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Compliance Requirement under the Rules

1. Requirement of the Ethics Committee (Rule 6)

Whoever intending to conduct a clinical trial, bioavailability study, or bioequivalence study must obtain approval from an Ethics Committee, which must be registered with the Central Licensing Authority under Rule 8.

2. Constitution of Ethics Committee for clinical trial (Rule 7)

The Ethics Committee must have at least 7 members from medical, non-medical, scientific, and non-scientific fields, including:

(i) 1 lay person

(ii) 1 woman

(iii) 1 legal expert

(iv) 1 independent member from a related field (e.g., social scientist, NGO representative, ethicist, or theologian)

Ethics Committee Requirements & Procedures:-

1. 1. Members shall comply with applicable rules, Good Clinical Practice (GCP) guidelines, & regulations to protect trial subjects.
   2. Every member of the Ethics Committee shall be required to undergo such training & development programmes as may be specified by the Central Licencing Authority from time to time. If failure to do so leads to disqualified to hold the post of Ethics Committee.
   3. Medical & clinical members must hold a postgraduate degree, have relevant experience, & understand their roles.
   4. Committee may include representatives from specific patient groups (e.g., HIV, genetic disorders) as needed.
   5. Members with a conflict of interest shall not oversee clinical trial / bioequivalence protocol, & must sign a declaration confirming no conflict.
   6. Members with conflict of interest may voluntarily withdraw from meeting, with written notice to the Chairperson.
   7. All conflicts of interest must be documented in the meeting minutes.

        3.  Form CT-02: Registration of Ethics Committee for Clinical Trial or BA/BE Study (Rule 8 (1),(2),(3),(3A),11)

(1) Every Ethics Committee, constituted under rule 7, shall make an application for grant of registration to the Central Licencing Authority in Form CT-01.

(2) The Ethics Committee shall furnish such information and documents as specified in Table 1 of the Third Schedule of New Drugs and Clinical Trials Rules, 2019 along with the application made in Form CT-01.

(3) CLA shall grant registration or reject application within 45 working days. If no response is received, registration is deemed granted, allowing clinical trials to begin.

(4) Applicant receiving deemed approval shall inform CLA in Form CT-02A

(5) Functions of Ethics Committee shall be as per Rule 11 of New Drugs and Clinical Trials Rules 2019

4. Form CT-02A: Information To Initiate Functioning of Ethics Committee for Clinical Trial/Bioavailability, Bioequiv. study (Rule 8 (3A), (4), (5))

The applicant who has got deemed approval under the proviso to clause (ii) of sub-rule (3) shall, before initiating the functions of the Ethics Committee, inform the Central Licensing Authority in Form CT-02A and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-02A which shall become part of the official record and shall be called deemed registration of the Central Licensing Authority.

An applicant Ethics Committee aggrieved by the decision of rejection of the application by the Central Licencing Authority, may file an appeal before the Central Government in the Ministry of Health and Family Welfare within 60 working days from the date of the receipt of order of such rejection.

The Central Government may, after such enquiry, as considered necessary & after giving an opportunity of being heard to the appellant referred to in sub-rule (4), shall dispose of the appeal filed under that sub-rule within a period of 60 working days from the date on which the appeal has been filed.

5. Proceedings of Ethics Committee for clinical trial (Rule 12)

Ethics Committee requires at least 5 members to review a protocol: a medical scientist, clinician, legal expert, social scientist, & lay person. It may form sub-committees & include non-voting external experts. Any membership change must be reported to the Central Licensing Authority within 30 days.

(1) No clinical trial or bioavailability or bioequivalence protocol and related documents shall be reviewed by an Ethics Committee unless at least five of its members as detailed below are present, namely:—

(i) medical scientist (preferably a 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.

(2) The Ethics Committee may constitute one or more sub-committees of its members to assist in the functions assigned to it.

(3) The Ethics Committee may associate such experts who are not its members, in its deliberations but such experts shall not have voting rights, if any.

(4) Any change in the membership or the constitution of the registered Ethics Committee shall be intimated in writing to the Central Licencing Authority within thirty working days.

6. Maintenance of records by Ethics Committee for clinical trial (Rule 13)
   Ethics Committee shall maintain the following records for a period of 5 years after completion of every clinical trial or bioavailability study or bioequivalence study, namely:-
   (i) constitution & composition of Ethics Committee;

(ii) curriculum vitae of all committee members;

(iii) standard operating procedures followed;

(iv) national & international guidelines referred;

(v) copies of the protocol, data collection formats, case report forms, investigators brochures submitted for review;

(vi) all correspondence with members and investigators;

(vii) Meeting agendas & signed minutes by Chairperson;

(viii) copies of decisions communicated to applicants;

(ix) records relating to any order issued for premature termination of study with a summary of the reasons thereof;

(x) final study reports, including digital formats (CDs, videos, etc.);

(xi) recommendation given by Ethics Committee for compensation;

(xii) records of serious adverse events, subject medical management, & compensation paid

7. Appeal against Suspension or Cancellation of registration (Rule 14)

   If the Central Licensing Authority believes that an Ethics Committee has violated any provision of the Act or rules, it may issue a show cause notice, outlining the non-compliance and specifying a time frame for the Committee to respond.
   If the Ethics Committee (EC) or any of its members is dissatisfied with an order issued by the Central Licensing Authority for suspension/cancellation of registration of EC for clinical trial, any order made under Rule 14(3) they may appeal to the Central Government within sixty working days of receiving the order.
   Upon receiving the appeal, the Central Government may conduct an enquiry if needed and, after giving the appellant an opportunity to be heard, issue an appropriate order within sixty working days from the date of appeal submission.

8. Ethics Committee for biomedical and health research (Rule 15)

Any institution or organisation which intends to conduct biomedical and health research shall be required to have an Ethics Committee to review and oversee the conduct of such research as detailed in National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.

9. Constitution of Ethics Committee for biomedical and health research (Rule 16, 17(11))
   It shall review & oversee biomedical & health research before initiation & throughout its duration.

An institution or organisation or any person shall conduct any biomedical and health research with the approval of the Ethics Committee for biomedical and health research registered under rule 17.

10. Form CT-03: Registration of Ethics Committee for Biomedical Health Research (Rule 17 (1), (2), (3), (4), (6), (7), (8), (9))

(1) An Ethics Committee constituted under rule 16, shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research under these rules for which an application shall be made in Form CT-01 to the said authority.
(2) The application shall be accompanied with the information and documents as specified in Table 1 of the Third Schedule of New Drugs and Clinical Trials Rules, 2019 .
(3) On receipt of application in Form CT-01, the authority designated shall grant provisional registration which shall remain valid for a period of two years.
(4) After the grant of provisional registration, the authority designated shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these rules have been complied with, grant final registration to Ethics Committee in Form CT-03.
(5) The registration granted in Form CT-03 shall remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the authority designated.

11. File an appeal in case of rejection of Application (Rule 17 (4), (5))

(1) After the grant of provisional registration, the authority designated shall scrutinise the documents and information furnished with the application, and if not satisfied, reject the application, for reasons to be recorded in writing and the final registration in Form CT-03 shall supersede the provisional registration granted under sub-rule (3).

(2) An applicant who is aggrieved by the decision of the authority, may file an appeal within sixty working days from the date of receipt of such rejection before the Central Government in the Ministry of Health and Family Welfare, and the Central Government, may, after such enquiry as is considered necessary in the facts and circumstances of the case, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days

   12.  Oversight of clinical trial site by Ethics Committee (Rule 20)

The work of every clinical trial site shall be overseen by an Ethics Committee for clinical trial registered under rule 8, before initiation and throughout the duration of the conduct of such trial.

  13.  Form CT-4A: information to initiate clinical trial for new/investigational drug in India for research/manufacture (Rule 23)

           If a drug is discovered and developed in India, and a complete application under Rule 21 is filed, the CLA must respond within 30 days. If not, approval is deemed granted. The applicant must notify the CLA via Form CT-4A, which will be treated as automatic approval.

Rule 26:- The permission to initiate clinical trial granted automatic approval under rule 23 in Form CT 4A shall remain valid for a period of two years from the date of its issue, unless extended by the Central Licencing Authority.

 14. Regulatory Exemption for Academic Clinical Trials under Specified Conditions (Rule 28 (1))

No Central Licensing Authority approval is needed for academic clinical trials if they:

(i) involve only approved drugs for new research purposes;

(ii) have prior Ethics Committee approval;

(iii) do not submit findings to the Authority; and

(iv) are not used for promotion.”

         “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licencing Authority or regulatory authority of any country for marketing or commercial purpose.

  15.  Ethics Committee notify CLA when overlap between an academic clinical trial and a clinical trial (Rule 28 (2), (3), (4))

(1) In case of doubt or overlap between an academic clinical trial and a clinical trial, the Ethics Committee must inform the Central Licensing Authority within 30 working days.

(2) The Authority must clarify within 30 days; if not, permission is deemed unnecessary.