punishing the quality and raw materials of drugs "