ATLA 32, Supplement 1, 411–415, 2004 411

Fourth World Congress Issues in animal research

Animal Experimentation and Ethics in India: The CPCSEA

Makes a Difference

Shiranee Pereira,1 Prema Veeraraghavan,1 Sonya Ghosh2 and Maneka Gandhi3

1Consultant, Committee for the Purpose of Control and Supervision of Experiments on Animals,
Thiruvanmiyur, Chennai, India; 2Nominee, CPCSEA, Vasant Kunj, New Delhi, India; 3Chairperson, CPCSEA,
New Delhi, India

Summary — The Committee for the Purpose of Control and Supervision of Experiments on Animals
(CPCSEA) is a statutory body formed by the Act of the Indian Parliament under the Prevention of Cruelty
to Animals Act 1960. Formed in 1964, it was revived in 1998, under the committed chairpersonship of
Maneka Gandhi. In the last two years, the CPCSEA has bettered the life of the animals in laboratories
across India. This committee is composed of members of the scientific community, regulatory authorities
and animal activists. The CPCSEA functions with a brilliant network of volunteers who liaise with the lab-
oratories. For the first time in India: over 665 laboratories are registered with the CPCSEA; Institutional
Animal Ethics Committees (IAECs) are constituted in every laboratory, which are only empowered to
approve research project proposals that use rats, mice, guinea-pigs or rabbits; every project that uses
canines, ovines, bovines or non-human primates can only be conducted if approved by the panel of sci-
entific experts constituted for this purpose; guidelines on laboratory animal care and practice have been
formulated and enforced; a protocol for the production of immunobiologicals from equines has been for-
mulated and ratified by the Supreme Court of India; the CPCSEA has been deliberating on alternatives and
working out modalities to introduce alternatives in basic/regulatory research and education, in keeping
with the international arena; the CPCSEA, to date, has rehabilitated and homed over 300 dogs, 150
equines, 200 non-human primates and several cattle, cats, birds, rabbits and mice; the CPCSEA proactively
trains and guides scientific and non-scientific personnel on issues of alternatives and laboratory animal
welfare; and the CPCSEA has fought legal issues on laboratory animal care and use and have had verdicts
that favoured alternatives and animal welfare.

The greatness of a nation and its moral progress can be judged by the way its animals are treated.
Mahatma Gandhi

Key words: animal experimentation, CPCSEA, ethics, India.

Address for correspondence: Shiranee Pereira, Committee for the Purpose of Control and Supervision
of Experiments on Animals, No.13/1, 3rd Seaward Road, Thiruvanmiyur, Chennai-600 041, India.
E-mail: [email protected], [email protected]

Introduction mittee shall be designed to secure the following

objectives.
Article 51A(g) of the Constitution of India reads
that it is the fundamental duty of every citizen of 1. That, in cases where experiments are performed
India “to protect and improve the natural environ- in any institution, the responsibility is placed on
ment including forests, lakes, rivers and wildlife the person in charge of the institution, and that,
and to have compassion for living creatures”. In in cases where experiments are performed out-
1960, the Prevention of Cruelty to Animals Act was side an institution, by individuals, the individu-
promulgated by an act of the Indian Parliament. als must be qualified, and the experiments are
Section 15 of the Act provides for constitution, by performed under their full responsibility.
the Central Government of India, of the Committee 2. That experiments are performed with due care
for the Purpose of Control and Supervision of and humanity, and that, as far as possible, exper-
Experiments on Animals (CPCSEA), to supervise iments involving operations are performed under
and control experiments on animals. the influence of some anaesthetic of sufficient
Section 17(1) of the Prevention of Cruelty to power to prevent the animals from feeling pain.
Animals Act 1960 lays down as the duty of the
committee to take all such measures as may be 3. That, in the course of experiments performed
necessary to ensure that animals are not subject to under the influence of anaesthetics, if an animal
unnecessary pain or suffering before, during or becomes so injured that recovery would involve
after the performance of experiments on them. serious suffering, it will be euthanised while still
The Act defines that the rules made by the com- anaesthetised.
412 S. Pereira et al.

4. That experiments on animals are avoided wher- Hundreds of animals, which were found in labora-
ever it is possible to do so; e.g. in medical tories in acute stages of physiological and psycholog-
schools, hospitals, colleges, etc., if other teach- ical trauma, were rescued and rehabilitated.
ing devices such as books, models, films and the Laboratories were cleaned, and good laboratory prac-
like may equally suffice. tices are being introduced. The capture and use of
domestic, impounded and wild animals has been out-
5. That experiments on larger animals are avoided lawed and categorically stopped. The wisdom of the
when it is possible to achieve the same results alternatives concept has been introduced to a nation
by experiments upon small laboratory animals, ignorant of, and disinterested in, the science of
such as guinea-pigs, rabbits, frogs and rats. reduction, refinement and replacement. Careful
restrictions were introduced in the use of vertebrates
6. That as far as possible, experiments are not per- in research and the use of animals in contract
formed merely for the purpose of acquiring research with multinationals outside India. Four-
manual skill. hundred honorary workers throughout the country
liaise with the CPCSEA, and they represent the com-
7. That animals intended for the performance of mittee in each of the institutes, inspecting, reporting
experiments are properly looked after both before and helping implement the rules governing the use
and after experiments. and care of laboratory animals. The success of the
CPCSEA in the last two years has been largely due
8. That suitable records are maintained with res- to the efforts of these honorary workers, who have
pect to experiments performed on animals. volunteered to work for the cause of animals and
have weathered physical assault, lock ups and verbal
Hence, in 1998, on the initiative of Smt. Maneka abuse to carry the mission forward.
Gandhi, Chairperson, CPCSEA (fourth author of The CPCSEA, for the first time in India, has
this paper), for the first time in India the Breeding introduced the following changes in laboratory ani-
of and Experiments on Animals (Control and mal use and care.
Supervision) Rules were officially notified in the
Gazette of India by the CPCSEA and they became
the first ever effective rules governing experimen- 665 laboratories register with the CPCSEA
tation on animals in India.
For over three decades since the first CPCSEA It has been made mandatory by law that every insti-
was constituted in 1964, precious little was done to tution that uses animals for the purpose of educ-
alleviate the suffering of laboratory animals in ation, biomedical research and/or regulatory
India, and apparently, the previous committees purposes, or uses animals for the production of vac-
failed to impose the laws and lacked effective meth- cines and immunobiologicals must register with the
ods for the implementation, and a dismal scenario committee. When registered with the CPCSEA,
continued in laboratories across India. Gruesome they are constantly monitored, and their animal
acts of cruelty in the guise of science and ignorance housing facilities are inspected. Currently, 86 med-
were perpetrated on animals, during which the ical universities, 80 pharmacy colleges, 35 veteri-
degree of sentience, ethics, scientific rationale or nary universities and 464 institutions that use
purpose were of least concern. A large majority of animals for biomedical/regulatory research, have
the animal houses continued to be in an abysmally registered with the CPCSEA.
poor condition. Non-existent animal houses, sheds
and store rooms, dark and damp dungeons were
referred to as animal houses. Moribund animals Institutional Animal Ethics Committees
were researched upon; old and sick non-human pri- (IAECs) constituted in registered laboratories
mates were caged in isolation in rusty cages for 20
years or more; animals were regularly picked off the An eight-member IAEC that includes a nominee of
street or from the wild; others were bludgeoned or the CPCSEA is constituted in every registered insti-
bled to death; euthanasia and analgesia were tute as a necessary prerequisite. All research proj-
scantly practised, good laboratory practices were ect proposals using small animals, such as rats,
unknown and neither law nor science were revered. mice, rabbits or guinea-pigs, have to be approved by
In the last two years, India has, for the first time, the IAEC before initiation. Every member of the
seen an ambitious clean-up mission of laboratories IAEC has the right to question/disapprove of a proj-
that use animals, due to the efforts of the CPCSEA, ect; unapproved proposals are referred to a sub-
under the chairmanship of Smt. Maneka Gandhi. In committee of experts for scrutiny and possible
a country where scientists were looked upon as high approval. The IAEC cannot approve research proj-
priests, and laboratories were considered the sanc- ects on large animals, such as dogs, cats, non-
tum sanctorum of research, the climb was steep and human primates, cattle, goats, sheep, and so forth,
difficult. and can only recommend the same to the sub-com-
Animal experimentation and ethics in India 413

mittee of the CPCSEA, which, alone, has the power nance, housing and care; hence, they have been
to approve projects on higher vertebrates. observed to be neglected in terms of their
health, hygiene and basic medical attention.

Constitution of an expert sub-committee for

scrutiny and approval of research projects The CPCSEA guidelines for laboratory
on large animals animal facilities

An expert sub-committee, headed by one of India’s An expert committee, chaired by the Secretary,
most senior and reputed scientists, Dr Ranjit Roy Department of Biotechnology, Government of India,
Chaudhury, will scrutinise and study every and including representatives of the Indian Council
research project on large animals before considera- of Medical Research, the Indian Council of
tion for approval. In the last two years, eight meet- Agricultural Research, the National Institute of
ings of the sub-committee have been held, and less Immunology, the Central Drug Research Institute,
than 30% of the proposals were found to be worthy the Indian Institute of Science, the All India
of approval. Thus, hundreds of animals that would Institute of Medical Sciences, the Indian Veterinary
otherwise have been used in futile scientific Research Institute, Ranbaxy Laboratory Ltd. and
research have been saved by virtue of the stringent the CPCSEA, was constituted with the goal of pro-
scrutiny and control of this sub-committee. moting the humane care of animals used in biomed-
The observations of this sub-committee of the ical and behavioural research and testing. The basic
CPCSEA have been that: objective of the committee is to provide specifications
that will enhance animal well-being, as well as qual-
— Due to their high level of sentience, the use of ity, in the pursuit of advancement of biological
large animals in research requires a deep delib- knowledge that is relevant to humans and animals.
eration. Their use can be justified only if positive These guidelines, referred to as the CPCSEA
results based on the same hypothesis have been Guidelines for Laboratory Animal Facility, were rat-
obtained using small animals. The CPCSEA has ified by the national committee of the CPCSEA in
observed that most laboratories in India that use 2002, and they have been made mandatory for all
non-human primates do not strictly adhere to research laboratories that use animals. The guide-
this practice and simultaneously work on both lines cover aspects of veterinary care, animal pro-
small and large animals, despite the fact that curement, quarantine, stabilisation and separation,
Rule 17(e) of the Prevention of Cruelty to surveillance, diagnosis, treatment and control of dis-
Animals Act 1960 makes mandatory working ease, animal care and technical personnel, durations
with small animals first. for which animals can be used in experiments, phys-
ical restraint, physical plant, social environment,
— 90% of the large animal laboratories have ad activity, food, sanitation and cleanliness, waste dis-
hoc arrangements to house non-human pri- posal, pest control, emergency, weekend and holiday
mates, canines, sheep, goats, buffaloes, horses care, recordkeeping, Standard Operating Pro-
and so forth, and do not have scientifically cedures/Guidelines, anaesthesia (including euthana-
planned animal houses or adhere to scientific/ sia), and a section on transgenic animals.
ethical norms of experimentation.

— Several laboratories have been observed to hold The CPCSEA protocol for the care and
surplus animals and to design research projects management of equines used in the
specifically to use these animals. production of immunobiologicals

— Large animals that carry several zoonotic dis- In India, there are eight institutes that use equines
eases have been observed being procured by for the production of immunobiologicals, mainly anti-
institutes from open markets and small farm- snake venom sera. During the initial visits of the
ers, without knowledge/screening of health sta- CPCSEA to these institutes, there was shocking and
tus before using them for experiments. compelling evidence of the most egregious and unsci-
entific methods in practice in terms of animal welfare
— In several laboratories throughout the country, and care, and it was observed that the ethical issues
dogs, horses, sheep and monkeys in states of ill of animal use were of absolutely no concern to any of
health, as well as geriatric animals, were these scientific institutes. Blind and lame animals
observed to be subjected to severe and invasive were regularly bled for 12–18 litres of blood at
research processes. monthly intervals. In the Haffkine Institute, Pune,
the authorities have built a memorial for a horse that
— Research project proposals involving large ani- has donated 5000 litres of blood. Euthanasia was
mals do not include expenses for their mainte- unknown or not practised, and animals were “bled to
414 S. Pereira et al.

death” in the most savage manner. Pregnant mares WP.216/2001, asked the Government of India to con-
were injected with venom and bled, and foals were sider banning the neurogenic anti-rabies vaccine.
born blind and deformed. Animals died painful After 50 years of the Semple vaccine in India, and
deaths in large numbers, due to liver rupture, unno- 20 years of the World Health Organization (WHO)-
ticed and uncared for. An unscientific and unethical recommended ban on neurogenic sheep brain anti-
culture reigned in these institutes, and the voiceless rabies (Semple) vaccine, on the initiative of the
animals have languished in pain and died miserable CPCSEA, the country will soon finally move into a
deaths over several decades. new era of the safe and painless TCARV.
Veterinarians were found to be ignorant of
equine care and practice. Bleeding was done in open
sheds and stables; bleeding rooms and aseptic con- Discontinuation of the classical LD50 test
ditions were not a part of the bleeding procedure.
Oversized, crude, metallic cannulae were unhesitat- On the recommendations made by the CPCSEA
ingly used, leading to open wounds and abscesses. Sub-committee for Alternatives, the Registration
In this dismal period of July–August 2001, the Committee of the Directorate of Plant Protection,
CPCSEA intervened to introduce scientific and eth- Quarantine and Storage, Ministry of Agriculture,
ical norms of practice. The CPCSEA was forced to agreed in principle to replace the guidelines as
issue directives to suspend bleeding to improve the given in the Gaitonde Committee for the acute
health of the horses used, and to rehabilitate sev- oral LD50 test in rats and mice with the alterna-
eral sick and old equines. tives as suggested by the OECD, namely test
Sensing the need for a standard document on the guidelines 420, 423 and 425. An Expert Group
subject, the CPCSEA has prepared a scientific pro- has been constituted to examine the alternative
tocol for animal care and use in the production of methods and to suggest the appropriate amend-
biologicals from equines, and this need has been ments in the Insecticides Rules 1971. A represen-
further reinforced by the Supreme Court of India, tative of the CPCSEA will be a member of this
which led to the Honorable Court’s direction that group.
the protocol formulated by the CPCSEA must be
followed and must be made mandatory throughout
the country in institutes that use equines. Limulus amebocyte lysate (LAL) assay
A 19-member committee, headed by Dr Kiran
Singh, Deputy Director General (Animal Sciences), The sub-committee for alternatives has submitted a
was responsible for the formulation of this protocol. list of 70 biomedical products for the safety testing,
The protocol covers aspects of general requirements for which the LAL assay can be adopted in lieu of
of equines, selection and quarantine, housing and the rabbit pyrogen test, to the Chairman, Indian
hygiene, nutrition and feeding, endoparasite con- Pharmacopoeia (IP) and Drugs Controller General
trol, immunisation and bleeding, maintenance of of India. The committee has been specially consti-
records and documentation, care of sick and injured tuted by the IP to look into this matter, and it is in
equines and a section on common disorders the final stage of implementation.
observed in equines.

ECVAM and ICCVAM validated alternatives

Alternatives to the use of animals in
research and education The alternatives validated by the European Centre for
the Validation of Alternative Methods (ECVAM) and
The CPCSEA has constituted a sub-committee to rec- the US Interagency Coordinating Committee on the
ommend the use of alternatives in research and educ- Validation of Alternative Methods (ICCVAM), such as
ation. On the initiative and the recommendations of the EpiDerm™ skin corrosivity test, the rat skin tran-
this sub-committee, the regulatory authorities and the scutaneous electrical resistance (TER) test,
Ministry of Health of the Government of India have Corrositex®, the 3T3 NRU (neutral red uptake)
taken steps to introduce the following alternatives. phototoxicity test and the local lymph node assay
(LLNA), have been recommended by the sub-commit-
tee to the regulatory authorities for implementation.
Tissue culture anti-rabies vaccine (TCARV)

In the last two years, the CPCSEA has repeatedly and In vitro production of monoclonal antibodies
persistently reiterated the urgent need to replace the
use and production of the neural tissue vaccine with The commercial production of monoclonal antibod-
TCARV in several meetings and fora. The CPCSEA ies by the ascites method has been banned.
finally brought it to court when the Supreme Court of However, the production houses have asked for a
India, in its interim orders dated 15.02.2002 in the two-year phase-out period.
Animal experimentation and ethics in India 415

Rescue and rehabilitation of laboratory animals repeatedly taken to court. The rescue of 227 bea-
gles, ratification of the CPCSEA Guidelines for the
The CPCSEA has also actively rescued and rehabil- Care and Management of Equines Used in the
itated animals that were found in acute conditions Production of Biologicals, and an initiative of the
of physical and physiological trauma, including Government of India in the replacement of the
cases of non-human primates languishing in cages Semple Vaccine with TCARV, have been the result
for 20 years, showing signs of self-mutilation and of verdicts of the Supreme Court of India.
muscle atrophy; beagles with congenital defects due
to inbreeding; and equines that were old, blind and
lame, yet being bled 18–20 litres of blood. Conclusion
The People for Animals (PfA), India’s largest ani-
mal welfare organisation, with 170 chapters and with It is an undeniable fact that some of the research
animal shelters across the country, has come forward being carried out in Indian laboratories raises
to help the CPCSEA in its rescue endeavours. Other numerous ethical questions that need to be debated
animal welfare organisations have also come forward publicly. The importance of public debate and con-
to extend their local support, as necessary, through- sensus on the issue of the ethical use of animals for
out the country. India’s first non-human primate research needs to be stressed, particularly in light
rehabilitation centre, The Hanuman Vatika, was of the negligible outcome of scientific research in
started by the PfA, New Delhi, in 2001. India, despite huge amounts of publicly funded
To date, 277 beagles have been homed, and 53 grants. A glaring example is the fact that from 1956
mixed-breed dogs, 175 equines, 216 non-human pri- until the present, only 14 medicines invented by
mates, 33 sheep, 124 chickens, 110 rabbits, 5 cobras,
Indian scientists have been approved and released
and several birds, rabbits mice, frogs and rats, have
by the Drug Controller of India. Several Chambers
been rescued and rehabilitated.
of Commerce have even touted India as a cheap
testing ground for both preclinical animal trials and
human trials.
Training of scientific and non-scientific personnel
However, the groundswell of sympathy for ani-
In the last two years, the CPCSEA has been proac- mal suffering and the abhorrence of moral double
tively training honorary workers of the CPCSEA on standards are becoming apparent in the country.
issues of laboratory animal care and use, project Concern for animals is overtly evident among the
proposal scrutiny, alternatives, rescue and rehabili- general population. Some scientists today consider
tation, and rules and regulations pertaining to ani- it important to look for alternatives to animal
mal experimentation in India. Two booklets, experimentation. Animal rights proponents have
Guidelines for CPCSEA Nominees and Guidelines become vocal in questioning the subsidising of ani-
for an Effective Laboratory Check have been pub- mal experiments from public funds and the taxpay-
lished by the CPCSEA. ers’ money. The conflict between the scientists and
Similarly, workshops on issues of animal han- animal rights supporters has already been trans-
dling, anaesthesia and euthanasia, good laboratory ferred into the political arena, and soon the politi-
practices, alternatives, and so on have been con- cians will have to come clean on their positions on
ducted across the country, with the help of subject animal rights.
experts. Meanwhile, the CPCSEA continues to press for
the implementation of existing rules and to lobby
for the constitutional protection for animals, more
Legal cases humane forms of animal experimentation, and the
renunciation of non-critical research. At stake, we
The CPCSEA, in its efforts to implement good lab- believe, is the basic regard for life in all its forms,
oratory practices and alternatives to the use of ani- which has been pushed down the list of priorities in
mals in research and education, has been the nation’s struggle toward progress.