Drug Export NOC from CDSCO
If you manufacture a drug only for export and it is not approved for sale in India, or it is a new drug or a banned drug, you need a No Objection Certificate (NOC) from a CDSCO zonal office before you make it. Since 15 May 2024 these NOCs come from CDSCO, not the State Drugs Controller, and since 7 March 2025 one NOC covers a full year. We prepare the application and file it on the SUGAM portal.
What it is
A drug export NOC is permission from the Central Drugs Standard Control Organisation (CDSCO) to manufacture a drug purely for export when that drug cannot be sold in India. It covers unapproved new drugs, approved new drugs being made for a foreign buyer, and drugs that are banned for the Indian market. Your manufacturing licence lets you make medicines. The NOC tells the regulator that this product, from this site, is meant only for a foreign market.
Until 2024 your State Licensing Authority issued these NOCs. CDSCO then withdrew that delegation, and from 15 May 2024 the CDSCO zonal offices issue them online through the SUGAM portal. CDSCO’s notice of 7 March 2025 then changed the format: instead of one NOC per purchase order, you now file a one-time Integrated Registration Form (IRF) and get an NOC valid for one year. Narcotic and psychotropic (NDPS) drugs are the exception and still need order-wise, quantity-wise NOCs.
Picture a Faridabad formulation unit that gets an order from an African distributor for a fixed-dose combination India has banned, but which is registered in the buyer’s country. The plant, the licence and the staff are all in place. What’s missing is the NOC, and without it the first batch can’t start.
Who it applies to
Licensed formulation and API makers
Manufacturers holding a valid licence in Form 25, Form 28 or Form 28-D who want to make an unapproved or new drug for an overseas buyer. If you don’t yet hold a licence, see our drug licence registration service first.
Exporters of banned formulations
Some fixed-dose combinations and molecules are prohibited for sale in India but still registered abroad. Making them for export needs the NOC before production starts.
Contract and loan-licence units
Say a Gurugram merchant exporter places export batches with a third-party plant in Haryana. The NOC sits with the manufacturing site, so the plant’s licence holder applies, and the exporter supplies the buyer-side documents.
Why it matters
Makes the batch lawful
A drug not approved in India can’t be made on your domestic licence alone. The NOC is what makes that production lawful.
Clears the shipment at the port
At the port, the CDSCO port office checks the NOC, the reconciliation and the batch test certificate before releasing the consignment.
Covers a year in one filing
Under the 2025 system you don’t chase a fresh NOC for every order. In practice, a clean IRF gives you a year of planned exports under one approval.
Documents required
For the IRF (registration)
- Export NOC application form, filled for each product
- Legal undertaking from the manufacturer
- Copy of your manufacturing licence (Form 25, 28 or 28-D)
- Reconciliation of earlier export quantities
- Status of the product’s approval in the importing country
For release at the port
- The valid export NOC
- Reconciliation details for the consignment
- Test report or batch release certificate
- Purchase order, export invoice and shipping bill details
Company basics
- SUGAM portal login of the licence holder
- Importer Exporter Code (IEC)
- Authorised signatory details and authorisation letter
- Product composition, strength and dosage form
How it works
Sort each product into its category
We confirm whether your product is an unapproved new drug, an approved new drug, a banned drug or an NDPS drug. The category decides the route and the paperwork.
Prepare the Integrated Registration Form
We draft the IRF, the undertakings and the reconciliation, and check them against your licence and the importing country’s documents.
File on SUGAM and follow up
We file on the SUGAM portal to the CDSCO zonal office for your site and answer any query raised. The zonal office is expected to verify the IRF and issue the NOC within seven working days.
Ship each consignment and keep the count
For each consignment we help you put together the port-release file and keep the quantity reconciliation up to date for the year.
Timelines
Seven working days
CDSCO’s 7 March 2025 notice asks zonal offices to verify the IRF and issue the NOC within seven working days of a complete application.
One year of validity
The NOC is valid for one year from the date of registration. Here is the catch: once it lapses, export production on that product must pause. So plan the renewal a few weeks ahead.
Unexported stock
Made too much? Stock not yet shipped can go in a later order if over 60% of its shelf life remains. Otherwise it must be destroyed under the State Licensing Authority’s supervision.
What happens if you skip the NOC
Unlawful manufacture
Making an unapproved or banned drug without the NOC is manufacture in breach of the Drugs and Cosmetics Act, 1940, and can put your manufacturing licence itself at risk.
Consignment held at port
Without a valid NOC and matching reconciliation, the port office will not release the shipment. Your buyer’s delivery date slips, and letters of credit often carry a last shipment date that won’t wait.
Stock you must destroy
Export-only stock can’t be sold in India. If it can’t be shipped in time, it ends up destroyed under supervision, which is a direct loss.
Frequently asked questions
Who issues the drug export NOC now?
The CDSCO zonal office for your manufacturing site issues it. From 15 May 2024 CDSCO took back the power it had delegated to State and UT Licensing Authorities, so applications go online through the SUGAM portal to the zonal office. Your State Drugs Controller still holds your manufacturing licence and supervises destruction of unexported stock, but the export NOC itself is a CDSCO approval. We file and follow up with the zonal office for you.
Which drugs need an export NOC?
Unapproved new drugs, approved new drugs and drugs banned for sale in India need an NOC when made only for export. A drug already approved and sold in India does not, because your normal licence covers it. Narcotic and psychotropic drugs follow their own order-wise route. We check your product list against these categories before filing, so you only apply where the rules require it.
How long is the export NOC valid?
The NOC is valid for one year from the date of registration. This is the change CDSCO brought in through its notice of 7 March 2025. Earlier, exporters often needed a fresh NOC for each purchase order. Now one Integrated Registration Form covers your planned exports for the year, subject to the NOC’s conditions. We track the expiry date and start the renewal early, so you are not left without cover.
How long does CDSCO take to issue it?
The zonal office is required to verify the IRF and issue the NOC within seven working days. The clock runs only on a complete file. A missing undertaking or a reconciliation that doesn’t match your licence brings a query and restarts the wait. We check every document against your licence before filing, to keep the approval inside that window.
What is the Integrated Registration Form (IRF)?
The IRF is a one-time registration on the SUGAM portal that replaces order-by-order NOC applications. It carries the export NOC form, the manufacturer’s legal undertaking, the licence copy, reconciliation of earlier exports and the product’s approval status in the importing country. Once the zonal office verifies it, you get a one-year NOC. We prepare the IRF so it covers every product and market you plan to ship to.
Do I need a separate NOC for narcotic or psychotropic drugs?
Yes. NDPS drugs were kept out of the one-year system. They still need an NOC that is specific to the purchase order and the quantity, under the existing guidelines. The Narcotics Commissioner’s export authorisation is a separate requirement on top of this. If your range includes NDPS products, we plan the two tracks together so one approval doesn’t hold up the other.
What happens to stock that isn’t exported within the year?
It can go in a later export order if more than 60% of its shelf life remains. If less remains, the stock must be destroyed under the supervision of the State Licensing Authority. That rule makes production planning important: make what the order needs, not extra. We keep a running reconciliation for you so you always know how much export-only stock is on hand.
What else do I need to ship the goods?
You need an Importer Exporter Code from DGFT, and to export without paying IGST you file a Letter of Undertaking on the GST portal for each financial year. Many pharma exporters also take Pharmexcil membership for an RCMC. None of these replace the CDSCO NOC; they sit beside it. We can handle the IEC registration and the LUT filing in the same engagement, so your export file is complete in one go.
Do you test the product or inspect my plant?
No. Testing is done by your own quality control lab or an approved testing laboratory, and inspections are carried out by the regulator. Our role is the application, the documents, the SUGAM filing, the follow-up with the zonal office and the ongoing reconciliation. We work alongside your QA and regulatory team, so the technical data you already have reaches CDSCO in the right format.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Ready to begin?
Send us your product list and export plan, and we will tell you which items need an NOC and file the IRF on SUGAM.