Last Updated on August 4, 2025 by The Health Master
Export NOC
The Central Drugs Standard Control Organisation (CDSCO) has revised the guidelines related to export NOC (No Objection Certificate) for drug exports.
These revised guidelines aim to simplify the process for manufacturers dealing with both approved and unapproved drugs, particularly fixed-dose combinations (FDCs) and New Chemical Entities (NCEs), for boosting up the pharmaceutical exports.
Why the CDSCO Revised Its Export NOC Guidance
The CDSCO, India’s primary drug regulatory body, initially issued its guidance document for export NOCs in May of this year.
The core objective was to establish a clear, two-step process for obtaining NOCs from its zonal offices for manufacturing unapproved or approved new drugs destined for international markets.
Changes for Unapproved FDCs
One of the most important changes related to unapproved fixed-dose combinations (FDCs) in India.
Previously, obtaining an export NOC for these formulations, as well as unapproved new drug products (NDPs) and banned drugs, strictly mandated approval from the National Regulatory Authority (NRA) of the importing country.
The revised guidance introduces a crucial alternative: manufacturers of finished formulations of FDCs can now submit approval status from a Stringent Regulatory Authority (SRA) country.
This includes major pharmaceutical markets like the United States, European Union Member States, Canada, Japan, Australia, or Switzerland, if NRA approval from the importing country is unavailable.
Previous Requirement: Compulsory approval from NRA of the importing country.
Revised Requirement: Approval from NRA OR SRA country (USA, EU, Canada, Japan, Australia, Switzerland).
The revised guidelines also give greater flexibility to New Chemical Entity (NCE) batches and other research-related activities.
Validity and Timelines for Export NOCs
Validity Period: Each export NOC is valid for one year from the date of registration or until the sanctioned amount is exhausted, whichever comes first.
Timeline: The two-step procedure for NOC issuance has a defined timeline of seven days.
Specific Cases: A quantity-specific and purchase order-specific NOC will be issued for each individual order or consignment for NDPS drugs (Narcotic Drugs and Psychotropic Substances) and banned drugs.
Two-Step Export NOC
Step 1:
- Registration of company at Zonal Office
This initial phase involves an online registration process that requires some key documents:
- One-time online registration of company.
- Submission of the export NOC.
- Legal undertakings from the applicant.
- Copy of the manufacturing license.
- Reconciliation data for previous exports.
- Approval status of the NRA of importing country (or SRA approval for FDCs/NCEs as per new guidelines).
Requirement of several documents for:
- Active Pharmaceutical Ingredients (APIs)
- Finished Formulations
- Research & Development (R&D) and New Chemical Entity Batches
Step 2:
- Consignment Release at Port Office
- The second step focuses on the release of the consignment, primarily through online document submission at the port office.
What is an Export NOC?
An Export NOC is a mandatory approval from the CDSCO required by the Indian manufacturers to export specific drugs, especially unapproved new drugs.
Which countries are considered Stringent Regulatory Authorities (SRAs) by CDSCO?
The CDSCO recognizes the United States, European Union Member States, Canada, Japan, Australia, and Switzerland as Stringent Regulatory Authorities (SRAs). Approvals from these bodies are now accepted as an alternative to NRA approval from the importing country for certain export NOCs.
What is the timeline for obtaining an Export NOC?
The CDSCO has streamlined the process to a two-step procedure with a fixed timeline of seven days for the issuance of a regular Export NOC.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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