Indian Drug Regulator Apex, Standard Control Organization Central Drugs Standard (CDSCO), has shifted the approval process for drug imports completely online to improve transparency, responsibility and ease of business.
This reform applies to drugs imported in bulk for non-medical purposes-known as “dual use drugs”-running in sectors, such as medicines, food and animal feed, according to two officials and documents reviewed by mint.
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One -year night, less renewal
The new dual use system, running on the Sugam portal, represents a one -year certificate for the approved importer without objection (night). This step reduces the administrative burden of frequent renewal.
“CDSCO for strengthening“ easy business ”has streamlined the process of issuing dual use Night for drugs imported in large for non -medical use through Sugam portal. Furthermore, to reduce the stress of compliance with the regulations, the CDSCO started the question of one -year night, which is submitted conditions for such medicines, ”said drug control in India, in the circle for participation.
The process includes an initial online registration request and a night from the CDSCO Zonal office, followed by approval to release shipments from ports. In addition, candidates will be able to monitor the use of imported materials in the supplier chain to ensure greater responsibility.
Two -phase process
The new system is designed to provide a smooth experience for the importer. The process is divided into two main phases:
Phase I. (Step 1): This is an online application for registration and night from Zonal or Sub-Zonal Office CDSCO. The registration process, which began on August 5, 2025, requires applicants to submit a prescribed document list, including evidence of the address, forms, and a valid ID for the authorized person. The granting of dual use of the night is verified by the affected zone or sub-zone office and can be issued within seven working days of the application.
Phase II (Step 2): After receiving a valid dual use, the Night from the Zonal or Sub-Zonal Office must submit documents online to the port office at the time of imports for the release of consignments.
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Improved traceability
The key innovation in the system is the supplier chain module that allows you to monitor each shipment of import in real time. Data submitted during imports are verified by ports. The system also includes a approval module, open throughout the night to follow the recurring edition of the shipment.
Approved applications and updates will be visible to zonal, sub-zonal and port offices on the Sugam portal, ensuring coordination and supervision of the agency.
“It’s for easy business. It used to be a physical application, now it is a digital system. It creates easy trackability and helps create a national database,” said the first official, which he knew.
The new online dual use system on the Sugam portal will be alive 31. August 2025. Starting September 1, 2025, only users who are registered and approved by CDSCO will have, because two -night traders or real manufacturers will be allowed to apply for a double night on the new portal.
Legal compliance with regulations
The aim of the system is to ensure a uniform implementation of the rule of 43 rules of drugs and cosmetics from 1945, which controls mass imports of drugs for non -medical purposes. All applications will be subject to a technical review by a representative of the drug controller (India) affected by the zones.
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“For the pharmaceutical and related industry, this new game converter is a converter. Previously, this process was so cumbersome and time took. Now this online system with a uniform platform will shorten the time and effort to ensure authorization, which is more efficient,” the second official said.
(Tagstotranslate) CDSCO
