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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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