Regulatory update on Indian clinical research approval timelines

The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry and investigators that clinical trial approval will be given within 180 days of submission of clinical trial application provided all the submitted documents are complete. Also clinical trial protocol amendments will be approved within 60 days, if consultation of the New Drugs Advisory Committee (NDAC) is not required. The notification was issued on January 24, 2014.

The new timelines and guidelines from the DCGI have been welcomed by Renu Razdan, vice president of the Association of Contract Research Organizations (ACRO) India and also the chief operating officer, Max Neeman Medical International, a leading Indian CRO.

In another step to further make clinical trials transparent and safe, the DCG] made it compulsory in November 2013, to not just obtain written informed consent from subjects participating in drug trials but also present audio visual recording of informed consent process of each new trial subject.