India, preferred choice for clinical research

10 September 2009 | News

India, preferred choice for clinical research



As global pharma companies re-visit their strategies by dovetailing speed, cost of drug development and tapping high-growth pharma markets in their business models, India is emerging as the preferred choice for clinical research services. This prognosis is held out by a FICCI-Ernst & Young (E&Y) paper on the compelling reasons for doing clinical research in India.
The Indian market is growing by leaps and bounds and is gearing itself to becoming one of the fastest growing clinical research destinations with a growth rate that is two-and-a-half times the overall market growth. India participates in 7% of global phase III and 3.2% of phase II trials with industry-sponsored trials having grown at a spectacular 39% CAGR between 2004-08.
The FICCI-E&Y paper notes that the number of industry-sponsored phase II-III sites in India has grown by 116% over the last 15 months and India has moved up from rank 18 to 12 across the 60 most active countries. India ranks second in Asia after Japan in its number of industry-sponsored phase II-III clinical trial study sites and accounts for nearly 20% of all Asian study sites.
Dr Surinder Kher, senior vice president, Vanthys Pharmaceutical Development and chairman, Clinical Research Task Force, FICCI, said, “The drug development scenario in India has  transformed in the last 10 years. This transformation has not only brought India to the attention of the pharmaceutical world for clinical research but many big pharma and biotechs have developed the so called ‘India Strategy’ as a part of their growth strategies. This is the beginning of the road towards scientific innovation including clinical research and the vision of India  being the drug development hub. India is  probably in the best situation than ever before to achieve this vision  with the complete commitment and partnerships between the government, industry and the academia that we have been witnessing especially in the last few years. This certainly is an exciting time.”
As the world’s third-largest producer of drugs by volume, with the third-largest drug research and development workforce, India is a major player in the pharmaceutical industry. The most active 25 pharmaceutical companies worldwide, based on the number of study sites registered, are also active sponsors of clinical studies in the country
The number of investigators in India has also grown the fastest among Asian, Latin American and Eastern European countries with a 42% CAGR between 2002–08. India has one of the fastest subject recruitment rates globally (nearly three to five times the global average), with screen failure and drop out rates lower by nearly 40–50%, as compared to global averages. As a result, India contributes 15–30% of global enrollment in multi-centric studies where it is a participant.
Data submissions from India in the recent past have been part of at least 13 successful NDA approvals.
Not surprisingly, therefore, India is ranked third across all countries after the US and China in terms of its overall attractiveness as a clinical trial destination, according to a recent AT Kearney global survey.

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