Three years after the central government lifted the ban on contract animal research, the Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA) has decided to come out with specific guidelines that need to be complied for contract animal research sanctions. The requirements in the guidelines are expected to give a complete picture of the plans and objectives of the proposed research. All applications that fulfill the required conditions as per the guidelines can be cleared by CPCSEA without further delay thereby facilitating faster disposal of files.

Since timely clearances is an essential ingredient in ensuring business contracts both from within and outside the country, the decision of the committee has to be seen as extremely pro-active as far as the future of contract animal research is concerned. This sector is projected to grow tremendously in the coming years if the timely availability of laboratory animals can be ensured.

The CPCSEA guidelines, the draft of which is ready, seek details on the reasons for contract research (and not their own research programme), the product that they intend to develop, details of the agreement the contract research organization (CRO) has with the original researcher, the financial implications of the research, the status of the animal facility (whether it is registered with CPCSEA or not) etc. The sanctions for contract research involving foreign companies will however be based on its importance from a national perspective. The sub-committee of CPCSEA that is into the drafting of the guidelines is chaired by Dr Vasantha Muthuswamy, Dy DG, Indian Council of Medical Research (ICMR).

According to sources, the faster clearances for contract research proposals will encourage more R&D companies to get their work done through CROs, thereby avoiding the pains of maintaining their own animal facilities. Less number of facilities can be easily monitored; they can also be well maintained by the CROs. In the absence of contract research sanctions, all the companies and institutions who need to conduct research would have been compelled to register themselves with CPCSEA and also develop own animal facilities thereby giving rise to more number of such institutions.

As per the amendments to the Breeding of and Experiments on Animals (Control & Supervision) Rules, 1998, (under the Prevention of Cruelty to Animals Act, 1960) notified on February 15 2001, animal experimentations can be conducted on contract basis too, with a prior permission of the Committee for the Purposes of Control and Supervision of Experiments on Animals (CPSCEA).

The CPCSEA is also in the process of selecting two nominees each for the Institutional Animal Ethics Committees (IAEC) across the country. The committee has already identified two nominees each for more than 800 IAECs, HL Attri, member secretary CPCSEA informed Pharmabiz. While one of them will be part of the ethics committee, the other one would be a standby nominee who will be given charge of monitoring the animal facility. IAEC meetings can be held if either of the nominees is present.

The contract research guidelines as well as the current rules of the CPCSEA on various other issues related to animal experimentation will also be circulated in a wider manner so as to create more awareness about the changes among the researchers and pharma industry.