The Ministry of Environment & Forests is deliberating on an option to empower the Institutional Animal Ethics Committees (IAECs), attached to the 1300 registered institutions for drug trials on animals, for approving preclinical trials on select species of large animals, in an effort to reduce the procedural delay in approval of large animal studies for drug development, it is learnt.
At present, the power to sanction study approvals on large animals like rabbit, cats, dogs, monkeys and cattle breeds are vested with the national committee of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), a statutory body formed by the Prevention of Cruelty to Animals (PCA) Act, 1960. As per the rules, the committee has regular meetings in every alternate month to analyse the requests from research institutes.
The ministry, at present, is taking stock of the requirements of the pharmaceutical research institutes in conducting large animal studies to collect information about the need for such a decentralisation of power, according to a top official from the committee.
The idea is just in the infant stage and the government is taking stock of the industries to probe on ways to make the process simple and effective, said an official from CPCSEA. “We have come across so many issues related to the large animal studies and the effort is to understand the requirements of the industry and to check how we can simplify the procedures without compromising on the regulations,” he added.
At present, the national committee scheduled to meet on 20th of every alternate month is laden with huge amount of works, including approval for large animal studies. Meanwhile, the IAEC, which is set up in every institution registered with the ministry for animal studies, is required to meet as and when a fixed number of projects are pending for approval with the respective institution.
The move, if materialised, would help the pharma companies conducting either in-house drug development or contract research for overseas firms to cut down the deadlines of research, comments Dr Syed S Y H Qadri, secretary, Laboratory Animal Scientist's Association (LASA).
The delay in getting approval for large animal studies is affecting the amount of research we can do in India at present. “At a time when Indian pharma industry is growing fast in research and development sector and in contract research, several companies are outsourcing large animal studies to countries like Netherlands due to the regulatory hurdles here,” said Dr Qadri.
“Imagine that if a company is conducting a contract research for an overseas client and the cost they have to spend on outsourcing a part of their study to another country. If the responsibility for approval is with the IAEC, we could hasten the studies as per the targets,” he added.
Till 2006, the approvals for clinical studies on large animals has been scrutinised by a Sub-Committee on Large Animals. With the reconstitution of CPCSEA in the year, the sub-committee was dissolved and the onus of scrutiny and approval was delivered to the committee.
The Central Animal Facility at All India Institute of Medical Sciences (AIIMS), New Delhi, animal research facility at Central Drug Research Institute (CDRI), Lucknow, Experimental Animal Facility at National Institute for Research in Reproductive Health (NIRRH), Mumbai are some of the centres where large animals are used for experiments. Major companies including Dr Reddy's Lab, Sun Pharma, Advinus Therapeutics and clinical research organisations like Jai Research Foundation also have facilities to keep and conduct tests on large animals.