The Central Drugs Standard Control Organisation (“CDSCO”) has revised the process of issuing No Objection Certificates (NOC) for the export of unapproved/approved new drugs from India as of 7th May 2025 impacting both, drugs that have received marketing approval in India and those that are currently unapproved for sale within the country but are intended solely for export. This essentially means that there is now, a revised and unified process for all new drugs being exported, regardless of their domestic approval status, with the exceptions of Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs, which retain their previous, quantity-specific NOC requirement.
All manufacturers holding valid licences in Form 25, 28 and 28D for manufacturing of drugs under the Drugs & Cosmetics Act 1940 are now mandated to make online applications for Export NOC through SUGAM Portal along with the prescribed checklist of documents where the NOC will be valid for 1 year from the date of registration.
The CDSCO, as the drug regulatory authority in India, has issued a guidance document offering a comprehensive overview of the new procedure for clear understanding of the stakeholders. Recognizing these changes is crucial for ensuring compliance and navigating the evolving regulatory landscape.
Prior to the recent centralization by CDSCO, export NOCs were issued by State Licensing Authorities (SLAs) for the export of unapproved/banned/new drugs. With an aim to reduce the compliance burden, this process has been revised and now NOCs are to be issued to all manufacturers from the respective Zonal offices of CDSCO through the online SUGAM portal.
“The revised Export NOC system has streamlined the previous process, eliminating the need for applicants to submit individual applications with purchase orders (POs) for each specific quantity. Instead, a one-time Integrated Registration Form (IRF) is now required, valid for an entire year before the grant of the Export NOC. This eliminates the need for repeated submissions of NOCs for every new order and a significant reduction in paperwork. Once the IRF is approved, the concerned Zonal Office will issue the NOC within seven working days from the date of application. The new system therefore makes the process considerably easier to comply, offering exporters unprecedented flexibility than the previous regime.
Key Highlights:
- Manufacturers holding valid license copy in Form -25, Form-28, and Form 28D can obtain No Objection Certificate (NOC) from Zonal offices of CDSCO.
- The No Objection certificate (NOC) will be granted for Unapproved/Approved New drugs from Zonal offices of CDSCO for export purpose only.
- The No Objection certificate (NOC) will be issued for a period of 1 year from the date of Registration.
- The process involves a one-time registration at the zonal office, followed by consignment release procedures at the port office.
After the issuance of valid Export NOC from the Zonal Office, the manufacturer/applicant needs to submit certain dynamic details in online mode, at the time of release of consignments by the concerned port office. Meanwhile, Un-exported quantities can be used for subsequent export orders within 60% of the residual shelf life. If the shelf life is below 60% the material must be destroyed in the presence of the SLA.
This revised system, as introduced by CDSCO, not only aims to promote “ease of doing business” for pharmaceutical and medical device exporters but also attempts to streamline the application process through the mandatory online submission via the SUGAM portal, enhancing efficiency and transparency. The move towards a digital platform would also lead to an expedited application review and approval process, ultimately fostering a more favourable and less cumbersome regulatory environment for the Indian export industry in this sector. Furthermore, with the issuance of a 1-year NOC, the compliance burden on exporters will be significantly reduced and the longer validity period would offer increased predictability for export planning and logistics.
Written by: Animesh Ankur
Co-authored by: Amiya Mukherjee
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