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Warning letters, 483s, Recalls, Import Alerts, Audit observations

The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of Export No Objection Certificates (NOCs) for new, unapproved, and banned drugs will transition from State Licensing Authorities (SLAs) to Central Drugs Standard Control Organization (CDSCO) Zonal Office Heads. This directive marks a departure from the previous delegation of authority to SLAs established in August 2018. Manufacturers seeking to export these categories of drugs must now secure NOCs online through the SUGAM portal. Subsequently, with the acquired NOC, they can apply for a Manufacturing License for export purposes from the respective SLAs.

DCGI Notification on Export NOCs for New Drugs

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