109 NOC's for manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose 2024-Apr-30 454 KB

IMP-12/1/2024-eoffice

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Government of India Directorate General of Health Services Central Drugs Standard Control Organization (Import & Registration Division)

To

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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.75/2018/Misc./03 4(NOC) dated 2"4 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'Oay, 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 Accordingly, power delegated to State/UT Licensing Authority stands withdrawn w.e.f. 15 th May, 2024 and such NOC's shall be granted by the Head of respective CDSCO Zonal office w.e.f.15" May 2024. Further All State/UT Drugs Controllers are required to handover all NOC's issued from 2oth August, 2018 to14thyay, 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.e.f.15th 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 / eer (Dr. Rajeev Si aghuvanshi) Drugs Controller General (India)

drashekar Rao Joint Drugs Controller (India) will be Nodal and designated person at CDSCO, HQ for said activity.

Yours faithfully / eer (Dr. Rajeev Si aghuvanshi) Drugs Controller General (India)

tile 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 India

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‘ile No. IMP-12/1/2024-eoffice (Computer No. 7581)

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F.No.X.11035/210/2018-DR (Pt)

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‘ing Me DCGI, CDSCO, FDA Bt 2 New Dethl- 110002 a Subject:export NOC form “unapproved/bannedinew drugs solely tor purpose ~ré i | above Please referto aber 8200817 dated 03.01.2023 on subject cited wherein you Han in supersession of earlier CDSCO order issued issued requiring that’ : e NOC from respective zonal offices of CDSCO before taking ng licens es from SLAs for the manufacture of Unapproved/Banned/New aig sfor[export purpose.] ‘$ 2. in this regard, matter has been[examined] by this ministry and it is to inform you that industry must be fac itated to file fresh. for NOCfor manufacture of unapproved/banned/new drugs solely for export purpose from beh2024 at a single designatedand the applicationsperson onlycan onbe-oritinydisposed) modebypS CDSCOongthrough of contact their respective[at] COSCO zonal[headquarters] offices. 3.nandFurther, CDSCO_maygive necessary direction to all State/UTdrugs controller to provisionsover detailssince 20TE.of all= such"exportSipermissionses given bythem under the delegated This is issued with approval of Hon'ble HFM

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provisionsover detailssince 20TE.of all= such"exportSipermissionses given bythem under the delegated This is issued with approval of Hon'ble HFM

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