Abstract: The Indian pharmaceutical industry is one of the fastest growing sectors of the Indian economy and has made rapid strides over the years. From being an import dependent industry in the 1950s, the industry has achieved self-sufficiency and gained global recognition as a producer of low cost high quality bulk drugs and formulations. Having proved its mettle in international market, India is now on the helm of taking up the challenge of proving its efficiency as capital for global clinical trials.
A number of factors favor the recognition of India as hub for CR due to which the multinational companies have identified it as their ideal destination. Firstly, there are numerous government funded medical and pharmaceutical institutions having state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials. Secondly, India can boast of a large well-trained and qualified manpower that is well versed in English as a means of communication. Most importantly, there is vast clinical material, which can be utilized. In terms of the cost efficiency, India works out to be a cheaper option as the cost to conduct a trial here is lower by 50 to 75% than that in either United States or European Union. R&D costs in India are much less than those in the developed world and it is possible to conduct both New Drug Discovery Research and Novel Drug Delivery System programs at competitive rates. Additionally, while clinical trials cost approximately $300 to 350 million abroad, they cost about Rs.100 crore in India (http://www.ciionline.org). There is a good communication link which, favors fast recruitments and approvals. Thus, the studies can be completed quickly and provide edge over competitors.
India is a land of diversity where alternative systems of medicine like ayurveda, unani, siddha, and homeopathy are practiced with equal fervor as allopathy. Thus, clinical studies for their evaluation can also be conducted with ease. Internationally, there has been recognition of the Indian advantage which is luring pharmaceutical companies to adopt collaborative outsourcing strategies so as to tap the potential to its fullest. Owing to these factors the India is globally attracting collaborative contract proposals for conducting clinical trials and many have already come forward to set up their clinical research organizations (CRO's)
Irrespective of the fact that a drug has been developed in India or abroad, or whether its clinical studies have already been conducted abroad, every new drug needs evidence from CR to support its launch. Thus, whether it is a new chemical entity or an existing drug that is being marketed for new indication, clinical studies have to be conducted. Similarly, launch of new formulations, drug delivery systems or even new fixed dose combination, requires clinical data before it can be marketed. Hence, it is obvious that the area of CR holds immense scope and promise for without the supporting data drug launches are not feasible. CR should not be merely viewed as a subsidiary to pre-clinical research. On the contrary it is of prime importance for it has to be conducted even in cases where pre-clinical studies are not warranted (new formulations/fixed dose combinations/ bioequivalence). |
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