Swadhin Mondal, Dinesh Abrol | Institute for Studies in Industrial Development | March 2015
Abstract
This study shows that many global clinical trials organisations have relocated their clinical trial (CT) research units to India. The Indian CT industry has become one of the most cost ‐ efficient destinations in the world. It is growing fast and has emerged as a popular destination for global clinical trials. However, the process followed by the pharmaceutical companies for conducting CTs has raised some critical issues. First of all, the Indian CT industry has not been able to ensure rapid technological transformation and the building of capabilities required for development of new drugs despite receiving help from the internationally acclaimed CROs in India. Although the CT industry has been able to take advantage of financial gain from the global clinical trial activities conducted in India, capability ‐ building for development of new drug is not occurring in a manner that can help the country tackle public health challenges. Second, over the past few years, the CT industry has come to face regulatory challenges. It is confronted with some serious ethical issues on account of its conduct with regard to containing deaths. Between 2010 and 2012, around 2500 people died because of adverse effects of drugs under trial. But, only a few participants received compensation in case of injury sustained or death. The authors of this paper argue that the Government of India needs to establish a policy framework for the Indian CT industry to provide for easy access to affordable drugs developed through adaptive clinical trials and create a regulatory environment capable of ensuring the conduct of clinical trials without violation of humanitarian ethics and other social norms.