The journey of clinical research in India spans centuries, marked by significant milestones and advancements in scientific, ethical, and regulatory domains. From early trials conducted by pioneers like James Lind to modern standards shaped by landmark events such as the Nuremberg Code and the adoption of Good Clinical Practice guidelines, India's progression reflects a commitment to ethical conduct and patient welfare. The Indian Council of Medical Research (ICMR) has played a pivotal role in this evolution, establishing national research centers and ethical committees to oversee biomedical research. Regulatory frameworks, exemplified by Schedule Y of the Drugs and Cosmetics Act, have adapted over time to align with global standards, facilitating India's integration into the international clinical development landscape. Despite challenges and setbacks, including misconceptions surrounding regulatory reforms, India's clinical trial ecosystem continues to evolve, driven by a dedication to ethical research practices and excellence in healthcare.
Keywords: clinical research; ethical guidelines; evolution; india; regulatory framework.
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