Group No. 13.vhuuuuuuuuuhhhhuuuuuhhhhpdf

Pharmaceutical Jurisprudence of Bpharmacy third year semester 5th

2. Annasaheb Dange College Of B. Pharmacy, Ashta
Active learning session
Pharmaceutical Jurisprudence
Presented By-
Gouri Mirje. (61)
Vikramsinh Misal. (62)
Prajyot Mohite. (63)
Snehal Mohite. (64)
Atharv More. (65)
Under guidance of-
Mr. Nikhil Patil Sir
M Pharm, Quality Assurance
Assist. Prof. ADCBP, Ashta

3. Prevention of Cruelty to animals Act-1960:
Content-
Objectives
Definitions
Institutional Animal Ethics Committee

4. Introduction
ThePreventionofCrueltytoAnimals(PCA)Act,1960(amendedin
1982),wasenactedtopreventtheinflictionofunnecessarypainor
sufferingonanimals,
BeforethisAct,differentregionsofIndiahadseparaterules,sothe
GovernmentofIndiaappointedacommitteetostudythematter.Based
onitsrecommendations,thisActwaspassed..

5. TheActprohibitsbeating,kicking,torturing,mutilating,poisoning,
overloading,cruelkilling,confining,chaining,orabandoning
animals.Italsomakesanimalfightingandshootingcompetitions
illegal.

6. Toregulateanimalexperiments,theCommitteeforthePurposeof
ControlandSupervisionofExperimentsonAnimals(CPCSEA)was
constituted,ensuringanimalsarenotsubjectedtounnecessary
sufferingbefore,during,orafterexperiments.
Furthermore,theBreedingofandExperimentsonAnimals(Control
andSupervision)FurthermoreRules,1998(amendedin2001&2006)
wereframedtoensureethicalstandardsinanimalresearch.

7. Object
Themainobjectofthisactis
1.Topreventtheinflictionofunnecessarypainorsufferingon
animalsaswellastopreventcrueltytoanimals.
2.Toamendthelawsrelatingtothepreventionofcrueltytoanimals.

8. Definitions
"Animals":Thistermincludesanylivingcreatureexcepthuman
being.
Phooka"or"DoomDev":Itincludesaprocessinwhichany
substanceorairisintroducedintothefemaleorganofamilchanimal
withtheintentionofdrawingoffanysecretionofmilk.
"Cruelty":Itisnotdefinedunderthisactbutitroughlymeansthe
inflictionofunnecessarypainorsuffering.

9. IAEC:"InstitutionalAnimalsEthicsCommittee"meansabodyof
comprisingofagroupofpersonsrecognizedandregisteredbythe
committeeforcontrolandsupervisionofexperimentsonanimalsin
anestablishment,constitutedandoperatedasperproceduresspecified
bythecommittee.

10. InstitutionalAnimalsEthicsCommittee(IAEC)
TheInstitutionalAnimalEthicsCommittee(IAEC)isalocalbody
thathasbeenapprovedbyCPCSEAtoconductanimalexperiments.
TheCPCSEArecognisesandregistersabodymadeupofagroupof
people.
Experimentsmustbeconductedunderthesupervisionofaqualified
person,andaccordingtoIAEC.

11. CompositionofIAEC
1)Abiologicalscientist,
2)Twoscientistsfromdifferentbiologicaldisciplines,
3)Aveterinarianinvolvedinthecareoftheanimal,
4)Scientistin-chargeofanimalsfacilityoftheestablishmentconcerned,
5)Ascientistfrom,outsidetheinstitute,
6)Anon-scientificsociallyawarememberand
7)AnomineeofCPCSEA.

12. Objectives
a)Experimentsshallbeperformedunderthesupervisionofaperson
dulyqualifiedinthatbehalf,thatis,DegreeorDiplomaholdersin
VeterinaryScienceorMedicineorLaboratoryAnimalScienceofa
UniversityoranInstitutionrecognisedbytheGovernment.
b)Experimentsareperformedwithcareandhumanityandthatasfar
aspossibleexperimentsinvolvingoperationsareperformedunderthe
influenceofsomeanestheticofsufficientpowertopreventthe
animalsfeelingpain.

13. c)Animalswhich,inthecourseofexperimentsundertheinfluence
ofanesthetics,aresoinjuredthattheirrecoverywouldinvolveserious
suffering,areordinarilydestroyedwhilestillinsensible.
d)Experimentsonlargeranimalsareavoidedwhenitispossibleto
achievethesameresultsbyexperimentsuponsmalllaboratory
animalslikeguinea-pigs,rabbits,mice,rats,etc.
e)Asfaraspossible,experimentsarenotperformedmerelyforthe
purposeofacquiringmanualskill.

14. f)Animalsintendedfortheperformanceofexperimentsare
properlylookedafterbothbeforeandafterexperiments.
g)Suitablerecordsaremaintainedwithrespecttoexperiments
performedonanimals.

15. FunctionsofIAEC
TheprimarydutyofIAECistoworkforachievementoftheobjectives
asmentionedabove.
IAECwillreviewandapprovealltypesofresearchproposals
involvingsmallanimalexperimentationbeforethestartofthestudy.
Forexperimentationonlargeanimals,thecaseisrequiredtobe
forwardedtoCPCSEA inprescribedmannerwiththe
recommendationofIAEC.

16. TheminimumqualificationfortheIAEC
Membersisasbelow:
B.V.Sc.Or
(ii)M.Sc.(Zoology/AnimalSciences/AnimalBiotechnology),or
(iii)M.Sc./M.Tech(LifeSciences,BiologicalSciences/
Biochemistry/Biotechnology/BiomedicalEngineering)with
experienceinanimalhandlingandanimalresearch,or
(iv)M.Pharm,withexperienceinanimalhandlingandanimal
research,orv.MD/MSwithresearchexperienceinlaboratoryanimal
handling.

17. Authority under which IAEC is constituted and
duration :
TheIAECofanestablishmentisconstitutedbyCPCSEAatthetime
ofregistrationforaperiodof5years.
Duringthese5years,revisioninIAECSmaybemadeindeserving
caseswiththeapprovalofCPCSEA.
TheIAECwouldbereconstitutedatthetimeofrenewal,duly
approvedbyCPCSEA,foranother5years.

18. Theestablishmentsarerequiredtosendnamesof5membersat
thetimeofconstitutionandateveryreconstitution.Itismandatory
thatatleasthalfofthemembersofIAECarenewatthetimeof
reconstitution

19. IAEC Requirements:
1.Thedurationofappointmentisforaperiodof5years.
2.Thecommitteeisrequiredtobereconstitutedatthetimeofrenewal
ofregistrationandatleasthalfoftheinternalIAECmembersisrequired
bereplacedatthetimeofrenewal.
3.Amembercanbereplacedintheeventofdeathorlong-termnon-
availabilityorforanyactionnotcommensuratewiththeresponsibilities
laiddownintheguidelinesdeemedunfitforamember.

20. 4.Amembercantenderresignationfromthecommitteewith
properreasontodoso.
5.Allmembersshouldmaintainabsoluteconfidentialityofall
discussionsduringthemeetingandsignaconfidentialityform.
6.ConflictofinterestshouldbedeclaredbymembersoftheIAEC

21. 7.IAECisrequiredtoformulateaSOPforitsworkingrequirements
andfollowitinallthemeetings.
8.ForeignNationalsshallnotbeallowedasmemberoftheIAECs
ofanyestablishments.