Importer & Manufacturer | CDSCO

12 February, 2025

Enforcement Date: 22 February, 2025

Implementation of Additional Variant Module on SUGAM Portal

As part of the e-governance initiative (F. No. D. 21013/230/2016 dated 02.12.2016), the Central Drugs Standard Control Organization (CDSCO) has introduced an online facility on the SUGAM portal for submitting applications and obtaining approval for additional variants of already registered cosmetic products. This new provision aims to enhance and streamline the process of cosmetic registration, import, and post-approval changes. The module will become operational soon. Stakeholders are encouraged to take note of this update and submit their applications through the SUGAM online portal for addition of the variants.

Applicable For: Importer & Manufacturer

Reference Number: F.No. COS-11018(11)/15/2024-eoffice Notification Link

Guide to CRO Registration on SUGAM Portal

Importer | CDSCO 12 March, 2025

The document provides a comprehensive guide for Clinical Research Organisations (CROs) to register on the SUGAM Portal. It details the registration process for both new and existing users, including filling out Form CT-07B(Application for Registration Renewal of Clinical Research Organisation), submitting necessary documents, and making payments. The guide also covers steps for profile completion, application submission, and communication with the CDSCO during the processing of the application.

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Summary of Guidance Document for Issuance of No Objection Certificate for Manufacture of Unapproved/Approved New Drugs for Export Purpose

Manufacturer | CDSCO 12 March, 2025

This document explains the Online procedure, on SUGAM Portal, for manufacturers with valid manufacturing licenses in Form-25, Form-28, Form-28D to obtain a No Objection Certificate (NOC) from CDSCO for exporting unapproved or approved new drugs. It is a Two steps procedure involves One time registration process at zonal office and Procedure for release of consignment at port office. It covers the requirements for Online submission, registration at zonal offices, and the necessary documents, such as the Export NOC Form, legal undertakings, manufacturing license, reconciliation details, and approval status in the importing country. The NOC is valid for one year and must be verified by the relevant zonal office.

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Gastro Resistant Tablets/Capsules Delayed Release Tablets/Capsules consider as New Drugs under NDCT rules, 2019

Importer | CDSCO 08 March, 2025

State/UT Drugs Controllers are requested to ensure uniform implementation of definition of New Drug as defined under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019 that modified or sustained release form of a drug including Gastro-resistant Tablets/Capsules /DeIayed release Tablets/Capsules (Enteric Coated Tablets/Capsules) or novel drug delivery system shall always be deemed to be new drug as per the provisions of Act & Rules made there under.

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