CDSCO issues Guidance on import of vaccine by private sector.

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The Central Drugs Standard Control Organization on 4th May 2021 has issued procedures for import COVID vaccine by private entity or Government sector entity.

The importer / authorized agent of the manufacturer of the vaccine shall obtain the New Drug Permission under the New Drugs and Clinical Trials Rules, 2019 and Import registration/license from CDSCO, if the vaccine is not yet approved/ licensed in India.

              Once the license is obtained, the importer/ authorized agent can import the vaccine  and if the vaccine to be imported is already approved and import licence has been obtained from CDSCO, then any entity including private sector entity can procure the vaccine from the importer / licensee for its use as per the National Guidelines.

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