India has become a global hub for clinical drug trials on human subjects, reportedly worth $400 million USD and growing by over 30% per year. Until the 1990s, most clinical research was carried out in academic medical centers and financed by the Government. Recently, commercial interests have started dominating the drug trial scene in which the financial bottom-line can override ethical and human rights concerns. A number of factors are responsible for the current increase in drug trials conducted in India. These include the low cost of experiments, almost 60% less than comparable trials in Europe or the US, and access to a large pool of illiterate and relatively less educated patients with a wide variety of diseases. Trials became easier after the 2005 amendment of the Drugs and Cosmetics Act of 1940 permitting concurrent trials. These factors and the absence of specific laws to protect patients have lead to widespread corruption in clinical drug trials.
Rampant corruption has been alleged from the highest policy level down to local institutions. The regulatory mechanism is steered from the drug controller’s office at the center with little involvement and control at the local levels. Bioequivalence trials offer participants large payments in violation of existing ethical guidelines inducing poor people to risk their lives. At present, sound and ethical clinical trials depends mostly on personal integrity and honesty of the investigator concerned. While corruption is so widespread, there are no specific laws to prosecute illegal or unethical activities.