India's Clinical Trial Regulations: History, Recent Changes, Knowledge and Impact

A robust regulatory system in compliance with global regulatory guidelines has been developed over the past decade to attract global stockholders and expand clinical research in India. The Indian history of drug regulation, in particular, goes back to the British colonial era. In 1940, the Drugs and Cosmetic Acts become the Drugs and Cosmetics Rules of 1945 in India. India’s government has developed various ethical and regulatory guidelines over a period under these rules through a regulatory agency known as the Indian Council of Medical Research. Details of these modifications have been described previously. This chapter outlines the history of India's clinical trial regulations, recent changes, knowledge of Indian researchers, and the impact of India's new drugs and clinical trial rules of 2019.