Regulation/Guidelines

Third Amendment in Drugs & Cosmetics Rules, 2013

  • 10th July, 2013

In the Drugs and Cosmetics rules 1945, after rule 122DC, the following rule shall be inserted, namely:-

122 DD. Registration of Ethics Committee-(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 45 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 an 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 trial 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 authorised 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 any record, data or any other document related to clinical trial and 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 cancelled 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 3 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 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 90 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 non- scientific 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 approval 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 and adequacy of confidentiality safeguards.

3. In the said rules, in Schedule Y in Appendix VIII relating to the Ethics Committee –

(A) for paragraph 1, the following paragraph shall be substituted, namely:-

      “l.    Requirements and guidelines for registration of Ethics 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 case of any serious adverse event occurring to the clinical trial subjects during clinical trial, the Ethics Committee shall analyze 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 1 member whose primary area of interest or specialization is Non-scientific and at least 1 member who is independent of the institution. Besides, there should be appropriate gender presentation on the Ethics committee.

c) The Ethics committee can have as its members, individuals from other institution 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 ethics 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 to the review and be recorded so in the minutes. All 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 registration, replacement or removal of members.

d) Address of the office of the Ethics Committee

e) Name, address, qualification, organizational title, telephone number, fax number, e-mail, mailing address and brief profile of the chairman.

f) Name, qualification, organizational title, telephone number, fax number, e-mail, mailing address of the members of the Ethics Committee. The information shall also include member’s specialty (primary, scientific or non- scientific) member’s affiliation with institutions and patient group representation, if any.

g) Details of the supporting staff.

h) In the case of Ethics Committee existing before 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 if 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

l) Policy to monitor or prevent the conflict of interest along with standard operating procedures.

m) If the committee has been audited or inspected before, give details.

4. Maintenance of Record:

All documentation and communication of an Ethics committee are to be dated, filed and preserved according to the standard operating procedures. Strict confidentiality shall be maintained during access and retrieval procedures. Record 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 brochure, 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 safety maintained after the completion or termination of the study for not less than 5 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 regulation for safeguarding the rights, safety and well-being of the trial subjects”;

(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.