Clinical trials in India are governed by rules defined in Schedule Y of the Drug and Cosmetics Rules, 1945. During the revision of Drugs and Cosmetics Rules, 2005, the Schedule Y was comprehensively amended to take the Indian regulations on par with globally acknowledged definitions and measures.
DOWNLOAD Schedule Y HERE Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945. The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is […]