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All stakeholders need to work together to rebuild confidence and trust amongst the global community in doing clinical research in India now that we have a more conducive regulatory environment in India for the conduct of clinical research.
2010 to merely 480 trials( with 253 approved) in 2012 and further to 207( with 73 approved) in 2013, it scaled down to two figure statistics.
The larger negative public opinion generated through political rhetoric, biased media trials and unwanted judicial activism led to the demise of a young industry. The fluctuating regulations added to the uncertainty. As a consequence, India was no longer considered to be a favorable place for carrying out trials. While things have moved a bit in last two years due to few new initiatives to help streamline the regulations, there is a lot more to improve the outlook. The mainstream media have now toned down a bit on its blind criticism, but activists still are on an oath to chase what they perceive an evil industry.
According to market observers, one and a half decade-old India CRO industry can still overcome early challenges to report a decent growth figures. Even the latest figures say that approximately more than 2000 clinical trials are happening in India which comparatively is a good figure if we look at the earlier slump. While lower costs has been a crucial factor in making India an
Suneela Thatte, President, Indian Society for Clinical Research( ISCR)
attractive destination for global companies looking to conduct large-scale trials, there are other factors like skilled and knowledgeable investigators and expertise, increased compliance towards quality issues, a large patient pool and unmet medical needs of the population also help to lure foreign companies. The focus areas mostly are cardiology, endocrinology, anti-psychiatric, respiratory, diabetic and antiinfection drugs. Even vaccines have been a major area of opportunity but at the same time the trials in this area are the ones that are most tainted so far.
What drives the Indian CRO industry?
Clinical research is an indispensable part of the drug development process, and India has a large potential to contribute in this process. Clinical trials account for over 40 per cent of the costs of developing a new drug, and as per estimates a standard drug could be tested in India for as little as USD 90 million, which is 60 per cent of the cost of testing in the US.
With the increase in number of CROs in India today, the market for clinical trial outsourcing remains high. The major
advantages in India are costeffectiveness, knowledge and availability of cheap manpower. However, it is yet to reach a level that was expected. The expectations have not been met because of certain issues. Among these are the unavailability of enough qualified manpower, mushrooming of unethical CROs, unwanted delays in regulatory affairs and competition from other countries. Therefore, we need to evolve fast and catch up with the competition that may overtake us completely, if we do not address the issues proactively.
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India has some of the highest brain power in the world and should benefit more from conducting larger number of clinical trials of new drugs under development.
Prof Meir Perez Pugatch Dutch expert
Another favorable trend is the CROs engaging in new business development and expanding their range of services. The growth trend was particularly in the areas of data management, pharmacovigilance and clinical trial management. Until 2000,
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