Clinical trials are an important but risky process for developing new drugs and medicines. In India, clinical trials are regulated by the Drugs and Cosmetics Act of 1940 and its amendments. However, the regulatory framework is still weak with instances of non-compliance, such as trials being conducted without proper protocols or registration. Several Supreme Court rulings have aimed to strengthen protections for clinical trial participants in India by requiring innovation, safety, and benefit for India to be established before approving trials. Nonetheless, problems persist due to the large financial interests involved and more regulatory reforms are still needed.