Compensation is a widely debated issue globally in the context of clinical trials and the regulations concerning compensation vary across countries. In India, Compensation in the context of clinical trial related adverse events, ranging from relatively minor harm to major injuries or even disastrous injuries (leading to permanent disability or even death) are some of the issues being raised consistently. In January, 2013, Government devised a formula to determine compensation for serious adverse events of death occurring during the clinical trial and in May, 2014 a set of formulae has been devised to determine compensation for clinical trial related injury (other than death).
Sama has been engaged with issues related to clinical trials and has worked towards a constructive dialogue between various stakeholders to deliberate on various ethics and regulation issues related to clinical trials.
In this context, a two-day national seminar is being organised by Sama Resource Group for Women and Health along with LOCOST Therapeutics, Public Health Foundation of India (PHFI) and Third World Network (TWN). The seminar, scheduled to be held between 14 and 15 July 2014, will be attended by multiple stakeholders such as Principle Investigators, Civil Society Members, Ethics Committee Members, Pharma representatives, CRO representatives, bioethics experts, and academicians. The seminar aims to discuss the mechanisms for compensation including the recent formulae.