The New Drugs and Clinical Trial Rules 2019 have been lauded by the regulatory experts. The new regulations have laid the pathway to patient-science-centric human studies bringing in clarity, transparency, time predictability and harmonized it as per the ICH guidelines.
The new rules defined by CDSCO includes timelines for clinical trials of new drugs, increased application fees, hiked compensation for injury or fatality as per defined formula. They are still working on some logistic issues, like IT and bandwidth.
But, they assured the stakeholders that the new rules have achieved the objective of legal clarity, rationality and harmonization with the world.
One of the major changes in new rules is that Schedule Y has been replaced by new CT Rules 2019 for humans, but it is still for veterinary drugs and medical devices.
The definitions of new drug, New Chemical Entity and biomedical research are now clearer. Three types of Ethics Committee (EC) have been defined as well for institutional, independent and biomedical research. EC needs to be registered with DCGI.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like