For a long time, India has been a hotbed for companies in several major industries looking to outsource and “off-shore” services in an effort to speed development, reduce costs, while hoping to maintain a high level of quality. Today, the process of discovering and testing new drugs is following a similar path and India has a leading role.
There is a tremendous amount of excitement about markets such as India, Central and Eastern Europe and more recently, China. But like any new and exciting trend, we need to buffer that excitement with an understanding of reality. There are tremendous benefits being realized by companies now conducting studies in India, but those companies have also developed an understanding of the cultural intricacies, workforce talent pool, site and study conduct challenges and an improving yet dynamic regulatory environment. Understanding these realities and how to work in them is critical to future success.
India – A Preferred Destination: Why the Industry is Acting on India
As is widely known today, sponsors operating in mature drug development markets including the US and Western Europe are facing difficult challenges in moving their compounds efficiently through the pipeline, whether it be a shortage of beds for Phase I units, delays in contracting and budgeting, or patient recruitment challenges, the costs and timelines associated with bringing new compounds from the bench to bedside is greater than ever before. These issues have forced the industry out of its comfort zone resulting in a rapid globalization process over the last 10 years. Likewise, regions and countries around the world have adapted to and benefited from this globalization.
In very recent years, India has adapted its laws and regulatory guidelines to allow global biopharmaceutical companies access and confidence in conducting clinical trials there. Strong national resources and advantages in medical education and practice, patient populations and the prevalence of 1st and 3rd world diseases have made India not only an open destination, but also an attractive destination. In fact, the well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of key categories, including - perhaps most importantly to many companies - the regulatory environment and timelines.
Overall India advantages becoming known:
- Well-credentialed, acclaimed physician base
- Growing market for patent-protected therapies
- Faster, cost-effective studies
- Marketing & Supply Chain infrastructure
- Large treatment-naïve patient population
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