CDSCO Updates Export NOC Procedure for New Drugs

Indian regulatory agency, CDSCO has updated the requirements for application and issuance of Export NOC for Unapproved Drugs / Unapproved New Drugs. As per the new procedure published by CDSCO on 7 May 2025, if the drug is approved by National Regulatory Authority (NRA) of the importing country for one firm, this shall be considered applicable for other applicants.

Earlier CDSCO had done away with the system of Quantity specific and Purchase Order (PO) specific NOCs and streamlined the process of grant of Export NOCs to reduce the compliance burden on applicants. On 7 March, 2025 CDSCO had notified guidelines for Export NOC system with provision for issuing Export NOCs with one year validity. Applications are to be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/ and Export NOCs will be processed within seven working days from registration. However, applicants need to submit approval status of the drug as issued by the National Regulatory Authority (NRA) of importing country. This requirement is now revised. Applicant’s still need to submit approval status of the drug in the importing country issued by the NRA of the country. However, if the drug (API or formulation) is registered and approved by the NRA for a specific firm, this approval may be considered applicable for other applicants.

CDSCO has published the new guidance for Issuance of No Objection Certificate (NOC) for manufacture of Unapproved / Approved New drugs for export purpose in the CDSCO portal (Click here) along with applicable document templates.

Related post: CDSCO Notifies New Online Export NOC System