Two major supervision key Chinese pharmaceutical enterprises of API and generic drugs are frequently "banned" when they go to sea

Source: Beijing Business Daily on April 19, 2016, the reporter learned that the US Food and drug administration has listed two Chinese pharmaceutical enterprises on the import warning list According to incomplete statistics, since 2009, 40 Chinese pharmaceutical companies have appeared on the FDA's import warning list Industry insiders pointed out that with the implementation of the consistency evaluation policy for generic drugs, the share of pharmaceutical exports in enterprise revenue will be larger and larger in the future If drugs are "banned" by relevant regulatory authorities in Europe and the United States, it will cause unprecedented impact on the performance of enterprises Recently, the US Food and drug administration put Xinxiang pharmaceutical Co., Ltd and Xinxiang Tuoxin Biochemical Co., Ltd on the import warning list All drugs and APIs produced by the two companies (such as adenosine, choline, uridine and other pharmaceutical intermediates) will be subject to the disposal of "seizure without inspection" by the US customs when they are exported to the United States, which means that the products of the two companies are completely prohibited from exporting to the United States It is understood that the two pharmaceutical companies were completely blocked by the food and Drug Administration of the United States due to the non-compliance of GMP (i.e GMP) on-site inspection Beijing Business Daily reporter saw on the official website of Xinxiang pharmaceutical Co., Ltd that the company established Tuoxin group with Xinxiang Tuoxin Biochemical Technology Co., Ltd at the beginning of 2005 A variety of its products have reached the standards of USP and EP The products are exported to more than 20 countries and regions in the Americas, Europe, Southeast Asia, etc., and an international marketing network has been initially formed A reporter from Beijing business daily tried to contact the company's head to inquire about the details of the ban, but no one answered the phone In fact, it is not a case that Xinxiang pharmaceutical Co., Ltd has been blacklisted by the food and Drug Administration of the United States In March last year, the FDA found that the production of API deviated from cGMP standard (international GMP standard) seriously, including the phenomenon that the laboratory data was not recorded in time, during the inspection of the famous domestic API and finished drug manufacturer Haizheng Pharmaceutical (12.660, 0.00, 0.00%) in Zhejiang factory At the same time, Haizheng pharmaceutical had a large number of customer complaints about insufficient content and excessive impurities in 2012-2014, but the original data has been deleted According to the inspection results, the US Food and drug administration put 13 APIs of Haizheng pharmaceutical into the import warning list It is understood that the actual sales revenue of these 13 varieties of APIs in the U.S market from January to August 2015 was 177 million yuan, and the sales revenue in the U.S market from September to December 2015 was expected to be 62 million yuan In the first half of last year, the net profit of Haizheng pharmaceutical fell 78.33% year on year Since 2009, 40 Chinese pharmaceutical companies including Kyushu pharmaceutical and China Resources Sanjiu (22.70, 0.00, 0.00%) have appeared on the FDA's import warning list It is worth noting that most of these enterprises export to the U.S market are APIs and generic drugs, and these two categories have also become the focus of the FDA in recent years As China has become the second largest importer of API after India, more and more Chinese pharmaceutical companies are applying for API in the United States But the long-term export experience does not allow enterprises to obtain a relatively loose regulatory atmosphere Since last year, the US Food and drug administration has substantially increased the number and frequency of inspectors in China's GMP API production base, with frequent heavy fists In January this year, Haixiang Pharmaceutical (10.17, 0.00, 0.00%) was listed During the inspection of SFDA, it was found that the integrity of laboratory data was insufficient, and some drugs could not enter the U.S market temporarily Industry insiders said that the "lack of laboratory data integrity" mentioned by the US Food and drug administration is also a common problem for the vast majority of Chinese pharmaceutical enterprises that have been "banned" According to the results of on-site GMP inspection of Chinese pharmaceutical enterprises conducted by the United States and the European Union last year, the main problems focus on the data level, including incomplete data, inaccurate data, falsification of analysis reports, replacement of records, re copying of records, inconsistency between date and signature, etc Generic drugs are another major focus of overseas regulation In January of last year, the domestic pharmaceutical enterprises, such as Xiantai pharmaceutical and Puluo Kangyu pharmaceutical under North China Pharmaceutical (6.940, 0.00, 0.00%) and Zhejiang Puluo Kangyu under North China Pharmaceutical (6.73, 0.00, 0.00%) failed to pass the GMP inspection of the European Union due to the existence of document fraud and other problems, so the products also lost the opportunity to enter the European Union market The regulation will also be tightened "With the introduction of the policy of generic drug consistency, the regulation of Chinese enterprises by the US and the European food and Drug Administration will be further tightened." Shi lichen, head of Beijing Dingchen Medical Consulting Center, told Beijing Business Daily that at present, the proportion of export drugs in the business of many enterprises is very small, about less than 10% However, after the implementation of the conformity evaluation policy of generic drugs, the proportion of export business will be greatly increased If the enterprises encounter sanctions from the United States and the European Union due to their own problems at this time, the performance of pharmaceutical enterprises will be greatly affected It is understood that at present, there are nearly 5000 pharmaceutical enterprises in China, of which generic pharmaceutical enterprises account for more than 90% This year, the state has increased the adjustment of the generic pharmaceutical industry Now, the draft for opinions on generic drugs has been issued, which requires that the quality and efficacy of the generic drugs should be consistent with that of the original drugs in the future Industry insiders predict that the export of generic drugs may account for more than 30% of the revenue of pharmaceutical export enterprises in the future If the quality of drugs can be guaranteed, this policy is undoubtedly good for enterprises But if there is a problem in the quality of drugs and they are "seized" by the food and Drug Administration of the United States, then the pharmaceutical enterprises will face an unprecedented blow Today, the FDA's monitoring of Chinese APIs and preparations has shifted from spot checks to routine checks, he said In addition, the inspection of the production process of Chinese enterprises is also being strengthened As the US Food and Drug Administration's supervision becomes more stringent, other countries will take a warning and increase the inspection of China's APIs and preparations The result of the above three points is that "going out" pharmaceutical enterprises will face more stringent inspection If they do not "go out", they will increase the difficulty of "going out", such as the difficulty of obtaining FDA certification for production lines If Chinese pharmaceutical companies want to go smoothly on the way to sea, on the one hand, they must strictly abide by every GMP requirement, and at the same time, they must strengthen the research and development of independent innovative drugs which are still in the blue ocean state On the other hand, it is also a wise choice to build factories, mergers and acquisitions in the United States, and to build its own R & D institutions and marketing channels.