The reporter recently learned from Changchun Customs that Changchun Customs successfully cracked a case of "electronic water passengers" smuggling countries that banned imports of drugs with a value of more than 13 million yuan. According to the case, five stores, such as the “Mr. Zhou Zhou Purchasing†and “Indian Shopping Purchasingâ€, are suspected to have smuggled imported drugs from more than ten countries such as Sophie Buwei and Dhakavir from India. Using online trading methods to make huge profits in domestic high-priced sales.
With the prosperity of the Indian generics market, the identity of India's “World Pharmacy†has been widely recognized. In recent years, China has frequently smuggled Indian drug cases. Due to price and quality, some patients rely on various types of drugs produced in India, of which the generic drug market is the most active. Experts said that the development of China's generic drugs needs to be accelerated. Before the end of October this year, the State Council's Medical Reform Office will complete the formulation of guidelines for reform and improvement of generic drug management policies.
Smuggling of Indian drug cases frequently
A generic drug is an imitation that is identical to the original drug in terms of dosage, safety and efficacy, quality, function, and indications. After the patent protection period expires, other countries and pharmaceutical companies can produce generic drugs. However, in India, the patent law allows for the compulsory license of drugs, in the case of “the public’s reasonable demand for the patented invention is not metâ€, or “the public cannot obtain the patented invention at a reasonable priceâ€, the Indian pharmaceutical factory At home, new drugs that are still under patent protection can be forcibly copied and exported to regions and countries with no relevant production capacity.
In recent years, China has frequently smuggled Indian drug cases. In Shanghai alone, six cases of sea taming foreign drugs have been concluded since 2013, and many Haitao people have received different degrees of penalties. The reason behind the frequent smuggling of drugs is the slow development of China's generic drug industry.
Among the cases of Haitao's generic drugs, the most famous is the Lu Yong case. In 2002, Wuxi Renlu of Jiangsu Province was diagnosed with chronic myelogenous leukemia. In order to control the disease, he must continue to take the “Gleevec†anticancer drug produced by Swiss Novartis. The price of the drug is 23,000 yuan per box. 25,000 yuan, in 2004, after using the Swiss imitation of the Swiss anticancer drug "Gleevec", the price is very high and the effect is exactly the same, after which he began to help other patients to buy generic drugs. On July 21, 2014, the Qijiang City Procuratorate of Hunan Province filed a public prosecution against Lu Yong for the crime of ban on credit cards and the sale of counterfeit drugs. After that, 493 leukemia patients jointly wrote a letter requesting the judicial authorities to exempt Lu Yong from criminal punishment.
At the same time, along with the continuous development of Internet technology, online sales of generic drugs has become a new model, but also brought more problems. In June 2014, the State Food and Drug Administration issued a document prompting consumers not to purchase overseas purchasing anticancer drugs through the Internet. At the same time, the State Food and Drug Administration reminded consumers that anticancer drugs are prescription drugs. According to the Interim Provisions on the Examination and Approval of Internet Drug Trading Services, the Internet prohibits the sale of prescription drugs. There are 184 drug retail enterprises approved by the food and drug regulatory authorities with online sales of non-prescription drugs. However, according to incomplete statistics, from November 2010 to the beginning of 2015, the State Food and Drug Administration has published a total of 122 websites for illegal online drug purchases, including overseas purchasing imported drugs.
The gap between domestic generic drugs and original research drugs is obvious
Some experts believe that the reason why the smuggling of drugs frequently occurs, the core reason for traceability is the lack of development of China's generic drug industry. The reason is that although China's patent law is different from India's, India's becoming a "world pharmacy" does not depend solely on the convenience given by Indian law, but more importantly, the guarantee of production technology and drug quality.
As a major producer of generic drugs, India exports medicines to more than 200 countries around the world. 20% of the world's generic drugs come from India, and vaccines and biopharmaceutical products are exported to 150 countries. What is more worth mentioning is that more than 60% of Indian generic drugs are exported to developed countries such as the United States, Europe and Japan. Among them, nearly 40% of the generic drugs in the US market are from India.
From the US market's acceptance of Indian generics, it is not difficult to see that in addition to low prices, Indian generics are more reliable. It is understood that in India, the production management regulations of excellent pharmaceutical companies directly comply with the FDA (Food and Drug Administration) certification, there are currently 119 FDA-approved pharmaceutical companies in the country, and can export about 900 FDA-approved drugs to the United States. And pharmaceutical raw materials, there are more than 80 pharmaceutical companies certified by the British Medicines Agency. In addition, the cost of production by Indian FDA approved by the US FDA is 65% lower than in the US and 50% lower than in Europe. Coupled with low-cost manufacturing, strong technology, a large number of qualified English-speaking technicians and high-quality products, Indian pharmaceutical manufacturers can obtain a large number of outsourcing production contracts, which further promotes the scale expansion and industrial innovation of pharmaceutical plants.
The domestic generic drugs are greatly reduced in credibility. The industry insiders admit that the quality problems of generic drugs in China are mainly reflected in the fact that some generic drugs are inconsistent with the original drug and have a large gap with the international advanced level; There are quality differences, and there are many differences in the number of enterprises that declare and produce the same imitations. “The domestically produced generic drugs have poor stability and many side effects, which may cause allergic reactions, but it is better to change the original original drug to the target. Therefore, domestic famous hospital doctors still recommend imported drugs in the face of patients with severe and special diseases. It is not from the price considerations, more is to ensure the effectiveness of treatment," said the person said.
China's generic drug development needs to be accelerated
According to the requirements of the previous regulatory authorities, the consistency evaluation of Chinese generic drugs does not need to be directly related to the original original drug, or it can be a generic drug already listed, because the tolerance of the standard may cause the gap between the generic drug and the original drug to become larger. Phenomenon, the final generic drug and the original drug's efficacy completely lost consistency.
In addition, there are many loopholes in the process, process, quality control and other key links of Chinese pharmaceutical manufacturers. The standards for regulatory standards for pharmaceutical certification are far from the international standards, and the implementation is insufficient. These factors have made it difficult for Chinese generic drugs to be recognized by the industry. .
Therefore, the development of China's generic drugs needs to be accelerated. According to the key tasks of the 2017 medical reform as determined by the State Council, the guiding documents for reforming and improving the generic drug management policy will be completed by the end of October 2017.
According to the "Opinions on Further Reforming and Perfecting the Policy of Drug Production and Circulation and Use" issued by the General Office of the State Council at the beginning of the year, it is emphasized that it is necessary to speed up the evaluation of the consistency of quality and efficacy of listed generic drugs. The "Opinions" mentioned that pharmaceutical manufacturers are encouraged to actively purchase reference preparations according to relevant guiding principles, and rationally select evaluation methods to conduct research and evaluation. For the reference preparations to be imported, speed up import approval and improve customs clearance efficiency. The bioequivalence test shall be subject to record-keeping management, and qualified medical institutions, institutions of higher learning, scientific research institutions, and other social inspection and testing institutions shall be allowed to carry out conformity evaluation bioequivalence tests according to law.
Food and drug supervision and other departments should strengthen guidance to enterprises and promote the task of consistency evaluation on schedule. Relevant information will be released to the society in a timely manner for the drug that has passed the consistency evaluation, and it will be included in the catalogue of drugs that can replace each other with the original drug. If the number of production enterprises that have passed the consistency evaluation of the same variety of drugs reaches more than three, the varieties that fail the consistency evaluation are no longer selected in the centralized procurement of drugs; if there are no more than three, the products that have passed the consistency evaluation are preferentially purchased and used. .
"Developing generic drugs is first of all to solve the problem of the use of myrrh. Now the consistency evaluation is mainly to solve the problem of using good medicine. The reference object is the original drug." Experts said that speeding up drug consistency evaluation is only a means. The ultimate goal is to let the people use safe and effective medicines. They can't do the consistency requirements, and they can't use the medicine for the sake of consistency.
The insiders suggest that this process still needs to learn from the experience of Indian drug manufacturers, strict consistency evaluation standards, benchmarking with the original research drugs, and the certification standards are in line with the international standards, which will change the existing production processes, quality control, etc. of some pharmaceutical companies. The process, in the long run, is the way out for the long-term development of Chinese pharmaceutical companies.
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