One Drug, Multiple Manufacturing Facilities: CDSCO approves manufacturing of new drug in additional sites

New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has apprised drug makers that they can manufacture a new drug in their additional manufacturing site, on condition that they establish similarity by way of technology transfer with respect to the manufacturing process.

The matter has been examined and it has been decided that if CMC data is generated by a manufacturer in one of its manufacturing facility and based on the data, the approval has been granted to the manufacturer for manufacturing of the new drug in that facility, the same data may be utilized by the same manufacturer for manufacturing of same product in its additional manufacturing sites.

However, this can be carried out with necessary permission or license provided that the manufacturer establishes the similarity by way of technology transfer with respect to a manufacturing process, equipment, process parameters, process capability and bridging validation for technology transfer wherever required etc. between the proposed additional manufacturing sites and the approved manufacturing site.

Also Read: Grant of Manufacturing License for Drugs: DTAB recommends amendment of Drugs and Cosmetics Rules, 1945