Mandatory ethics panel oversight, explanation within 30 days of a death & compensation rules coming
The Union health ministry and the drug regulator’s office are preparing to introduce norms and notifications to monitor clinical trials in a better way. In the wake of criticism of the existing guidelines, the ministry has planned to make it mandatory for every clinical trial site to have an internal ethics committee. It wants these committees to be registered with the drug regulator. The ministry is also working on norms for payment of timely compensation to victims in such trials.