This document explains the Online procedure, on SUGAM Portal, for manufacturers with valid manufacturing licenses in Form-25, Form-28, Form-28D to obtain a No Objection Certificate (NOC) from CDSCO for exporting unapproved or approved new drugs. It is a Two steps procedure involves One time registration process at zonal office and Procedure for release of consignment at port office. It covers the requirements for Online submission, registration at zonal offices, and the necessary documents, such as the Export NOC Form, legal undertakings, manufacturing license, reconciliation details, and approval status in the importing country. The NOC is valid for one year and must be verified by the relevant zonal office.
This guidance document from CDSCO explains how manufacturers with valid manufacturing licenses in Form-25, Form-28, Form-28D, can obtain a No Objection Certificate (NOC) through SUGAM Portal, for exporting of unapproved or approved new drugs.
Its Two Steps Procedure:
Step 1: The process starts with a one-time registration at the zonal office using the Integrated Registration Form (IRF), which is valid for one year. Applicants need to submit documents, including;
- Export NOC form
- Legal undertakings in Annexure -I (by the Bulk Drug Manufacturer)/ Annexure -II (By the Formulation Manufacturer)
- Copy of Manufacturing License 4. Reconciliation details 5. Approval status in Importing country.
Step 2: Procedure for release of consignment at port office, During this Step, An applicant/Manufacturer is required to submit documents in Online mode and requires submission of the documents at the time of Export: - Valid Export NOC
- Reconciliation details for the Quantity exported in the prescribed Online module.
- Test/ Batch Release Certificate
- Purchase order (PO) /Export Invoice (EI) /Shipping Bill (SB)details(PO/EI/SB)
The NOC, issued within seven working days, ensures compliance with guidelines set by the Ministry of Health and Family Welfare and Rule 94 of the Drugs and Cosmetic Act, 1940. This document standardizes and streamlines the drug exportation process.