Price comparison of "4 + 7" drugs between China and India: if Indian generic drugs come to China, how much will the drug price fall?

Remember last summer's hot movie "I'm not the God of medicine"? Driven by interests, a drug dealer who finds his inner goodness and imports a large number of anti-cancer generic drugs cheaply from India by smuggling has challenged the authority and bottom line of the law, but also made hundreds of cancer patients and their families see the hope of survival The butterfly effect of the film on the market of imported anticancer drugs is still disturbing, and may even have a national impact Some time ago, there was industry rumors that Indian generic pharmaceutical companies were ready to participate in the "4 + 7" bidding (11 pilot cities of centralized drug procurement, such as Beijing, Tianjin, Shanghai and Chongqing), and some pharmaceutical companies said that their drug prices might fall another 20% - 30% on the basis of the bid price According to the official website of the State Food and drug administration, the "China India drug regulatory exchange meeting" was recently held in Shanghai The leaders of the drug regulatory departments of both sides personally led the team to attend the meeting This conference has a very important point to pay attention to: the policy and bidding process of Chinese drug bidding and purchase This makes people wonder: is a large number of Indian generic drugs really expected to enter the Chinese market? Most of India's generic drugs are cheaper than domestic generic drugs As a big generic drug country known as the "world pharmacy", India produces 20% of the global generic drugs In 2015, its generic drugs accounted for about 70% of the Indian drug market, and drugs were exported to more than 200 countries in the world, with an export volume of US $17.27 billion from 2017 to 2018 For a long time, Indian generic pharmaceutical companies have also had great ambitions for China, a huge pharmaceutical consumer market As a "big business", China and India have not made a decisive breakthrough in the pharmaceutical field, the times of India said in its report on the above-mentioned China India drug regulatory exchange meeting India hopes that China will come up with a clear road map on opening up its market to Indian drugs and clear up various regulatory barriers faced by Indian companies in China At present, 22 of the 25 drugs winning the bid for "4 + 7" drug centralized procurement in China are generic drugs The reporter selected imatinib mesylate tablets for the treatment of chronic myeloid leukemia, gefitinib tablets for non-small cell lung cancer patients and olanzapine tablets for schizophrenia, three drugs with a large number of patients, and compared the prices of Indian and domestic generic drugs Imatinib mesylate sounds strange In fact, it's the generic name of the anticancer drug "Lenin" (in reality, Gleevec produced by Novartis in Switzerland) in the movie "I'm not the God of medicine" Since the expiration of patent protection of "genuine" Gleevec in China in April 2013, domestic generic drugs such as Xinwei of Jiangsu Haosen, genico of Zhengda Tianqing and nolinine of Petrochemicals Group have been listed successively In the "4 + 7" list of selected varieties of urban drug centralized procurement, imatinib mesylate tablets are listed in the list Xinwei, a 100 mg * 12 tablets / plate * 1 plate / BAG * 5 bags (60 Tablets) generic drug manufactured by Haosen, Jiangsu Province, has a median price of 623.82 yuan After the announcement of "4 + 7" bidding results, several media have reported that the price of domestic "Gleevec" after reimbursement will be lower than that of Indian generic drugs Is it true? As there is no official quotation of India's generic drugs at present, the reporter tries to verify the price of India's version of greavel through various channels The reporter first found on the Internet that a medical company quoted a price of 900-1000 yuan for 100mg * 120 tablets of the drug In order to get the exact price, the reporter then called the consultation phone marked on the website and the other side replied "980 yuan per bottle" When the reporter asked "is this the official selling price of Indian drugstores", the other side replied "we are overseas medical service institutions, the company is just to build a platform for drug purchase between patients and Indian drugstores" In the process of the reporter's access to the materials, many articles introducing India's drug purchasing experience and Indian Pharmaceutical mentioned India's medicinecentre drugstore At present, the Chinese version of the drugstore's website in China has been launched The reporter and friends in the United States searched the website at the same time, and found that the average price of 100 mg * 120 pieces of Indian Gleevec was 37.52 US dollars (about 258.11 yuan) Later, the reporter contacted a staff member who called himself medicinecentre pharmacy in India After adding wechat, the reporter found that most of the staff's circle of friends were small videos of medicines mailed by Chinese users under their real names For the price of 100mg * 120 tablets of India's Greaves, the other side offered 800 yuan When asked why it is inconsistent with the price of the website, the other party said, "if you place an order on the website, you will contact the website It has nothing to do with us If you want to buy from us, you will contact us." In order to further verify the price of the drug, the reporter inquired about the quotation of Apollo online pharmacy in India through friends in the United States Apollo medical group is the largest medical group in India, with a price of 10260 rupees (1030 yuan) for 100mg * 120 pieces, and 708 rupees (4248 Rupees) for 100mg * 10 pieces So far, we have obtained four quotations of 100 mg * 120 tablets of the Indian version of Gleevec: 980 yuan, 258 yuan, 800 yuan, 1030 yuan, equivalent to half of the price of 60 Tablets of 490 yuan, 129 yuan, 400 yuan, 515 yuan, etc., which are lower than the bid price of 623.82 yuan for domestic generic drugs Entering the Chinese market may require huge operating costs However, it seems reckless to conclude that the price of all Indian generic drugs is lower than that of domestic generic drugs For example, the Indian generic price of olanzapine, a schizophrenic drug, is an exception Why is that? The original research drug of the drug is zaeple of Lilly company of the United States The winning product of "4 + 7" is olannine, a 10 mg * 7 tablet generic drug produced by Haosen of Jiangsu Province, with a bid price of 67.51 yuan The reporter tried to explore the price of the generic version of the drug in India through the above-mentioned channels The response from multiple consultations was "no such drug", and the drug was not found on the official websites of the two pharmacies However, in the domestic e-commerce platform to search "olanzapine tablets", in addition to zapra, olanning, Changzhou Huasheng Pharmaceutical Co., Ltd has produced the most generic drugs, olanzhi, which is produced by India's Dr redI laboratory Co., Ltd The reporter inquired the registration certificate No h20150141 of the drug on the official website of the drug administration and found that olanzyme had been listed in China as an imported drug The drug has two specifications: 5mg * 20 tablets and 10mg * 20 tablets The price of the former varies from 105 yuan to 217 yuan, and the latter from 199 yuan to 269 yuan We use the lowest price of each specification to calculate whether it is cheaper than domestic generic drugs If it is 105 yuan, the price of 5mg * 14 tablets is 71.4 yuan; if it is 199 yuan, the price of 10mg * 7 tablets is 139.3 yuan The conclusion is that no matter what kind of specification, its price in China is higher than the bidding price of euranning 67.51 yuan Therefore, it is not necessarily that the price of the drug in India is higher than that of domestic generic drugs, but that the price of the drug as an imported drug after entering the Chinese market is higher than that of domestic generic drugs Why is the price of Indian generic drugs with obvious cost advantage higher than that of domestic generic drugs in the domestic market? "It's normal." In the face of reporters' questions, Shi lichen, founder of Beijing Dingchen pharmaceutical management consulting company, said that Indian pharmaceutical companies have almost no large-scale sales capacity in China Unlike other multinational pharmaceutical companies, for example, Pfizer's sales team in China may be as many as thousands of people If Indian pharmaceutical companies enter China and only establish a sales team of 5600 or 7800 people, the cost will be higher than before A lot "After entering China, we have to develop hospitals one by one (medical representatives) This cost and later maintenance, the whole operation cost is very huge." He said The European Union and the United States are the two largest generic markets in India, even surpassing its own Why? "Because Europe and the United States are mainly purchased by commercial insurance companies directly, there is no need for pharmaceutical companies to build sales teams." In addition, the cost of examination and approval is relatively large For example, India's population and race are different from China's, and some supplementary clinical experiments should be conducted according to the yellow race, "the length and cost of this cycle cannot be predicted." He said Wan Zhe, chief economist of the international cooperation center of the national development and Reform Commission, also told the reporter of the daily economic news (micro signals: nbdnews) that the low price of generic drugs in India is only relative Imported drugs need to be listed in China, and they need to be approved layer by layer, which will generate a series of import costs The final price may not necessarily be lower than that of domestic generic drugs However, India's generic pharmaceutical industry chain is complete and mature, some standards and specifications are well integrated with the international and American standards, and the quality is relatively guaranteed But Mr schlichen said that if our national health insurance bureau directly purchases (generic drugs in India), the whole nature will change The government purchases at a reasonable price and pays directly for medical insurance in the hospital This will speed up the purchase and reduce the price The original research pharmaceutical enterprises and domestic generic pharmaceutical enterprises are facing challenges According to statistics, there are more than 7000 Pharmaceutical Enterprises above Designated Size in China, but more than half of them are generic pharmaceutical enterprises What is the response of domestic pharmaceutical companies to the news that India's generic drugs may open up the Chinese market and participate in the "4 + 7" bidding? To this end, the reporter of the daily economic news (micro signal: nbdnews) consulted a number of pharmaceutical companies, and many pharmaceutical executives said that if a large number of Indian generic pharmaceutical companies enter the Chinese market, the impact on domestic pharmaceutical companies cannot be underestimated "This has already begun." One of the drug executives told reporters that Indian generic drug companies will definitely bring a big impact on domestic enterprises, "we are also observing how the SFDA will put in, how the standards are, of course, depending on the further attitude of the health insurance bureau." If a large number of Indian generic drugs can enter the Chinese market, it will be good for medical insurance control and patient payment cost reduction, but it may not be good for domestic enterprises, he said On the other hand, for the sake of safety, there are differences between generic drugs and original drugs It is not uncommon that 0.001% impurities lead to strong adverse reactions or even fatal cases Gao Ronghui, general manager of Jiemai pharmaceutical consulting services Co., Ltd., is also cautious about a large number of Indian generic pharmaceutical companies entering the Chinese market He said in an interview that the United States recently published a book about exposing the inside of generic drugs, which exposed many problems of data fraud, fraud and poor quality of Indian generic pharmaceutical companies However, a medical industry observer told reporters that Indian generic pharmaceutical enterprises are of high quality and low price, which is certainly welcomed by the government, but to some extent, it will further suppress the living space of domestic generic drugs, and the integration and concentration of domestic pharmaceutical enterprises will accelerate "If Indian enterprises come in, it is suggested to supplement domestic data and flight inspection for Indian varieties, which will only play a" catfish effect " The executives said Some insiders believe that it is expected that the approval of imported generic drugs will be accelerated after China's accession to ICH, but at present, the mutual recognition of overseas clinical data is still in the process of exploration, and the standards of which trials need to be supplemented by overseas clinical data have not been established, and the possibility of large-scale approval in the short term is relatively low In the long run, if the imported generic drugs meet the domestic consistency evaluation criteria, the price