Indian Regulatory - Suppose unapproved drug in India for marketing & manufacturering

(Dattu Wadekar) #1

Suppose unapproved drug in India for marketing & manufacturering and manufacturer want to export same drug in other country, Which type of licence required for that and process of application.

(Sapna) #2

First if drug is unapproved in india. But manufacture want to export then we take NOC from CDSCO. After that we proceed to state licence

1 Like
(Dattu Wadekar) #3

Dear Madam,

lots of thanks…!!!

One more query
If manufacturer want manufacturing of Unapproved Drugs in India for registration purpose not for any commercial use. Which type NOC required from CDSCO. @sapna5854

(Sapna) #4

If u sell drug in india . Then submit the complete information about drug e.g. v clinical trials etc. in delhi CDSCO.