Govt initiate steps to promote clinical trials in India

This particular step by the CDSCO puts to rest the concerns raised by different stakeholders (to the health ministry) in India to eliminate the repeat steps of tests and data submissions.

A similar step has been taken to ease the administrative procedure where the Ethics Committees can also approve requests for new clinical trial sites and new investigators to be added to a clinical trial without CDSCO’s approval as long as the ethics committees conduct “due diligence.”, as reported by the zeenews.com.

As per the new norms, researchers will no longer need the permission of the Drug Controller General of India (DCGI) for “academic/research purposes that are non-regulatory in nature.” However, the Ethics Committee is still required to inform the DCGI of the study and the DCGI will have 30 days to object to the decision to not seek its approval.