File No, ECR/S78/A pollo/Ins/OR/2013/Re-Registration-2016 Government of India Ministry of Health & Family Welfare Directorate General of Health Services Office of Drugs Controller General (India) Central Drugs Standard Controt Organization FDA Bhawan, Kotla Road, New Dethi ~ 110 002, India Dated: 9509 Committee Apollo Hospital, Bhubaneswar First Floor, Quality Office, Apolo Hospitals Bhubaneswar, Plot No. 251, Sainik Sehool Road Unit -15, Samantapuri, Bhubaneswar-751008 India Sub: - Ethics Committee re-registration No. ECR/246/Ius/OR/2013/RR-I6 issued under Rule 122DD of the Drugs & Cosmetics Rules! 945. Sir/Madam, Please refer to your applica Committee. Based on the documents submitted by you, this office hereby re-registers the ETHICS COMMITTEE situated at APOLLO HOSPITAL, BHUBANESWAR, FIRST FLOOR, QUALITY OFFICE, APOLLO HOSPITALS, BHUBANESWAR, PLOT NO, 251, SAINIK SCHOOL ROAD, UNIT -15, SAMANTAPURI, BHUBANESWAR-751005, INDIA with Re-registration Number ECR/246/Ins/OW/2013/RR-16 as per the provisions of Rule 122DD of the Drugs and Cosmetics Rules, 1945 subject to the following conditions: » 4/"" ne, ion submitted to this Directorate for the re-registration of Ethics |. The re-registration shall be in force from 22.04.2016 to 21.04;2019, unless it is sooner suspended or cancelled. 3 i 2. This registration is subject wo the conditions Speci ude ule 122DD and Appendix Vil of Schedle-Y of Drugs and Cosmeties Act, 1940:and Rules 1945, i 4. The Ethics Committee shall review and accord its approval toa clinical trial at appropriate intervals as specified in Schedule Y and the Good Clinical Practice Gujdelines:for Clinical Trials in India and other applicable regulatory requirements for safeguarding the fights, safety qd wellbeing’of the trial subjects. A. In the case of any serious adverse event occurring 16 the elinical trial subjects citing the clinical trial, the Ethies Committee shall analyze and forward its opinion’ as. per procedures specified under APPENDIX XII of Schedule ¥ 5. The Ethies Committee shall allow ingpectors or officials authorized: by the Central Drags Standard Control Organization to enter provide ade premises to inspect any record, data.og any document related to clinical trial and s (0 any query raised by’ such inspgctors'or officials, asthe case may’be, in relation (o the 6. The licensing authority shall be informed in writing in case of any change in the membership or the constitution of the ethies committee takes place. 7. All the records of the ethics committee shall be safely maintained after the completion or termination of the study for not less than five years from the date of completion or termination of the tial (Both in hard and soft apie) aller vivine sus apnensmity te aly catase he uch an pi shuld not heat b wvising seeing the reasnins Hhevefore, suspend or cancel th: registration of the Ethies Commitee Far such pviad gs considered Page 1 of 2File No, ECR/S78/A pollo/Inst/OR/2013/Re-Registration-2016 9. Ethics Commitee shall consist of not less than seven members and is subject to a maximum of 15, One among its members, who is from outside the institute, shall be appointed as chairman, one member as a Member Secretary ancl rest of the members shall be from Medical, Scientific, Non-Medical and Non-sciemtifie fields ieluding lay public. 10. The committee shall include at least one member whose primary aren of interest or specialization is Non scientific and at least one member who is independent ofthe institution besides; there should be appropriate ‘gender representation on the Ethies Committee stitutions or Communities, iPrequired. edule, Good Clinieal Practice rd the tights, safety and well IL, The Ethics committee can have as its members, individuals fiom other hi 12, Members shoutd be conversant with the provisions of clinical tials under this S Guidelines for elinical tials in tndia and other-regulatory requirements to safe being of the trial subjects, : ni of Ethies Committee shall be'at least five members with the following, 13, For review of each protocol the quo representations: - vitologisty |. Basic medical scientist (preeratly one ph HL Clinician : IL Legal expert : IV, Social scientist or representative of non-goyernmental voluntary agency or philosopher or cthicist or theologian oF a Sif person, /) 3s Y. Lay person from conitnity 14 ‘The members representing medial scientist ai einiiany shold have Postgraduate qualiicatfon experience in their respective fieldsand avare Of their role and responsibilities as committee member 15. As far as possible, based on the requigement oF research area suchas HIV, Ger patient group may also be represented in tie-Ethies Committee, ie disorder, etc., spevitie 46, ‘There should be no conflict of interest. The meihbéré shall voluntarily withdraw from the Ethies Committee meeting while making a decision on an application which evokes a conflict of interest which may be indicated in weiting to the Chairman prior to the review and be recorded so in the minutes, All members shall sign a declaration on conflict of interest 17. Subject experts or other experts may be invited to the meetings for their advice. But no such expert shall have voting rights cate is issued to you on the basis of declaration’submission by you that yours isan Institution and re is sought for Institutional Ethies Committee. 18. This ceri registration 19. Funding mechanisins for the Ethies Committee to support their operations should be designed to ensure that the ‘committees and their members have no financial incentive to approve or reject particular studies 20. SOP"s for funding of the Bthics committee in order to support their operations must be maintained, The recotds of income & expenditure of Ethics Committee shall be maintained for review and inspection. 21, ‘The Chairman of Ethics Committee shall enter into MOU with head of institation, that necessary support and facitities and independence will be provided to Ethies Committee and their records will be maintained as lon iil monitoring of clinical til protocols of other investiyator(s) al 22, Ethies Committee may undertake the review ‘and site(s) who do not have their IEC, subject fo the condition that the ether sites are within the loco- regi ‘and community settings similar to that of the registered Ethics committee. The approving ethies committee ‘must be willing (© accept their responsibilities for the study at such trial site(s) and the trial site(s) willing to accept such an arrangement 23, Ethics Committee shall review and approve the suitability of the investigator and wal site for the proposed tial ‘The ethics committee shall undertake proper causality assessment of SAE"s with the help of subject experts where required, for deciding relatediess and compensation, as per condition no (4) mentioned above. (Hn. 8G, Staci some Brags Contratter (1) & Licensing Authority Page 2of2