The figure 6-1 below highlights the procedure, which is undertaken to obtain licenses for APIs in India.

Figure 6‑1  API License Procedure

Applicant

Application to IND Filing Application (Form

Ethical Committee 45A) to CDSCO Head-Quarters

Report of Ethical Examination by New

Committee Drug Division

If Positive Detailed Review by

Within 12 Weeks IND Committee

Recommendation
by DCGI

IND Application
Approved

Clinical Trials Started

Application (Form 41) for New

If Not API Registration to DCSCO

Review by DCGI

If complete

Refused to Grant License License Granted

Source:  Various Industry Sources

15 Indian API Market Outlook 2022