As a part of ongoing effort to raise the standards of the conduct of clinical trials in India, Central Drugs Standard Control Organization (CDSCO) has recently issued a new draft guidance document for the industry that outlines new requirements for obtaining Clinical Trial and New Drug Approvals.
This document is still a DRAFT and has been provided by CDSCO to the pharmaceutical industry for any comments or suggestions which can be provided to CDSCO latest by 24th August 2011. CDSCO will consider all suggestions and issue a final document over the next few months.
Please feel free to download the draft document here:
DOWNLOAD: CDSCO Draft – Approval of Clinical Trials and New Drugs