[02nd
February 2023] Whereas a draft of the
Committee for the Purpose of Control and Supervision of Experiments on Animals
(CPCSEA) Administrative Rules, 2022 was published in the Gazette of India,
Extraordinary, Part II, section 3, sub-section (i) vide notification of the
Government of India, Ministry of Fisheries, Animal Husbandry and Dairying
number G.S.R. 292(E), dated the 11th April, 2022, inviting objections and
suggestion from all persons likely to be affected thereby, within a period of
thirty days, from the date of which copies of Official Gazette containing the
said notification were made available to the public; And whereas, the copies of
the said Gazette were made available to the public on the 11th April, 2022; And whereas the objections
and suggestions received in respect of the said draft rules, have been duly
considered by the Committee for Control and Supervision of Experiments on
Animals; Now, therefore, in exercise
of the powers conferred under section 15 read with section 38 of the Prevention
of Cruelty to Animal Act, 1960 (59 of 1960), the Central Government hereby
makes the following rules, namely:--- (1)
These rules may be called the Administrative
(Committee for Control and Supervision of Experiments on Animals) Rules, 2023. (2)
They shall come into force on the date of
their publication in the Official Gazette. (a)
"Act" means the Prevention of
Cruelty to Animals Act, 1960 (59 of 1960); (b)
"Board" means the Animal Welfare
Board of India established under section 4 and as reconstituted from time to
time under section 5A of the Act; (c)
"CCSEA" means the Committee for
Control and Supervision of Experiments on Animals established under sub-section
(1) section 15 of the Act, (hereinafter referred to as "Committee); (d)
"Chairman" means the Chairman
nominated under sub-section (2) of section 15 of the Act; (e)
"Member" means a Member of the
Committee for Control and Supervision of Experiments on Animals; (f)
"Member-Secretary" means the
Member-Secretary to the Committee for Control and Supervision of Experiments on
Animals; (g)
"IAEC" means Institutional Animal
Ethics Committee; and (h)
"Experimentation" means any
programme or project involving use of animal for the acquisition of knowledge
of a biological, physiological, ethological, physical or chemical nature; and
includes the use of animal in the production of reagents and products such as
antigens and antibodies, routine diagnostics, testing activity and
establishment of transgenic stocks, for the purpose of saving or prolonging
life or alleviating suffering or significant gains in well being for people of
the country or for combating any disease whether of human beings or animals; (1)
Additional Secretary or equivalent or Joint
Secretary, In-Charge of Animal Welfare; (2)
Joint Commissioner or Deputy Commissioner,
In-Charge of Animal Welfare; (3)
Representative, Animal Welfare Board of India
not below the rank of Secretary, Animal Welfare Board of India; (4)
President, Veterinary Council of India, New Delhi
or his Representative not below the rank of Secretary, Veterinary Council of
India; (5)
President, Pharmacy Council of India, New
Delhi or his Representative not below the rank of Secretary, Pharmacy Council
of India; (6)
Representative of Central Drugs Standard
Control Organization, New Delhi not below the rank of Deputy Drugs Controller; (7)
Chairman, National Medical Commission, New
Delhi or his Representative not below the rank of President, National Medical
Commission; (8)
Chairman, University Grants Commission, New
Delhi or his Representative not below the rank of Secretary, University Grants
Commission; (9)
Representative of Indian Council of Medical
Research, New Delhi not below the rank of Scientist - F; (10)
Representative of Council of Scientific and
Industrial Research, New Delhi not below the rank of Scientist - F; (11)
Representative of Indian Council of
Agricultural Research, New Delhi not below the rank of Scientist - F; (12)
Representative of Department of
Biotechnology, New Delhi not below the rank of Scientist - F; (13)
Three members from the field of
Pharmaceutical Science, Bio-Statistics, Veterinary Sciences and Zoology-
Members; (14)
Two members, expert of Livestock or equines
or dogs and non human primates- Members; and (15)
Two socially aware members having knowledge
of animal ethics, welfare and alternatives to animal experimentation-Members. (1)
Any casual vacancy arising in the office of a
Member shall be filled by Central Government in the manner provided in one or
the other of the clauses of rule 4, according to the capacity in which such
person had found a place in the Committee as a Member. (2)
A Member appointed to fill a casual vacancy
shall hold office as long as the Member whose place he fills would have been
entitled to hold office, if the vacancy has not occurred. (1)
A Member, other than the Chairman, may by a
letter addressed to the Chairman, resign from membership. (2)
The Chairman may resign from membership by a
letter addressed to the Secretary to the Government of India of the
administrative Ministry. (3)
A resignation shall take effect from the date
of its acceptance or on the expiry of thirty days from the date of resignation,
whichever is earlier. (a)
absents himself from three consecutive
meeting of the Committee without the leave of the Committee; or (b)
has been adjudged as an insolvent, or; (c)
has been accused of an offence involving
animal cruelty and moral turpitude; or (d)
has became physically or mentally incapable
of acting as such Member. (e)
has violated the condition of confidentiality
of Membership. (a)
registration of establishments engaged in
breeding of animals and conducting experiments on animals and renewal of
registered establishments. (b)
constitution, re-constitution and revision of
the Institutional Animal Ethics Committee. (c)
approval of animal house facilities for Small
and Large animals. (d)
examination of research protocols for
experimentation on animals or pre-scrutinisation of research protocols on large
animals and their approval. (e)
inspection of animal house facilities of
establishments, institutes and centres where experimental animals are kept for
research, production of Biopharmaceuticals and Breeding purpose. (f)
conducting conference, seminar, workshops,
nominee trainings and the like for the awareness of laboratory animal welfare
and ethics and to promote the principles of the replacement, reduction and
refinement with respect to use of animals for experiments and teaching or
training purposes and to recognise the available non- animal methods and
non-animal derived biological products as per the mandate of Committee. (g)
to advise the Government regarding the
welfare of animals meant for experimentation in research institutions,
pharmaceutical companies and educational institutions. (h)
to ensure implementation of rules and
guidelines of the Committee made under the said Act for welfare of animals. (i)
analyse inspection reports submitted by the
nominee of Committee and scrutinise the minutes of the Institutional Animal
Ethics Committee meeting submitted by the establishment. (j)
make efforts to tap more and more
establishments housing laboratory animals and bring them under the ambit of the
Committee. (k)
any other work related to Laboratory Animal
Welfare as per the mandate of the Committee assigned as per the said Act. (l)
revision of the guidelines of Committee,
their dissemination, implementation and monitoring. (m)
grading of animal house facilities purpose
wise categorically like that:- (i)
Medical college set up, (ii)
Pharmacy college set up, (iii)
Veterinary college set up, (iv)
Research Institute set up, (v)
Pharma industry set up, (vi)
Vaccine industry set up, (vii)
Life sciences University set up, and the
like. (n)
maintenance of database on the available
non-animal methods for experiments, teaching and training. (1)
The meeting of the Committee shall be held once
in every month. (2)
The meetings shall ordinarily be held at the
headquarters of the Committee but the Chairman may, if necessary, fix the venue
of the meetings at places other than the headquarters of the Committee. (1)
The applications or proposals received in the
office of the Committee through its dedicated web portal shall be considered
and processed as per the following timelines:- Serial Number Activities Timelines 1 Approval of
registration and constitution of Institutional Animal Ethics Committee or
Amendment in registration seven working
days 2 Renewal of
registration and re-constitution of Institutional Animal Ethics Committee or
Revision of Institutional Animal Ethics Committee or Change of Nominee three working
days 3 Pointing out
deficiency and rejecting the protocol back to the organization by the
Committee three working
days 4 Evaluation of
the protocol by sub-committee of Committee and forwarding to the Committee
for consideration seven working
days 5 Evaluation
and decision on the Large Animal research protocols, if all other
prerequisites as per Committee are fulfilled. thirty
working days 6 Committee
Meeting once in a
month (2)
The above timelines are subject to submission
of all the requisite details and documents by the establishments. (3)
All matters wherein the deliberation of the
Members of Committee is required shall be considered either at its meeting or
by circulation of papers. (4)
When a matter is referred by circulation of
papers, any Member may request that the matter may be considered at a meeting
of the Committee and thereupon the Chairman may direct that it to be so
considered. Provided that if three or
more Members make such a request, the Chairman shall direct that it be so
considered. (5)
The proposals shall be considered deemed to
be approved, if it is lying pending for more than one month even after
completion of proposal in all respect or the Committee did not deliberate on
the proposal for one month. (6)
The proposals shall be considered rejected if
the queries or clarifications raised by the Committee are not replied or
complied with within the stipulated time. (1)
There shall be an Annual General Meeting once
in a year. (2)
At one of its General Meeting each year, the
Member-Secretary shall submit the annual report and the yearly accounts of the
Committee for the working of proceeding financial year for the approval of the
Committee. (1)
The Chairman shall convene a special meeting
of the Committee on the written requisition of fifteen Members of the
Committee. (2)
Any requisition made by the Members of the
Committee shall specify the object of the meeting proposed to be called and
shall be left at the address of the Member-Secretary or posted to his address. (3)
Upon such requisition, the Chairman shall
give notice of a meeting to be held within thirty days after the receipt of
such requisition. Provided that at any meeting
in which less than eleven members are present, the Chairman may adjourn the
meeting to a date not less than fourteen days later and inform the Members
present and notify other Members that he proposed to dispose of the business at
the adjourned meeting irrespective of the quorum and it shall thereupon be
lawful to dispose of the business at such adjourned meeting irrespective of the
number of members attending. (1)
If the Chairman is not present at any meeting
of the Committee, the Members shall choose one among themselves to be the
Chairman of the meeting. (2)
In case the difference of opinion amongst the
Members at the meeting of the Committee, the opinion of the majority shall
prevail. (3)
Each Member shall have one vote and if there
shall be equality of votes on any matter to be decided at a meeting of the
Committee, the Chairman of the meeting shall have a casting vote. (4)
No business which is not on the agenda shall
be considered at any meeting without the permission of the Chairman. (5)
The consensus of the Members present in a
particular meeting shall prevail. Provided that if any Member
places on record an objection to any protocol on the basis of availability of
an alternative to use of animals, such a protocol proposing to use an animal
shall be rejected. Provided that if any Member
places on record an objection along with scientific justification, seeking
reduction of the number of animals proposed to be utilised in any protocol
being deliberated upon, the Committee shall seek an explanation and
justification for the proposed number of animals from the applicant before
further deliberations. (1)
The Committee may resolve to constitute such
other Committee or sub-Committees from amongst its Members for the
administration of its affairs and for carrying out its functions. (2)
The Committee may co-opt such persons to the
Committees or sub-Committees appointed under sub-rule (1) as it considers
necessary and suitable, and may permit them to attend the meetings of such
Committees or subCommittees and such persons shall include subject-matter
experts, including experts in animal-free experimentation methods, from
government organisations, non-government organisations, and the public sector. (3)
A person co-opted under sub-rule (2) for any
purpose shall have the right to take part in the discussions relevant to that
purpose, but shall not have the right to vote. (4)
No official or non official Member of
Committee shall be nominated as member of Institutional Animal Ethics Committee
of his institution or other institutions. (1)
The Member, other than ex-officio Member,
shall be paid such honorarium as may be determined by the Central Government. (2)
A sitting fee of rupees six thousand shall be
provided to all the non-official Members of the Committee or subCommittee and
other Expert Committees or the amount prescribed by the Ministry of Finance,
Government of India time to time for sitting fees. (3)
A Member of the Committee who is not an
official shall be entitled to draw Travelling Allowance and Incidental
Expenditure in respect of any journey performed for the purpose of attending a
meeting of the Committee or sub-Committee thereof or any other association or
institution to which he is appointed or nominated as a representative of the
Committee or any other journey in connection with the work of the Committee
performed under the direction of the Chairman. (4)
A Member of the Committee who is an official
shall be entitled to draw, in the circumstances mentioned under sub-rule (3)
travelling and daily allowance in accordance with the travelling allowance
rules applicable to him from his organisation or Ministry or Department. (5)
Where a person who is not official or a
Member is asked by the Chairman of the Committee to perform any journey for the
purpose of attending a meeting of the Committee or sub-Committee thereof or any
other journey in connection with the work of the Committee he shall in respect
of such journey be entitled to the payment of travelling or conveyance
allowance or daily allowance at the rates as per the Government of India
guidelines for entitlement of class-I officer. (1)
The Chairman shall preside over meetings of
the Committee. (2)
The Chairman shall be responsible for the
proper functioning of the Committee and the implementation of its decisions and
the discharge of its duties under the Act. (3)
The Chairman shall, - (a)
cause important papers and matters to be
presented to the Committee as early as practicable; (b)
cause to be maintained on account of the
receipt and expenditure of the Committee; (c)
cause an annual report of the working of the
Committee to be prepared which after being approved at its Annual General
Meeting shall be submitted to the Central Government; (d)
authorise a member or any other person to
proceed on work connected with the Committee to any part of India; (e)
institute criminal proceedings against
employees; (f)
exercise such administrative control over all
employees of the Committee; and (g)
approve proposals for Travelling Allowances
and other remuneration such as sitting fees of the Members or Officials or
Staff of the Committee as per extant Government of India procedures. (1)
The Member-Secretary shall work under the
general control of the Chairman who may delegate to him all or any of the
following powers and duties namely:- (a)
convening of meetings of the Committee for
under the direction of the Chairman; (b)
drawing up agenda for each meeting under the
Chairmans directions and applying the same to each Member of the Committee,
along with the notice of the meeting; (c)
maintenance of minutes of meetings of the
Committee; (d)
furnishing to the Central Government copies
of all reports, including annual reports and returns and necessary documents
required under the Act or the rules; and (e)
preparation of the annual budget of the
Committee. (2)
The Chairman may, with the permission of the
Committee, delegate to the Member-Secretary any other function of the Committee
or of the Chairman. (3)
The Member-Secretary shall exercise such
financial powers delegated to him as per the provisions laid down in existing
General Financial Rules or amendments made there under and the procedures laid
down in various orders by Ministry of Finance, Department of Personnel and
Training, Ministry of Law and Justice, Ministry of Urban Development and
Central Vigilance Commission from time to time. (4)
Delegated powers shall not be further
re-delegated to sub-ordinate officer and Head of Department or organisation
shall be responsible for the correctness, regularity and propriety of the
decisions taken by them within delegated powers so authorised. (5)
The Member-Secretary shall keep a record of
the Members of the Committee and their addresses. (6)
If a Member changes his address, he shall
notify his new address to the Member-Secretary who shall thereupon enter his
new address in the record, but if the Member fails to notify his new address,
the address on official record shall for all purpose be deemed to be the
Members address. (1)
In accordance with the sub-section (4) of
section 15 of the Act, the funds of the Committee shall consist of grants made
to it from time to time by the Government and of contributions, donations,
subscriptions, bequests, gifts and the like made to it by any person except
from individuals or parties with any potential bias or stake in its decisions,
including any one or any group that uses animals for experiments or teaching or
training purposes. (2)
The Committee shall divide the Grants in
various head of expenditure and allot the grants in those heads which shall be
approved in the first meeting of financial year followed by the approval of the
Integrated Finance Division of the administrative Ministry while sending
demands for Grants. (3)
The income of Committee through registration
and renewal fee, and any other fee or penalty or charges (such as late fee etc)
imposed by the Committee on institutions regulated by the Committee. (1)
The budget estimates of the Committee for
every financial year beginning with the 1st day of April and ending on the 31st
day of March following shall be prepared by the Member-Secretary. (2)
The Committee shall consider and approve the
budget estimates with such changes as it thinks fit at the meeting fixed for
the consideration of the budget estimates. (3)
The budget estimates as approved by the
Committee shall be submitted to the Central Government for their formal
approval before the 31st March or such other date as the Central Government may
fix for the purpose. (4)
Subject to such orders as may be issued by
the Central Government from time to time, no expenditure shall be incurred
until the budget is sanctioned by the Central Government and expenditure
authorised by a competent authority in the Committee. (1)
The bankers of the Committee shall be State
Bank of India. (2)
All funds of the Committee shall be paid into
Committees account and shall not be withdrawn except on cheques signed by the
Member-Secretary. (3)
The cheque books shall remain in the personal
custody of the Member-Secretary. (1)
The Committee shall maintain proper accounts
and other relevant records. (2)
The accounts of the Committee shall be
audited annually by the Comptroller and Auditor General of India or by any
person appointed by him in this behalf and any expenditure incurred by him in
connection with such audit shall be payable by the Committee to the Comptroller
and Auditor - General of India. (3)
The internal audit may also be carried out by
the Integrated Finance Division of administrative Ministry or the internal
Auditor appointed by the Committee. (4)
The Comptroller and Auditor - General of
India and any person appointed by him audit the accounts of the Committee shall
have the same rights, privileges and authority in connection with such audit as
the Comptroller and Auditor - General of India has in connection with the audit
of Government accounts and, in particular, shall have the right to demand the
production of books, accounts, connected vouchers and other documents and
papers and to inspect the office of the Committee. (5)
The audit and accounts report shall be placed
before the Annual General Meeting of the Committee for consideration. (6)
The accounts of receipts shall include a
statement of all sums received by the Committee during the financial year which
shall be shown under the following heads namely:- (a)
money received from the Central Government; (b)
processing fee received from establishments; (c)
other moneys received by the Committee; and (d)
interest accrued from the investment of such
money as aforesaid. (7)
The receipts shall be shown under each of the
heads specified under sub-rule (6) and the opening balance shall also be
stated. (8)
The expenditure incurred during the financial
year shall be shown under the following heads, namely:- (a)
administration of the Committee including
payment of salaries, travelling expenses and the like; (b)
measures taken in connection with the
functions of the Committee, each item shall be shown separately; and (c)
miscellaneous. (9)
The closing balance for the financial year
shall be shown at the foot of the accounts on the expenditure side; and (10)
The Committee shall maintain accounts as per
the Financial Rules laid down by the Ministry of Finance. (1)
As per section 16 of the said Act, subject to
the control of the Central Government, the Committee may appoint such number of
officers and other employees as may be necessary to enable it to exercise its
powers and perform its duties and may determine the remuneration and other
terms and conditions of service of such officers and other employees. (2)
The office of the Committee shall engage manpower
as may be required by them time to time for performing its functions after
taking the approval from the Committee. (1)
All the expenditure to be made as per General
Financial Rules, laid down by the Ministry of Finance as per delegation of
financial powers from time to time. (2)
The Member-Secretary shall be empowered to
incur expenditure as per the delegation of Financial Powers delegated to him
from time to time with the concurrence of Integrated Finance Division and with
the approval of Secretary of the administrative Ministry and in pursuance of
the Delegation of Financial Power Rules, 1978.Administrative
(Committee For Control And Supervision Of Experiments On Animals) Rules, 2023
In these rules, unless the context otherwise requires,-
The head quarter of the Committee for Control and Supervision of Experiments on
Animals shall be at New Delhi.
The Central Government shall constitute Committee for Control and Supervision
of Experiments on Animals as per section 15 of the Act with the following
Members, namely:-
The Central Government shall nominate Additional Secretary or equivalent or
Joint Secretary, in-Charge of Animal Welfare to be its Chairman.
The Central Government shall nominate Joint Commissioner or Deputy
Commissioner, in-Charge of Animal Welfare to be its Member-Secretary.
The membership of a Committee Member may cease, if a Member;-
Committee shall be reconstituted from time to time on the expiration of every
three years from the date of its reconstitution, as per rule 4.
The Committee shall discharge the following functions, namely;
Every notice calling a meeting of the Committee shall state the date, time and
place at which such meeting will be held and shall be served upon every Member
of the Committee not less than seven days before the day appointed for the
meeting, other than the Annual General Meeting in which case the period of
notice shall be not less than fifteen days.
Eleven Members of the Committee shall form a quorum at every meeting of the
Committee;
If, during any financial year, for any reasons, substantial modification in the
budget estimates as finally approved by the Central Government is likely to the
involved, the Committee shall submit for approval to the Central Government
supplementary estimates in such form and on such date as the Central Government
may direct.
The Member-Secretary shall withdraw a permanent advance of rupees ten thousand
to be re-couped as and when required, to meet the petty expenditure of the
office of the Committee.
The Assets of the Committee created out with the expenditure of the Government
fund to be maintained in the Committee through a register of assets.