Latest New Drugs and Clinical Trials Rules News & Updates

New Delhi, June 26 (IANS) The Union Ministry of Health and Family Welfare on Friday said it has proposed amendments to the Drugs Rules, 1945 to simplify the procedure for obtaining permission for import of drugs for examination, test or analysis, commonly known as through Form 11.The amendment introduces an acknowledgement-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes.The amendment is expected to significantly reduce the compliance burd…

New Delhi, Jan 28 (IANS) Union Ministry of Health and Family Welfare on Tuesday notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, which will help reduce drug development timelines, as well as strengthen the clinical research and pharmaceutical development ecosystem.The amendments are aimed at simplifying regulatory processes, reducing approval timelines, and promoting ease of doing business.The regulatory reforms will provide substantial benefits to stakeholders wh…