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NoC for Manufacture of unapproved/Banned/New drugs solely for Export Purpose from May 15th, 2024

CDSCO has issued a directive to all state and Union Territory drug controllers concerning the issuance of No Objection Certificates (NOCs) for the manufacturing of unapproved, banned, or new drugs exclusively for export purposes. These NOCs are granted in accordance with the guidance document released by CDSCO on April 30, 2024.

CDSCO has conveyed to industry stakeholders that this decision, sanctioned by the Honorable Health and Family Welfare Minister, aims to streamline processes, allowing the industry to submit fresh applications for NOCs for the manufacture of such drugs for export purposes starting May 15th, 2024. Applications for NOCs will be accepted solely through online channels via CDSCO zonal offices. Manufacturers are mandated to obtain NOCs from the respective Zonal Offices of CDSCO through the online SUGAM Portal before obtaining a Manufacturing License from the State Licensing Authority to produce unapproved, banned, or new drugs intended solely for export. To read more about it, click here.

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