21 May 2019 | News
There has a been demand from all over the country seeking clarifications on various issues
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 transformed 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), Translational Health Science & Technology Institute (THSTI), Department of Biotechnology, Government of India organised a half day ‘Interactive meet on New Drugs and Clinical Trials Rules 2019: Its understanding and impact’ 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 and was viewed by institutions in India and abroad.
The Keynote Address was delivered by Dr. S. Eswara Reddy [DCG(I), CDSCO] and Prof. Y. K. Gupta [Principal Adviser (Projects), THSTI, DBT] delivered the talk highlighting the changes and rationale behind.
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 A. K. Pradhan [DDC(I), CDSCO].
Following regulatory changes were highlighted:
Several queries by the attendees were responded succinctly by the regulator and panelists. CDSA, THSTI announced starting of an interactive discussion forum on clinical research related issues in national interest.