Sama Resource Group for Women and Health conducted a capacity building workshop on ‘Ethics and Regulation of Clinical Trials in India’ on the 8th and 9th of January (2016) in Mumbai. It was the fourth in a series of such workshops conducted by Sama in the last two years. The main objective of these workshops has been to build capacity of various stakeholders involved in clinical trials in India by foregrounding it in the protection of the rights of clinical trial participants. Given the fact that the field of clinical trial as well as its ethical and legal regulations is still evolving in India, we strongly believe that this kind of workshop acquires utmost significance.
The Mumbai workshop was attended by ethics committee members, medical doctors/researchers/students, academics, civil society and health rights activists etc. The issues that were discussed during the two day Mumbai workshop included the basic introduction to clinical trial, problems of placebo controlled trials and data sharing, various factors such as the TRIPs agreement and amendments in the Drugs and Cosmetic Act and Rules preparing the ground for the phenomenal growth of the clinical trial sector in India, ethical and legal challenges etc. The issues of ethics and regulation remain the primary focus of the two day workshop and various case studies were used to familiarize the participants with different dimensions of ethics and law in the context of recent growth in the clinical trial sector in India.
Sama has been successful in engaging with the policy makers on issues related to biomedical research. The engagement at policy level is important as it allows for meaningful translation of research and advocacy efforts in the area of clinical trials and patient rights into implementable policies and guidelines.
Sama is playing a major role in the revamping of the ICMR Ethical Guidelines on Biomedical Research and is contributing to the section on research on vulnerable populations. Revamping of the guideline is a major policy initiative and is expected to make it more contemporary and equipped to deal with the challenges associated with current biomedical research. The Executive Director of Sama has been invited to be a member of the reconstituted Central Ethics Committee on Human Research of ICMR.
Sama is also working closely with the Ministry of Health and Family Welfare. The Ministry had sought inputs from Sama on the proposed Assisted Reproductive Technology bill and has agreed to co-organise a workshop on vaccines with Sama. The policy level stakeholders have been supportive of the OSF supported research of Sama on the theme of clinical trials and are keen to be part of the dissemination exercise scheduled to happen in April 2016. The ownership and buy in from the Ministry and policy makers will be crucial for taking the research findings to the next level.
