Abstract:

India is one of the major destinations for conducting clinical trials. The Drug Controller General of India (DCGI) is the governing body responsible for all pharmaceutical-research and regulatory issues in India. While conducting clinical trials in India, regulations have come to ensure safety and well-being of the study subjects in the trial.

But, it has seen due to unethical Clinical Trials, Subject's rights were compromised and unprotected. This is one of the main reasons for the clinical research amendment and make regulation subject friendly by protecting the right, safety and well-being of the subject participant in the trial. So, the results of clinical studies are more credible, and authenticate.

But, some of regulatory amendments become a challenge for Research Industries and its stakeholders.

Hence, this study identifies following things:

· Reason of Regulatory amendment in India

· Comparative study between previous and amended regulation

· Impact of this Regulatory amendment on Subject’s protection, Research Industry and Stakeholder (includes Sponsors/Investors, Industry, Investigators and Ethic Committee)

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