PXL/HO/Cir-008/2024-25                                                                            Date: 02.05.2024

Hyderabad

Subject: DCGI OM dtd 30/4/24 -NOC's for Manufacture of Unapproved/ Banned/ New Drugs Solely for Export Purpose-Reg

Please be informed that the DCG(I) vide Order No: IMP 12/1/2024/e-Office dt: 30.04.2024 issued a revised guidance for obtaining NOC’s for manufacture of unapproved/banned/new drugs solely for export purpose. 

It has been decided  that Industry must be facilitated to file fresh applications for NOC for manufacture of unapproved/approved new drug/ banned drugs solely for export purpose from 15^th May,2024 on online mode (SUGAM Portal) through CDSCO Zonal offices. Accordingly powers delegated to State/UT licensing authorities (vide Letter of F.No:7-5/2018/Msc./034 (NOC) dt: 2nd August 2018) stands withdrawn w.e.f 15th May 2024 and all such NOC's shall be granted by the Head of respective CDSCO Zonal office w.e.f 15th May 2024. The DCGI OM is attachedfor your reference. 

Members are advised to take note of the above guidance while applying for NOC & Manufacturing license for unapproved/banned/new drugs solely for export purpose.

Regards,

Udaya Bhaskar

Director General 

ENCL: DCG(I) OM