New Regulations Affecting Indian Clinical Trials
In order to improve the quality of clinical trials conducted in India, regulatory authorities are in the process of implementing new regulations. Along with measures to reduce regulatory approval timelines, down to one month in some cases, there has been a major push to enforce a stricter pharmacovigilance program.
With the new system, sponsors are required to request approval from a central licensing authority and all trials must be registered with the Clinical Trials Registry of India. These changes occurred as a result of reports of high patient mortality – more than 2,600 clinical trial participants died in Indian clinical trials between 2005 and 2012. In response to these statistics, the Indian Supreme Court demanded that clinical trials be better regulated before the start of 2014. India’s national elections in May 2014 are also expected to have some impact on the future course of the country’s clinical research industry.
In 2012, 500 clinical trials were approved in India, the highest recorded number to date. Over the past year, there has been a steady decline in outsourced clinical trials in large part due to the new regulations – the National Institute of Health (NIH) withdrew forty ongoing clinical trials last year, and several US and European companies have stopped medical trials in the country. Lack of clarity as to when and how the new system will be implemented has been a big cause for concern, especially among foreign sponsors. Consensus from the beginning of 2014 indicates that industry experts continue to view the country’s regulatory environment as unstable.
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