Clinical Trials in India: Towards Effective Regulation A Critical Analysis of the Regulatory System in India


  • Unmesha S. Patil, Shruti Das


The methodology adopted for the research is primarily doctrinal, whereby the researcher has examined the domestic laws and regulations as regards Clinical Trials and the various international and national literature available on the topic at hand.


Ensuring effective, affordable and accessible health-care is a continuous effort which assumes special significance in a country like India where one of our greatest assets, on the basis of sheer numbers, is the human resource. Clinical Trials with their twin goals of ascertaining effectiveness and safety of medical interventions are an indivisible part of medical research. However the subjects of the experimentation being humans, there is a unique set of issues involved. Respect for persons, beneficence and justice have been identified as the three core principles for research involving human subjects in the Belmont Report. Ensuring that these are reflected in the practices involved, is a task of the regulatory system revolving around clinical trials. Apart from this crucial task, the regulatory system also needs to ensure that the clinical trials as a tool of research is facilitated and used to the best of advantage for the cause of medicine. Thus it has the task of balancing the ethics of the matter with the practicalities involved. An effective Regulatory set-up, thus becomes a very crucial element to effectively address all the other issues involved in this subject. This paper therefore aims to critically analyze the regulatory system of clinical trials in India.