India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has moved the approval process for importing drugs entirely online, aiming to improve transparency, accountability, and the ease of doing business.
This reform applies to drugs imported in bulk for non-medicinal purposes— also known as ‘dual-use’ drugs— commonly used in sectors such as pharmaceuticals, food, and animal feed, according to the two officials and documents reviewed by Mint.
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One-year NOC, fewer renewals
The new dual use system, launched on the SUGAM Portal, introduces a one-year No Objection Certificate (NOC) for approved importers. This move reduces the administrative burden of frequent renewals.
“CDSCO to further enhance ‘ease of doing business’ has streamlined the process of issuing Dual Use NOC for drugs imported in bulk for non-medicinal use through SUGAM Portal. Further to reduce the compliance burden, CDSCO has initiated an issue of one-year NOC, subject to prescribed conditions for such drugs,” said Drugs Controller General of India, in a circular to stakeholders.
The process involves an initial online application for registration and NOC from the CDSCO zonal office, followed by the approval for release of consignments from the ports. In addition, the applicants will be able to track the use of imported materials in the supply chain to ensure greater accountability.
Two-phase process
The new system is designed to provide a hassle-free experience for importers. The process is divided into two main phases:
Phase I (step 1): This involves an online application for registration and NOC from the CDSCO’s zonal or sub-zonal office. The registration process, which began on 5 August 2025, requires applicants to submit a prescribed checklist of documents, including address proof, an undertaking form, and a valid ID for the authorised person. The grant of a Dual Use NOC is verified by the concerned zonal or sub-zonal office and may be issued within seven working days of the application.
Phase II (step 2): After receiving a valid Dual Use NOC from the zonal or sub-zonal office, the applicant must submit documents online to the port office at the time of import for the release of consignments.
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Enhanced traceability
A key innovation in the system is the Supply Chain Module, which allows real-time tracking of each import consignment. Data submitted during import is verified by port offices. The system also includes a reconciliation module, open throughout the NOC’s validity, to monitor repetitive consignment releases.
Approved applications and updates will be visible to zonal, sub-zonal, and port offices on the SUGAM portal, ensuring inter-agency coordination and oversight.
“It is for ease of doing business. Earlier it was a physical application, now it is a digital system. It will create easy traceability and help build a national database,” the first official aware of the matter said.
The new online Dual Use System on the SUGAM Portal will become live on 31 August 2025. Starting 1 September 2025, only users who are registered and approved by the CDSCO as Dual Use NOC traders or actual manufacturers will be permitted to apply for Dual Use NOCs on the new portal.
Legal compliance
The system aims to ensure uniform implementation of Rule 43 of the Drugs and Cosmetics Rules, 1945, which governs bulk drug imports for non-medicinal purposes. All applications will be subject to technical review by the Deputy Drugs Controller (India) of the concerned zones.
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“For the pharmaceutical and related industries, this new system is a game-changer. Earlier, the process was so cumbersome and time taking. Now, this online system having a unified platform will reduce the time and effort required to secure permissions, make it more efficient,” said the second official.