India – a hub for clinical research

February 25th, 2010 by Team Healthizen
Clinical Trial While most clinical trial failures are attributed to a delay in recruiting patients on time, extending clinical trials to newer geographies is the only solution to reduce research costs and decrease drug development time. Hence, both multinational and Indian pharmaceutical companies have been strengthening their clinical research departments while international contract research organizations (CROs) have begun diverting their attention towards India for their futuristic plans and goals. The world is shrinking by virtue of rapid advances in telecommunications and information technology.  

India’s participation in early phase research logically facilitates early regulatory review of clinical data with the opportunity for the drug to enter the market at the same time as in developed countries. Patients participating in clinical trials get free medical care inclusive of investigations and medicine, thereby improving the quality of their healthcare. Investigators update their knowledge to international standards and keep themselves abreast of the latest in drug research with their efforts being globally recognized. Hospitals that allow clinical trials are benefited due to the fact that companies are ready to invest in the development of their infrastructure.

Although India has witnessed unprecedented growth in the last decade, there are yet a number of issues that surface when setting up clinical trials here. Issues related to manpower, infrastructure, regulatory compliance, ethical issues, and data management must be analyzed and tackled effectively for greater credibility and sustainability. Electronic Data Management Systems are being used these days as these offer better controllability and security. Analyzing the trends, addressing the risk/benefit balance, dealing with policy issues, and strategically planning to achieve the desired ends, are vital for both the international company as well as its domestic counterpart, offering support through an alliance, a merger, an acquisition, or simply as a contract research agreement.

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