Why is India a Great Location for BA/BE Studies But Not For Clinical Trials?

About half of all BA/BE studies to support generic drug applications are conducted in India. On the other hand, only about 2% of interventional clinical trials have sites in India. And it does not seem that these numbers will change in the near future. To see the cause for this huge disparity, one needs to look no further than the recent history of clinical trials in the country and the current clinical trial rules in India. India is home to about 17% of the World’s population, and about 20% of the global disease burden. India also boasts of a predominantly younger, educated, English-speaking population. However, India has had major problems with conducting clinical trials for global acceptance. About 10 year ago, in 2007, India was seen as a beacon of hope for the emerging markets as a rapidly developing clinical trial location. Indian regulators had taken the approach of trusting clinical trials approved by developed regulatory bodies such as the FDA, EMA, Health Canada, and PMDA, to speed up clinical trial approvals in the country making it an attractive location for global clinical trials looking for faster and inexpensive recruitment. However, the clinical trial enterprise rapidly lost its reputation due to reports of several incidences of unethical practices in clinical trials, rampant corruption, and inexperienced regulators with extremely limited resources who were unable to regulate the rapidly growing clinical trial industry in the country. To control the corruption, Indian regulators first declared a moratorium on all clinical trial approvals grinding the system to a screeching halt, followed by adding onerous processes for review of clinical trials, ultimately announcing unrealistic and untenable rules, intended to safeguard subjects in clinical trials but in reality killing the chance of any reasonable controlled clinical trial to be conducted. The most controversial was the rule that requires financial compensation for all subjects in clinical trials who experience any adverse events, whether or not investigational drug related. The core purpose of a clinical trial is to evaluate the safety of an investigational compound and hence adverse events are expected in some subjects participating in clinical trials. Requiring financial compensation beyond the cost of managing adverse events subjects the sponsor to unreasonable penalty, and creates an atmosphere of mistrust and blackmail due to malicious claims by the study participants. The compensation rule is credited with the en masse departure of most non-Indian and even Indian clinical trial sponsors from the country. The only studies that can be still conducted are the BA/BE studies that do not involve safety issues and are conducted in healthy participants. At the height of its clinical trials industry in 2007, India hosted about 1200 clinical trials with projections of reaching about 3000-5000 trials in a few years. Today, India is host to about 100 clinical trials with only 3 trials getting ready to initiate at the time of writing of this piece. The clinical trial approval and compensation rules are still the law of the land. With no proposals to revise these rules, it would be unreasonable to expect any sponsors to attempt controlled Phase 2 or 3 clinical trials in India.