CDSCO gives clarification on manufacturing of new drug by a manufacturer in their own multiple manufacturing sites

Sep 04, 2019 | by Avantis RegTech Legal Research Team


The Central Drugs Standard Control Organization (CDSCO) on August 30, 2019, issues Circular in order give clarification on manufacturing of new drug by a manufacturer in its own additional site. The manufacturer needs to obtain license or permission from concerned Authority for generation of Chemistry, Manufacturing and Control (CMC) data. It is decided that if CMC data is generated by a manufacturer in one of its manufacturing facility and based on the data the approval or permission has been granted to the manufacturer for manufacturing of the new drug in that facility. The same data may be utilized in its additional manufacturing sites with necessary permission or license provided the manufacturer establishes similarity by way of technology transfer with respect to manufacturing process, equipment, process parameters, process capability and bridging validation for technology transfer wherever required between the proposed additional manufacturing sites and the approved manufacturing site.

[Circular No. F.No. 12-44/2019-DC (PT-Misc)]

 

 


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