Section 122DD(10) in The Drugs and Cosmetics Rules, 1945
(10)The Ethics Committee whose registration has been suspended or canceled by the Licensing Authority, may, within ninety days of the receipt of the copy of the order, prefer an appeal to the Central Government and the Central Government may after giving an opportunity of being heard, confirm, reverse or modify such order.Explanation.- For the purpose of this rule an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards.];
