Outsourcing Clinical Trials: Advantage India

Abstract: Beleaguered by ever-increasing cost pressures, shorter product life cycles and various regulatory challenges in the West, the pharmaceutical industry is turning to opportunities in low-cost Asian countries such as India. Alliances with local companies, contractual outsourcing arrangements and establishment of local subsidiaries enable these enterprises to access openings in India, especially in the area of clinical research. The interest of pharmaceutical research companies in India is justified by several factors, including cheap labour, low infrastructure costs and a genetically diverse, drug-naive population of over a billion people with myriad diseases. The availability of highly specialized and motivated investigators in conducting clinical research studies is another benefit. Furthermore the progressive attitude of Indian Government, as shown by amendments in Schedule Y and new GCP standards, have helped in creating a better environment for clinical research in the country. Indian clinical trials market in 2006 was US$ 140m and is growing at a CAGR of 40% for the last 3 years. All these advantages will drive the growth of clinical trial outsourcing industry to scale up to US$ 600m by 2010.

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