The Indian Society for Clinical Research (ISCR) has lauded the Supreme Court order directing the clinical trial companies to re-examine the 152 human studies.
The Court considered 162 cases for which approval has been given by the DCG(I) since the New Drug Advisory Committees were formed in 2011. The court expressed satisfaction with the process of approvals that were set in place for the trials approved since January 2013 and has asked that all trials approved before December 2012 should also have similar clearances to ensure the safety of patients in a clinical trial and minimize serious adverse events, according to ISCR.
“This is an encouraging development and we are glad that the Court and the regulatory bodies are taking measures to ensure the implementation of a robust regulatory framework. As a professional organisation representing clinical research professionals across the stakeholder spectrum, ISCR is fully supportive of the need for a more transparent and regulated environment for the conduct of clinical trials in India which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected,” said the ISCR Spokesperson.
The Society noted that the value and role of clinical research in ensuring better and more effective treatment for several thousands of patients in India is often overlooked. It is only through clinical research that we have found and will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world. If we have to find better and more cost effective cures for these diseases in a population that is multi-racial and heterogeneous, it is necessary to conduct clinical research in India.
Shekhar Gupta, COO, D2L Pharma Research Solutions, Bangalore said, “The recent ruling by the apex court will set a paradigm for the clinical research industry. The new moves will ensure a conducive environment for conducting trials with safeguarding the patients’ interest and also promoting research to address the unmet medical needs of the country. The final assessments and outcomes on the temporary ban on the 162 drug trials, will set up the road ahead for the industry and we hope that India becomes a global centre of excellence for research and development.”