With the growing research in the field of medicine, the risk of adverse events may also surge. Hence, stringent guidelines should be followed to avoid the loopholes and prevent the drops of adverse events from entering the umbrella of medical research. This article gives a brief regulatory requirement of clinical trials. Physicians shoulder the multiple responsibilities of patient care, administration, teaching, and research; among which, research is enormously rewarding.
In India, the National Regulatory Authority is the Central Drugs Standard Control Organization (CDSCO). It safeguards and improves public health by promising the safety, efficacy and quality of drugs, medical devices and cosmetics. The Drugs Controller General of India (DCGI), a CDSCO official, approves and regulates clinical trials in our country. Drugs and Cosmetics Act has formats for clinical trial protocols,…