CPCSEA

Dr. Dheeraj Mulchandani

1. PRESENTED BY: Dr. Dheeraj Mulchandani PG Resident Dept. of Pharmacology (CMC, L udhaina ) CPCSEA

2. LEARNING OBJECTIVES Aim, principles and functions of CPCSEA Guidelines laid by CPCSEA

3. overview Introduction to CPCSEA CPCSEA and IAEC Aim, Principles and functions of CPCSEA Guidelines laid by CPCSEA Conclusion Bibliography

4. The principal of anatomy and physiology are true for humans and especially mammals. Certain strains or breeds of animals get the same disease or conditions as humans. They help ensure the effectiveness and safety of new treatments.

5. LAWS FOR EXPERIMENTAL ANIMALS IN INDIA

6. CPCSEA The Committee for the Purpose of Control and Supervision of Experiments on Animals ( CPCSEA ) S tatutory committee, established under Chapter 4, Section 15(1) of the Prevention of cruelty to Animals Act 1960. National level expert committee to scrutinize and approve the research projects conducted using animals.

7. Introduced a national Good Laboratory Practice ( GLP ) document Introduced the credo of 3R principles 2004 – CPCSEA officially accepts the concept of the 4 th R

8. CPCSEA AND IAEC Role of CPCSEA is to monitor animal experiments through ethics committee set up in institution ( IAEC ) CPCSEA nominee – important link between CPCSEA and IAEC. IAEC scrutinize all the projects proposals for experiment on animals -- For small animals – gives the final approval -- For large animals – makes its recommendation to CPCSEA

9. AIM To promote the humane care of animals use in biomedical and behavioral research and testing. To provide quality in gaining advanced biological knowledge that is relevant to humans and animals

10. PRINCIPLES Principle No.1 “ Experiments on animals” may be carried out for t he purposes of advancement by new discovery . OR Knowledge which is expected to be useful for saving or prolonging human life or alleviating suffering

11. 52 Principle No.2 . Animals lowest on the phylogenetic scale should be used for any experimental procedure . . Cockroach (Invertebrates) < Birds < Rodents < Canines < Bovine/Equines <Primates (e.g. Rhesus macaque)< More evolved Primates (e.g. chimpanzee)

12. 53 Principle No.3  Proper use of animals in experiments and avoidance of pain and suffering inflicted on experimental animal s By using appropriate sedation, analgesia or anaesthesia . 

13. 54  Principle No.4 Persons engaged in animal experimentation have a moral responsibility for the welfare of the animals after their use in experiments. .

14. Principle No. 5 The living conditions of animals should be appropriate for their species and contribute to their health and comfort

15. FUNCTIONS OF CPCSEA 40 Main activities Registration of establishments conducting animal experiments or b reeding of animals . Selection and appointment of Nominees in the IAEC. Approval of Animal House Facilities:

16. 4. Permission for Conducting Experiments involving use of Animals. 5. Recommendation for import .

17. GROUND RULES The Member – Secretary would take a decision on any application for registration within two months of receipt Application for permission for conducting experiments are brought before CPCSEA by MS. IAEC of an establishment is constituted by CPCSEA at the time of registration for a period of 5 years.

18. GUIDELINES

19. To promote humane care of animals used in research GOAL

20. 4 VETERINARY CARE  Adequate veterinary care must be provided and is the responsibility of a veterinarian.  Daily observation.

21. 5 All animals must be acquired lawfully as per the CPCSEA guidelines. A health surveillance program for incoming animals should be carried out to assess animal quality . Methods of transportation should be taken into account. ANIMAL PROCUREMENT

22. 6 QUARANTINE, STABILIZATION AND SEPARATION  A n effective quarantine minimizes the chance for introduction of pathogens into an established colony. minimum duration of quarantine - Small lab animals - 1 week and - Larger animals - 6 weeks

23. 7  Newly received animals should be given a perio d of physiologic, psychologic and nutritional stabilization before their use. Physical separation of animals by specie s is recommended.

24. Observe for signs of illness, injury, or abnormal behavior. Unexpected deaths and signs of illness shoul d be reported. If animals are known to be exposed to an infectious agent the group should be kept intact and isolated during the process of diagnosis, treatment, and control. Diagnostic clinical laboratory must be available. SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL OF DISEASE

25. 9 Employ people who are trained in laboratory animal science. They should be provide for both formal and on-the-job training. ANIMAL CARE AND TECHNICAL PERSONNEL

26. PERSONAL HYGIENE PPE – e.g. change of uniforms, footwears . Use disposable gear . No permission to eat, drink, smoke or apply cosmetics in animal rooms.

27. 12 Institutional Biosafety Committee. The procedures must be reviewed by both the Institutional Biosafety committee and Institutional Animal Ethics Committee (IAEC). ANIMAL EXPERIMENTATION INVOLVING HAZARDOUS AGENTS

28. 14 Multiple surgical procedures not to be practiced unless specified in a protocol and only approved by the IAEC. DURATIONS OF EXPERIMENTS No animal should be used for experimentation for more than 3 years unless adequate justification is provided. MULTIPLE SURGICAL PROCEDURES ON SINGLE ANIMAL

29. 15 Brief physical restraint can be accomplished manuall y or with devices. Prolonged restraint of any animal should be avoide d. Less restrictive systems, such as the tether system or the pole and collar system should be used when compatible with research objectives. PHYSICAL RESTRAINT

30. The following are important points for the use of restraint equipments : 16 Not be used simply as a convenience in handling or managing animals Minimum time. Should be given training to adapt to the equipment. Observe the animal at appropriate intervals. Veterinary care should be provided if lesions or illness associated with restraint are observed.

31. 17 LOCATION OF ANIMAL FACILITIES TO LABORATORY Isolated far away from human habitation . This separation can be done by putting animal quarters in separate building, wing, floor or room.

32. 18 FUNCTIONAL AREAS Sufficient animal area is required to - Ensure separation of species or isolation of individual projects when necessary; Receive , quarantine, and isolate animals; Provide for animal housing.

33. PHYSICAL FACILITIES 19 (1)Building material ( 7 ) C o r r i d o r (2)Animal room doors (8) Exterior windows Floors Drains (5)Storage areas (6)Experimental area

34. 20 (a) TEMPERATURE AND HUMIDITY CONTROL   18 to 29°C temperature range 30% to70% relative humidity (b) VENTILATION Heating, ventilation and air conditioning system should be designed with 12-15 air cycles per hour ENVIRONMENT

35. 21 (c) POWER AND LIGHTING  A time-controlled lighting system Emergency power should be available in case of power failure ( d ) NO I S E C ON T R O L

36. (a) CAGING O F HOUSING SYSTEM :  Provide adequate space  Comfortable environment   Easy access to food and water;  Provide adequate ventilation   ANIMAL HUSBANDRY

37. 24 (b) SHELTERED OR OUTDOOR HOUSING :  Accessible to all animals, sufficient ventilation, and prevent accumulation of waste materials and excessive moisture.

38. 26  W A T E R Continuous access of fresh, potable, uncontaminated drinking water. Periodic monitoring of microbial contamination.

39. SANITATION and CLEANLINESS  Cleaning with detergents and disinfectants with Sodium hypercholrite to destroy pathogenic organism.  Wire – bottom cages other than rodent cages should be washed at least every 2 weeks.  C ages can be disinfected by rinsing at a temperature of 82.2 C (180 F ) or higher.

40. WASTE DISPOSAL 27   Remove regularly and frequently . The most preferred method of waste disposal is Incineration. Animal tissues, carcasses, and hazardous wastes should be lined with leak – proof, disposable liners. 

41. RECORD KEEPING 28 The Animal House should maintain following records : Animal House plans , which includes typical floor plan, fixtures. Animal House staff record and there health record All SOPs related to experiments, care and management of animals. Breeding, stock, purchase and sales records

42. Minutes of Institutional Animals Ethics Committee Meetings Records of experiment conducted with number of animals used. Clinical records of sick animals. Water, feed, and bedding material analysis report

43. STANDARD OPERATING PROCEDURES (SOPs ) 29 The Institute shall maintain SOPs describing procedures / methods adapted with regard to  Animal Husbandry  Maintenance  Breeding  Animal house activities  Experimentation records.

44. The SOP should contain the following : Name of the Author Title of the SOP Reference of previous SOP on the same subject and date. N ormal value of all parameters Detail information of the instruments used with methodology.

45. TRANSPORT OF LABORATORY ANIMALS The main considerations for transport of animals are: Mode of transport Containers Food and water during transit Protection from transit infections Injuries and stress

46. ANAESTHESIA AND EUTHANASIA 32

47. COMMONLY USED ANAESTHETIC DRUGS FOR LABORATORY ANIMALS Mouse Rat Hamste r Rabbit Cat Dog Monkey Guinea pig 22-24 i/m 22-24 i/m - 22-24 i/m 30 i/m 30 i/m 15-40 i/m 22-24 i/m Drugs ( m g / k g) K E T A MI -NE PENTO- B AR BIT ONE 35 i/v 50 i/p 25 i/v 50 i/p 35 i/v - 30 i/v 40 i/p 25 i/v - 20-30 i/v - 35 i/v - 30 i/v 40 i/p THIOPE NTONE S O D I U M 25 i/v 20 i/v 20 i/v 20 i/v 25 i/v 25 i/v 25 i/v 20 i/v 50 i/p 40 i/p 40 i/p - - 60 i/p 55 i/p UR E THA NE - 0.75 i/p - 0.75 % 1.25 i/v 1.50 i/p 1.0 i/v 1.0 i/v 1.5 i/p 33

48. EU T H A N A S I A 34 Death, without causing anxiety, pain or distress with minimum time lag phase. Minimum physiological and psychological disturbances. Compatibility with the purpose of study and minimum emotional effect on the operator. Location should be separate from animal rooms and free from environmental contaminants.

49. EUTHANASIA OF LABORATORY ANIMALS (A – Methods Acceptable for species of animals indicated NR – Not Recommended) Species M o u se Ra t Hamster Guinea p i g Ra bb it Ca t Do g M o n k e y a) PHYSICAL METHODS Electrocution Exsanguination Decapitation Cervical dislocation N R N R A A N R A A A N R A A A N R A N R N R N R A N R N R N R A N R N R N R N R N R N R N R N R N R N R b) INHALATION OF GASES Carbon mono oxide Carbon di oxide C O 2 + C h l o r o f o rm Halothane A A A A A A A A A A A A A A NR NR A A A A A A NR NR A A A A A A A A c) DRUG AD M I N I S TRA TION Barbiturate overdose Chloral hydrate overdose Ketamine overdose Sodium Pentothol (IP) NR I M / IP IP (IP) NR I M / IP IP (IP) NR (I M / I P ) IP (IP) NR I M / IP IP IV,IP IV I M / IV IV IV I V ,IP I V ,IP I V ,IP IV IV IV IM IM I M / IV IV 3 I 5 V

50. SUMMARY Laws related to animals The 3 R and introduction of the 4R Introduction of GLP Goal

51. BIBLIOGRAPHY Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA). Available from cpcsea.nic.in ( Last accessed on 2019 July 4 ) Badyal DK, Desai C. Animal use in pharmacology education and research: The changing scenario. Indian J Pharmacol , 2014, 43: 257-65. Gandhi M, Husain O, Panjwani R. Animal laws of India, 3 rd edition.