There are 3 types of application for Import of API/FF in India:

1 )Fresh Application in Form-40 both for Human/ Vet Drugs

2 )Endorsement Application for Drug on already registered site- in Form-40 both for Human/ Vet Drugs

3 )Re-registration in Fomr-40 both for Human/ Vet Drugs

If the application drug comes into the definition of New Drugs based on the DCGI circular dated 30.12.2016- we take care to file for the regularization application in the SND Division -as per requirement under Rule 122A of the Drugs & Cosmetics Act & Rules thereunder.

 (For Human drugs -regularization application is submitted on Online Sugam Portal under CT-18, whereas for Vet Drugs -regularization application is still submitted offline as per form-45A requirements.)

 Form-10 Import Licence Application, based on:

 – Form-9 issued by Indian Agents

– Form-9 issued by Foreign Manufacturer