Compensation conundrum

Pressured by questions tabled in parliament that point to a lack of adequate enforcement of regulations, the DCG(I) has abruptly initiated action to ensure payment of compensation for trial-related injuries. While it is astounding that non-compliance to the existing regulations could have gone unnoticed by quality assurance staff as well as by the ethics committees and the regulator, for over six years, sudden enforcement of the regulation has thrown up issues and challenges that are difficult to resolve in the absence of an adequately debated and thought-through guidance. In implementing regulations for suo moto compensation, India is seeking to establish a practice not previously tested elsewhere in the world. There is no doubt that industry must support the idea of putting patients first, but procedural considerations in fixing causality and determining the quantum of compensation promise to raise questions of morality, ethics, and jurisprudence that will not be easy to answer.