CDSCO Launches One-Year Online Dual Use NOC System for Bulk Drug Imports
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has introduced a new online Dual Use No Objection Certificate (NOC) system on its Sugam Portal for drugs imported in bulk for non-medicinal purposes, with a validity of one year. The move is aimed at streamlining approvals under Rule 43 of the Drugs and Cosmetics Rules, 1945, as part of the government's "ease of doing business" reforms and to "reduce compliance burden on the stakeholders."
According to the CDSCO circular dated 4 August 2025, “The registration process will start from 05.08.2025, the system will go live on 31.08.2025 and from 01.09.2025, it will be mandatory for all Dual Use NOC Traders and actual manufacturers to apply through this revised online system.”
Under Rule 43, “dual use” refers to drugs imported for non-medicinal purposes, including use as intermediates in pharmaceuticals, food and feed supplements, cosmetics, or other industrial applications.
Two-Phase Process
Phase I – Registration & NOC Issuance
Applicants must register on the Sugam Portal under the “Dual Use NOC” role, submit the Integrated Registration Form, and upload mandatory documents such as address proof, undertaking form, and ID proof of the authorised person. After verification by CDSCO headquarters, “the NOC will be issued by the concerned CDSCO Zonal/Sub-Zonal office within 07 working days.”
Phase II – Port Clearance
Once an NOC is granted, clearance at the designated port office requires submission of a covering letter, Certificate of Analysis, bill of entry, product labels, and invoices.
The system will also feature a Supply Chain Module to track imports and reconcile quantities during the NOC validity period. CDSCO stated this mechanism will ensure “uniform implementation of Rule 43” while safeguarding against misuse.
To view the original notice, click on the link below:
