Centre notifies Rules for CCSEA with provisions for deemed approval & grading of animal house facilities
The Central government has notified the administrative Rules for the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory Committee to regulate and monitor experiments on animals to prevent cruelty to animals, with provisions for deemed approval and grading of animal house facilities in medical colleges, pharmacy colleges, pharma and vaccine industry, among others.
The ministry of fisheries, animal husbandry and dairying, which published the draft notification of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) Administrative Rules, 2022, on April 11, 2022, has now said that the CCSEA has considered the objections and suggestions received in respect of the Draft Rules before notifying Rules now. It may be noted that the Ministry has in between changed the name of the Committee to ‘Committee for Control and Supervision of Experiments on Animals.
In addition to the functions assigned for the Committee under the Draft Rules, the final notification ‘Administrative (Committee for Control and Supervision of Experiments on Animals) Rules, 2023’, mandates the Committee to grade the animal house facilities purpose wise and categorically in medical colleges, pharmacy colleges, veterinary colleges, research institutes, pharma industry, vaccine industry and life sciences universities and others.
The notification also provides the Committee with the powers to revise the guidelines of the Committee, their dissemination, implementation and monitoring and the responsibility to maintain a database on the available non-animal methods for experiments, teaching and training, which were not present in the draft notification.
The other functions of the Committee, according to the draft and the final notification, include registration of establishments engaged in breeding of animals and conducting experiments on animals and renewal of registered establishments; constitution, re-constitution and revision of the IAEC; approval of animal house facilities for small and large animals; examination of research protocols for experimentation on animals or pre-scrutinisation of research protocols on large animals; and inspection of animal house facilities of establishments, institutes and centres where experimental animals have been kept for research, production of biopharmaceuticals and breeding purpose.
It also has to advise the government regarding the welfare of animals meant for experimentation in research institutions, pharmaceutical companies and educational institutions; to ensure implementation of rules and guidelines of the Committee made under the Prevention of Cruelty to Animal Act, 1960 (59 of 1960) for welfare of animals; analyse inspection reports submitted by the nominee of Committee and scrutinise the minutes of the IAEC meeting submitted by the establishment; make efforts to tap more and more establishments housing laboratory animals and bring them under the ambit of the Committee; and any other work as per the mandate of the Committee assigned as per the Act.
The Rules stipulate that the headquarters of the Committee shall be at New Delhi and the Central government shall constitute the Committee as per the relevant section of the Prevention of Cruelty to Animals Act, 1960 with 19 members, instead of the suggestion for 20 members in the draft notification.
According to the timeline finalised under the Rules, the approval of registration and constitution of Institutional Animal Ethics Committee (IAEC) or Amendment in Registration has to be disposed of in seven working days; renewal or registration and re-constitution of the IAEC or revision of IAEC or change of nominee in three working days; pointing out deficiency and rejecting the protocol back to the organisation by the committee in three working days; evaluation of the protocol by sub-committee and forwarding to the Committee for consideration has to be completed in seven working days from then.
Evaluation and decision on the large animal research protocols, if all other prerequisites as per the Committee are fulfilled, has to be completed in 30 working days. The CCSEA has to hold Committee meetings once in a month, ordinarily held at the headquarters in Delhi. The timelines are subject to submission of all the requisite details and documents by the establishments.
“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,” says the final notification. Eleven members of the Committee shall form the quorum for every meeting. It also has the powers to constitute committees or subcommittees for the administration of its affairs.
The timelines have been almost the same for the last couple of years, after the CPCSEA modified it from the earlier one in which the CPCSEA Committee meeting was scheduled to be held once in two months. The other timelines were of a minimum of 15 days in the earlier schedule. It has also removed the need for a no-objection certificate to import laboratory animals, which was earlier a mandate.
The Rules also elaborate the funding to the Committee, and other administrative matters. While the draft notification had provisions allowing the funds of the committee to be from grants made by the government and of contributions, donations, subscriptions, bequests, gifts and the like made to it by any person, the final notification adds that such funding “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”.
It may be noted that the Department has in November, 2021, reconstituted the Committee, with 19 members including experts in the field. The term of the Committee, unless sooner dissolved, is three years from the date of its Constitution.
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