The National Consultation on Regulation of Drug Trials

We would like to announce the release of the report on ‘The National Consultation on Regulation of Drug Trials.’ The Consultation held on 26-27thSeptember, 2011, was an effort towards initiating a dialogue around the existing gaps in policy and its implementation vis-à-vis the regulation of drug trials, towards developing an appropriate framework for future intervention strategies in this regard. The Consultation was organised by Sama –Resource Group for Women and Health, Centre for Studies in Ethics and Rights (CSER); Low Cost Standard Therapeutics (LOCOST), All India People’s Science Network (AIPSN),Drug Action Forum, Karnataka (DAF-K) along with Dr Amar Jesani.

 Recognising the urgent need for furthering transparency in trials, protection of participant rights, and implementation of the highest standards of independent inquiry, this National-level Consultation was attended by nearly 60 participants, who mainly comprised of representatives from health networks, the medical and scientific community, research organisations, media, activists, legal experts, women’s groups and policy makers towards evolving concrete recommendations for policy and regulation on these issues.

 Some of the main themes that were discussed at the Consultation include –

The new division of labour in commercialised research and the CRO industry;

Regulatory standards vis-à-vis the conduct of clinical trials in India;

Pressing dilemmas and Issues with regard to the existing systems of regulation;

Issues of public health vis-à-vis clinical trials;

Role of ethics committees and dilemmas in governance.

The concluding session facilitated a platform for collective strategizing over future interventions towards people-centric clinical research.

The speakers included Amar Jesani, Kaushik Sundar Rajan, Pushpa Bhargava, Brinda Karat, Arun Bhatt, Sandhya Srinivasan, Vasantha Muthuswamy, Sarojini, Anjali, C.M.Gulhati, Deapica, Parsottam Parmar, Rachna, Roli Mathur, Sujith Chandy and many others. The sessions were moderated by Anant Phadke, Amit SenGupta, Vineeta Bal, Satyajit Rath, Chinu Srinivasan, Jacob Puliyel, Samiran Nundy, Nandini Kumar to name a few. Discussions were also held with VM Katoch (DG ICMR), officials from MOHFW and DCGI.

The report in documenting its proceedings closely follows the structure of the Consultation. While presentations have been addressed in verbatim to maintain their authenticity the central concerns and points discussed following the presentations have been highlighted at the end of each session along with the comments from the chairs and discussants.

 If you would like copies, please do write to us at sama.womenshealth@gmail.com .