| BANGALORE, India, Feb. 21 - At the crowded Diacon Hospital here, some 100 diabetics throng daily to consult with Dr. Arvind Sosale, the hospital's director and lead diabetes specialist. But on a recent morning, the pace in his consulting room was unhurried, despite the rush outside. |
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| It was the one morning a week the doctor reserves for the select few who participate in the clinical tests he often conducts for Western pharmaceutical companies. In part because of the attention he lavishes on the patients, in part for the free medical tests and supply of drugs involved, Dr. Sosale has a ready supply of subjects to the trials. |
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| That is just one of the lures for the drug companies. |
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| Over the last two decades, India's abundant, skilled, low-cost and English-speaking labor pool has attracted sophisticated outsourcing work. |
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| Lately, Western drug makers, which have sent some pharmaceutical manufacturing as well as development work to this country, have been ramping up their outsourcing of clinical research here. |
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| Companies like Roche Holding of Switzerland, GlaxoSmithKline of Britain, Sanofi-Aventis of France, and Pfizer and Eli Lilly of the United States have been sending clinical trial work to India either through their own units or by subcontracting to Indian businesses. |
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| The development of a new drug typically takes several years and can cost hundreds of millions of dollars. |
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| Clinical tests on patients, to check for efficacy and safety, account for two-thirds of that cost. And drug makers recruit hundreds, and in some cases thousands, of people for the clinical trials. |
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| Western patients are often wary of participating. But India has a large population asking, "When can we get started?" said Dr. Sosale, who has conducted clinical tests for Eli Lilly, Novo Nordisk, Sanofi-Aventis and AstraZeneca. |
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| According to Charles Beever, a vice president and the head of the worldwide pharmaceutical practice at the consulting firm Booz Allen Hamilton in New York,"India's huge patient population also offers vast diversity, making the country an ideal site for clinical trials." |
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| Ashish Singh, a partner in the health care practice of the Bain & Company consulting firm, said participants could be found in about half the time it takes in the West. |
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| And a recent report published by Cutting Edge Information, a pharmaceutical consulting firm based in Durham, N.C., found that drug companies could cut the cost of clinical testing by more than 60 percent by going to developing countries like India. |
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| But recruitment of the poor and illiterate for testing has raised ethical questions in India and abroad, with critics calling it exploitation. |
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| "In the past, clinical research has fallen short of desired global standards, and there have been some aberrations, like unauthorized clinical trials," said Utkarsh Palnitkar, director for health sciences at Ernst & Young India. |
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| Critics also claim there have been adverse test results that have gone unreported. But such problems are increasingly a thing of the past, as the industry matures, Mr. Palnitkar said. |
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| For one thing, the Indian government has become stricter. Last month, for instance, it amended the rules governing clinical trials, mandating that ethical boards be set up to oversee the trials and strengthening standards governing the informed consent process. Moreover, bigger global clinical trial companies are coming to India, bringing international standards that Indian companies are adopting in order to compete. |
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| At the Reliance Group's clinical research unit in Mumbai, for instance, patients are led through the informed-consent process, in their own language. |
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| (There are 18 official Indian languages, hundreds of others and thousands of dialects.) |
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| Hospitals are subjecting investigators like Dr. Sosale to stringent assessments by ethics committees. And the Western drug companies are conducting their own audits. |
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| As these changes take hold, the Indian industry is projected to grow even faster. Total revenue for Indian companies from outsourced clinical tests has already grown to an estimated $122 million in 2003 from $30 million in 2001, according to Bain & Company. |
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| Louise Dunn, a spokeswoman for GlaxoSmithKline, said it is outsourcing clinical trials to Brazil, Mexico and China, as well as India. |
