India has released a 186-page draft document containing drug clinical trial rules for consultation and publication. The document covers the full range of clinical trial activities, from ethics committee for clinical trial, bioavailability and bioequivalence studies to injury compensation. The draft document is open to objections and suggestions for 45 days.
The draft document defines many key clinical trial terms before detailing the rules that will apply to drug manufacturers and other stakeholders at each step in the process. Also included in the document are forms that companies will need to use to apply for permission to carry out certain activities, such as the manufacture of unapproved active ingredients. Publication of the draft rules is a step in the right direction as India attempts to arrange their approach to clinical trials.
The Central Drugs Standard Control Organisation (CDSCO) India has aimed to reduce the time it takes to approve clinical trials, and make the process more transparent. The draft rules are intended to help address current problems with clinical trials in India, such as the lack of standardisation of research application reviews.
UPDATE 2020: THE CDCSO HAS NOW FINALISED THESE RULES FOR PUBLICATION, WHICH CAN BE ACCESSED HERE.