The Central Drugs Standard Control Organisation (“CDSCO”) has issued the following Notifications to give information regarding processing of certain applications under the New Drugs and Clinical Trial Rules, 2019 (“Rules”):
Notification dated 20th February 2020:
This Notification states that the applications for grant of permission in CT-11 / CT-14 / CT-15 / CT-17 for manufacturing or import of new drugs for test and analysis, clinical trial or BA / BE study, shall be processed by CDSCO within 7 working days of receipt of the applications.
Notification dated 21st February 2020:
This Notification states that the applications for permission to conduct BA / BE study of New Drugs for export purpose in Form CT- 07 and for Import Licence for import of study drug in Form CT-17, shall be processed by CDSCO within 15 working days of the receipt of application.
Source : Central Drugs Standard Control Organisation
