**Summary:**
This notice, issued by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, on April [Q] 2019, announces the implementation of the New Drugs and Clinical Trials Rules, 2019, effective from March 19, 2019. These rules govern the regulation of new drugs, investigational new drugs for human use, clinical trials, bioequivalence studies, bioavailability studies, and Ethics Committees.
The notice informs applicants that all applications for approvals related to the aforementioned categories must now be submitted online through the SUGAM portal, adhering to the relevant checklists provided therein. Applicants are required to prepare applications offline using the forms specified in the New Drugs and Clinical Trials Rules, 2019, and upload scanned copies to the corresponding sections in the SUGAM portal checklist.
The Gazette notification containing the New Drugs and Clinical Trials Rules, 2019, including the necessary forms, is available on the CDSCO website (www.cdsco.gov.in). The SUGAM portal has been updated to accommodate the online submission of applications under the new rules.
Applicants are also required to submit fees as per the Sixth Schedule of the New Drugs and Clinical Trials Rules, 2019, and upload a copy of the T.R. Challan or Bharat Kosh receipt in the designated section of the checklist. For further clarification, stakeholders may contact the CDSCO IT Cell at ithelpdeskcdsco.nic.in.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India involved in health services.
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
New Drugs and Clinical Trials Rules, 2019: A set of regulations governing new drugs, investigational new drugs, clinical trials, bioequivalence studies, bioavailability studies, and Ethics Committees in India.
SUGAM Portal: An online portal for submitting and processing applications related to new drugs and clinical trials in India.
Drugs and Cosmetic Rules, 1945: The previous set of rules governing drugs and cosmetics in India, now superseded by the New Drugs and Clinical Trials Rules, 2019 for new drugs and clinical trials.
Ethics Committee: A committee that reviews and approves research involving human participants, ensuring ethical conduct.
Sixth Schedule of New Drugs and Clinical Trials Rules, 2019: Specifies the fees required for various applications under the New Drugs and Clinical Trials Rules, 2019.
Bharat Kosh: A portal for making online payments to the government of India. Used for paying fees related to applications under the New Drugs and Clinical Trials Rules, 2019.
F. No.12-22/2019-DC (Pt-Misc-SND)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Subsequent New Drugs Division)
Dated: | Q APR 2019
NOTICE
Subject: Uploading of applications through SUGAM Portal in accordance with New
Drugs and Clinical Trials Rules, 2019- Reg.
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 new drug are submitted and processed
online through SUGAM portal.
In light of the New Drugs and Clinical Trials Rules, 2019, it is brought to the notice of
applicants that they should submit their application as per the relevant checklist provided in
the SUGAM portal.
The application Form for specific purpose should be prepared offline in the relevant
Form as per the New Drugs and Clinical Trials Rules, 2019 and a scan 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.gov.in. Necessary provisions in this regard has 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 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.