**Policy Summary: Central Drugs Standard Control Organization (CDSCO) - NOCs for Manufacture of Unapproved/Banned/New Drugs Solely for Export**
Effective May 15, 2024, the Central Drugs Standard Control Organization (CDSCO) is centralizing the issuance of No Objection Certificates (NOCs) for the manufacture of unapproved, banned, or new drugs intended solely for export. This authority, previously delegated to State/UT Licensing Authorities on August 20, 2018, is now withdrawn. All fresh applications for NOCs must be submitted online through the CDSCO Zonal Offices via the SUGAM Portal, starting May 15, 2024. Manufacturers are required to obtain NOC from respective Zonal Offices of CDSCO through online mode SUGAM Portal before issuing Manufacturing License from SLA for manufacture of Unapproved/Banned/New Drugs for export purpose. State/UT Drugs Controllers are directed to handover all NOCs issued from August 20, 2018, to May 14, 2024, to their respective CDSCO Zonal Offices. Sh. Ranga Chandrashekar Rao, Joint Drugs Controller India, will serve as the Nodal and designated person at CDSCO HQ for this activity. This change is implemented with the approval of the Hon'ble HFM and aims to facilitate the industry while ensuring regulatory oversight.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
CDSCO Zonal Offices: Regional offices of the Central Drugs Standard Control Organization responsible for various regulatory functions including granting NOCs.
StateUT Drugs Controllers: Drug regulatory authorities in various States and Union Territories of India.
NOCs for Manufacture of UnapprovedBannedNew Drugs Solely for Export Purpose: No Objection Certificates required for manufacturing unapproved, banned, or new drugs exclusively for export purposes.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
Sh. Ranga Chandrashekar Rao: Joint Drugs Controller India, designated as the nodal person at CDSCO HQ for NOC related activities.
SUGAM Portal: Online portal for submitting applications to CDSCO.
IMP-12/1/2024-eoffice
. Government of India
Directorate General of Health Services Central
Drugs Standard Control Organization
(Import & Registration Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Dated: 20 APR md
To
All States/UT Drugs Controllers
Subject: NOC’s for Manufacture of Unapproved/Banned/New
Drugs Solely for Export Purpose -Reg
NOC’s for manufacture of unapproved/banned/new drugs solely
for export purpose are granted as per the Guidance Document issued
by CDSCO.
The above activity was delegated to State licensing
Authorities w.e.f. 20th August, 2018 vide letter of F.No.7-
5/2018/Misc./03 4(NOC) dated 24 August, 2018
Now, it has been decided with the approval of Hon'ble HFM
vide Ministry F. No. X.11035/210/2018-DR (Pt) dated 218t June, 2023
that Industry must be facilitated to file fresh applications for NOC for
manufacture of unapproved/approved new drug/banned drugs solely
for export purpose from15'thMay, 2024 on online mode through
CDSCO Zonal Offices. Accordingly, power delegated to State/UT
Licensing Authority stands withdrawn w.e.f. 15 th May, 2024 and
such NOC's shall be granted by the Head of respective CDSCO
Zonal office w.e.f.15tOMay 2024. Further All State/UT Drugs
Controllers are required to handover all NOC's issued from 2oth
August, 2018 to14thmay, 2024 to respective Zonal Offices of CDSCO.
All manufacturers may be informed that they are required to
obtain NOC from respective Zonal Offices of CDSCO through online
mode (SUGAM Portal) w.ef.i5th May 2024 before issuing Manufacturing
License from SLA for manufacture of Unapproved/Banned/New Drugs for
export purpose.
Sh. Ranga Chandrashekar Rao Joint Drugs Controller (India) will
be Nodal and designated person at CDSCO, HQ for said activity.
Yours faithfully
1
ALr8
(Dr. Rajeev Si aghuvanshi)
Drugs Controller General (India)
‘ile No. IMP-12/1/2024-eoffice (Computer No. 7581)Copy
1. All Zonal/Sub-Zonal/Port Offices of CDSCO for necessary action.
2. All stake holders through CDSCO website.
Copy for information to:
1. Deputy Secretary (Drug Regulation), MoH F & W, Govt. of India
2. Joint Secretary, (Drug Regulation), MoH F & W, Govt. of India359764172023
To
DCGI, CDSCO,
New Dethi- 110002
Subject; NOC |
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This is issued with approval of
Yours faithfully,