India's drug import process gets an online upgrade
New Delhi, Aug. 6 -- 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-or 'dual-use' drugs-commonly used in sectors such as pharmaceuticals, food, and animal feed, according to the two officials and documents reviewed by Mint.
The new dual use system, launched on the SUGAM portal, introduces a one-year no-objection certificate (NOC) for approved importers. This 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.
The process is divided into two main phases. The first phase involves an online application for registration and NOC from the CDSCO's zonal or sub-zonal office and requires applicants to submit a prescribed checklist of documents.
In the second phase, 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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