I am using old drug molecule but it’s formulation not sell in India since 4 year. so can you suggest which document require for sell in India? Also is it require BA/BE study?
One it has been banned and second it has been over shadow by better molecule or more updated form of molecule for a particular indication.
If it is not banned, then you will require same documents as needed for other molecules for sale like wholesale/retail drug license etc. It requires pharma study, not BA/BE study.