The patients who died during a clinical trial does not euqal to patients who died BECAUSE of the clinical trial. If a cancer patient died during a clinical trial, it is very likely due to the disease itself than due to the drug. Annual death of 221 in India due to clinical trials is definitely an exagerrated number (most of the deaths are not related to the drug). There are IRB and regulatory agencies in India as well. Although they are not as organized and experienced as FDA, they are not completely ignorant either.

To be approved by FDA, the trials has to enrolled some patients from US, in most cases. In many cases, the majority of the patients are from US. But data management and programming work can be outsourced to other countries, such as India and China.

By the way, the drug that caused the disaster for pregnant woman was never approved by FDA and never sold in US. It was only approved and sold in Europe. It was not approved by FDA for safety concerns. It was often cited as an example to show the expertise and competence of FDA. FDA is very found of themself for that case.