Sama along with Low Cost Standard Therapeutics (LOCOST), Centre for Studies in Ethics and Rights (CSER), Drug Action Forum – Karnataka (DAF-K), All India People’s Science Network (AIPSN) and Dr. Amar Jesani organised a national level Consultation on the “Regulation of Drug Trials” during September 26-27, 2011.
The Consultation planned across two days, provided for a series of discussions on cross-cutting themes related to the conduct of drug trials in India including: ethical challenges in biomedical research; ethical responsibilities of researchers; rights of participants, particularly those from marginalized and vulnerable communities; intersections of clinical trials and public health, global and national contexts, business and commerce, etc; legal instruments that can strengthen regulatory mechanisms and manage conflicts of interest, and; ensuring greater transparency, accountability and public knowledge and vigilance.
This Consultation attended by over 50 people facilitated a platform to promote dialogue and deliberation between a range of stakeholders, particularly, civil society, and the medical community and policy makers, towards evolving concrete recommendations for policy on these issues. Dr. L. C. Goyal, Additional Secretary and Director General, CGHS, MoHFW, Mr. A. K. Pradhan, Deputy Drug Controller, CDSCO and Dr. V. M. Katoch, Director General, ICMR also attended specific sessions and provided their inputs. The consultation resulted in a set of specific recommendations regarding the ethics and governance of clinical trials.