Prevention of Cruelty to Animals Act
Prevention of Cruelty to Animals Act-1960: Objectives, Definitions, CPCSEA - brief overview, Institutional Animal Ethics Committee, Breeding and Stocking of Animals, Performance of Experiments, Transfer and Acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties.
PHARMACEUTICAL JURISPRUDENCE
Alok Bains
1/18/20247 min read
Prevention of Cruelty to Animals Act-1960: Objectives, Definitions, CPCSEA - brief overview, Institutional Animal Ethics Committee, Breeding and Stocking of Animals, Performance of Experiments, Transfer and Acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties. Subject Pharmacy Law and Ethics.
Prevention of Cruelty to Animals Act 1960
Objective: To prevent the unnecessary pain or suffering of animals.
Definitions
“Captive Animal” means any animal (not being a domestic animal) in custody, whether permanent or temporary, or which is subjected to any device to prevent its escape from custody.
“Domestic Animal” means any animal which is under control to serve some purpose for the use of man.
“Phooka” or “Doom dev” includes any process of introducing air or any substance into the female organ of an animal with the object of drawing off from any secretion of milk.
CPCSEA - brief overview
The Committee for the Prevention, Control, and Supervision of Experiments on Animals (CPCSEA) is an organization that regulates the use of animals for scientific and educational purposes.
Objective: The main objective of CPCSEA is to control and supervise experiments on animals for the advancement of scientific knowledge. It ensures that experiments are conducted with utmost care and consideration for the welfare of the animals involved.
Functions: CPCSEA regulates the use of animals in research by issuing guidelines and monitoring compliance. It approves the establishment and functioning of animal houses. It also reviews and approves research proposals involving the use of animals.
Inspections and Oversight: CPCSEA conducts regular inspections of facilities involved in animal experimentation in institutions and laboratories. It ensures that adherence to ethical standards and complies with the guidelines laid down by the committee.
Record-keeping: Institutions conducting experiments on animals shall maintain detailed records of the experiments, number and species of animals used, methods employed, and the results obtained. CPCSEA reviews these records during inspections.
Training and Awareness: CPCSEA promotes awareness about the ethical treatment of animals in scientific research. It also encourages the training of personnel involved in animal experimentation to ensure that they have the necessary skills and knowledge to minimize any harm to the animals.
Approval Process: Researchers and institutions intending to conduct experiments on animals must obtain approval from CPCSEA before commencing their work. The committee assesses the scientific and ethical aspects of the proposed experiments.
Ethical principles adopted by CPCSEA for the use of animals in scientific experiments
Principle 1
“Experiments on animals” may be carried out for the purposes of advancement by new discovery of physiological knowledge; or of knowledge which is expected to be useful for saving or prolonging human life or alleviating suffering; or for significant gains in the wellbeing of the people of the country; or for combating any disease, whether of human being, animals or plants.
Principle 2
Animals that may give scientifically valid results should be used for any Experimental procedure. Experiments should be designed with the minimum number of animals to give statistically valid results. If possible prefer an alternate method not involving animal testing.
Principle 3
Proper use of animals in experiments to avoid or minimize pain and suffering on experimental animals. All scientific procedures with animals that may cause more than momentary pain and/or suffering should be performed with appropriate sedation, analgesia, or anesthesia.
Principle 4
Persons engaged in animal experimentation have a moral responsibility for the welfare of the animals after their use in experiments. Euthanize animals only in the following situations:
(a) When the animal is paralyzed and is not able to perform its natural functions;
(b) The animal exhibits obvious signs of long-term extreme pain and suffering.
(c) In situations where the animal experimented upon would be life-threatening to human beings or other animals.
Principle 5
The living conditions of animals should be appropriate for their species and contribute to their health and comfort. The housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian. Another scientist in a relevant discipline trained and experienced in the proper care, handling, and use of the species can also direct the appropriate condition.
Institutional Animal Ethics Committee (IAEC)
Institutional Animals Ethics Committee means a local body comprising of a group of persons recognized and registered by the CPCSEA for the purpose of control and supervision of experiments on animal performed in an establishment. It works in an establishment to permit experiments on small animals through Rules for Breeding and Experiments on Animals (Control and Supervision). Institutional Animals Ethics Committee operates in accordance with procedures specified by the CPCSEA.
Composition and Constitution of IAEC
1. Chairman of the committee: Preferably Head of the Dept.
2. A Biological Scientist
3. Two Scientists from Different Biological Disciplines
4. A Veterinarian Involved in The Care of Animal
5. A Scientist in Charge of Animals Facility
6. A CPCSEA Main Nominee & A CPCSEA Link Nominee
7. A Scientist from Outside the Institute
8. A Socially Aware Nominee
A member secretary would be nominated by the institution from amongst the nine members. IAEC will be reconstituted for 5 years. Midterm reconstitution may be requested to CPCSEA in special cases such as death, long time non‐availability or violation in responsibilities of IAEC. Request for renewal of registration and reconstitution of IAEC will be uploaded to CPCSEA website, along with required documents. A hard copy will also be sent to CPCSEA along with required demand draft for reconstitution fees.
Quorum Requirements: A minimum of 6 members is required for quorum. The presence of CPCSEA main/link nominee is mandatory for every meeting. Link nominee will attend in case main nominee conveys his unavailability in writing (hard copy or email) to the Chairman IAEC. Socially aware member’s presence is compulsory in cases referred to CPCSEA at least in one meeting in a calendar year.
Frequency of IAEC Meetings
1. Minimum 2 meetings will be held in 1 year.
2. Additional meetings will be held as and when necessary.
3. Regular meeting will be called in month of March and September.
4. Even if there are no projects, frequency of meeting will be maintained;
5. The Animal House In‐Charge will maintain and provide all relevant record to the committee members.
The Chairperson will conduct all meetings of the IAEC. If the Chairperson is not available, an alternate Chairperson will be elected by the members present from among themselves. The Member Secretary will be responsible for organizing the meetings, maintaining the records and communicating with all concerned. Copy of minutes will be uploaded to CPCSEA website as well as hard copy will be sent to Member Secretary, CPCSEA within 15 days of meeting, if no genuine cause of delay is in existence.
Breeding of and Experiments on Animals (Control and Supervision) Rules, is part of the Prevention of Cruelty to Animals Act, 1960
Definitions:
"Breeder" means a person including an institution, which breeds animals for the purpose of transfer to other authorised institution for performing experiments;
Breading of animals
1. Only registered establishment shall carry on the business of breeding of animals or trade of animals for the purpose of experiments.
2. Application for registration. –
3. (a) The application for registration by a breeder shall be made in the specified format to the Member- Secretary or any other officer authorised in this regard by the Committee.
4. (b) The Member-Secretary or the authorised officer of the Committee asks for information relating to premises where the experiments are to be conducted, animal housing facilities, details of breeding of animals and its trade, other infrastructure, availability of manpower trained in handling animals and for verification of facts mentioned in the application for registration If satisfied, establishment/breeder shall be registered. (c) A breeder/establishment on registration shall comply with the conditions as specified at the time of registration.
Stocking of animals: The animals shall be stocked by the breeder and the establishment in the following manner:
1. Animal houses shall be located in a quiet atmosphere undisturbed by traffic.
2. The premises shall be kept tidy, hygienic and the animals protected from drought and extremes of weather;
3. Animal cages for small animals and stables for large animals shall be used.
4. Size of cages/stables should be large enough that animals can live in comfort and overcrowding is avoided;
5. Where standards have been laid down by the Indian Standards Institution, the cages, the stable shall conform to those standards;
6. Animals attendants must be suitably trained and experienced,
7. Animals shall be looked after, before and after the experiments by a trained and experienced attendant;
8. There shall be satisfactory arrangements for looking after the animals during off hours and on holidays.
Transfer and acquisition of animals for the experiment.
1. A breeder shall not transfer any animal to an establishment that is not registered under these rules.
2. An establishment shall not acquire any animal other than from a registered breeder/establishment.
3. Every establishment after the acquisition of animals shall not transfer such animal or animals to any other establishment or person except to a registered breeder/establishment.
4. The animals used for experimentation may be given for domestic use.
5. No animal shall be imported by a breeder or an establishment that is available in the country.
6. A breeder or establishment shall comply with the directions given by the Committee.
Records
1. Establishment Animals Ethics Committee shall maintain a record of the animals under its control and custody in the specified format.
2. Establishment Animals Ethics Committee shall furnish information to the Committee from time to time in the specified format.
3. All laboratories shall inform the exact number/ species of animals to the Member Secretary or any officer authorized in this regard by the Committee.
Power to suspend or revolve registration
Committee may suspend the registration, If the report of the authorised officer of the Committee states that the rules are not being complied with by any establishment or breeder or Institutional Animals Ethics Committee. The committee will give a reasonable opportunity to the establishment or breeder or Institutional Animals Ethics Committee to explain his position before the suspension of registration. The committee may suspend registration for a specified period or indefinitely. Committee may allow the establishment; breeder or Institutional Animals Ethics Committee to carry on subject to special conditions imposed by the Committee.
The Committee may issue directions for the care and protection of the animals that are under the custody or control of such establishment or the breeder.
Establishment or breeder or Institutional Animals Ethics Committee shall cease to perform any experiment on, any animal or acquire or transfer any animal.