The Central Drugs Standard Control Organization(CDSCO) vide its notification dated 20th February 2020 has directed all state drug controllers to give bioavailability-bioequivalence (BA/BE) study approvals for export and also approvals for manufacturing, import of new drugs for test and analysis within seven days under the New Drugs and Clinical Trials Rules, 2019.
CDSCO has received concerns on certain aspects of submission and processing of applications for abovesaid approvals. Therefore in order to streamline the process, it has been decided that such application shall be processed by CDCSO(HQ)/ Zonal/Sub-zonal offices within 7 working days of receipt of the application.
Click here to read the Notification.
