Nata Menabde, WHO Representative to India, said that there are “significant concerns” and that vulnerable populations were exploited and informed consent processes were not adequately followed in Madhya Pradesh. She added that monitoring of trials must be strengthened in India along with training investigators—the doctors who run clinical trials.

The change in patent laws in 2005 led to a stricter Indian patent regime, which was enacted as part of World Trade Organization negotiations. It also strengthened the interest of multinational drug companies in clinical trials and hence, the number of clinical trials in India rose sharply after 2005.

Clearly trials have become a profitable business for clinical research outsourcing (CROs) companies who are the third parties that do trials on behalf of drug makers. As per the consultancy Frost & Sullivan, the CRO industry generated $485 million in revenue in 2010-11 and has been growing about 12 percent every year. The number of CROs grew from a small number before 2005 to more than 150 today. It was also noted that top 20 CROs earn more than 70 percent of the industry's revenues. But, there is no government registry for CROs in India.