ETHICAL CHALLENGES IN CLINICAL TRIALS IN INDIA: EXAMINING INFORMED CONSENT AND EXPLIOTATION RISKS
Keywords:
clinical trial, ethical consideration, informed consent, exploitation risks, CDSCO.Abstract
The recent report from a hospital of Gujarat disclosed illegal trials from almost half a decade, unreported and unethical. This was not the first or unique instance. Indian history is chequered with reported ethical violations and clinical trials. India, after 2005, has become one of the most preferred locations for clinical trials. This raises the issue of the local population's vulnerability to exploitation under the guise of scientific advancements. A persistent concern is that the studies in which they participate may ultimately remain financially out of reach or practically inaccessible to them. Compounding this issue, India's regulatory framework including the ethics committees responsible for overseeing clinical trial conduct and ensuring compliance with international ethical standards, as well as the primary authorities that grant approval for clinical trials has been found inadequate in addressing the ethical challenges that arise. In light of these concerns, this paper examines clinical trials and their regulatory landscape in India. Further, it deals with the ethical concerns connected therewith, the inadequacies in the present laws and conclude the paper with recommendations.
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