File No.

EC/24/000202
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Ethics Committee Registration Division)

FDA Bhawan, Kotla Road,

New Delhi - 110002, India
Dated: 25-Jul-2024

To

The Chairman
INSTITUTIONNAL HUMAN ETHICS COMMITTEE -
DEEPA HOSPITAL
DEEPA HOSPITAL
486, 2nd St Stanes Rd, KNP Puram, Odakkadu,
Tiruppur, TIRUPPUR Tiruppur Tamil Nadu - 641687
India

Subject: Ethics Committee Registration No. ECR/2001/Inst/TN/2024 issued under New Drugs and Clinical
Trials Rules, 2019.

Sir/Madam,

Please refer to your application no. EC/NEW/INST/2024/17233 dated 03-May-2024 submitted to this
Directorate for the Registration of Ethics Committee.

Please find enclosed registration of the Ethics Committee in Form CT-02 vide Registration No.
ECR/2001/Inst/TN/2024. The said registration is subject to the conditions as mentioned below:

Yours faithfully

Digitally signed by RAJEEV SINGH RAGHUVANSHI

RAJEEV SINGH DN: c=IN, o=CENTRAL DRUGS STANDARD CONTROL

ORGANISATION, ou=CENTRAL DRUGS STANDARD CONTROL
ORGANISATION,
2.5.4.20=42d7189b1c0981bb5a263a4a73d025ff4b11b680a91f0

RAGHUVANSHI
8773480400a43ee361b, postalCode=110002, st=Delhi,
serialNumber=657f5e47d940985d8f03bdc902d0e1fe73cfa12a1
a126ea94fa5701124a19013, cn=RAJEEV SINGH RAGHUVANSHI
Date: 2024.07.26 14:14:12 +05'30'

(Dr. Rajeev Singh Raghuvanshi)

Drugs Controller General (I) &
Central Licensing Authority

Conditions of Registration

1. The registration is valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central
Licencing Authority. Provided that if the application for renewal of registration is received by the Central Licencing Authority
ninety days prior to the date of expiry, the registration shall continue to be in force until an order is passed by the said
authority on such application.

2. This certificate is issued to you on the basis of declaration/submission made by you.

3. Composition of the said Ethics Committee is as per the Annexure.

4. No clinical trial or bioavailability or bioequivalence protocol and related documents shall be reviewed by an Ethics
Committee in meeting unless at least five of its members as detailed below are present in the meeting, 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.

5. The Ethics Committee shall have a minimum of seven and maximum of fifteen members from medical, non-medical,

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scientific and non-scientific areas with at least,
(i) one lay person;
(ii) one woman member;
(iii) one legal expert;
(iv) one independent member from any other related field such as social scientist or representative of non-governmental
voluntary agency or philosopher or ethicist or theologian.

6. One member of the Ethics Committee who is not affiliated with the institute or organization shall be the Chairperson, and
shall be appointed by such institute or organization and one member who is affiliated with the institute or organization shall
be appointed as Member Secretary of the Ethics Committee by such Institute or organization.

7. The Ethics Committee shall consist of at least fifty percent of its members who are not affiliated with the institute or
organization in which such committee is constituted.

8. The committee shall include at least one member whose primary area of interest or specialisation is non-scientific and at
least one member who is independent of the institution.

9. The Ethics committee can have as its members, individuals from other Institutions or Communities, if required.

10. Members should be conversant with the provisions of New Drug and Clinical Trials Rules, 2019, 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.

11. The members representing medical scientists and clinicians shall possess at least post graduate qualification in their
respective area of specialization, adequate experience in the respective fields and requisite knowledge and clarity about
their role and responsibility as committee members.

12. 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.

13. 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

14. No member of an Ethics Committee, having a conflict of interest, shall be involved in the oversight of the Clinical trial or
bioavailability or bioequivalence study protocol being reviewed by it and all members shall sign a declaration to the effect
that there is no conflict of interest.

15. While considering an application which involves a conflict of interest of any member of the Ethics Committee, such
member may voluntarily withdraw from the Ethics Committee review meeting, by expressing the same in writing, to the
Chairperson. The details in respect of the conflict of interest of the member shall be duly recorded in the minutes of the
meetings of the Ethics Committee.

16. Any change in the membership or the constitution of the registered Ethics Committee shall be intimated inwriting to the
Central Licencing Authority within thirty working days.

17. The Ethics Committee shall review and accord approval to a Clinical trial, Bioavailability and Bioequivalence study
protocol and other related documents, as the case may be, in the format specified in clause (B) of Table 1 of the Third
Schedule of New Drugs and Clinical Trials Rules, 2019 and oversee the conduct of clinical trial to safeguard the rights,
safety and wellbeing of trial subjects in accordance with these rules, Good Clinical Practices Guidelines and other applicable
regulations.

18. Where a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining
approval of the protocol from the Ethics Committee of another trial site; or an independent Ethics Committee for clinical trial
constituted in accordance with the provisions of rule 7: provided that the approving Ethics Committee for clinical trial shall in
such case be responsible for the study at the trial site or the centre, as the case may be: provided further that the approving
Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be
located within the same city or within a radius of 50 kms of the clinical trial site.

19. Where a Bioavailability or Bioequivalence study centre does not have its own Ethics Committee,bioavailability or
bioequivalence study at that site may be initiated after obtaining approval of the protocol from the Ethics Committee
registered under rule 8:Provided that the approving Ethics Committee shall in such case be responsible for the study at the
centre:Provided further that both the approving Ethics Committee and the centre, shall be located within the same city or
within a radius of 50kms of the bioavailability or bioequivalence study centre.

20. Ethics committee shall indicate the reasons that weighed with it while rejecting or asking for a change or notification in
the protocol in writing and a copy of such reasons shall also be made available to the Central Licencing Authority.

21. Ethics committee shall make, at appropriate intervals, an on-going review of the trials for which they have reviewed the
protocol. Such a review may be based on the periodic study progress reports furnished by the investigators or monitoring
and internal audit reports furnished by the sponsor or by visiting the study sites.

22. Where any serious adverse event occurs to a trial subject or to study subject during clinical trial or bioavailability or
bioequivalence study, the Ethics Committee shall analyse the relevant documents pertaining to such event and forward its

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report to the Central Licencing Authority and comply with the provisions of Chapter VI, New Drugs and Clinical Trials Rules,
2019.

23. The Ethics committee shall undertake proper causality assessment of SAE’s with the help of subject experts wherever
required, for deciding relatedness and quantum of compensation, as per condition no (22) mentioned above.

24. Where at any stage of a clinical trial, it comes to a conclusion that the trial is likely to compromise the right, safety or
wellbeing of the trial subject, the Ethics committee may order discontinuation or suspension of the clinical trial and the same
shall be intimated to the head of the institution conducting clinical trial and the Central Licencing Authority.

25. Ethics committee shall comply with the requirements or conditions in addition to the requirements specified under the
Drugs & Cosmetics Act, 1940 and New Drugs and Clinical Trials Rues, 2019, as may be specified by the Central Licencing
Authority with the approval of the Central Government, to safeguard the rights of clinical trial subject or bioavailability or
bioequivalence study subject.

26. Ethics Committee shall review and approve the suitability of the investigator and trial site for the proposed trial.

27. The Ethics Committee shall maintain data, record, registers and other documents related to the functioning and review
of clinical trial or bioavailability study or bioequivalence study, as the case may be, for a period of five years after completion
of such clinical trial.

28. Funding mechanism for the Ethics Committee to support their operations should be designed and approved to ensure
that the committee and their members have no financial incentive to approve or reject particular study.

29. SOP’s for funding of the Ethics committee in order to support their operations must be maintained. The records of
income & expenditure of Ethics Committee shall be maintained for review and inspection.

30. The Chairman of Ethics Committee shall enter into MOU with head of institution, that necessary support and facilities
and independence will be provided to Ethics Committee and their records will be maintained.

31. The Ethics Committee shall allow any officer authorized by the Central Licencing Authority to enter, with or without prior
notice, to inspect the premises, any record, or any documents related to clinical trial, furnish information to any query raised
by such authorized person, in relation to the conduct of clinical trial and to verify compliance with the requirements of these
rules, Good Clinical Practices Guidelines and other applicable regulations for safeguarding the rights, safety and well-being
of trial subjects.

32. Where Central Licencing Authority is of the opinion that Ethics Committee fails to comply with any provision of the Drugs
and Cosmetics Act, 1940and New Drugs & Clinical Trials Rules, 2019, it may issue show cause notice to such Ethics
Committee specifying therein such non-compliances and the period within which reply shall be furnished by such Ethics
Committee. After consideration of the facts and reply given by the Ethics Committee, the Central Licencing Authority may
take one or more actions specified under provision of Rule 14, Chapter III of New Drugs and Clinical Trials Rules, 2019.

Annexure

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