CDSCO has clarified the rules on organizations that want to import drugs for use in academic clinical trials. The regulator will waive the need to obtain an import license provided certain conditions are met.
Under the New Drugs and Clinical Trial Rules, 2019, academic clinical trials are defined as studies in which an investigator, academic or research institution explores the use of an existing drug in a new context. Clinical trials of existing drugs in new indications, routes of administration, doses and dosage forms qualify, provided the study is not intended to support a filing for approval.
Trials that meet those criteria benefit from slightly different regulatory requirements, including a relaxing of the rules on seeking import licenses. CDSCO explained this week that a copy of the ethics committee approval, stating the quantity of drug being imported and why, can serve as clearance for importation, freeing sponsors of academic studies from the need to obtain a Form 11 license.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDg1Ng==
