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<<   作成日時 : 2010/07/07 20:31   >>

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 破壊と変革のヒンズー教女神カーリーを祭る古代の丘のふもとで、Sun Pharmaceutical Industries は米国向けのジェネリックの抗癌剤と抗てんかん剤を大量生産している。
 昨年410億ルピー(8億8000万ドル)の利益をあげ、今年の売り上げは20%増を見込んで工場を拡張した。ここでは製造困難な薬剤を作っていると、副社長は言う。近くをうろつく牛や水牛の群れを除けば、ニュージャージーの製薬工場といってもいいくらいの約80万平方メートル建物である。
 インドの製薬業は今年約13%成長して240億ドル以上となった。かつては開発途上国向けに安い製品を作っていた。しかし、欧米でのブランド薬品への価格圧力から、インドはグローバルな製薬業の大きな役割を担ってきている。インドは品質管理問題は抱えていたが、低価格薬製造の信頼性が中国で問題になったことで、有利になってきた。米国はインド製薬剤の最大輸出国である。
 インドは世界市場へ向けた重要な基地となっている。ムンバイを本拠地とする製薬企業Piramal Healthcareはジェネリック製薬部門を37億ドルでアボットに売却した。
 2008年に、日本の第一・三共はインド最大のRanbaxy Laboratoriesに出資した。昨年、グラクソはDr. Reddy’s Laboratoriesと提携し、ファイザーはClaris Lifesciencesと提携した等々。インドは低価格で良質の才能に恵まれており、高度な技術を必要とする製品を超低価格で提供できる。最近までは製薬はアウトソーシングできないという横柄な産業であったが、製薬巨人企業が研究・新薬開発の場所として動き始めた。
 北ムンバイのPiramalの研究所で、約300人の科学者が炎症、代謝異常、癌治療の新薬を研究している。低賃金のため、新薬開発に10-15億ドルかかる費用を1/10にすることが可能という。SunのGujaratの研究所では、650人の科学者が10,000匹の動物を使って、副作用の少ない薬を安く製造するために働いている。
 インド政府統計では薬品とそのサービスの輸出は前年より25%増加し、83億ドルとなった。しかし、最近は品質問題が影を落としている。ここ数年で数回Ranbaxyは製造違反をFDAに数回指摘され、5月にSanofi-Aventisはビン内の堆積物を指摘された。
 知的所有権問題も未解決で、2005年に特許法を強化したが、数十の知的所有権訴訟が世界中で争われている。偽薬の問題も依然としてはびこり、インドの薬剤に関する研究では、「薬」の3.6パーセントが全く有効成分を全然持っていないとわかったという。
 FDAは、インドの影響力の増大に呼応して、デリーとムンバイに事務所を開設した。検査官と技術専門家を含め12人の常勤職員を配置した(中国と同等である)。そしてFDAは、米国への輸出向けの工場として、中国では300だが、インドでは約900の工場を承認した。
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インドのジェネリック製薬会社の薬品の輸入を禁止/米国 ジェネリック医薬品
http://kurie.at.webry.info/200809/article_31.html
インドのジェネリック製薬企業が薬剤品質を偽装/米国
http://kurie.at.webry.info/200807/article_31.html
汚染ヘパリンは11ヶ国で見つかり 米国での死者は81人に
http://kurie.at.webry.info/200804/article_34.html
ヘパリン製剤関連死亡は62人と発表
http://kurie.at.webry.info/200804/article_12.html
世界を危険にさらす薬剤の恐怖
http://kurie.at.webry.info/200804/article_3.html
汚染ヘパリン製剤問題の核心はFDAにある/米国
http://kurie.at.webry.info/200803/article_28.html
中国産原料ヘパリン製剤 国内でも自主回収
http://kurie.at.webry.info/200803/article_17.html
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India Expands Role as Drug Producer
By HEATHER TIMMONS
Published: July 6, 2010
http://www.nytimes.com/2010/07/07/business/global/07indiadrug.html

画像HALOL, India ― Below an ancient hilltop temple to Kali, the Hindu goddess associated with destruction and change, Sun Pharmaceutical Industries churns out generic versions of cancer drugs and epilepsy medications bound for the United States.

Business is so brisk that Sun, with revenue of 41 billion rupees ($880 million) last year, predicts sales will grow 20 percent this year and is expanding its Halol factory.

“This site specializes in making difficult things,” Sampad Bhattacharya, Sun’s vice president in charge of operations, said during a recent factory tour. The blue and gray concrete building, which will be nearly 800,000 square feet after the expansion, would not look out of place in the pharmaceutical manufacturing centers of New Jersey, except for the herds of cattle and buffalo wandering nearby.

India’s drug industry ― on track to grow about 13 percent this year, to just over $24 billion ― was once notorious for making cheap knockoffs of Western medicines and selling them in developing countries. But India, seasoned in the basics of medicine making, is now starting to take on a more mainstream role in the global drug industry, as a result of recent strengthening of patent law here and cost pressures on name-brand drug makers in the West.

And while the Indian industry has had quality-control problems, it nonetheless benefits from growing wariness about the reliability of ingredients from that other historically low-cost drug provider ― China. The United States is India’s top export customer for drugs.

India is becoming a “base for manufacturing for the global market,” said Ajay G. Piramal, the chairman of Piramal Healthcare, a drug maker based in Mumbai. Eventually, in Mr. Piramal’s perhaps overly optimistic forecast, only the very first and very last steps of the business ― molecular drug discovery and marketing ― will be run by the West’s global drug giants.

Those companies “don’t create much value” in the steps in between, he said.

It is not only Indian executives, though, who are bullish about the pharmaceuticals industry here. Analysts, research groups and consultants have been making similar predictions in recent months.

Big pharmaceutical companies have come calling, too. This year, Mr. Piramal sold his generic drug business to Abbott Laboratories for $3.7 billion, the latest in a string of takeovers and joint ventures here.

Daiichi Sankyo of Japan helped kick off the foreign drug push into India in 2008 by buying a stake in Ranbaxy Laboratories, this country’s biggest drug maker. Last year, among other deals, GlaxoSmithKline formed a partnership with Dr. Reddy’s Laboratories; Pfizer tied up with Claris Lifesciences; Sanofi-Aventis took control of Shantha Biotechnics, and Bristol-Myers Squibb opened a research center in India with Biocon.

“There is a lot of good talent at a much lower price in India,” said Jim Worrell, the chief executive of Pharma Services Network, a Charlotte, N.C.-based consulting firm that is organizing tours of Indian factories for Western pharmaceutical executives who are considering outsourcing some of their business. “What I see happening now is manufacturing and even packaging and even formulation are moving to India,” Mr. Worrell said.

The shift to pharmaceuticals is part of a subtle, broader shift in the Indian economy. Moving beyond less sophisticated, outsourced services like telephone call centers, India has been advancing up the business value chain, particularly in law and medical diagnostics. Now it is showing a flair for manufacturing, particularly in goods demanding high-skill production and superlow prices.

Until recently, pharmaceuticals has been “an incredibly arrogant industry that has never outsourced,” said Sujay Shetty, an associate director with PricewaterhouseCoopers in Mumbai. But over the next several years, he predicts, “everything in the value chain will move to different parts of the world that are cheaper,” with India a major beneficiary.

The next opportunities for India could come at the more sophisticated end of the drug making spectrum, including research and development for the world’s drug giants and even development of proprietary medicines.

“We can crack the problem of patented drug discovery in India at a much lower cost” than in the West, predicted Mr. Piramal, who held onto his research and development operation, Piramal Lifesciences Limited, when he sold the rest of his company to Abbott.

At Piramal’s main laboratory in north Mumbai, about 300 scientists are researching new drugs aimed at inflammation, metabolic disorders and cancer. Mainly because of lower wages, if it costs big pharmaceutical companies “$1 billion to $1.5 billion to discover a new drug, we can do it in a tenth of the cost,” Mr. Piramal predicts.

G. V. Prasad, chief executive of Dr. Reddy’s Laboratories, said that Indian drug makers had the “ability to handle product development on a massive scale at a low cost.” Dr. Reddy’s original diabetes drug has completed Phase 3 clinical trials ― the last step before seeking Food and Drug Administration approval ― the farthest of any of its peers.

Meanwhile, at Sun’s stucco and glass laboratory in Gujarat, surrounded by white, pink and yellow bougainvillea, 650 scientists, backed by tons of expensive machinery and 10,000 animals in cages, are at work breaking down drugs with the aim of rebuilding them in cheaper ways with fewer side effects.

Revolutionary science is not only about developing a brand-new product, said T. Rajamannar, executive vice president of Sun Pharma Advanced Research. It also means learning how to make an existing drug “very efficiently,” he said.

For all the potential, though, India’s drug industry has a long way to go to fulfill its promise.

India exported about 384 billion rupees ($8.3 billion) in drugs and services for the pharmaceutical industry in the 2008-9 fiscal year, according to government figures, up 25 percent from the year before.

Recent growth, though, has been shadowed by quality problems. The F.D.A. cited Ranbaxy for manufacturing violations several times in recent years, and in February ordered a review of the company’s global manufacturing operations.

In May, Sanofi-Aventis recalled vaccines made by Shantha Biotechnics that were distributed to the World Health Organization after users complained about white sediment in the vials. In June, after floating matter was found in some plastic IV bags, Pfizer recalled injectible drugs made by Claris Lifesciences and sold in the United States.

Intellectual property is also an open question. Trying to change its outlaw image as a maker of illegal knock-offs, India toughened its patent laws in 2005. But dozens of intellectual property suits are still being fought between Indian and foreign firms in courts around the world. And big pharmaceutical companies still find securing protection of their intellectual property in India difficult.

Meanwhile, outright counterfeit drug making remains rampant in India, executives and analysts here say. A study this year of pharmaceuticals from Indian wholesalers found that 3.6 percent of the “drugs” had no active ingredients whatsoever.

All of which is why some drug executives in the United States say that their Indian peers may be too optimistic about their industry’s prospects.

“Cost is one issue, and yes it is important, but there are two other critical factors: intellectual property and quality and safety issues,” said Panos Kalaritis, the chief operating officer of Irix Pharmaceuticals, a Florence, S.C., contract research and manufacturing company, which competes with Indian laboratories and factories.

The F.D.A., in response to India’s growing influence, has opened two offices in this country ― in Delhi in early 2009 and another in Mumbai in June of last year. When fully staffed, the offices will have between them a dozen full-time employees, including inspectors and technical specialists, which is comparable to the F.D.A.’s presence in China.

Among other measures, the Indian offices will enable the F.D.A. to “verify that important products and the way they are manufactured meet U.S. health and safety requirements,” an agency spokeswoman said in an e-mail message.

While China is the undisputed low-cost maker of a multitude of consumer goods, India may have a rare edge in the drug industry. India’s long tradition of generics has fostered a robust educational system here for pharmaceutical scientists, as well as longer experience dealing with Western regulators.

The F.D.A. has issued about 900 approvals to plants in India to import drugs or raw materials for the industry to the United States, the vast majority in recent years, compared with more than 300 such approvals for China.

Indian companies have “a lot to offer and the cost advantage is huge,” said Swetha Shantikumar, a research analyst in Chennai with Frost & Sullivan, who predicted more buyouts of Indian firms by global giants in the near future. Chinese firms “don’t have the technical capacity to produce sophisticated drugs,” said Ms. Shantikumar.

“If you want to make simpler drugs like aspirin,” she said, “you manufacture them in China.”

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