CDSCO Launches Online Dual Use NOC System for Bulk Drug Imports via Sugam Portal
In a move aimed at streamlining regulatory procedures and reducing the compliance burden on industry stakeholders, the Central Drugs Standard Control Organisation (CDSCO) has announced the launch of a new online system for obtaining No Objection Certificates (NOC) for drugs imported in bulk for non-medicinal purposes. The system will go live on the Sugam portal starting August 31st, 2025.
The CDSCO, under the leadership of Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi, has also released a revised procedural checklist and a comprehensive guidance document to aid the industry in complying with the updated process. The new dual-use NOC will be valid for one year and is subject to specific conditions outlined in the guidance.
As part of the updated process, importers must complete a two-step application procedure: initial registration through the Sugam portal followed by submission of the NOC application to the designated zonal or sub-zonal CDSCO offices. Only approved traders and actual manufacturers registered on the portal will be eligible to apply from September 1 onward.
Applicants are required to provide key documents, including address proof, ID proof of the authorised representative, an undertaking, sales contracts, and detailed usage justifications. The CDSCO has stressed that applications must be submitted at least two months prior to the intended date of import to avoid delays.
Dual-use permission will not be granted for drugs intended for purification or sterilization purposes. The NOC is restricted to actual users and industries such as pharmaceuticals, food processing, and animal feed that utilize these drugs in non-medicinal capacities or at lower concentrations.
The new system is being implemented under Rule 43 of the Drugs and Cosmetics Rules, 1945, and is designed to ensure uniform application of the regulation. Each application will undergo a technical review by the Deputy Drugs Controller of the concerned zone before approval.
Click here to Access the official guidance document
Tags: CDSCO, Online Dual Use NOC System for Bulk Drug Imports, Sugam Portal.
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