Manufacturers with valid Form-25, Form-28, or Form-28D licenses can apply for a No Objection Certificate (NOC) from CDSCO zonal offices to export approved or unapproved new drugs from India. This online application process, guided by the Drugs and Cosmetics Act, 1940, includes registration at zonal offices and port clearance. It excludes NDPS and banned drugs, and the NOC is valid for one year or until the approved quantity is exhausted.
Manufacturers holding a valid license in Form-25, Form-28, or Form-28D, including their respective loan licenses, are eligible to apply for a NOC from the Zonal Offices of CDSCO for the purpose of exporting approved or unapproved new drugs from India.
This requirement follows guidelines issued by the Ministry of Health and Family Welfare under Rule 94 of the Drugs and Cosmetics Act, 1940. The procedure involves two main steps: registration with the zonal office and obtaining clearance at the port of export.
The NOC is issued for one year or until the approved quantity is fully exported, whichever comes first. After the initial approval, applicants must submit reconciliation details in a prescribed format along with necessary documents to obtain port clearance. This process excludes narcotic drugs, psychotropic substances (NDPS), and drugs banned in India, ensuring compliance with regulatory standards for drug export.
Documents required for Step I: Export NOC Form /Integrated Registration form (IRF), Legal Undertaking in Annexure -I /II, Copy of Manufacturing license, Reconciliation Data, NRA approval status of importing country. Documents required for Step 2: Valid Export NOC, Reconciliation details for the Quantity exported in the prescribed format, Test / Batch Release Certificate, Purchase order, Labels & Export License Copy from SLA.