Changchun customs has learned that the customs of changchun has successfully broken a case of the illegal import of drugs by electronic water customers with a crime of more than 13 million yuan. Case, according to an Internet cable shang dynasty platform "India zhou buy on sb's behalf", "India line items bought 5 stores" suspected of smuggling Sophie cloth wei from India, dhaka, he more than ten countries banned the import of drugs, such as immigration, and use the network transaction in the domestic high sales for profiteering.
As India's generic drug market booms, India's "world pharmacy" identity has been widely recognised. In recent years, there have been frequent smuggling of Indian drug cases in China. Due to price and quality, some patients have relied on India to produce all kinds of drugs, and the generic drug market is the most active. Experts say the development of generic drugs in China needs to be accelerated, and the state council reform office will complete the guiding document for the reform and improvement of the generic drug administration policy by the end of October this year.
Smuggling of Indian drugs is frequent
Generic drugs refer to the same kind of imitations that are used in dosage, safety and efficacy, quality, function and indication. When the patent expires, other countries and pharmaceutical companies can produce generic drugs. But in India, the patent law to allow drug compulsory license, in the event of a "public the reasonable demand for a patented invention not satisfied", or "the public can't at a reasonable price paid to obtain the patent invention", and so on and so forth, the Indian pharmaceutical industry in domestic can forcibly generic drugs is under patent protection, and can be exported to no relevant production capacity of regions and countries.
In recent years, there have been frequent cases of smuggling of Indian drugs in China. Only Shanghai has been able to review six overseas online shopping foreign drug cases since 2013, and several overseas online shopping people have been punished with varying degrees of punishment. The reason behind the frequent cases of drug smuggling is the slow development of the generic drug industry in China.
In the overseas online shopping generics case, the most famous case is lu yong. , 2002 people in wuxi city, jiangsu province Liu Yong leukemia was diagnosed with CML, to control the disease, he must continue to take the Swiss novartis production cancer drug gleevec, the drug carton price is in 23000 yuan to 23000 yuan, in 2004, for personal use in India's generic after Swiss anticancer drugs "gleevec" think the price is very high and effect is exactly the same, then he began to help other patients buying generics. On July 21, 2014, a procuratorate in yuanjiang, hunan province charged lu yong with a crime of obstructing credit card and selling counterfeit drugs. A letter from 493 patients with leukemia asked the judiciary to exempt lu yong from criminal punishment.
At the same time, with the continuous development of Internet technology, online sales of generic drugs have become a new model and brought more problems. In June 2014, the national food and drug administration (fda) issued a message indicating that consumers should not purchase overseas daigou for cancer drugs through the Internet. Meanwhile, the state food and drug administration has reminded consumers that cancer drugs are all prescription drugs. The Internet prohibits the sale of prescription drugs, according to the interim regulations on the approval of Internet drug trading services. There were 184 pharmaceutical retail companies approved by the food and drug administration to sell non-prescription drugs online. However, according to incomplete statistics, from November 2010 to early 2010, the state food and drug administration has already published nine times the total 122 illegal Internet purchasing medicine website, which purchased overseas imported drugs "repeatedly points".
The development of Chinese generic drugs for smuggling of Indian drugs is urgently needed. Source: economic reference report 2017-06-3007:50
The difference between domestic and original drugs is obvious
Some experts believe that the main reason for the frequent smuggling of drug cases is that China's generic drug industry is underdeveloped. The reason is that despite China's patent law different factors with India, but India has become the "world pharmacy" not just rely on Indian law for convenient, more important is the assurance of production technology and drug quality.
India, a major producer of generic drugs, exports medicines to more than 200 countries around the world, and 20 percent of the world's generic medicines come from India, and vaccines and biopharmaceutical products are exported to 150 countries. More importantly, more than 60% of India's generic drugs are exported to developed countries such as the United States and Europe, where nearly 40% of the generic drugs in the U.S. market come from India.
The acceptance of Indian generics from the us market shows that Indian generics are cheaper and more important than reliable quality. Learned, in India, excellent pharmaceutical factory production management specification directly follow the FDA (food and drug administration) certification, the current domestic have FDA certification companies a total of 119, exports to the United States about 900 from the FDA approved drugs and pharmaceutical raw materials, with the drug administration approved pharmaceutical factory has more than 80. Moreover, the cost of production of Indian drugs approved by the us FDA is 65 per cent lower than in the us and 50 per cent lower than in Europe. Plus with low-cost manufacturing, strong technology, a large number of English qualified technical personnel with high quality products, Indian pharmaceutical manufacturers can gain a large number of outsourcing production contract, which promotes the expansion of pharmaceutical and industrial innovation.
And the domestically produced generic drugs are greatly reduced on credibility, industry insiders said the quality problem of the generic drugs in China mainly displays in: some generic drugs do not agree with the original drug quality, with the international advanced level gap is larger; The generic drugs produced by different enterprises are of different quality and different quality. The number of enterprises that are declared and produced by the same generic variety is excessive and repeated. "Domestic generics stability is poorer, more side effects, can produce allergic reaction, but now is on the underlying original drugs. Therefore, domestic well-known hospital doctors in the face of severe and special disease still recommend the use of imported drugs, not from the consideration on the price, more is to ensure the effectiveness of the treatment." "Said the person.
The development of generic drugs in China has been accelerated
According to the regulatory requirements, the consistency of Chinese generic drug evaluation need not directly to the original drug, may also be listed generic drugs, because the standard error is allowed, could lead to a generic drugs and the original drug gap growing phenomenon, eventually generics and branded drug efficacy to lose consistency.
In addition, China's drug manufacturers, technology, process, quality control and other key hole is more, regulators for drug certification standards and international standard gap is larger, enforcement is also insufficient, these factors lead to Chinese generic drug is difficult to get the industry recognition.
Therefore, the development of Chinese generic drugs needs to be accelerated. According to the key tasks of the 2017 health reform determined by the state council, it will complete the guiding documents for the reform and improvement of the generic drug administration policy by the end of October 2017.
According to earlier this year issued by the general office of the state council concerning the further reform and improve the use policy for producing and distributing medicines of several opinions, stressing the need to accelerate the quality and consistency evaluation of curative effect of generic drugs already on the market. In the opinion, we should encourage drug manufacturers to select and choose their products according to the relevant guidelines, choose the evaluation method rationally and carry out research and evaluation. For the import of the reference preparation, speed up import and approval, improve the efficiency of customs clearance. The bioequivalence test records management, allowing qualified medical institutions, institutions of higher learning, scientific research institutions and other social testing organizations such as consistency evaluation of bioequivalence test in accordance with law.
The department of food and drug administration should strengthen the guidance of enterprises and promote the completion of the work task of conformance evaluation. In order to make timely delivery of relevant information to the society through consistent evaluation of drugs, the drug can be included in the list of alternative medicines. If the production enterprises with the consistency evaluation of the variety of drugs reached more than 3, they would not choose the varieties that did not pass the conformance evaluation in the case of centralized procurement of drugs; There are no more than three, priority procurement and use of a variety that has been assessed by consistency.
"The development of generic drugs, first of all, is the solution to the problem of myrrh. Now, to carry out the conformance evaluation, it is mainly to solve the problem of using the best medicine. The object of the reference is the original medicine." Consistency, experts say, accelerate the drug evaluation just means, the ultimate goal is to let people use safe and effective good medicine, both have to do the consistency requirements, also can't "myrrh available" for the sake of consistency.
The personage inside course of study suggested that the process still needs to be based on the experience of the Indian pharmaceutical manufacturers, strict consistency evaluation standard, and the original of the drug, at the same time keeping up with the international certification standard, it will change some drug companies existing production process, quality control processes, such as in the long run, this is the Chinese way of medicine enterprise long-term development. |
