FDA or Chinese medicine 38 products have been banned from entering the United States

Source: Cypress blue January 20, 2016 Democratic America and "selective anti counterfeiting" America are the world's largest pharmaceutical market, with a total value of about one third of the world's total The U.S pharmaceutical market not only has a large capacity, but also pursues and invests more in the development of innovative drugs than other countries In addition, the United States is the world's largest generic drug market Although the United States is the only country in the world with free pricing of medicine, its payment system has been overwhelmed by the economic crisis and patent cliff, and the proportion of generic drugs is increasing year by year For example, in 2014, the proportion of generic prescriptions was close to 90%, compared with less than 60% ten years ago Not only that, there are tens of billions of dollars of pharmaceutical sales lost patent protection every year in the United States, so the United States is not only a paradise for high-priced innovative drugs, but also a "battle ground" for generic drugs But it's not easy to get into the U.S pharmaceutical market, especially to achieve commercial success This is not only because the strict supervision of medicine and food in the United States is almost harsh, but also because the strictness of FDA has always been the benchmark of regulatory agencies in various countries What's more terrible is that the "mistakes" made by the United States to all enterprises (whether malicious or unintentional) can also be devastating if they are found For example, recently, Volkswagen in Germany was deeply involved in the "exhaust gate" incident The litigation loss alone is estimated to be $7.3 billion, and the maximum fine may be as high as $20 billion Although the United States is a democratic country, claiming that it will not discriminate against any foreign "economic invasion", it is unfortunate that the recent "heavy handed crackdown on counterfeit goods" has frequently appeared in foreign enterprises Of course, I have no intention to complain for Volkswagen The evidence of Volkswagen's "sophisticated software algorithm" is conclusive, and it's also my own responsibility to be punished But is there also a political tendency of national protectionism in it, and is the United States selectively cracking down on counterfeits? As we all know, India's generic industry is very developed, and even has the title of "world pharmacy" The United States is also the largest exporter of generic drugs to India, once nurturing a number of world-class star enterprises such as Ramsey, sipura, sunpharma, etc However, since the FDA found the lack of quality inspection records in lambertich plant in 2008, Indian generic drugs have encountered unprecedented Waterloo In order to closely monitor the production process of pharmaceutical plants in India, FDA opened two offices in India after 2009 and significantly increased the number of on-site inspectors and the frequency of on-site inspection Severely crack down on those products whose production process does not conform to the US GMP, which may lead to drug pollution and allergic reactions Those who maliciously falsify and refuse to mend their ways will be disqualified from applying for regulatory policies FDA no longer accepts new drug applications from these manufacturers, nor does it approve applications for related products that have been submitted And "imprisonment" will continue until the manufacturer ensures the "integrity" and "credibility" of the data In January 2015, the FDA banned the drugs produced by toransa pharmaceutical factory in rambsi from entering the United States due to quality problems This is the fourth banned Indian pharmaceutical company, with more than 700 banned drugs A series of FDA actions caused by these "counterfeiting incidents" have almost caused a fatal blow to India's generic pharmaceutical industry The once brilliant old generic companies, including Ramsey, were even sold The "incomplete data" incident in Haizheng and Jiuzhou triggered the fire China is the second largest importer of API after India, and more and more Chinese pharmaceutical companies are applying for generic drugs in the United States With the frequent setbacks of Indian pharmaceutical companies, the opportunity for "made in China" to enter the U.S market has been created People's daily even published an article in September 2014, "China's generics opportunities are here." Unfortunately, Haizheng's "incomplete data gate" earlier this year not only lost tens of millions of dollars, but also set an incalculable roadblock for Chinese pharmaceutical companies to enter the U.S market Of course, there is no denying that Haizheng pharmaceutical is a well-known manufacturer of API and a benchmark enterprise for API export From March 2 to 7, 2015, FDA found in the GMP inspection of API in Taizhou factory, Haizheng, that the laboratory data was not recorded in time, or the invalid data caused by the failure of system adaptability test was not recorded, and was deleted without report On September 10, 2015, FDA issued the API import warning letter to Haizheng Taizhou factory From the date of issuing the warning letter to the period when the rectification was approved by FDA, 15 API varieties, such as acarbose, were temporarily unable to enter the U.S market among the 29 API varieties currently allowed to enter the U.S market in Haizheng Taizhou factory The same problem occurred in Jiuzhou pharmaceutical industry last year Kyushu purchased the antiepileptic drug carbamazepine from other enterprises, but it was sent to the United States without quality inspection FDA inspectors have also found that there has been a lack of, or even suspected falsification of, records Therefore, camasi produced in Kyushu and Taizhou is also on the FDA's prohibited list The FDA or the Chinese made Haizheng "incomplete data gate" is likely to ignite and repeat the mistakes of India's generic drugs This is not sensationalism In fact, the US FDA has taken this opportunity to apply for a substantial increase in the number of on-site inspectors in China For example, before the FDA, there were only two on-site inspectors in China, examining about 700 GMP API production bases The number of inspectors has recently increased significantly to 26 Although these inspectors are not fully in place due to visa issues, FDA conducted 120 on-site inspections in China in 2014 Including the above Haizheng and Jiuzhou products, a total of 38 products have been banned from selling to the United States so far, which is the second most banned country after India And the FDA's measures are almost the same as those used to deal with generic drugs in India Some media also took the opportunity to sing down China Bloomberg News Agency became the Internet pusher of FDA's efforts in China with the prominent title of "discarded tests put fdaon notices China pushes drag exports" In addition, some media also linked the incident to the heparin pollution gate incident seven years ago In 2008, there was pollution of heparin APIs in China, which was allegedly related to 246 deaths caused by infection in the United States After several years of overhauling the quality of generic drugs in India (60% of on-site inspections are in India), the FDA expects to focus on China in the near future The way out for the internationalization of China's generic drugs depends on its own hard work There is no denying that "incomplete data, untimely records, replacement or copying of contents, falsification of analysis report, inconsistency of date and signature" and other phenomena found in FDA inspection occur from time to time in the industry If Chinese pharmaceutical companies want to march into the United States on a large scale, they must strictly abide by every GMP requirement, create "the reputation of the whole country's pharmaceutical industry", and make FDA helpless even if it wants to add a crime At the same time, we will build factories, mergers and acquisitions in the United States, and build our own R & D institutions and marketing channels The Japanese experience is a model for the successful internationalization of Chinese pharmaceutical enterprises.