Sama 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 such workshops acquire utmost significance.
The Mumbai workshop was attended by ethics committee members, medical doctors, researchers, students, academics, civil society and health rights activists. The issues that were discussed in the workshop included an 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.
The issue of ethics and regulation was 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.