Section 122DD in The Drugs and Cosmetics Rules, 1945
122DD. [ Registration of Ethics Committee. [Inserted by Notification No. G.S.R. 72 (E) dated 8.2.2013 (w.e.f. 21.12.1945)]
(1)No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of rule 21:Provided that any Ethics Committee, existing on the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty-five days from the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013.(2)An application for registration of Ethics Committee shall be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule Y.(3)The Licensing Authority after being satisfied that the requirements have been complied with, may grant registration to the Ethics Committee subject to such conditions as may be stated therein.(4)The Ethics Committee shall review and accord its approval to a clinical trial and also carry ongoing review of the trial at appropriate intervals, as specified in Schedule Y, and the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding the rights, safety and well-being of the trial subjects.(5)In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedures specified under APPENDIX XII of Schedule Y.(6)The Ethics Committee shall allow inspectors or officials authorized by the Central Drugs Standard Control Organisation to enter its premises to inspect any record, data or any document related to clinical trial and provide adequate replies to any query raised by such inspectors or officials, as the case may be, in relation to the conduct of clinical trial.(7)The registration, unless it is suspended or canceled, shall be valid for a period of three years from the date of issue:Provided that if the application for re-registration is received by the Licensing Authority within three months before the expiry, the registration shall continue to be in force until orders are passed by the said authority:Provided further that the Licensing Authority shall be informed in writing in case of any change in the membership or the constitution of the Ethics Committee takes place.(8)If the Licensing Authority is not satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and the conditions which must be satisfied before the registration can be granted.(9)If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.(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.];
