The CDSCO vide notification dated June 9, 2020, has clarified that the BA-BE study of New drugs in human subjects for export shall strictly comply with guidelines and procedures laid down irrespective of any difficulty in compliance arising out of the COVID 19 outbreak.
The outbreak of COVID 19 has caused difficulties to completely adhere to the approved protocols and regulatory provisions/procedures of various activities involved in the conduct of studies. Concerns have also been raised by stakeholders regarding the procedures to be followed by the volunteers, subjects, staff during screening, testing, conduct of study and other related activities in the context of COVID-19 situation.
It is reiterated in the notice that the protection of rights, safety and well being of trial subject is of utmost importance. If there arises an unavoidable situation where it is necessary to make amendments in protocol or modifications in the procedures, then the sponsor and BA-BE centre are advised to make assessments regarding the impact and to take decisions in consultation with the investigator and the ethics committee.
Click here to read the Notification.
