Generics controversial in China, the quality is lower than India
 
 
The 2014-10-26 source: the rule of law over the weekend
Publisher: WeiQin 

        According to the law of the pharmaceutical industry, the original medicine because of the disadvantage on the price after the patent expires, a lot of hard, while China's generics market share of around 97%, such an era, for China, is an opportunity, or challenge? 
 
        As if overnight, generics in China for its "golden age". 
 
        From January 1, 2012 to December 31, 2016 in five years, the world will have as many as 631 patent medicine expires. 
 
        Research and development of patented drugs due to the arrival of the peak, mean and holds the multinational pharmaceutical giant these drugs are farewell for more than 20 years of "patent monopoly" era; And that for developing countries, means that the generic drugs will have more market space. 
 
        According to the law of the pharmaceutical industry, the original medicine because of the disadvantage on the price after the patent expires, a lot of hard, while China's generics market share of around 97%, such an era, for China, is an opportunity, or challenge? 
 
        The arrival of the "patent cliff" 
 
        As the little blue pill in May this year the United States patents expire, China's pharmaceutical companies into a battle for generic blue pill. 
 
        The original name viagra's blue pills, also known as viagra. Viagra is originally the Pfizer to abandon drug for the treatment of coronary heart disease, was accidentally discovered in 1991 on the male sexual dysfunction has prominent curative effect. 
 
        Then, the magical blue pill with a "viagra" in the name of a popular all over the world. 
 
        Viagra to Pfizer earnings, has been made by the end of 2013, viagra has sold 300 million in the whole world, also became the most profitable Pfizer in the Chinese market "gold mine". 
 
        But in front of the huge benefits, the country's drug companies are only "indifferent", because the little blue pill is still in the patent protection, China's drug firms cannot be copied. 
 
        On May 12, 2014, however, viagra patent in China, this news let Chinese drug companies. 
 
        Weekend reporters under the rule of law on the administration of state food and drug supervision and management of website query to the guangzhou baiyun mountain pharmaceutical, hebei's pharmaceutical industry, jiangsu lianhuan pharmaceutical, mondial group in chengdu, sichuan source base pharmaceutical, biochemical pharmacy, Beijing zhongtian zhuhai kangda biochemical medicine, guangdong pharmaceutical engineering technology development center, nearly 20 enterprises, have been declared the viagra generics approval. 
 
        And these drug firms "replicas" if approved, can produce. 
 
        The relevant person in charge of hebei's pharmaceutical company said in an interview with reporters over the weekend under the rule of law, at present prepares for the generic drugs filing materials, sale in 2015 is expected to achieve. 
 
        "In addition to preparing to declare production, dichroa pharmaceutical is ready in the workshop. In the company's headquarter of sildenafil API workshop is currently in construction stage, is expected to be finished by next year, is located in jiangsu, a subsidiary of sildenafil preparation workshop has been finish." The official said. 
 
        Actually viagra's patents expire, only is the world's original drugs "patent cliff" a microcosm. 
 
        In generic drugs, within six months after a large number of listed price often dropped to about 20% of the patented drugs, and sales of patented drugs would fall by 70%, this phenomenon is called "patent cliff". 
 
        Peking University and medical senior partner Shi Lichen told reporters over the weekend, rule of law since 2012, the world will have more than 600 kinds of patent medicine gradually mature. For traditional Chinese medicine (TCM) for exclusive varieties, except the part nine compounds are generic drugs in the domestic market, a good chance. 
 
        China merchants securities research report], according to a survey of China's generics process greatly simplified and the cost is low, is expected in 2015, domestic generics scale may be close to 500 billion yuan. 
 
        And the drug companies punch, before patents expire, also prepared for early. 
 
        "Long ago began to prepare for, such as I do now, its business patent expires about 10 years. But because of approval will take a long time, so be prepared ahead of time." Guangzhou a drug firms project director yog (not his real name) for the rule of law reporters over the weekend. 
 
        "Burn money" of new drugs 
 
        International divides into the Drug patent medicine (sometimes referred to as the new drugs) and "Generic" (Generic Drug). 
 
        According to the world recognized programs, new drug research and development has a strict screening process. 
 
        The start of the laboratory, experimental staff need to get out one by one, try to nearly 10000 kinds of compounds, finally developed a new drug. Start from the laboratory until used for clinical patients, each new drug research and development cycle for an average of 12 to 13 years. 
 
        According to data provided by the pharmaceutical research and manufacturers association, its 29 multinational enterprise members in 2011 in new drug research and development on the total investment of more than $100 billion, member companies will be 20.5% of sales revenue each year on research and development, and each new drug research and development spending an average of $1.2 billion. 
 
        Another, according to a follow-up study for pharmaceutical companies, only three can recover the cost of every 10 kinds of drugs, only 1 in every 25000 compounds in profitable. 
 
        "Medicine is a special industry, there is no quick results, a new drug development, from the start, declare to clinical, sales, and finally to the ordinary people can use, is a very long process, need 10 to 15 years." The drug inspection industry in our country an expert on condition of anonymity told the rule of law over the weekend. 
 
        Our country in recent years, however, to speed up the steps of new drug research and development. 
 
        In June of 2007, China's pharmaceutical [0.77%] and biotechnology industry released the eleventh five-year plan, stressed the need to increase the innovative drug research and development, especially in new drug research and development with independent intellectual property rights. 
 
        Planning is an important part of the 2008 aims to accelerate domestic drug r&d project, "" national new drug innovation and development, the project funds of 660 million yuan. 
 
        "Countries also encourage new drug research and development in recent years, this policy can be displayed in 2008, at present our country is about 10 to 20 types of innovation." The above inspection industry experts. 
 
        But the new drug research and development is not imminent. China's "new drug" the vast majority are different types or different specifications of generic drugs. There is a field called "Me too" drugs, namely on the basis of new drugs, modified to find similar chemical structure is not protected by patents. 
 
        "What we call the new drugs is a way of western medicine research and development, the original drug research and development cost is very high, now the new drug research and development costs, the average cost to around $1 billion, the time it takes 10 years or so." Yog said. 
 
        For some domestic enterprises, it is impossible to spend $1 billion to a medicine, and western medicine research and development success rate is very low, yog said. 
 
        "Such as the third phase of clinical success rate is about 1/5000, if the drug molecules in the third phase of clinical problems, all of the money will lose." 
 
        Generics arises at the historic moment 
 
        Took off in the late 1980 s, China's pharmaceutical industry, a large number of pharmaceutical companies, at the peak across the country, large and small pharmaceutical factory added up to more than 5000, 600 in stark contrast with the United States. 
 
        China's accession to the WTO in 2001. In the same year, the food and drug administration issued the first "drug registration management method". 
 
        "Since 2002 generic drugs industry in China has entered a crazy era, everyone in the declaration, desperately take approval as much as possible, the trend has achieved the peak until the mid 2006, just four years in the food and drug administration group too much license." The drug inspection industry experts told the rule of law over the weekend. 
 
        Generics are not fake medicine, in the international market, all countries have the same strict requirements on generics. 
 
        In America, for example, the us food and drug administration (FDA) for approval of generic drugs must meet the following conditions: with the generic products contain the same active ingredients, including the active ingredient can be different; And generic products are indications, dosage forms, specifications, delivery way is consistent; The biological equivalent; Quality accord with the requirement of the same. The production of GMP (drug production quality management standard) standard and generic products are also strictly. , according to industry insiders, China's drug registration management measures for oral solid preparation to do bioequivalence test, but standard set too low, the comparison object is not fixed, declaration and approval process and left too many people in the operating space, makes fraud is very easy and convenient, this leads to a large number of didn't have the ability to produce generic drugs easily got the license and qualification of enterprises. 
 
        According to statistics, China's existing more than 189000 piece of 95% of the drugs listed license is issued before 2007, distributed in nearly 5000 pharmaceutical companies. In our country's generic level is relatively low. 
 
        Therefore, the quality of China generics controversial in the world, even landed in another generic power - behind India. 
 
        "The Indian drugs than much cheaper generic drugs in our country, and the effect and the original drug." Shi Lichen said. 
 
        With the low cost and price, India in the field of generic drugs, even with the pharmacy of the world ", the generic drug industry is very developed. Expensive drugs in general, western countries once listed, the Indian pharmaceutical companies in the country under the protection of the patent law can be generic products. 
 
        Published in 2009, the world health organization (WHO), according to the statistical yearbook of China into the WHO purchase catalog number of varieties for six, 194, India is far more than China. 
 
        Although there are some other factors behind this huge gap, but the underlying reason is that the majority of Chinese generic drug quality could not reach the requirements of the WHO. 
 
        Speaking of the gap and foreign generics, yog feel very grievance, "in fact many of our projects do well, but because our country's standards are relatively low, can give a person a kind of feeling of shanzhai, or is the effect of inferior quality and low price". 
 
        Haven't "drug expired, the examination and approval by" 
 
        Generics yog said the problem of low standard, also clearly aware of the relevant state department. 
 
        On February 13, 2012, the state council issued "the national drug safety" twelfth five-year "plan", clearly put forward "part of the quality of generic drugs and the international advanced level there is a big gap". 
 
        "Planning" is put forward, to the 2007 revision of the drug registration management measures for approval prior to implementation of generics, by instalments with the generic quality consistency evaluation, 570 of them into the national list of essential medicines and the clinical commonly used chemical medicine in 2015. 
 
        It is understood that the 570 kinds of commonly used drugs involved, 2400 companies, 33000 approval number, more than ninety percent of the approval document is approved before 2007. 
 
        At the end of November 2012, national food drug administration established the generic quality consistency evaluation office, and start the evaluation work. 
 
        "Generic drug quality evaluation is a common international practice, the United States in 1971 to start the bioequivalence evaluation, after 10 years, eliminated more than 6000 kinds of drugs. The similar project, launched in 1975 to 36000 drugs reviewed. Japan launched the drug quality evaluation in 1997 project, has completed about 730 varieties." China association of enterprises with foreign investment market access to drug research and development industry committee director zhu bo told the media in an interview. 
 
        But the work progress obviously doesn't go well in China. 
 
        Two years ago, at the beginning of the work, the Chinese academy of medical sciences, Beijing union medical college, the deputy director of the institute of drug Du Guanhua said in an interview with the media, it is very difficult. 
 
        Two years later, Du Guanhua of rule of law over the weekend reporters: "the fact proves that the accuracy of this two years ago, I said." 
 
        "Japan's technology can go up, caught the core. Japanese technology have to ascend, by detecting follow this way to improve the quality of the drugs." Du Guanhua said, "but haven't reached our technology, the rise of drug quality is to rely on science and technology to support, rather than simply by testing. Testing alone is not enough." 
 
        As of August 2014, the work is still in the stage of groping method. National food drug administration announced the stage to do 75 directory of drugs, only completed five drugs method argument. 
 
        "Do a good job in the consistency of the most important is the core problem, what I call the core means should is consistent with the therapeutic effect of drugs, rather than the quality standard of consistency evaluation." Du Guanhua said. 
 
        In addition to the determination of standard for drug firms for being one of the most is the food of the food and drug administration for examination and approval system. 
 
        Domestic responsible for new drug registration is food drug administration of the drug approval center (CDE), the agency is 120 people, the formal establishment of many years have not changed. 
 
        That 120 people including officials, management is responsible for the review of medicine is only more than 70 people, more points and traditional Chinese medicine, western medicine and pathology and clinical toxicology, etc. And approval of new drugs. 
 
        And the United States food and drug administration (FDA) registered more than 2000 employees, so the approval time perhaps a year or so. 
 
        "People naturally slow, less time for examination and approval of generic drugs in our country is about five years or so." Yog told the rule of law over the weekend. 
 
        A long time for examination and approval of drug firms both anxious and helpless. 
 
        Yog is doing a project, has made progress to tablets and capsules, "but if approval is not down three to five years, have been making good medicine will shelf life, can only throw away or destroy". Yog said. 
 
        It is not without precedent. 
 
        In 2012, yog drug firms have finished a batch of API, the shelf life of two years, but the examination and approval or lack of progress, the last more than 100 catties of API all overdue. 
 
        "Only one over twenty of the people to the FDA, fast, of course not." Yog said.
 
 
 
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