The Central Drugs Standard Control Organization, 2019 has released a circular dated 10th April, 2019, with regard to uploading of applications through SUGAM Portal in accordance with the New Drugs and Clinical Trial Rules, 2019.
Background:
The new Drugs and Clinical Trial Rules, 2019 have been published with effect from 19th March, 2019 with a view to regulate New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability and ethics committee. The Rules provide various Forms for submission of application and grant of approvals of various categories of new drugs and clinical use. Earlier, the applications for approval of New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability and ethics committee were required to be submitted as per the provisions prevalent in the Drugs and Cosmetics Rules, 1945.
Key highlights:
Through this circular, the applicants have been requested to submit their application as per the relevant checklist provided in the SUGAM portal.
- The application form for specific purpose must be prepared offline in the relevant Form as per the New Drugs and Clinical Trial Rules, 2019
- A scanned copy of the same must be uploaded in the respective item as provided in the checklist.
- The Applicants are also required to submit fees as per the Sixth Schedule of the New Drugs and Clinical Trial 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 checklist.
In case of further clarifications, the stakeholders have been directed to contact the IT Cell of CDSCO at email it-helpdesk@cdsco.nic.in.
Source: Ministry of Health and Family Welfare
