The Central Drug Standard Control Organization in its notice dated 18th February, 2020, has issued clarification regarding applicability and the processing of application for grant of permission submittedby manufactures under New Drugs and Clinical Trial Rules, 2019.
Highlights:
The New Drugs & Clinical Trials Rules, 2019 is only applicable for new Drugs and Investigational New Drugs for human use and not applicable for drugs which are not considered as New Drug or Investigational New Drug.
The new drugs are approved based on their composition, dosage form, indication, use, patient population, etc.
No permission from CLA may be required for conduct BA/BE study of such drug, but needs to conducted with due approval of respective ethics committee.
The Application for grant of permission to manufacture new drug or investigational new drug for test and analysis shall be submitted to the zonal officer of cdcso and in case the applicant intends to use the new drug for CT or BA/BE study in human, the same should be done after obtaining prior permission. Further, the Applicant shall clearly mention in their application, the site where the product will be manufactured.
Click here to read the Notification.
