Central Drugs Standard Control Organization (CDSCO) (Medical Devices Division), Directorate General of Health Services vide its notification dated 19th June 2020, issued a clarification regarding import of diagnostic kits/ reagents for Research Use Only(ROU) for academic purposes.
It is clarified by the notification that the products meant for ‘Research Use Only’ shall be used only by academic research institutions and shall not be used for any diagnostic or therapeutic purposes.
However, the applicant needs to submit an undertaking in this regard at the concerned port office of CDSCO stating that the imported products shall be used by the research institution for academic research purpose only and shall not be used for any in-vitro diagnostic/ therapeutic purpose in diagnostic labs/ hospitals. Such products shall be labelled as “for research use only”.
Click here to read the notification.
