Clinical Trials: Waking From Slumber?

In 2011 the size of the clinical trials business in India was estimated to have grown to c. $1.6 billion. The growth has been rapid, and some of the factors that are said to have contributed include the patent protection laws introduced in 2005, India's diverse gene pool and low costs. Some also point to the relatively low levels of compensation payable when all does not go to plan. The Supreme Court at least feels that all is not as it should be in the light of reports that almost 2,242 people have died in India during clinical trials.

Clinical trials are conducted by Contract Research Organisations (CROs) under regulation by the Central Drugs Standard Control Organisation (CDSCO). CROs conducting clinical trials are meant to constitute ethics committees at the location of the clinical trial. These committees must approve the proposed trials, monitor them, and be concerned for the protection of the rights and interests of subjects participating in the trials. These