Query:
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?
Response:
For being used by companies for selling any molecule may have two conditions:
One it has been banned and second it has been over shadow/replaced by better molecule or more updated form of molecule for a particular indication.
If it has been banned then you can’t sell it. But if it is not banned, then you will require same documents as needed for other molecules for sale like wholesale/retail drug license and for manufacturing like pharmaceutical manufacturing License etc. Hope above information is useful to you for any query and suggestion, mail us at pharmafranchiseehelp@gmail.com