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^raR ^rfttrr 5Ri -^cjiPi* i r t a HCIMH g> a ^ k n <£ fci^ wr f̂ EjR" 3 ^ afhr ?w [ m U 133^-11014/8/2011-^1^*^] 3T?^I %. 1cTn3T, tf*pKJ Tlf^f • q ^ faWtlT : T£rT t W T W T * , 3?fa^RT tf. T£P 2 8 - 1 0 / 4 5 - ^ (1 ) efffasf 21 f^SWT, 1945 SRT WfclcT ftn^ «f 3^k 3Tf^T ̂ mt^R 3lf* l^RT U m^T.fT. 63(3T) TTTCte 1 TR^tt, 2013 ' I «•*"»!• '»»» ' f f X ' v i i W ' '""TBH"'' T i »pi ' -""imiit l . MUH^wuiiauaBii i.ii.ax. • [qFIiI_7§TT5 3(i)] *?TOT ^ T < N M ^ : an*fl*IR«l 7 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION New Delhi, the 8th February, 2013 G.S.R. 72(E).— Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published, as required by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India, Ministry of Health and Family Welfare (Department of Health), number G.S.R.573(E), dated the 17thJuly, 2012, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 17mJuly, 2012, inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a period of forty five days from the date on which the copies of the Official Gazette of the said notification is published were made available to the public;
And whereas copies of the Gazette were made available to the public on the 23rd July. 2012;
And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government;
Now therefore, in exercise of the powers conferred by sections 12 and 33 of the Dmgs and Cosmetics Act, 1940 (23 of 1940), the Central Governmer* alter consultation with the Drugs Technical A J ^ ^ ^ e ^ m a k ^ following rules further to amend the Drugs and Cosmetics Rules, 1945, namely.
1. (1) These rules may be called the Drugs and Cosmetics (Third Amendment) Rules, 2013.
(2) They shall come into force on the date of their publication in the Official Gazette.
THE GAZETTE OF INDIA ; EXTRAORD[NARY [PART I I^SEC
2.
ScSle Y ' ^ PSr P r 0 C e d U r e S S p e d f i e d U"d e r APPENDIX x"of Z S e a d e o X ^ ? a " y d ° C U m e n ' r e l a , e d t 0 d i " i c a l trial and PPMSSJ: S str~—•sha"be - * i ; , Pr0^idfL cl t h a t i f t h e aPP'ication for re-registration is received hv th« * ' l * | *MIIM . liiaildlllHBIIidiMHi
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 ) J f ^ . ' cens ing 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 cancelled 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.';
3. In the said rules, in Schedule Y, in Appendix Vill relating to Ethics Committee,- (A) for paragraph 1, the following paragraph shall be substituted, namely:- Requirements and guidelines for registration of Ethics "I.
Committee
1. Scope:
Ethics Committee shall review every clinical trial proposal and evaluate the possible risks to the subjects, expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee 5-33 ^x/iZ-2 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] shall analyse and forward its opinion as per procedures specified in APPENDIX XII of Schedule Y.
2. Composition of Ethics Committee:
(a) Ethics Committee shall consist of not less than seven members and one among its members, who is from outside the institute, shall be appointed as Chairman; one member as a Member Secretary and rest of the members shall be from Medical, Scientific, Non-medical and Non-scientific fields including lay public.
(b) The committee shall include at least one member whose primary area of interest or specialization is Non-scientific and at least one member who is independent of the institution.
Besides, there should be appropriate gender representation on the Ethids Committee.
(c) The Ethics Committee can have as its members, individuals from other Institutions or Communities, if required.
(d) Members should be conversant with the provisions of clinical trials under this Schedule, Good Clinical Practice Guidelines for clinical trials in India and other regulatory requirements to safeguard the rights, safety and well-being of the trial subjects.
(e) For review of each protocol the quorum of Ethics Committee shall be at least five members with the following representations:
(i) basic medical scientist (preferably one pharmacologist);
(ii) clinician;
(iii) legal expert;
(iv)social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian or a similar person;
(v) lay person from community.
<f) The members representing medical scientists and clinicians should have Post graduate qualification and adequate experience in their respective fields and aware of their role and responsibilities as committee members.
(g) As far as possible, based on the requirement of research area such as HIV, Genetic disorder, etc., specific patient group may also be represented in the Ethics Committee.
(h) There should be no conflict of interest. The members shall voluntarily withdraw from the Ethics Committee meeting while making a decision on an application which evokes a conflict of interest which may be indicated in writing to the Chairman prior [qFTII—W^3(i)] •RRCT ̂ i mm : zmWH 11 to the review and be recorded so in the minutes. Ail members shall sign a declaration on conflict of interest.
(i) Subject experts or other experts may be invited to the meetings for their advice. But no such expert shall have voting rights.
3. Information required to be submitted by the applicant for registration of Ethics Committee:
(a) Name of the Ethics Committee
(b) Authority under which the Ethics Committee has been constituted, membership requirements, the term of reference, conditions of appointment and the quorum required.
(c) The procedure for resignation, replacement or removal of members.
(d) Address of the office of the Ethics Committee.
(e) Name, address, qualification, organisational title, telephone number, fax number, e-mait, mailing address and brief profile of the Chairman.
(f) Names, qualifications, organisational title, telephone number, fax number, e-mail and mailing address of the members of the Ethics Committee. The information shall also include member's specialty (primary, scientific or nonscientific), member's affiliation with institutions and patient group representation, if any.
(g) Details of the supporting staff.
(h) In the case of Ethics Committees existing before the publication of the Drugs and Cosmetics (Third Amendment) Rules, 2013,-
(i) type of clinical research reviewed by the committee (e.g.
pharmaceuticals, devices, epidemiological, retrospective, herbals, etc.).
(ii) documents reviewed for every clinical trial protocol including Informed Consent documents.
(iii) information in respect of number of meetings of the committee and documentation of the minutes of meetings of these committees concerning clinical trials.
(iv) information regarding review of serious adverse events reported during the conduct of the trial.
(i) The standard operating procedures to be followed by the committee in general.
(j) standard operating procedures to be followed by the committee for vulnerable population.
(k) Policy regarding training for new and existing committee members along with standard operating procedures.
£33 GTfe-t{ 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART n__S E C 3 ( j ) ] 0) Policy to monitor or prevent the conflict of interest alonq with standard operating procedures.
(m) If the committee has been audited or inspected before give details. ' a
4. Maintenance of Record:
All documentation and communication of an Ethics Committee are to oe dated, filed and preserved according to the standard operatinq procedures. Strict confidentiality shall be maintained during access and retrieval procedures. Records should be maintained for the following, namely:-
(a)The constitution and composition of the Ethics Committee;
(b) The curriculum vitae of all the committee members-
(c) Standard operating procedures followed by the committee;
(d) National and international guidelines;
(e) Copies of the protocol, data collection formats, Case Report Forms, Investigator's brochures, etc., submitted for review;
(f) All correspondence with committee members and Investigators regarding application, decision and follow up;
(g) Agenda of all Ethics Committee meetings;
(h) Minutes of all Ethics Committee meetings with signature of the Chairman;
(i) Copies of decisions communicated to the applicants
(j) Record of all notification issued for premature termination of a study with a summary of the reasons;
(k) Final report of the study including microfilms, compact disks or Video-recordings.
All records 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 trial (Both in hard and soft copies).
5 The Ethics Committee shall be open to inspection by the officers authorised by the Central Drugs Standard Control Organisation who may include an officer of the State Drug Control Authority concerned to verify compliance to the requirements of Schedule Y, Good Clinical Practices guidelines and other applicable regulationfor safeguarding the rights, safety and well-being of the trial subjects "• [W\ II—WZ 3(i)] ÎTCW ^RTIFSR^ : aramTFI 13 (B) for the figure and words "2. Format for Approval of Ethics Committee", the figure and words "III. Format for According Approval to clinical trial protocol by the Ethics Committee." shall be substituted.
[F. No. X-11014/8/2011-DFQC] ARUN K. PANDA, Jt.Secy.
Foot Note j— The principal rules were pubHshed in the Official Gazette vide notification No. F.28-10/45-H (1), dated 21st December 1945 and last amended vide notification number G.S.R. 63(E), dated the 1st February, 2013.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.