CDSCO Issues clarification on manufacturing of new drug in multiple manufacturing sites


The Central Drugs Standard Control Organization (CDSCO) through its circular dated 30th August 2019 has issued a clarification on manufacturing of new drug by a manufacturer in its own additional site.

Every manufacturer has to obtain license or permission from the concerned authority for generation of Chemistry, Manufacturing and Control (CMC) data.

It has been decided that if the manufacturer generates CMC data for one of its manufacturing facility and based on the data the approval/ permission would be granted to the manufacturer for manufacturing of the new drug in that facility and 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.

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