Since January 2013, Indian regulatory authorities have announced a spate of laws and guidelines that will make a huge impact on the clinical trial sector in India.
These changes are the need of hour. If made in a pro-active manner over a period of several years, various stakeholders such as the industry, investigators and ethics committees that these rules impact, will have had adequate time to adapt to them. Instead, these changes have been reactive – in point, a reaction to the Supreme Court’s orders.
Besides, the manner in which they have been made will only serve to make clinical trials in India slow and expensive, compelling sponsors to look at alternatives.
Continue reading “Guest column : India’s new regulatory environment hostile to clinical trials”