HCFI CERTIFICATION EXPERT COMMITTEE
HCFI CERTIFICATION EXPERT COMMITTEE
                           OF
HEART CARE FOUNDATION OF INDIA

Standard Operating Procedures (SOP)
 

1. OBJECTIVE:
The objective of the HCFI Certification Expert Committee (hereinafter referred to “Committee”) of Heart Care Foundation of India (hereinafter referred to as “HCFI”) is to verify and check the applications for certification received by HCFI and after scrutiny to give its opinion whether HCFI should give its certificate or not.

2. ROLE OF COMMITTEE
The Committee will study and approve (if found worthy)/disapprove (if not found worthy)/ approve subject to certain conditions all such types of applications for certifications received from HCFI with a view to ensure that the HCFI only gives certificate only to products /concepts which are health & environment friendly. The goals of Committee, however important, would never be permitted to override the health and well-being of the public at large.

The Committee will take care that the cardinal principles of ethics viz. Autonomy, Beneficence, Non - malfeasance, Confidentiality and Justice are taken care of in scrutinizing and reporting of the application received for certification. The committee will ensure that the applicant has given all relevant documents, products, research papers, etc. The committee will also examine compliance with all regulatory requirements, applicable guidelines and laws.

Committee has the right to discuss and review the application with the applicant and/or its representative. The decision of the Committee will be final and binding.

3. COMPOSITION AND APPOINTMENT OF COMMITTEE
The Committee will be constituted and its members appointed by the Board of Trustees of HCFI. The composition of the Committee would be multidisciplinary and multi-sectorial so that it safeguards the interests and welfare of all the sections of the society / community.

3.1    The Composition of Committee: The committee will comprise of not less than5 members. The members would include: –
3.1.1    Engineer Anuj Sinha, Former Director, Ministry of Science and Technology, Government of India – Chairperson
3.1.2    Dr. Uday Kakroo, Advisor of HCFI – Member Secretary
3.1.3    Dr. K. K. Kalra, Consultant Quality Control of India - Member
3.1.4    Dr. N. V. Kamat, Former Director General Health Services, Delhi Government - Member
3.1.5    Ms. Ira Gupta, Advocate - Member
3.2    The committee shall have both genders representation


4.   TERM OF COMMITTEE MEMBERS
4.1    The tenure of Committee members would be for a period of 1 year.
4.2    At the end of 1 year the Committee would be reconstituted by the Board of Trustees of HCFI.
4.3    The membership of every member is renewal.
4.4     Board of Trustees of HCFI can replace a member in the event of death or long-term non-availability or because of any action not commensurate with the responsibilities of the members.
4.5    A member can tender resignation from the committee with proper reasons to do so by giving at least one month’s notice.
4.6     Conflict of interest will be avoided when making appointments, but where unavoidable there will be transparency with regards to such interest.
4.7   All Members should maintain absolute confidentiality of all discussion during the meeting and shall sign a confidentiality form.
4.8    Conflict of interest should be declared by members of the Committee as and when applicable.

5.    QUORUM REQUIREMENTS  
All decisions would be taken in the Committee meetings and not by circulation of project proposals. A minimum of 3 members are required to compose a quorum. However, in emergent situation, a proposal may be considered by circulations.

6.    OFFICES
6.1    The Chairperson will conduct all meetings of the Committee. If, for any reason which is beyond control, the Chairperson is not available, then the Member Secretary shall conduct the meeting and in absence of both Chairperson and Member Secretary, shall be elected from the members present, who shall conduct the meeting.
6.2    The Member Secretary shall be responsible for organizing the meetings, maintaining the records and communicating with all the concerned members, persons, etc. He/she shall prepare the Minutes of the Meetings and get it approved by the Chairperson before communicating to the other members of Committee.
6.3     For purpose of official work, a dedicated staff & a helper shall be provided to Member Secretary.  They shall be paid remuneration through HCFI.

7.    APPLICATION PROCEDURES
7.1    All applications for certification shall be submitted to HCFI in plain paper or via email by any individual, company, partnership firm, etc.
7.2    The date of meeting shall be intimated to the Applicant, for presentation and discussion.
7.3    The decision of Committee shall be communicated to the Applicant. The decision of Committee could be one of the following: (a) Approved (b) Not approved (c) Resubmit with revision (d) Approved subject to modification.
7.4    The decision of Committee shall be communicated in writing. If revision is to be made, the revised document with the required number of copies shall be submitted within the stipulated period of time as specified in the communication or before the next meeting of Committee.
7.5    A non-refundable fee of Rs. 50,000/- shall be remitted along with the application for any certification to HCFI via cheque, bankers’ cheque, draft, electronic transfers in the account of HCFI.
7.6    In case of resubmit also, a non-refundable fee of Rs. 50,000/- shall be remitted along with the resubmission form to HCFI via cheque, bankers’ cheque, draft, electronic transfers in the account of HCFI.


8.    DOCUMENTATION:
For a thorough and complete review, all applications shall be submitted with the following documents:
1.    Application in a plan paper or via email
2.    The identity proof of an applicant like Aadhar Card in case of individual, Certificate of Incorporation in case of Company, Partnership deed in case of partnership firm, Registration Certificate in case of Society, Trust, etc.
3.    Authorization letter in case of company, trust, society, partnership firm, etc.
4.    Nonrefundable fees of Rs. 50,000/-
5.    All documents, prior certificates from various authorities received by the applicant with respect to the product for which certification is required.


9.    REVIEW PROCEDURES:
9.1    The meeting of the Committee shall be held and additional meetings may be held as and when required.
9.2    The applications shall be sent to the members at least 7 days in advance.
9.3    Each application shall be extensively reviewed by at least two (2) members.  
9.4    Decisions shall be taken by consensus after discussions, and whenever needed voting will be done.
9.5    Applicants or their authorized representatives shall be invited to offer clarifications, present the proposal or elaborate on specific issues.
9.6    Independent Consultants/Experts shall be invited to offer their opinion on specific research proposals, as and when required.
9.7    The decisions shall be minute and Chairperson’s approval taken in writing.
9.8    The decision of the Committee shall be conveyed to the HCFI by the letter, signed by the Chairperson.
9.9    Minutes of the meeting shall be recorded and the minutes shall be approved at the next meeting.


10.     DECISION-MAKING & COMMUNICATION OF DECISION TO HCFI
In making decision on application, the Committee shall take the following into consideration:
10.1    Members shall discuss various issues before arriving at a consensus decision.
10.2    Decisions shall be taken by Committee members only. Experts will give their opinion, but will have no voting rights.
10.3    A member shall withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises and this shall be indicated to the Chairperson prior to the review of the application and shall be recorded in the minutes of meeting also.
10.4    Decisions shall be in the form of (a) Approved (b) Not approved (c) Resubmit with revision (d) Approved subject to modification/ clarification. Decisions shall be communicated in writing by the Member Secretary to HCFI with reasons wherever required.
10.5    The format of the approval is given in Appendix ‘I’ or as per application requirement.
10.6    Modified proposals may be reviewed by an expedited review through identified members.
10.7    A negative decision on an application shall be supported by clear stated reason.
10.8    In cases of conditional decision, clear suggestions for revision and the procedure for having the application re-reviewed shall be specified.


11.    RECORD KEEPING AND ARCHIVING
All documents and communication of the Committee shall be dated, filed and archived. Documents shall be archived for a minimum period of five (5) years from the date of the receipt of the application.

Documents that are to be filed and archived include but are not limited to:

11.1    Curriculum Vitae (CV) of all members of Committee.
11.2    Copy of all applications with enclosed documents
11.3    Minutes of all meetings duly approved by the Chairperson.
11.4    The constitution, written standard operating procedures (SOPs) of the Committee and periodical /annual reports.
11.5    Records of all income and expenses of the Committee, including allowances and reimbursements made to the Committee members.
11.6    The agenda of the Committee meeting
11.7    Correspondence by Committee members with applicants and concerned parties regarding application, decision, follow up etc.
11.8    A copy of the decision /approval and any advice or requirements sent to an applicant.
11.9    All written documents received during the follow up.
11.10    Final report of the approved application.
11.11    A register shall be maintained for applications. All the details of applications like date of receipt, date of discussion, date of approval, follow up and date of final reports shall be recorded in the said register.


12.    ACCEPTANCE AND APPROVAL OF STANDARD OPERATING PROCEDURE (SOP)
This Standard Operating Procedure (SOP) has been discussed, accepted and approved by all the members of the Committee and on confirmation, the same has been duly approved by the Board of Trustees of HCFI. Any change or update, as recommended by Committee shall be required to be approved by the Board of Trustees of HCFI.


                                                                                                                                                                    Date:
Chairperson
Member Secretary
Members


 

ANNEXURE I

 

To,

Dr KK Aggarwal
Padma Shri Awardee
National President of Heart Care Foundation of India
E-219, Greater Kailash – I
New Delhi


Sub: Application dated _________ received from __________.

Dear Dr.

    The HCFI Certification Expert Committee has reviewed and discussed the application dated ___________ received from _____________.

The following documents were reviewed:

1._______
2.___________


The following members of the ethics committee were present of the meeting held on (date, time, place).

_______ Chairperson of the ethics committee
_______ Member Secretary of the ethics committee
_______ name of each member with designation


We approve / disapprove/ approve subject to modification / approve subject to certain conditions the product / building / to be certified by HCFI in its presented form.


Yours sincerely,

Chairperson
HCFI Certification Expert Committee

 

ABOUT HCFI

Heart Foundation Of India was Founded in 1986 as a National Charitable Trust with the basic objective of creating awareness about all aspcets of health for people from all walks of life incorporating all pathies incorporating low cost infotainment modeules under one roof.

Contact

Head Office,
E-219, Greater Kailash I,
New Delhi - 110048

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