Some of the powerful animal rights groups are holding up the initiative of the Union Ministry of Environment to change the Breeding Rules for animals for pharmaceutical research. The ministry has been trying its level best to bring a comprehensive amendment to the current Breeding Rules for some time but with no success.

The research based pharmaceutical companies and other R&D institutions engaged in drug discovery are finding it extremely difficult to carry out their projects as the procurement and use of laboratory animals are becoming impossible under the current rules.

The ministry had organized two brain storming sessions in the last couple of months, but there has been no progress in discussions due to the stiff opposition from the animal rights groups. The effort was to mainly alter the breeding rules in the country and make it on par with the internationally accepted rules followed by the developed countries.

The need for harmonization of The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) regulations with those of the developed countries such as USA is one of the long-standing demands of the scientific community. Delay in import clearances, lack of prompt communication from expert consultants, absence of central breeding facilities etc are also issues that need urgent attention. The problems were highlighted during a Round Table Conference organized by Ranbaxy Science Foundation's (RSF) on "Ethics in Animal Experimentation" few months ago.

The scientific community complains that the existing definition of animal experimentation brings in everything that one do with animals under the same umbrella. They wanted this to be prioritized and animal experimentation for drug discovery given special consideration. The current requirement of maintaining a day-to-day breeder register, absence of registered breeders, lack of sufficient breeding centres have all been posing much hurdles before the scientific community. They wanted the Ministry to have a look into the entire rules and make appropriate changes.

If one goes by CPCSEA rules, even fishes, cockroaches and earthworms, when used for experimentation purposes would have to be sourced from registered breeders. Interestingly, there are no breeders for most of these animals. Even horses cannot be provided by registered breeders, it is learnt. The industry as well as the research institutions have been asking for a one-time clearance for many of the experiments. As per the present rules, the institution would have to apply for separate clearance even for minor procedures. Lack of coordination between the CPCSEA and the customs authorities is also creating hurdles for the industry when it comes to import of animals.

According to sources, the earlier brain storming sessions never got into the core issues. They expect the Ministry to continue with its efforts to bring in a favorable change in breeding rules.

The CPCSEA is also meeting this week to discuss the follow up actions to be taken with regard to the proposed changes pending before the committee.