This article was contributed by PharmARCians, and was first published in www.pharmabiz.com.


BANGALORE, March 29, 2007- The Indian clinical research market is entering a pivotal period of change. Today, many major pharmaceutical companies are conducting clinical trials in India. Though the Indian clinical research market is still in the nascent stage, some feel that the hype over India emerging as a major player for conducting clinical trials is still a hype rather than reality.

In 2005, India's clinical research outsourcing market has grown up to $70.5 million. Industry insiders expect that India's clinical research market will grow further in the coming years; some even claim that the pace of the growth in the next five years will accelerate compared to that of the last five years. One of the estimations predicts that India's share of global clinical trials to rise to 5% by 2008 and 15% by 2011.

In this scenario, India presents the most immediate opportunity with the potential benefit in the shortest possible time addressing the most pressing issue for any pharmaceutical company, i.e. cost, quality and speed in clinical trials However, recently, a debate has emerged about the clinical research market in India: Is the 'India Advantage' a hype or reality? This can be addressed by understanding the drivers and barriers of the Indian clinical research market.

Drivers of the clinical research market:

1. Volume is one of the key reasons for conducting clinical research in India
2. An increasing number of English-speaking and GCP (Good Clinical Practice) trained investigators
3. The new patent regime of 2005 providing a higher level of comfort for doing clinical research in India
4. Communication/IT infrastructure in India are on par with the global standards
5. An increasing number of domestic accredited labs Barriers
6. High illiteracy rates in most parts of the country
7. Ethical practices are questioned; there is strong criticism that Indian patients are being treated like guinea pigs
8. Hidden costs: Majority of the Indian population does not have health insurance; costs that are normally covered by insurance companies in the Western countries have to be covered by sponsors in India
9. Bureaucratic and Regulatory delays hampering the clinical trial process
10. Lack of basic infrastructure
11. Quality investigators being the same for most of the CROs which leads to frequent rise in remunerations

Hype or Reality?

Considering the current scenario, there are gaps that still need to be addressed for the 'hype' to get transformed into a 'reality'. For bridging this gap, a number of measures need to be initiated collaboratively by various stakeholders including the government.

Though the current trend shows a lot of positives, the Indian clinical research industry is still in the nascent stage. The Indian clinical research market has to quickly come out of the 'euphoria' by eliminating the barriers within the shortest possible time and also strengthen its drivers to become a real potential player in the global clinical research market in the years to come.

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Media Contact:
Amrita Gupta
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