India Outpaces China As A Destination For Trials

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india1.jpgIndia has surpassed China to become Asia’s most popular destination for conducting clinical trials, reports The Times of India, citing India’s Planning Commission, which found that 139 new trials were outsourced to India recently compared to 98 in China. The market value for clinical trials outsourced to India is estimated at around $300 million, having increased by 65 percent in 2006, and is expected to reach $1.5 to $2 billion by 2010.

Why? There’s a diverse genetic pool, large patient pool, drug naive population, competent medical professionals, high quality hospitals and low cost of services, the paper writes. And the cost of conducting research in India is allegedly 20 percent to 60 percent lower than in developed countries - clinical researchers, nurse and IT staff are hired at less than a third of wages in the industrialized nations. While 20 clinical research organizations and 80 hospitals are engaged in trials, some CROs offer a menu of over 1,500 tests under one roof.

Data furnished by the Indian Pharmaceutical Alliance show that Glaxo led the list with 22 trials followed by Johnson & Johnson with 22, Lilly and Bristol-Myers Squibb had 17 each. Then came Pfizer with 16 trials and Sanofi-Aventis at 15 trials. According to the commission, two other factors contributed to the growth - India adopted stronger intellectual property rights (although Novartis may disagree) and the health ministry established a comprehensive framework of rules for conducting clinical trials.

The document released by Montek Singh Ahluwalia, however, pointed to one serious shortcoming - India is short by 30,000 to 50,000 research personnel, including trial investigators, auditors, personnel to serve on ethics committees and data safety management boards. The country’s regulatory infrastructure has been found to be weak and the office of the Drugs Controller is understaffed.

SR Dugal, who chairs the Institute of Clinical Research, tells the paper that India has a larger number of docs with a better reputation than their Chinese counterpart, but “at present, 40 institutes teach clinical trials as a subject. They produce 5,000 students annually. We, however, need 11,000 annually. By 2010, India will require 50,000 people specialising in clinical trials.”

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  1. This is a big no duh, India is responsive and sites get up in time to conduct a trial and getting a trial in China is like trying to dance in quicksand.

    I also believe India is also overtly committed to GCPs, whereas Chinese sites may be willing to follow them but the government has not overtly accepted them.

  2. GSK, Sanofi and Pfizer have been conducting clincial trials for years ..even before the stronger IPR law was adopted in 2005. Some of the others have come through in a much bigger way post 2005. There are still some bottlenecks on the regulatory front .. especially w.r.t. phase I trials … only allowed to be conducted in India if another phase I has been successfully completed elsewhere in the world. I suspect, if that is relaxed, the momentum could increase further.

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