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january 4

5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensur ...

january 4

INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed cons ...

january 4

7.4 Biological safety: (i) The dossier should contain a list of all materials of anim ...

january 4

the required audit of such manufacturing site by the registered Notified Body in the ...

january 4

Performance evaluation report from a laboratory designated under subrule (1) of rule ...

january 4

1.1 Introductory descriptive information on the in vitro diagnostic medical device, t ...

january 4

2.0 Device description and product specification, including variants and accessories ...

As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945.