PHARMACY ACT-1948.ppt

Pharmaceutical Jurisprudence

1. 1PHARMACY ACT -1948
MR. jagatpal Yadav
Faculty of pharmaceutical sciences Rama University,
Kanpur, (U.P)

2. CONTENT
HistoryofPharmacyAct
Objectives
Definitions
ThePharmacycouncilofIndia
ProvincialPharmacyCouncil
RegistrationofPharmacists
RenewalFees
RemovalofthenamesfromRegister
IssueofduplicateCertificatesofRegistration
OffencesandPenalties
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3. HISTORY OF PHARMACY ACT
InIndiatherewasnorestrictiontopractisetheprofessionof
Pharmacy.
Onecouldpractisethisprofessionasanyotherprofession.
Persons,havingnoknowledgeandhavingnoeducationin
pharmacyorpharmaceuticalchemistryorpharmacology,
wereengagedinthisprofession.
3

4. HundredsofcaseswerefoundbyGovernmentwhereinthe
compounding,mixing,ordispensingofmedicineswasbeing
donebypersonswhowerenotadequatelyeducatedinthisline.
Thesecausinggreatharmtothehealthofpeople.
Itwasfoundnecessarytoenactalawfortheregulationofthe
professionandpracticeofpharmacy.
4
Cont…

5. LIST OF AMENDING ACTS & ADAPTATION
ORDERS
TheAdaptationofLawsOrder,1950.
TheAdaptationofLaws(No.3)Order,1956.
ThePharmacy(Amendment)Act,1959.
ThePharmacy(Amendment)Act,1976.
ThePharmacy(Amendment)Act,1982.
TheDelegatedLegislationProvisions(Amendment)Act,
1985.
5

6. OBJECTIVES
TorestorethePharmacyprofessioninitsdueplaceinthehealth
services.
RaisingthestatusoftheprofessionofPharmacyinIndia.
ToregulatethepracticeofPharmacyinIndia.
ToprovideuniformeducationandtrainingthroughoutIndia.
Tomaintaincontroloverpersonsenteringtheprofessionof
pharmacy.
ToProtectthePublicHealth
–MedicalUseofDrugs
–DrugAbuse
6

7. DEFINITIONS
“PharmacyAct”
AnActtoregulatetheprofessionofpharmacy.
Medicalpractitioner:
Aperson,
1)Holdingaqualificationgrantedbyanauthoritynotifiedunder
section3oftheIndianMedicalDegreesAct,1916orspecifiedin
theSchedulestotheIndianMedicalCouncilAct1956;OR
II)RegisteredoreligibleforregistrationinaMedicalregisterofaState,
meantfortheregistrationofpersonspracticingtheModernscientific
systemofmedicine;OR
III)RegisteredinamedicalregisterofaState,who,althoughnotfalling
withinabovefirstandsecondclause,butisdeclaredbyageneralor
specialordermadebytheStateGovernment;OR
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8. (iv)RegisteredoreligibleforregistrationintheregisterofDentists
foraStateundertheDentistsAct,1948;OR
(v)WhoisengagedinthepractiseofVeterinarymedicineandwho
possessesqualificationsapprovedbytheStateGovernment.
RegisteredPharmacist:-
Apersonwhosenameisforthetimebeingenteredintheregister
oftheStateinwhichheorsheisforthetimebeingresidingor
carryingonhisprofessionorbusinessofpharmacy.
8
Cont..

9. PHARMACY COUNCIL OF INDIA
Thecentralcouncil(P.C.I)isconstitutedbytheCentral
government.
Firstcentralcouncilwasconstitutedin1949.
Itisreconstitutedeveryfiveyears.
CONSTITUTION OFP.C.I.
Itconsistsofthreedifferenttypesofmembers:
Electedmember
Nominatedmember
Ex-officiomember
9

10. 1.) Elected members:
1)Sixmembers,electedbytheUniversityGrantcommission(U.G.C).There
isatleastoneteacherofeachofthePharmaceuticalchemistry,
Pharmacy,&PharmacognosyandPharmacology.
2)Onemember,electedbyMedicalCouncilofIndia.
3)Onemember,electedbyStateCouncil,whoshallbearegistered
Pharmacist.
2.)Nominatedmembers:
1)Sixmembers,nominatedbytheCentralGovernment.Ofwhomatleast4
shallbepersonspossessingadegreeordiplomain,andpracticing
pharmacyorpharmaceuticalchemistry.
2)ARepresentativeoftheU.G.C.andarepresentativeoftheAllIndiaCouncil
forTechnicalEducation(A.I.C.T.E.).
3)OnemembernominatedbyeachStateGovernment,whoshallbea
registeredpharmacist.
10

11. C.)Ex-officiomembers:
1)TheDirectorGeneralofHealthServices.
2)TheDirectoroftheCentralDrugsLaboratory.
3)TheDrugsControllerofIndia.
ExecutiveCommitteeconsistingof:
President
Vice-president
Fivememberselectedbycentralcouncilfromitsmembers.
PresidentandVice-PresidentofCentralCouncilshallbeelectedbythe
membersoftheCouncilfromthemselves.
Thecouncilshallappoint,
-Aregistrar,actassecretary
-Otherofficerandservants.
11

12. FUNCTIONS OF P.C.I. :
A) Education Regulations (E.R.)
i)Minimum standard of education laid down by P.C.I. are known
as “Education Regulation”.
ii)They include,
MinimumqualificationforregistrationasaPharmacist.
iii.Minimum qualification for admission to Diploma in Pharmacy.
Duration of training and course of study to be covered.
iv.Condition to be fulfilled by the academic Institution and by the
Examining Authority.
v.Nature and period of practical training .
vi.The subjects of examination and minimum standard of passing.
vii.Condition to be fulfilled by the institution to be recognized for
giving practical training.
viii.Practical training contract form for Pharmacists. 12

13. B)ToregulatetheEducationRegulationinthestates.
C)ApprovaloftheInstitutionsprovidingcourseandexamination
forthepharmacists.
Procedure:
i)InstitutionhastoapplytoP.C.I/A.I.C.T.E.
ii)P.C.I/A.I.C.T.E.deputesitsinspectortovisittheinstitution.
iii)Inspectorthenreportstocouncilonwhichifcouncilis
satisfied,itapprovesthecourseofexamination.
13
Cont..

14. PROVINCIAL PHARMACY COUNCIL
Classification:
 Provincial pharmacy council
Separate state council Inter state agreement
(S.P.C.)
Joint state-state council of-(JPC)
council 1state serve the –(State)
14

15. CONSTITUTION OFSEPARATE STATE
COUNCIL(S.P.C.)
Itconsistsofthreedifferenttypesofmembers:
A.Electedmember
B.Nominatedmember
C.Ex-officiomember.
A.Electedmember:
1)Sixmembers,electedfromamongstthemselvesbyregistered
pharmacistsoftheState.
2)onememberelectedfromamongstthemselvesbythemembers
ofeachMedicalCouncilofthestate.
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16. B.Nominatedmember
1)Fivemembers,ofwhomatleastthreeshallbepossessinga
degreeordiplomainpharmacyorpharmaceuticalchemistryor
beRegisteredPharmacists,nominatedbytheStateGovernment.
C.Ex-officiomember
1)ChiefadministrativemedicalofficeroftheState.
2)GovernmentanalystnominatedbyStategovernmentunderthe
D&Cact1940.
3)OfficerinchargeofdrugscontrolorganisationoftheState.
16
Cont…

17. JOINT STATE PHARMACY COUNCIL
TwoormoreStateGovernmentscanagreethattheState
CouncilofoneStateistoservetheneedsoftheparticipating
States.
CompositionofJointStateCouncils:
Itconsistsofthreedifferenttypesofmembers:
A.Electedmember
B.Nominatedmember
C.Ex-officiomember.
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18. A.Electedmember:
3-5memberselectedamongstthemselvesbytheRegistered
PharmacistsofeachoftheparticipatingStates.
Onememberelectedfromamongstthemselvesbythemembers
ofeachMedicalCouncilofeachState.
B.Nominatedmember:
2-4membersnominatedbyeachparticipatingstate,ofwhom
morethanhalfpossessadegreeordiplomainpharmacyorbe
RegisteredPharmacist.
18
Cont…

19. C.Ex-officiomember:
1)TheChiefadministrativemedicalofficerofeachparticipatingState.
2)TheGovernmentAnalystofeachparticipatingstate.
3)Theofficerin-chargeofdrugscontrolorganisationofeach
participatingState.
ExecutiveCommitteeconsistingof:
President
Vice-president
Thesuchothernumberofthemember.
REGISTRATION OF PHARMACISTS
ThePharmacyAct,1948,providesfortheregistrationofpharmacists
Therearetwotypesofregister,
1)Firstregister
2)Subsequentregister
19
Cont…

20. TheRegistershallincludethefollowingparticulars,namely:
a)Thefullnameandresidentialaddressoftheregisteredperson.
b)Thedateofhisfirstadmissiontotheregister.
c)Hisqualificationsforregistration.
d)Hisprofessionaladdress,andifheisemployedbyanyperson,
thenameofsuchperson.
e)Suchfurtherparticularsasmaybeprescribed.
PREPARATION OF FIRST REGISTER
TheTribunalconsistingof:
-ARegistrar,actasSecretary.
20The Preparation and maintenance of Register:

21. Tribunalfixesthedateonorbeforewhichallapplicationsforregistrationwith
prescribedfeesareaccepted.
Allapplicationsareexamined.
Iftribunalissatisfied,itdirectstheentryofthenameoftheapplicantonthe
register.
QUALIFICATIONS FOR ENTRY ON FIRST REGISTER
Applicantshouldbeatleast18yearsold.
Applicantshouldresideorcarriesonthebusinessorprofessionofpharmacy
intheconcernedState.
Applicantshouldhold,
a)AdegreeordiplomainpharmacyorPharmaceuticalchemistry
b)ChemistandDruggistdiploma
21
Cont..

22. c)QualificationgrantedbyauthorityoutsideIndiawhichis
adequateforregistration.OR
d)DegreeofanIndianuniversitieswithnotlessthan3years
experienceindispensinginhospital.OR
e)Passedanexaminationfordispensersrecognizedbystate
government.
f)Notlessthan5yearsexperienceofcompoundingpriortothedate
notifiedbyTribunal.
22Cont…

23. SUBSEQUENT REGISTERS
Procedureforsubsequentregistration:
Fromtheregisteredpharmacistsofthefirstregisterconstitution
ofStatecounciltakeplace.
Applicationareinvitedwithinfixdate,addressedtotheregistrar
Ifregistrarfoundthatapplicanthasrequisitequalification,he
maydirecthis/hernametobeenteredinregister.
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24. If application has been rejected by registrar, he/she may
appeal to state council within 3 months of the rejection.
The decision of the state council shall be final.
REQUIREMENTS FOR SUBSEQUENT REGISTRATION
Applicantsshouldbeatleast18yearsoftheage.
Applicantsshouldcarryontheprofessionofthepharmacyinthe
concernedstate.
24
Cont…

25. QUALIFICATIONS FOR SUBSEQUENT
REGISTRATION
Thereare3differenttypesofqualificationsprescribed:
1)AfterthepreparationoffirstregisterandbeforeE.R.takeeffect.
2)AfterE.R.takeeffect.
3)Specialprovisions.
AfterthepreparationofFirstregisterandbeforeE.R.
takeeffect:-
SatisfiestheconditionsprescribedbytheCentralCouncil.
AregisteredpharmacistinanotherState.
Possessesaqualificationforregistrationgrantedoutsidethe
statesandareatleastmatriculates.
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26. After the Education regulations take effect:
Those who have passed an approved examination.
Those who possesses a qualification granted by authority outside India
and recognize by the P.C.I.
Those who are Registered Pharmacist in another State.
Special provisions:
Provision made under The Pharmacy Act 1959, apply to persons.
Affected by the partition in 1947.
Due to reorganization of the state in 1956.
Migrated to India.
Provision made under The Pharmacy Act 1976.
Those who possess degree or diploma in pharmacy or Pharmaceutical
chemistry.
Chemist & druggist diploma of Indian university .
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27. PassedanexaminationrecognizedfordispenserbyState
government.
Personapprovedas“Qualifiedpersons”before31
st
December
1969underD&CAct.
AnydisplacedpersonsfromBangladesh,Burma,Uganda,Sri
Lanka,werecarryingprofessionofpharmacyforperiodof5
yearspriortodateofapplication.
27Cont…

28. RENEWALFEES
Retentionofanameontheregister,subjecttothepaymentof
prescribedfeeannuallybeforethe1
st
dayofApril.
Ifarenewalfeeisnotpaidbytheduedate,theRegistrarshall
removethenameofthedefaulterfromtheregister.
Providedthatanamesoremovedmayberestoredtotheregister
onsuchconditionsasmaybeprescribed.
Onpaymentoftherenewalfee,theRegistrarshallissueareceipt
thereforeandsuchreceiptshallbeproofofrenewalof
registration.
Entryofadditionalqualificationsobtainedbyregistered
pharmacistshallbeenteredintheregisteronpaymentof
prescribedfees.
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29. REMOVAL OF NAME FROM REGISTER
ThenameofPharmacistmayberemovedfromregister.
Ifhisnamehasbeenenteredintotheregisterbyerror.
Ifhehasbeenconvictedofanyoffenceinanyprofessional
respectwhichrendershimunfittobekeptintheregister.
Iftheemployedpersonisregisteredpharmacist,hisnamemay
beremovedfromregister.
If,
Convictedofoffenceorheldguiltyofinfamousconduct.
Offencewasinvestigatedbyregisteredpharmacisthimself.
Iftherepetitionofsimilaroffenceorconductduringtheperiod
of12month.
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30. 30
OFFENCES PENALTIES
1. Falsely claimingto be a registered
pharmacist.
1.(a) Fine up to Rs. 500.00 on first
conviction.
(b) Fine up to Rs. 1000.00 and/or 6
months imprisonment of any
subsequent conviction.
2. Dispensed by unregistered persons.
Exception:
Medical practitioners.
2. 6 months imprisonment OR Fine up
to Rs. 1000.00 OR Both.
3.Failure tosurrender certificate of
registration.
3. Fine up to Rs. 50.00
4.ObstructingState pharmacy
council Inspectors.
4. 6 months imprisonment OR Fine up
to Rs. 1000.00 OR Both.
OFFENCES PENALTIES

31. REFERENCES
1)www.pci.nic.in/contents.htm.
2)Dr.G.K.Jani,PharmaceuticalJurisprudence,5
th
edition
2005-2006,Atulprakashan,Ahmedabad,pageno15-27.
3)http://144.16.72.182/vigyan/pharm.htm
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