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Upload application in SUGAM as per new Rules: CDSCO issues notice


Upload application in SUGAM as per new Rules: CDSCO issues notice

New Delhi: Through a recent notice, the Central Drugs Standard Control Organization (CDSCO) has informed that uploading of applications through SUGAM Portal should be in accordance with the New Drugs and Clinical Trials Rules, 2019.

The New Drugs and Clinical Trials Rules, 2019 have been published with effect from 19.03.2019 for regulation of New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability study and Ethics Committee.

The rules provide various Forms for submission of applications & grant of approvals of various categories of new drugs and clinical trials.

Earlier the applications for approval of New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability study and Ethics Committee were required to be submitted as per the provisions prevalent in the Drugs and Cosmetic Rules, 1945. Applications for various categories of the new drug are submitted and processed online through SUGAM portal.

In light of the New Drugs and Clinical Trials Rules, 2019, CDSCO brought to the notice of applicants that they should submit their application as per the relevant checklist provided in the SUGAM portal.

The notice informed that Application Form for the specific purpose should be prepared offline in the relevant Form as per the New Drugs and Clinical Trials Rules, 2019 and a scanned copy of the same should be uploaded in the respective item provided in the checklist. The  Gazette notification containing the New Drugs and Clinical Trials Rules, 2019 including the Forms is available at www.cdsco.qov.in. Necessary provisions in this regard have already been made in the SUGAM portal for the online submission of the applications.

Similarly, the applicants are also required to submit fees as per the Sixth Schedule of New Drugs and Clinical Trials Rules, 2019 for which they are required to upload the copy of T.R. Challan or receipt of Bharat Kosh in the respective item provided in the check-list.

For further clarification, if any, required by any stakeholders in this regard, they may contact the IT Cell of CDSCO at email it-helpdesk@cdsco.nic.in, the notice added.

Also Read: SUGAM registration Mandatory: CDSCO directs State drugs controllers to enforce rule



Source: self
1 comment(s) on Upload application in SUGAM as per new Rules: CDSCO issues notice

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  1. user
    Nihar Ranjan Panda April 22, 2019, 9:56 am

    dear sir/mam,

    usually form 29 is applied for test license (for R&D / ADL purpose). after getting successful result and 3 months stability data, we are applying for Product License (form 25/28).

    If we have already approved license in form 25/28, then why should we go for applying form 29.

    whats the additional benefit, we can get from this editorial?

    pls help to get it clear.

    regards

    Nihar