New Drug and Clinical Trial Rules 2019: Paradigm Shift in Indian Pharmaceutical Industries

ABSTRACTThe government notified the New Drugs and Clinical Trial Rules on 19th March 2019, to replace Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945. Many new desirable changes have been made and these will help clinical research and trials in India. However, there are discrepancies which offset some of the advantages offered by the new rules. Including timelines for many regulatory functions, is among the main advantages offered, but incorrect use of terms, duplication of rule numbers is likely to complicate the regulatory procedures. The changed classification of Ethics Committees is a welcome feature, but it is unclear why the composition recommended by ICMR is accepted for the EC for Biomedical and Health Research, but not for the one for Clinical Trials, Bioavailability and Bioequivalence Studies. The government would do well to consider the suggestions made herein and amend the New Drugs and Clinical Trial Rules 2019. Keywords: New Drugs, Clinical Trials, Ethics Committee, Compensation, Amendments.