New NOC From CDSCO Zonal Offices Required for Export of Unapproved Or Banned Drugs

The Central Drugs Standard Control Organization (CDSCO) has announced a simplified process for obtaining No Objection Certificates (NOCs) for exporting unapproved, banned, or new drugs. This notice was dated April 30, 2024.

Since August 2018, state licensing authorities handled NOC applications for unapproved, banned, or new drugs.

New Process for Obtaining NOCs

  • Industry can now submit new NOC applications online through CDSCO zonal offices.
  • State/UT licensing authority power to grant NOCs is withdrawn.

This new process is effective from May 15, 2024. Additionally, all NOCs issued by states from August 2018 to May 14th, 2024, need to be transferred to respective CDSCO zonal offices.

Benefits of New Process

  • Streamlined process for manufacturers.
  • Centralized record keeping for better oversight.

Manufacturers shall obtain NOCs from CDSCO zonal offices through the online SUGAM portal (effective May 15th, 2024) before applying for a manufacturing license from state authorities.

Mr. Ranga Chandrashekar Rao, Joint Drugs Controller (India) has been designated as the nodal person at CDSCO headquarters for this activity.