Another major loophole was that it was not mandatory to register the ethics committee. Many a times the panel was based outstation thus weakening the monitoring mechanism. Many a times, members of the ethics committee had conflict of interest. Also, neither were they trained nor they had the resources or independence to do the monitoring job well.
A new notification has been issued to ensure compensation for serious adverse event within a limited time frame. However, no credible, transparent and independent system to determine morbidity and mortality exists except total reliance on investigators, ethics committee and sponsors.
- Risk vs benefits to the subjects- If risks outweigh the benefits, the trial would definitely not be allowed
- Innovation vis-a-vis existing therapy- How is the new therapy different than the treatments or drugs already available
- Unmet need to the Indian population – Only those trials will be allowed which are related to diseases prevalent in India.
The Indian pharma companies are the richest in the world yet they don't carry out any research. Between 1985 and 2013, only seven drugs have been discovered in India. The court has not stopped any foreign drug to be tested in India which has obtained marketing approval abroad.