Animal experiments have frequently been a talking point in India. Maybe it is because we have always been compassionate not only to our fellow humans but also to animals and plants and perhaps, therefore, we do not find the mention of any animal experiments in the ancient scriptures of Indian system of medicine (Ayurveda and others). While, nothing can be taken away from our dedicated teachers who were extremely proficient at the art and science of experimental animal research, they made a significant contribution to science and today pharmacology in India rests upon a solid foundation laid by those stalwarts, one is compelled to admit that sporadic murmurs of dissent, against animal experiments were always heard at least in medical colleges. Emergence of clinical pharmacology signaled the change that was further boosted by “clinical research” (clinical pharmacology in its new avatar?). Arrival of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) on the scene has dealt a bigger blow to the animal experiments. The situation now is such that every single news, media report, press note, communication, or correspondence (from one ministry to another) creates ample flutter among (the already hyperexcitable) scientific community, which hardly dies down before the next wave sets in. Perhaps, the truth evades and confusion prevails as most of us (including this author) grope in the dark!
Maximum impact of these developments is seen on the undergraduate teaching of pharmacology in medical colleges. Therefore, most of what I say here pertains to them. Earlier, with some variation, the undergraduate students used to set up and perform the in-vitro experiments on their own both in regular practical classes as well as at the time of examination. This was replaced by in-vivo experiments and then by mere demonstrations. Now, at most places, only readymade graphs and charts are discussed and used at the time of examination. For all practical purposes, therefore, the existence of animal experiments (and animal house) is only namesake. The main question is, “has it affected the quality of pharmacology teaching?” There is no evidence to suggest this. Most of us will agree that the only objective of teaching pharmacology to medical students is to make them good prescribers. This can be easily achieved if in addition to theoretical inputs, the students are exposed to the relevant practical exercises, for example, demonstration of dosage forms, methods of drug administration, sources of drug information, assessing the promotional literature, prescription writing, detection, analysis and reporting of adverse drug reactions, P drugs, and cost–benefit analysis. Like many other institutions, we too have used them for the last one decade (in place of animal experiments and dispensing pharmacy) and our faculty and students have found them to be quite meaningful. Such exercises can be performed easily without any expensive gadgets or equipment. Computer simulation has also been recommended by some as an alternative to animal experiments. However, few such programs are available, they are expensive and their versatility is also doubtful. Moreover, it would be difficult to establish (and maintain!) a big computer laboratory for this purpose for 150–250 undergraduate students. Above all, if this is going to serve only a limited purpose then why take all the trouble?
Regulations of the Medical Council of India (MCI) have also been contradictory with regard to the undergraduate teaching of pharmacology. On one hand, it rightly promotes the incorporation of applied or clinical aspects in teaching and provides an adequate flexibility to frame the curriculum. Also, the recent recommendations of MCI do not ask for a central animal house and say that the “department of pharmacology may maintain an animal house”, which implies that the central facility is not required and that the departmental setup is optional. On the other hand, however, most assessors of the MCI insist for a central as well as the departmental animal house. As a result, all colleges do establish the animal house, obtain the CPCSEA license, and try to keep them functional (at least on the days of inspection!). Not only this, an Experimental Pharmacology laboratory is still required, and the recommended equipment includes a large number of items needed essentially for the animal work (long extension kymographs, operation tables, physiographs, etc.). This obviously leads to an avoidable waste of time, efforts, and resources, and the anomaly needs to be corrected. Without trying to divert, let me say here that a discussion should also be initiated about the duration (and the contents) of the pharmacology course and also about its status as a (stand-alone) independent subject in the undergraduate medical curriculum.
The situation is only slightly different in case of postgraduate education in pharmacology. Majority of the postgraduates opt for a career in clinical research, pharmaceutical industry, or teaching. Looking at the job requirements in these areas, animal experiments seem to be irrelevant. It is often said that the animal experiments provide a real insight into the intricacies of drug action and everyone should have an idea about the preclinical phase of drug development. It is also felt that animal experiments are something which very much “belong” to pharmacology; they can be used as dissertation topics and also serve as an important tool for evaluation at the time of final examination. Although animal experiments may be a necessity for graduates of pharmacy or biosciences, their role is debatable for medical graduates as the objectives can be met with other means. However, if there are any departments with a great deal of interest and expertise in animal research, they should be allowed to pursue it if they are in a position to meet the necessary infrastructural and regulatory requirements. It has been suggested that the departments should better develop some of the modern techniques that can be useful in drug research, as well as the postgraduate training and examination. Some of these can be cell (or tissue) culture, pharmacogenomics, sophisticated analytical methods, and the techniques used in molecular biology. This is most welcome as we already lag behind in this respect. However, it may be easier said than done. Beside monetary resources (required for initial investment, recurring expenses, and maintenance), the real problem may lie in the availability of suitably trained personnel. Clearly, our laboratories need both a paradigm shift and massive modernization and, besides others, the national agencies will have to play a major role in this.
It would be extremely controversial if use of animals is totally banned for research. I am not aware of any country where such a ban is applied, not even those where animal activists have been at their best. An argument can be made that there is no ban on the use of (even big) animals for transportation, sports, entertainment, and eating (!), then why only for research? Furthermore, small animals used in research are bred in captivity, and it could perhaps be difficult for them to survive outside the animal house and laboratories. True, every effort should be made to develop the alternatives, and while some of them are already in use, we are yet to have something which is as complete and comprehensive as an animal experiment. CPCSEA allows the use of animals for research aimed at new drug development. This activity is carried out primarily by pharmaceutical industry. Academic departments and research institutes also contribute significantly toward it. The use of animals, however, is not permitted for training, and it would be difficult to place someone totally untrained straight into the job. Although some training may be given while being a member of the research team, it would be appropriate to allow a provision for it particularly in the academic departments. In essence, it will be prudent for the scientific community to figure out at the earliest what and how it should be doing, and at the same time, the regulatory agencies, on their part, should also let us know in a loud, clear, well publicized, and considerate manner what we can do and what we cannot!
PS: With this issue of IJP my tenure as its Chief Editor comes to an end. I take this opportunity to thank the Indian Pharmacological Society for having given me this chance to serve it. I was ably supported by the worthy members of editorial team and I am grateful to them. I assure the Society of my unflinching, continued support in future too. - RKD