The Open Clinical Trials Journal

2013, 3 : 13-19
Published online 2013 June 14. DOI: 10.2174/1876821001103010013
Publisher ID: TOCTJ-3-13

RESEARCH ARTICLE
Realizing the Promise: India’s Strategic Shift from Outsourcing to Innovation

Shewale Sunil, * and Parekh Sameer
Department of Medical Affairs/Clinical Research, Serum Institute of India Ltd., Pune. India

* Address correspondence to this author at the Department of Medical Affairs/Clinical Research, Serum Institute of India Ltd., 212/2, Off Soli Poonawalla Road, Pune-411028, Maharashtra, India; Tel: +91-99609-80895; E-mail: ms.shewale85@gmail.com

ABSTRACT

Over the last decade the exclusive domain of pharmaceutical and biotechnology companies located in Western Europe and the United states have entered an era where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. Major issues being, the requirement to reduce the escalating costs and risks associated with drug development; and reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. In recent years there is drift; because the amount of clinical research and development activities conducted in emerging and non-traditional geographies has shown significant growth. The industry has recognized the opportunities and advantages that exist by conducting clinical trials in India; what is referred as the emerging market. As a result, many companies have flocked to India for better access to patients, lower costs and operational efficiencies. This article discusses the variety of factors that are behind the India’s transformation from a simple outsourcing destination to a potential hub of true clinical research growth and innovation

Keywords:

Clinical trial, India, outsourcing, innovation.