有多少印度制药公司向美国出口药品?(一)
2023-09-10 辽阔天空 3933
正文翻译

How many Indian drug companies are exporting to the USA?

有多少印度制药公司向美国出口药品?

评论翻译
Christopher VanLang
Why is the Indian pharmaceutical company Ranbaxy still allowed to do business in the United States?
I'm actually of the opinion that this whole disaster is very good for the future of the Indian Pharmaceutical industry.
From the sounds of what happen, the scandal is a product of what happens when a dirty company tries to go legitimate not unlike when a mobster tries to get clean. The US knows that Ranbaxy was a mobster and has a dirty past but it also knows that it's trying really really hard to clean itself up and do things right. The FDA has also been under significant pressure to make sure that there aren't drug shortages which is happening more and more since many of the plants in the US get shutdown shortly after patent expirations.

为什么印度兰伯西(Ranbaxy)制药公司仍然被允许在美国做生意?
事实上,我认为这场灾难对印度制药行业的未来非常有利。
从所发生的事情来看,丑闻是一个肮脏的公司试图合法化的产物,就像一个暴徒试图洗白一样。美国知道兰伯西是一个盗匪,有着肮脏的过去,但也知道它正在非常非常努力地清理自己,把事情做好。美国食品药品监督管理局也面临着巨大的压力,要求确保不会出现药品短缺,这种情况越来越多,因为美国的许多工厂在专利到期后不久就关闭了。

This is how generic drugs get made in countries like India. 5-8 years before the US patent expiration, organic chemists are figuring out how to synthesize the drug and break the US process patents. It takes another 2-3 years to scale-up and build a plant. This means that a generic company will probably be able to produce and sell a drug in countries with weak patent laws 2-3 years before the US patent expiry and set a world-wide generic price. This means that upon expiration, the drug essentially has to be supplied by a generic company.
I can tell you that the US pharmaceutical industry doesn't think very highly of Indian and Chinese manufacturers and it isn't because they do things inexpensively. It's because they do things cheaply. When you cut corners and brag about how you were successful in cutting corners, no is going to trust you in a highly regulated R&D business.

这就是印度等国家生产仿制药的方式。在美国专利到期前5-8年,有机化学家正在研究如何合成药物并打破美国工艺专利,还需要2-3年的时间来扩大规模并建立一个工厂。这意味着,仿制药公司可能能够在美国专利到期前2-3年在专利法薄弱的国家生产和销售药物,并设定全球仿制药价格。这意味着专利一旦过期,药物基本上必须由仿制药公司供应。
我可以告诉你,美国制药行业对印度和中国制造商的评价不高,并不是因为他们的产品成本低。这是因为他们做事很便宜。当你偷工减料,吹嘘自己是如何成功地偷工减料时,你再去搞一个高度监管的研发业务,是没有人会相信你的。

However, I recognize that companies like Ranbaxy need to exist since the US and the rest of the world does need generic drugs and places like Teva Pharmaceuticals aren''t going to be enough to provide Africa with drugs. For that to happen, you need to have whistleblowers making companies scared and freaking out to go legitimate and changing their company culture to do things correctly. I bet that Cipla and Dr. Reddy''s Laboratories (company) are currently going through their ranks and digging through their files. American-trained Indian scientists will be quickly replacing most of the upper management. The Department of Pharmaceuticals will be ramping up their inspections and coordinating with the FDA and EMA.
Those silly US evergreening patents that India seemingly is willing to ignore? They exist for a reason and most of them are trivial patents like "how to purify a compound" and "how to make a drug that meets FDA standards".
So why drugs from Ranbaxy and India? Frankly it''s still better than the alternatives. The European countries are only interested in the high-end generics. Japanese and Singaporean manufacturing facilities are already at capacity for brand name drugs. China is sadly in a more pathetic compliance and corruption state than India. The US''s only hope for cheap drugs is India .

然而,我认识到,需要存在像兰伯西这样的公司,因为美国和世界其他地区确实需要仿制药,而像梯瓦制药这样的公司不足以为非洲提供药物。要做到这一点,你需要有揭发者让公司感到害怕,让公司变得合法,并改变他们的公司文化,以正确地做事。我敢打赌,西普拉公司和:如瑞迪博士实验室有限公司目前正在调查他们的队伍并挖掘他们的档案。在美国接受培训的印度科学家将很快取代大部分高层管理人员。药品部门将加大检查力度,并与美国食品药品监督管理局和欧洲药品管理局进行协调。
那些愚蠢的美国常青树专利,印度似乎愿意忽视?它们的存在是有原因的,其中大多数都是不重要的专利,比如“如何纯化化合物”和“如何制造符合美国食品药品监督管理局标准的药物”。
那为什么是兰伯西和印度的药品呢?坦率地说,它仍然比其他选择要好。欧洲国家只对高端仿制药感兴趣。日本和新加坡的生产设施已经具备生产品牌药品的能力。可悲的是,中国的合规和FB状况比印度更差劲。美国唯一希望从印度获得廉价药物。

Kanthaswamy Balasubramaniam
Why doesn't the Indian government fund pharmaceutical companies in their own R&D? Is just claiming India as the biggest exporter of medicines enough?
Funding Pharma Research is the highest risk.
You could spend Billions on a potential drug and suddenly have to yank it off due to complications and side effects.
R & D for Biosciences and Pharma in US is funded mainly by the Private Sector (85%) and Grants and Trusts (10.5%) with barely 4.5% coming from the Federal Govt
US Pharma companies spend $ 87 Billion a year on R & D and an average of 19.32% of their Revenue on R&D.
Now Indian Pharma spend Rs. 317 Crore or $ 423 Million a year on R&D with 68.3% being Government Funded and only 31.7% or Rs. 105 Crore a year being Privately Funded.
US pays an average researcher with 10 yrs an average of $ 187,717 a year , India pays Rs. 4,66,208 a year
Plus there is a misuse of budget for R and D. Out of say Rs. 10 Crore a year for research for a new vaccine, only Rs. 5.8 Crore is available. The rest goes into miscellaneous.
Conclusion is We dont have Money for that sort of research and our developments are Shoddy and Shortcuts aiming for headlines for 10 days than a solution for 10 years.
Rather than investing profits into R & D , our Pharma companies prefer eating the profits and wealth.

为什么印度政府不资助制药公司进行自己的研发?仅仅宣称印度是最大的药品出口国就足够了吗?
资助制药研究是风险最高的。
你可能在一种潜在的药物上花费了数十亿美元,但突然由于并发症和副作用而不得不放弃。
美国生物科学和制药的研发主要由私营部门(85%)和赠款和信托基金(10.5%)资助,只有4.5%来自联邦政府
美国制药公司每年在研发上的支出为870亿美元,平均占其收入的19.32%。
现在,印度制药公司每年在研发上花费31.7亿卢比或4.23亿美元,其中68.3%由政府资助,只有31.7%或10.5亿卢比由私人资助。
美国给一个普通研究人员10年的薪水为平均每年为18.7717万美元,在印度,他们的薪水为平均每年为46.6208万卢比
研发预算被滥用。比如,每年有1亿卢比用于新疫苗的研究,但只有5800万卢比可用。其余的都变成了杂项开支。
结论是,我们没有钱进行这类研究,我们的发展是“以次充好”和“捷径”,目标是10天内成为头条新闻,而不是10年内的解决方案。
我们的制药公司更喜欢吃掉利润和财富,而不是把利润投资于研发。

Anonymous
Why doesn't the Indian government fund pharmaceutical companies in their own R&D? Is just claiming India as the biggest exporter of medicines enough?
Indian govt. wants results and huge taxes without doing any hard work or planning so we cannot expect anything from them as their only focus is privatising everything and huge collection of taxes for their own luxuries, they make policies for corpoarates and rich people and nnot concerned about sufferings of common man.

为什么印度政府不资助制药公司进行自己的研发?仅仅宣称印度是最大的药品出口国就足够了吗?
印度政府想要结果和巨额税收,而不做任何艰苦的工作或计划,所以我们不能对他们抱有任何期望,因为他们唯一关注的是将一切私有化和征收巨额税收为自己的奢侈生活买单,他们为企业和富人制定政策,而不关心普通人的痛苦。

George Regnery
Why do drug companies agree to sell their drugs cheaper to countries other than America?
Most drugs don’t cost much to make, once the maker has figured out the formula. That’s the hard part. A few have complex ingredients that are expensive to produce, but most of them do not. So drugs have a very low marginal cost (the cost required to produce an additional unit). Remember that with drugs, it’s not just the R&D that went into the successful drug, it’s the R&D that went into all the drugs that didn’t end up working.
So the drug company needs to recover its large fixed costs. It does this by charging a lot for each drug — much more than it costs to actually manufacture the product. Once it covers the raw materials and other direct costs, it needs to collect enough money to cover R&D.

为什么制药公司同意以更低的价格向美国以外的国家销售药品?
一旦制造商找到配方,大多数药物的生产成本都不高。这是最难的部分。有一些含有复杂的成分,生产成本很高,但大多数药物生产成本都不高。因此,药物的边际成本(生产额外单位所需的成本)非常低。记住,对于药物,不仅仅是成功研发出药物,而那些所有最终无效的药物也都是需要付出研发工作的。
因此,制药公司需要收回其庞大的固定成本。它通过对每种药物收取高额费用来做到这一点——比实际生产产品的成本高得多。一旦支付了原材料和其他直接成本,还需要筹集足够的资金来进行研发。

Now, if one country or several countries say they won’t allow the drug to be priced above a certain level, the drug company could say they won’t allow the drug to be sold there. A few people might get the drug in a neighboring country, but the drug company will likely make almost no money in that country. Furthermore, it runs the risk that there might be counterfeit production of the drug in that country, in which case the company will still make no money. If the drug company relents, it makes at least some money, and since drugs cost (usually) very little, something is better than nothing.

现在,如果一个国家或几个国家表示不允许该药物的价格超过一定水平,制药公司就会说他们不允许这种药物在那里销售。少数人可能会在邻国买到这种药,但制药公司可能在那个国家几乎赚不到钱。此外,它还面临着该国可能出现假药生产的风险,在这种情况下,该公司仍将赚不到钱。如果制药公司让步,它至少能赚到一些钱,而且由于药品成本(通常)很低,有总比没有好。
原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


There may be another reason: suppose the government of the other country didn’t care how the drug company priced its product. The drug company might still price its drug lower in another country because it knew people there wouldn’t be able to afford the drugs at US prices. Again, something is better than nothing (unless the something was less that the cost to actually produce the drugs). [A similar thing was discovered a few years ago in regards to textbooks: college textbooks were priced in countries like Indonesia and Thailand at levels that were a fraction of the cost for the exact same book in the United States. It wasn’t because those governments set prices on English language textbooks, it was because the textbook publishers realized that if they priced the books too high in those countries, almost no one would buy them. Since it doesn’t cost much to produce an extra textbook, the companies decided to price the textbooks lower in other countries.

可能还有另一个原因:假设另一个国家的政府不在乎制药公司如何定价。这家制药公司可能仍会在另一个国家降低其药品的价格,因为它知道那里的人们买不起高昂价格的美国药品。再说一遍,有总比没有好(除非某种药品比实际生产药物的成本更低)。[几年前,在教科书方面也发现了类似的情况:在印度尼西亚和泰国等国家,大学教科书的价格只是美国同一本书价格的一小部分。这并不是因为这些政府为英语教科书定价,而是因为教科书出版商意识到,如果他们在这些国家定价过高,那么几乎没有人会购买它们。由于生产一本额外的教科书成本不高,这些公司决定在其他国家降低教科书的价格。

If the United States also fixed drug prices to be low, drug companies might start to realize it’s not worth it to research new drugs, because they’ll never be able to recoup those costs. So when drug companies allow other countries to sell drugs cheaper, it does so realizing that those drugs won’t be shipped to the United States. If they can be (such as sent to the US from Canadian pharmacies), then this will undermine how their pricing works, and they’ll stop doing research. In a sense, US consumers are subsidizing research of drugs so people in other countries can buy drugs cheaper.

如果美国也将药品价格固定在较低水平,制药公司可能会开始意识到研究新药是不值得的,因为他们永远无法收回这些成本。因此,当制药公司允许其他国家以更便宜的价格销售药物时,它意识到这些药物不会运往美国。如果可以(比如从加拿大药店送到美国),那么这将破坏他们的定价方式,他们将停止研究。从某种意义上说,美国消费者正在资助药物研究,这样其他国家的人就可以买到更便宜的药物。

Jennifer Jones
Why do drug companies agree to sell their drugs cheaper to countries other than America?
Because if they don’t accept the prices other countries are prepared to pay for them then they won’t have a market in those countries.
In most other industrialized countries governments recognise that the high prices of medicines are a serious burden, and that government intervention in response to market failure is critical for affordability and access.
Where governments purchase, subsidize or reimburse part or all of the costs of large quantities of medicines they have considerable market power; this market power can be used to regulate prices directly, or as a means of moderating them indirectly. Many countries use health technology assessment to determine the clinical value of new drugs and regulate the prices to reflect the benefits of the drugs, so that a new drug that is no better than an existing drug doesn’t get a higher price, and a drug that is only marginally better only gets a marginally higher price. Which makes sense - after all you wouldn’t willingly pay ten times the price for this year’s model of TV if it was no better than last year’s. And they usually don’t allow more than modest inflation lixed price increases (after all the costs of production tend to go down not up with increasing volume).

为什么制药公司同意以更低的价格向美国以外的国家销售药品?
因为如果他们不接受其他国家准备支付的价格,那么他们就无法占据这些国家的市场。
在大多数其他工业化国家,政府认识到高昂的药品价格是一个严重的负担,政府对市场失灵的干预对可负担性和可及性至关重要。
当政府购买、补贴或偿还大量药品的部分或全部费用时,它们具有相当大的市场力量;这种市场力量可以用来直接调节价格,也可以作为间接调节价格的手段。许多国家采用卫生技术评价来确定新药的临床价值,规范药品价格,体现药品效益,这样一来,一种不比现有药物更好的新药就不会有更高的价格,而那种稍微好一点的药物,价格也会稍微高一点。这是有道理的——毕竟,如果今年的电视机不比去年的好,你是不愿意花十倍的钱买它的。它们通常只允许其价格与通胀挂钩的适度性上涨(毕竟,生产成本往往会随着产量的增加而下降,而不是上升)。

But the industry belly aches about how it spends on R&D (usually a lot less than on advertising and promotion!) and how only exorbitant and unrestrained prices will allow it to develop the next generation of ‘miracle cures’ yada yada (of which there are very few) when it’s really all about returns to shareholders and romancing venture capital. Well, I for one would rather make sure everyone could access the medicines we have now .
Many Americans rail at the actions of foreign governments in regulating drug prices, claiming (as other answers have argued) that Americans are subsidizing the rest of the world. The truth is that the pharmaceutical industry is highly profitable in every market; if companies weren’t profitable in other countries they wouldn’t continue to sell in them. Americans are forced to pay high prices because Americans are brainwashed into thinking the ‘free’ market can fix everything, because most legislators continue to accept industry money, and because there is no real political will to address the problem head on and regulate prices either directly or indirectly.
The idea of re-importing drugs from Canada is beyond stupid. That just means that the US government doesn't have the cojones to regulate drug prices itself and is going to let the Canadian Government do it instead. Insane.

但制药行业对其研发支出(通常比广告和促销支出少得多!)感到头疼,只有过高和不受限制的价格才能让它开发出下一代的“灵丹妙药”之类的东西(这种东西很少),而它真正关心的是股东回报和浪漫的风险资本。就我个人而言,我宁愿确保每个人都能获得我们现在拥有的药物。
许多美国人抱怨外国政府管制药品价格的行为,声称(正如其他答案所主张的那样)美国人在补贴世界其他国家。事实是,制药行业在每个市场都是高利润的;如果公司在其他国家没有盈利,他们就不会继续在这些国家销售。美国人被迫支付高昂的价格,因为美国人被洗脑,认为“自由”市场可以解决一切问题,因为大多数立法者继续接受行业资金,也因为没有真正的政治意愿来解决问题,直接或间接地调节价格。
从加拿大重新进口药品的想法是愚蠢至极的。不然这完全意味着美国政府没有监管药品价格的权力,而是让加拿大政府来监管——荒唐。

Christopher VanLang
Why do drug companies agree to sell their drugs cheaper to countries other than America?
It’s largely because Americans are willing to pay more for healthcare.
Sure there are a lot of things to be said about the lack of price controls and monopolies and greed. But at the end of the day, Americans have a higher price tag for health and are willing to spend a lot more to be healthy. This is true for other healthcare services that aren’t related to drugs. An MRI is more expensive. Surgery is more expensive. A hospital bed is more expensive. An IV is more expensive.
Drugs are more expensive in the US because the going rate for care is more expensive. As a percentage of the overall healthcare budget, drugs actually make up a smaller portion of the budget compared to other Western healthcare systems.
Americans say that they want to pay less for healthcare. However, until Americans are willing to pay less for healthcare, their costs won’t go down.

为什么制药公司同意以更低的价格向美国以外的国家销售药品?
这主要是因为美国人愿意为医疗保健支付更多的钱。
当然,关于缺乏价格控制、垄断和贪婪,还有很多话要说。但归根结底,美国人在健康上的花费更高,他们愿意花更多的钱来保持健康。对于与药物无关的其他医疗保健服务也是如此。核磁共振更贵。手术更昂贵。医院的病床更贵。静脉注射更贵。
在美国,药品更贵是因为现行的医疗费用更贵。与其他西方医疗保健系统相比,作为整体医疗保健预算的百分比,药品实际上只占预算的一小部分。
美国人说,他们希望在医疗保健上少花钱。然而,除非美国人愿意为医疗保健支付更少的费用,否则他们的成本不会下降。

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