Journal : Finance Date : Author : Finance reporter Sun Aimin, Cai Tingyi, He Tao] (Editor: yanqi) Page No. : NA
URL : http://app.caijing.com.cn/tags.php?tag=%E5%8D%B0%E5%BA%A6 http://app.caijing.com.cn/tags.php?tag=%E5%BC%AF%E9%81%93

 

弯道超车的印度模式

 

被称为“世界药房”的印度,生产了全球五分之一的仿制药,制药产业成为该国三大经济支柱之一,一个发展中国家,缘何能把仿制药销售到进口门槛苛刻的欧美发达国家?其弯道超车的经验与教训或可参考

Known as the “World Pharmacy”, India produces one-fifth of the global generic drugs, and the pharmaceutical industry has become one of the three pillars of the country’s economy.  As a developing country, can India not sell generic drugs to  developed countries like Europe and America withh their demanding import threshold? Its experience in leapfrogging can be used (by China) for reference.

印度仿制药再次成为国际药品行业的热门话题。2015年7月27日,欧盟执委会确认欧盟国家终止销售700种印度仿制药,愤怒的印度政府在8月取消了和欧盟进行中的双边自由贸易谈判。

Indian generic drugs has once again become a hot topic in the international pharmaceutical industry. On July 27, 2015, the European Commission confirmed that EU countries terminated the sales of 700 kinds of Indian generic drugs, and an angry Government of India canceled the ongoing bilateral free trade negotiations with EU in August.

欧盟的决定源于欧洲药品管理局去年发现印度GVK生物公司存在数据造假行为。该公司是印度最大的合同研究组织,曾接受多家药企的委托进行生物等效性测试。

An EU (European Medicines Agency) decision last year found that the Indian company GVK’s biological data to be fraudulent. The company is India’s largest contract research organization, and has commissioned a number of pharmaceutical companies to conduct bioequivalence tests

这只是欧美药品行业与管理机构对强大的印度仿制药产业的这一战役,而在此前的多番鏖战中,后者连连取胜。

This is just one battle that the European and American pharmaceutical industries and regulatory agencies fight against the strong Indian generic drug industry, and the latter has repeatedly won in many of the previous fierce battles.

被称为“世界药房”的印度,至2014年拥有约550家获得美国食品药品监督管理局(FDA)认证的药厂,有近200个药品进入世界卫生组织(WHO)采购目录,生产了全球五分之一的仿制药,制药产业成为该国三大经济支柱之一。

Going by the name “World Pharmacy”, India had about 550 pharmaceutical factories that have received the U.S. Food and Drug Administration (FDA) certification as recognised pharmaceutical companies in 2014, and nearly 200 drugs selected in the procurement catalog of the WHO. Wth production at one fifth of global generic drugs,  the pharmaceutical industry is one of the three pillars of the country’s economy.

为保护药业,印度对药品进口严格管控,定高关税,对外企投资限定最高门槛。至今,印度仿制药行业比中国先进十年以上,而且这个差距还在进一步拉大。

To protect the pharmaceutical industry, India has imposed strict controls on drug imports, set high tariffs, and a maximum threshold limit for foreign investment. So far, the Indian generic industry is more than a decade advanced than China, and this gap is widening.

印度药品制造商协会会长S.V.Veerramani在去年访华期间表示,印度制药工业年总产值300亿美元,糖尿病、心血管和精神类疾病治疗药物增长很快,印度医药出口额150亿美元,110亿美元的制剂产品主要出口到欧美等规范市场。

President of India Pharmaceutical Manufacturers Association, SV Veerramani, said during his visit to China last year that the annual output value of the Indian pharmaceutical industry was 30 billion US dollars, and therapeutic drugs for diabetes, cardiovascular diseases and psychiatric disorders were growing rapidly.  Indian pharmaceutical exports were 15 billion US dollars, and 11 billion US dollars worth preparation products were  exported to Europe, America and other developed markets.

一个发展中国家,缘何能把仿制药销售到进口门槛苛刻的欧美发达国家?

Can a developing country not sell generic drugs to developed countries like Europe and America with a demanding import threshold ?

 

一手严控,一手扶持  Strict Control on One Hand and Support on the Other

 

过去的15年,印度药品制剂取得了突飞猛进的发展——其仿制药已占领全球绝大部分中低端市场。这得益于印度政府在1970年痛下决心,降低药价,扶植独立的本土药业。

Over the past 15 years, Indian pharmaceutical preparations have made rapid development. Its generic drugs occupy most of the middle and low-end market. This is attributable to the Indian government’s determined effort in the 1970s to reduce drug prices, and foster an independent, indigenous pharmaceutical industry.

印度医药也有着波折的历史。跨国药厂一度控制了80%-90%的印度医药市场,99%的专利药掌握在这些公司手里,至上世纪60年代,印度的药价位列全球市场的高价之林。

Indian pharma has had twists and turns  historically. Multinational pharmaceutical companies once controlled 80% -90% of the Indian pharmaceutical market, and 99% of the proprietary were in the hands of these companies. Up until the 1960s, Indian drug prices ranked high in the global pharmaceutical market.

为让印度人能获得平价药,印度政府先废除了食物药品和化学品专利,并限制跨国企业在印度制药公司持有的股份,以及对某些制剂药和原料药价格的管控。 这些政策让外国药厂因而放弃了印度市场,本土公司快速接收空白市场,至1990年时,印度的制剂药自给,原料药几乎能达到自给。

To enable Indians to obtain affordable drugs, the Indian Government first abolished  food, drug and chemical patents, and restricted the stock held by multinational enterprises in Indian pharmaceutical companies. It also imposed controls on prices of certain drug preparations and active pharmaceutical ingredients. These policies made the foreign pharmaceutical companies give up the Indian market, and local companies quickly took over the vacant market. By 1990, Indian drug preparation had achieved self-sufficiency, and active pharmaceutical ingredients near self-sufficiency.

印度政府废除了英国殖民时期的专利保护法,于1970年颁布新《专利法》,不承认国际上的化合物专利,允许印度制药公司仿制生产专利药品,只要生产工艺和其他药厂专利注册的生产工艺有区别就行,这让印度药厂发展出逆推制药流程的专业能力。

The Indian government abolished the patent protection law of the British colonial period, and promulgated a new “Patent Law” in 1970, which did not recognize the international patents on compounds, and allowed Indian generic pharmaceutical companies to produce patented drugs so long as the production process was different from that of the pharmaceutical factories holding patents. That fostered expertise in reverse pharmaceutical engineering.

而此前,葛兰素、诺华、拜耳等国际知名药企已经在印度设厂,新《专利法》颁布后,失去生存空间的外国药企全部撤离,本土工作人员大量进入印度药企中,这客观上促进了印度本土制药产业的发展。

Previously, GlaxoSmithKline, Novartis, Bayer and other internationally renowned pharmaceutical companies had set up factories in India. After the new “Patent Law” was enacted, all the foreign pharmaceutical companies that lost living space withdrew from India, and a large number of local staff joined the Indian pharmaceutical companies, which objectively promoted development of the Indian pharmaceutical industry.

中国医药质量管理协会副会长孙新生回忆,上世纪80年代在美国休斯敦大学攻读药学博士期间,身边的同学大都是印度人,这些学生毕业后大部分留在美国,在美国药企从事产品研发,或者进入FDA从事药品监管。

Vice President of the China Pharmaceutical Quality Management Association, Sun Xinsheng, recalled that, during the 1980s when he studied in the University of Houston for Doctor of Pharmacy, most of his classmates were Indians, and the majority of these students stayed in the US after graduation, engaged in product development in American pharmaceutical companies, or in the drug enforcement agency FDA.

印度新《专利法》颁布后,大批在美国就职的印度人回国,入职本土药企。这为印度制药行业的人才储备,为仿制药的研发、行业监管的升级、国际竞争的参与奠定了扎实的基础。

After India’s new “Patent Law” was promulgated, a large number of Indians who worked in the United States returned to India and joined local pharmaceutical companies. This laid a solid foundation for the talent pool for the Indian pharmaceutical industry, research and development of generic drugs, industry regulation and supervision upgrades and participation in international competition.

印度药企的人才成本只是美国的七分之一,这是印度制药成本比欧美降低30%-40%的原因之一。印度产业联盟的研究显示,研发一款新药的成本在印度约为1亿-2亿美元,在美国则需要5亿-9亿美元。

The personnel costs of Indian pharmaceutical companies are just one seventh that of U.S. companies, which is one of the reasons that Indian pharmaceutical costs are 30% -40% lower than those in Europe and America. Research on the Indian Industrial Union shows that the cost of developing a new drug in India is about 100 million -200 million US dollars, as compared to 500-900 million in the US.

同时,政府降低了行业进入门槛,几千家中小企业迅速蜂拥而至,抢食市场大饼。印度政府成立了五家国企,其中包括联合国协助成立的印度斯坦抗生素有限公司(The Hindustan Antibiotic Ltd),以及借助前苏联之力的印度制药有限公司(IDPL)。

Meanwhile, the government lowered entry barriers in the industry, and thousands of small and medium enterprises quickly flocked to snatch a piece of the market pie. The Indian government set up five state-owned enterprises, including the Hindustan Antibiotic Ltd, which was established with the support of the UN, and the Indian Drugs and Pharmaceuticals Limited (IDPL) on teh strength of the former Soviet Union.

在印度政府的协作下,1961年IDPL成立了5家制药厂,3家子公司,本以生产抗生素、合成药和手术器械为主,后来企业所在地印度南部城市海得拉 巴(Hyderabad)意外发展成聚落,现在该地至少有200多家中型药企,其中三分之一的老板都曾在IDPL就职过。被欧盟质疑的GVK生物公司也在 海得拉巴。

In collaboration with the Government of India, IDPL established five pharmaceutical factories and 3 subsidiaries in 1961, originally mainly engaged in production of antibiotics, synthetic drugs and surgical instruments. Later the city of Hyderabad in southern India, where the enterprise was located, developed into a settlement unexpectedly. Now there are at least over 200 medium-sized pharmaceutical companies in this area, one third of these entrepreneurs having worked in IDPL. The GVK biotech company which was challenged by the EU is also located in Hyderabad.

直到2005年,印度加入世界贸易组织,才恢复药品专利。据联合国大学(United Nations University)的研究显示,在35年市场保护期间,印度本土制药公司从1970年的2257家快速增加到2005年的2万家。

Not until 2005, when India joined the WTO, were the drug patents resumed. According to a study of the United Nations University, during the 35 years of market protection, the number of Indian pharmaceutical companies increased rapidly from 2257 in 1970 to 20,000 in 2005.

印度产业联盟的研究数据显示,本土企业的前250家控制了印度70%的市场,前10家控制了40%市场。

India Industrial Union research data shows that the top 250 local enterprises controlled 70% of the Indian market, 40% of it by the top 10.

而在政策配合下,外国制药公司在印度市场的占有率于2005年降到20%以下。

At the same time, coordination of policy resulted in the market share of foreign pharmaceutical companies in India falling below 20% by 2005.

 

借力FDA Leveraging FDA

 

在仿制药产业上,印度始终是美国的好学生。

In the generics industry, India has always been a good student of the United States.

印度参照美国的仿制药准入与监管标准,升级本国的制药产业。现在,97%的印度本土制药为已不受专利保护的第二或三代药品。印度还借鉴了FDA的药品监管手段,吸收了美国制药行业的做法,推动本国仿制药企业加强研发、升级制备工艺。

India upgraded the country’s pharmaceutical industry with reference to the US generics access and regulatory standards. Now 97% of the Indian local pharmaceuticals are second or third generation drugs without protection of patents. India has also referred to FDA drug regulatory mechanisms, absorbing the US pharmaceutical industry practices, with a view to promoting its own generic drug companies, strengthening their R&D and upgrading the preparation process.

美国国际贸易委员会(U.S. International Trade Commission)对印度制药业研究后认为,印度制药业的竞争力,除了会说英语的低成本研发人才外,大量FDA认证的工厂也起到关键作用。

After the U.S. International Trade Commission studied the Indian pharmaceutical industry, it believed that competitiveness of the Indian pharmaceutical industry also played a key role , in addition to the factors of English-speaking personnel, low-cost R&D  and abundance of FDA-approved facilities.

印度制药企业自上世纪80年代起,就认为国内市场太小而主动往美国拓展,1984年Cipla成为第一家拿到FDA认证的药企,之后整个行业不断跟进。

Since the 1980s, Indian pharmaceutical companies realised that the domestic market was too small, and started to take the initiative to expand to the US. In 1984 Cipla became the first pharmaceutical company certified by FDA; after that the entire industry followed in its footsteps.

彼时,中国还没有一家外企进驻,市场监管、药品研发的理念也很晚才引入。

At that time, there was not one foreign enterprise entering China, and the concept of market supervision and drug research and development was introduced very late.

普华永道中国的行业分析师谢蒂(Sujay Shetty)对《财经》记者表示,现在经FDA认证的药厂对遵循FDA的标准已有很深认识,而且不少企业正进一步投资以维持在市场的领先地位。

Price Waterhouse Coopers China industry analyst Shetty (Sujay Shetty) told the reporter of “Finance” that now the FDA-approved pharmaceutical factories already have deep understanding of FDA standards, and a lot of companies are making further investment so as to maintain their position as market leaders.

由于采用了FDA的监管模式,印度药物监管部门对本国制药企业的监管也极其严格,保证了印度药品可以远销到欧洲、美国。

As a result of the adoption of the FDA’s regulatory model, the Indian pharmaceutical regulatory supervision department also exercises very strict supervision and quality control of the domestic pharmaceutical companies, so as to ensure that the Indian drugs can be exported to Europe and the United States.

如今,印度的雷迪博士实验室、太阳制药、兰伯西实验室、鲁宾制药、格伦马克制药和阿拉宾度制药都是国际化的药企,其国际化程度与美国著名药企相当。

Today, India’s Dr. Reddys Laboratories, Sun Pharmaceutical, Ranbaxy Laboratories, Rubin Pharmaceuticals, Glen Mark Pharmaceutical and Aurobindo Pharma are all international pharmaceutical companies, with a degree of internationalization equivalent to that of the well-known pharmaceutical companies in the United States.

等到印度政府2005年再修《专利法》,又为药企带来了大量的研发和制造订单。跨国药企为了降低成本和增加营收,在过去十年将大量的制造、临床研究,以及包装标示等,外包给颇得FDA认证精髓的印度药企。

Until the Indian government revised the “Patent Law” again in 2005, this brought a lot of R&D and manufacturing orders to pharmaceutical companies. In order to reduce costs and increase revenues, multinational pharmaceutical companies outsourced a huge amount of manufacturing, clinical research, and packaging, labeling etc to the India pharmaceutical enterprises that had been granted the FDA certificationb over the last decade.

仅2005年,印度的合约制造商和研究机构的营业额比2004年增长了40%。

In 2005 alone, the turnover of the Indian contract manufacturers and research institutions increased by 40%, compared to 2004.

可以说,借助FDA模式,以及数家在印度积极发展的跨国药企的帮忙,印度被塑造成了医药制品链条中重要的部分,成为完成制剂制造的重镇。

It can be said that, with the FDA model and the help of a number of multinational pharmaceutical companies in India, India positioned itself in an important niche in the pharmaceutical product chain, as a manufacturing center for complete preparations.

 

面临大考 Facing the Final Examination

 

尽管供应着全球大批仿制药的印度制药行业风光无限,其在欧美国家的狙击下仍然暗藏隐患。

Although the Indian pharmaceutical industry supplies a huge amount of generics globally, it still has to face trouble and criticism from the US and Europe.

不同于中国制药行业聚拢4000多家企业的局面,印度的制药工业已经实现了较高的产业集中度。竞争在2005年后继续加剧,印度制药企业进入整合兼并。2010年,IDPL部下的10家企业,5家被迫关闭,3家进入亏损状态。

Unlike China’s pharmaceutical industry spread (more than 4,000 enterprises), India’s pharmaceutical industry has achieved a relatively high degree of industrial concentration. Competition continued to intensify after 2005, and Indian pharmaceutical enterprises entered the stage of mergers and integration. In 2010, among 10 subsidiaries of IDPL, five were forced to shut down, three entered a loss making situation.

FDA对药品生产标准控制也更趋严厉,在频繁地、不间断的检查中,印度仿制药企暴露出管理、道德和诚信问题,众多仿制药企业受到了警告。1996年 美国刚开始实行警告制度时,FDA共发出152封警告信;2012年上升到753封;2013年前十个月就发出了近600封,这其中相当一部分发给了印度 仿制药企业。

FDA’s control of drug production standards has become more severe with frequent on-site inspections, exposure of Indian generic pharmaceutical companies’ management, ethics and integrity issues, and warnings to many generic drug companies. In 1996, when the United States began doing so, FDA issued a total of 152 warning letters; in 2012 it rose to 753 letters; in the first ten months of 2013 it issued nearly 600 letters, a considerable number of which were sent to Indian generic drug enterprises.

被警告的仿制药企多是在生产过程中,未能一直严格执行药品生产质量管理规范(CGMP),如出现设备清洁程度不足、生产记录缺失、员工未经过现行CGMP培训等问题。处罚结果一般是在下次通过检查之前,禁止该厂所生产的药品出口到美国。

The generic pharmaceutical companies being warned are mostly the ones that failed to strictly implement the Current Good Manufacturing Practices (CGMP), reflected in lack of hygiene in the equipment, missing production records, uuntrained staff (in prevailing CGMP) and such issues. The punishment is usually prohibition of the factory from export of manufactured drugs to the US until it clears the next inspection.

据《医药经济报》报道,2015年截至目前,已有6家印度制药企业被FDA列入黑名单。至此,印度有39个曾经获批出口美国的制药基地,均由于监管问题失去了这个资格。

According to a report of the “Pharmaceutical Economics News”, 6 Indian pharmaceutical companies have been blacklisted by FDA up to now. So far, 39 Indian pharmaceutical manufacturing bases, which had been approved for export to the United States, have lost that certification due to regulatory problems.

8月印度与欧盟的口角,源于欧洲药品管理局在5月的一份报告提到,去年在对GVK生物公司现场核查中发现,每9个受检的试验中就有1个违规,这份报告建议叫停GVK参与的药品销售。

In August, the altercation between India and the European Union originated from one report of the European Medicines Agency in May, which mentioned that  one of every nine test subjects was found to be in violation in the field inspection in the GVK Biotech Company last year. Thus this report recommended suspension of GVK from participation in drug sales.

GVK生物公司被发现心电图数据造假。这并不是检验生物等效性的核心数据,但欧盟认为其没有遵守行业的规范,数据造假背后延伸出更核心的问题:GVK的质量体系存在严重缺陷。

GVK Biotech Company was found to be falsifying electrocardiogram data. This was not a core aspect of the data required for the bioequivalence test. However, the EU felt that it failed to comply with industry norms, and that there was a more critical problem behind the false data:  seriously flaws in GVK’s quality system.

同样的事2013年也发生过,新德里药厂Ranbaxy Laboratories因为提供造假数据,最后被美国司法部以刑事罪起诉,该药厂在认罪后,被处以5亿美元罚金。

The same thing happened in 2013, when the New Delhi based pharmaceutical factory, Ranbaxy Laboratories, was sued by the US Department of Justice for criminal offenses because of its having provided false data. It was sentenced to a fine of $500 million, after it pleaded guilty.

由于发生一连串的造假事件,印度药品出口从过去数十年的12%-13%年增长,急速下降到去年的3%。

Due to a series of fraudulent incidents, the export growth rate of Indian drugs declined sharply from 12% -13% p.a. over the past several decades to 3% last year.

欧美国家针对印度仿制药企的多次诉讼也表明,不少印度制药公司存在数据可靠性问题。隐瞒失败结果、进行非正规分析、删除电子数据、在电子数据采集系 统中禁用审计跟踪、编造培训数据、重复分析不合格样品直至通过、回测过去数据、不公布稳定性失败报告等,似乎已经成为印度制药业界暗黑的秘密。

The multiple litigation against Indian generic pharmaceutical companies by European countries also showed that, there were a lot of data integrity issues of Indian pharmaceutical companies. Hiding failure results, performing non-formal analysis, deleting electronic data, disabling  audit tracking in the electronic data collection system, making up training data, duplicated unqualified sample analysis until adoption, back testing past data, not publishing stability failure reports, etc., all these seem to be dark secrets of India’s pharmaceutical industry.

企业高级管理人员及公司管理层大多或明或暗地支持这种做法,甚至在有些情况下采取鼓励态度。

Senior corporate executives and company management were believed to have supported these practices explicitly or implicitly, and in some cases even encouraged them.

行业人士和分析师认为,层出不穷的造假,反映的是印度“差不多”达到80%就可以的文化问题,这在欧美要求100%精确的制药业是不被允许的。

Industry sources and analysts believe that the unending cases of falsity reflect an Indian cultural issue — the attitude that “more or less” 80% target achievement was  acceptable, something that is not permitted in Europe and America (that seek a norm of 100% achievement).

印度制药联盟秘书长沙阿(DG Shah)指出,这些事件反映出印度药厂对技术和监管人员训练不足,他们正积极修正制药缺陷,其中也包括和FDA的合作。

Shah (DG Shah), Secretary-General of Indian Pharmaceutical Alliance pointed out that, these cases reflected lack of training of their technical and supervisory staff by Indian pharmaceutical firms. They are now actively making amends on the manufacturing defect front, and on cooperation with FDA.

但他不认为这些药企是有目的的造假,反过来说,欧美国家的举措,也不可避免地包含对印度法院撤销或拒绝跨国药企专利的愤怒。

But he does not think that these pharmaceutical companies purposefully perpetrated fraud. On the contrary, the initiatives taken by the European countries also stemmed from anger against Indian courts for their rejection of multinational pharmaceutical enterprise’s patent bids.

此前在与欧美药企的诉讼官司中常常取胜的印度仿制药,近年来也尝到了败绩。

The Indian generic drugs that had frequently won lawsuits against pharmaceutical companies in Europe previously, also tasted defeat in recent years.

2013年6月,印度的跨国仿制药企业Sun制药公司和以色列Teva制药公司在美国的仿制药业务遭遇重大挫折,二者被美国新泽西法院裁定侵犯美国辉瑞公司的Protonix药品专利,分别被判赔偿辉瑞5.5亿美元和16亿美元。

In June 2013, the Indian multinational generic drug company, Sun Pharmaceuticals, and the Israeli Teva Pharmaceutical Company suffered a major setback in their generics business in the United States. Both companies were booked by the New Jersey court for violation of the Protonix drug patent of the U.S. Pfizer Inc, and were sentenced to indemnify Pfizer $550 million and $1.6 billion respectively.

巨额的赔偿金严重削弱了Sun制药的竞争力,使其收购瑞典Meda制药和以色列Taro制药有限公司的谈判不得不推迟。

The huge compensation severely weakened competitiveness of Sun Pharmaceuticals, and its acquisition of Sweden Meda Pharmaceuticals and negotiation with Israel’s Taro Pharmaceuticals had to be postponed.

辉瑞公司对Sun制药公司诉讼的坚持,有可能被其他具有雄厚实力的原研药企业所效仿。未来,印度仿制药企业或许将遭遇越来越多的专利侵权诉讼。

Pfizer Inc’s pursuit of proceedings against Sun Pharmaceuticals is likely to be emulated by other similarly well endowed primary research enterprises. Indian generic drug companies may probably face more and more patent infringement litigation in the future.

谢蒂认为,“经过这些事件后,我们认为(印度)此行业长远来说,将变得更强”。并分析,目前印度制药业面临的挑战是,克服FDA的标准检测、增加创新、持续提高研发技巧、发展新生物医学技术。

Shetty opined that “after these incidents, we believe that in the long run, this industry in (India) will become stronger.” And analyzes that the current challenges facing the Indian pharmaceutical industry is to overcome the FDA standards test, increase innovation, continuously improve research and development skills, and develop new biomedical technologies.

据谢蒂观察,印度药企基于市场考量,也开始和中国药企合作,他预期这个趋势将会越来越明显。

According to Shetty’s observation, Indian pharmaceutical enterprises began cooperaion with Chinese pharmaceutical companies based on market considerations, and this trend can be expected to manifest itself more and more in the future.

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