The “New Drugs and Clinical Trials Rules 2019” was released on March 19, 2019 by CDSCO, Ministry of Health & Family Welfare, Government of India. This regulation is a turning point for drug innovation and promoting ethical clinical research in India. It is of utmost importance that all stakeholders (pharmaceutical industry, national scientific laboratories, contract research organisations, scientists and academicians, innovators and start-ups) including international partners are fully aware of the changed regulatory landscape in India. There has a been demand from all over the country seeking clarifications on various issues. Realising this, Clinical Development Services Agency (CDSA) organised a half day ‘Interactive meet on New Drugs and Clinical Trials Rules 2019: Its understanding and impact’ on May 17, 2019 at THSTI, NCR Biotech Science Cluster in collaboration with Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare.
Over 535 participants from more than 180 institutions participated in this interactive meet. The interactive session was live streamed, which was viewed by institutions in India and abroad.
The Keynote Address was delivered by Dr. S. Eswara Reddy [DCG(I), CDSCO]. Prof. Y. K. Gupta [Principal Adviser (Projects), THSTI, DBT] delivered the talk highlighting the changes and rationale behind the meeting. The panel discussion was addressed by Prof. Gagandeep Kang [Executive Director, THSTI], Prof. Shinjini Bhatnagar [Dean, Clinical Research, THSTI], Prof. Usha Menon [Strategy Lead, CDSA, THSTI], Prof. Y. K. Gupta and Shri. A. K. Pradhan [DDC(I), CDSCO].
Several queries by the attendees were responded succintly by the regulator and panellists. CDSA, THSTI announced starting of an interactive discussion forum on clinical research related issues in national interest. Future interactive sessions will be announced in the websites.
Recording of this session and several such activities/courses can be accessed at http://thsti.res.in/cdsa/archive-training/