CDSCO export NOC guidance brings one-year NOCs and a 60 percent shelf-life rule

What changed

The Central Drugs Standard Control Organization (CDSCO) posted a revised guidance document on NOCs for manufacturing unapproved and approved new drugs for export, dated 17 July 2025 on its public notices page. An earlier version of this system was reported in spring 2025, and Lexplosion describes it as applying from 7 May 2025. The July version is the one on the CDSCO website today.

The guidance sets a two-step process for manufacturers holding licences in Form 25, Form 28 or Form 28-D, including loan licences:

• Step I, registration. The applicant files an online Integrated Registration Form once with the CDSCO zonal office. The NOC may be issued within 7 working days of the application and is valid for 1 year from registration or until the sanctioned quantity is used up, whichever is earlier.
• Step II, release at the port. For each consignment the applicant submits the NOC, reconciliation of quantities exported, the certificate of analysis, purchase order, invoice or shipping bill details, the original label and the state export licence. The port office verifies them.

The key points list 5 working days for Step I and 2 for Step II. Quantity-specific and purchase-order-specific NOCs are discontinued except for NDPS and banned drugs, which still get a NOC for each order or consignment.

The applicant must submit the drug's approval status from the importing country's regulator. Where that is not available, the guidance allows alternatives, such as CDSCO approval for approved new drugs or approval in a listed stringent authority country (United States, EU member states, Canada, Japan, Australia or Switzerland) for unapproved formulations. For unapproved NDPS-category APIs and banned APIs, the importing country's approval is mandatory. For third-country exports, the requirements apply to the end-use country.

Unexported formulation stock can be reused for a later export order only within 60 percent of its residual shelf life, and API stock within 3 months. Below that, it is destroyed in the presence of the State Licensing Authority. The legal undertakings bar an applicant from reapplying for 1 year if it submits falsified documents.

Who it affects

• Indian manufacturers of drugs unapproved in India or approved there as new drugs, made solely for export.
• Hospitals, importers, CROs and NGOs abroad that source such products, including NCE batches for clinical trials, which need IUPAC name details, a certificate of analysis and test procedures.

What it means for buyers

Repeat orders should move faster, because a manufacturer with a valid one-year NOC does not need a new NOC for every purchase order. In return, buyers may be asked for regulatory documents earlier, because the importing country's approval status is part of the registration.

The 60 percent rule means older unexported stock is destroyed rather than offered for a new order. It is not a promise of the shelf life a buyer will receive.

What to do now

1. Share your marketing authorisation, import permit or special-access approval with the manufacturer early, since it may be needed for the NOC.
2. For third-country or re-export arrangements, name the end-use country, because the requirements apply there.
3. For NDPS or banned drugs, plan for a per-order NOC and longer lead times.
4. Agree the minimum shelf life on delivery in the order itself.

See also Indian export rules buyers should know and shelf-life requirements in medicine supply.