The Central Drugs Standard Control Organisation (CDSCO) is facilitating the export of unapproved and approved new drugs from India.
A manufacturer with a valid license can obtain a No Objection Certificate (NOC) from CDSCO zonal offices for this purpose.
The application for the NOC involves a two-step online process: registration at the zonal office, followed by clearance for consignments at the port office.
This procedure applies to unapproved and approved new drugs, excluding narcotic drugs, psychotropic substances, and banned drugs.
Applicants must first apply to the zonal office with the required documents for a one-year validity Export NOC.
The required documents include:
- An automatically generated Export NOC Form/Integrated Registration Form (IRF).
- A digitally signed legal undertaking.
- A copy of the manufacturing license.
- Reconciliation data of previously issued NOCs.
- NRA approval status of the importing country.
If NRA approval is unavailable, alternative documents related to the Active Pharmaceutical Ingredient (API) and Finished Formulation (FF) may be submitted, depending on the drug’s approval status in India and other countries.
For Research & Development (R&D) and New Chemical Entity (NCE) batches, specific documentation requirements also apply.
After obtaining a valid Export NOC, applicants must submit further details at the port office for consignment release.
This includes:
- Selecting the Export NOC through the auto-fetch system.
- Submitting reconciliation details for the exported quantity.
- Uploading a Certificate of Analysis (COA).
- Providing Purchase Order (PO), Export Invoice (EI), and Shipping Bill (SB) details.
- Submitting the original product label.
- Providing an export license copy.
Key changes to the process include discontinuing quantity-specific/PO-specific NOCs (except for NDPS and banned drugs) and issuing Export NOCs with a one-year validity.
Conditions are outlined for using unexported quantities of formulations and APIs for subsequent export orders, with provisions for the destruction of stocks with limited shelf life.
The CDSCO aims to issue NOCs within 7 days (5 working days for Step I and 2 working days for Step II).
