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Pharmaceutical legislation notes

1. PHARMACEUTICAL
LEGISLATIONS
1

2. Syllabus:
•Introduction
•StudyofDrugsEnquiryCommittee
•HealthSurveyandDevelopmentCommittee
•HathiCommitteeandMudaliarCommittee.
•CodeofPharmaceuticalEthics–Definition
•PharmacistOath.
•MedicalTerminationofPregnancyAct.
•RighttoInformationAct.
•IntroductiontoIntellectualPropertyRights(IPR)
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3. Thelawrelatedtopharmacyprofession,drugs,medicines,
cosmeticsaffectinghealthofhumanbeingsandanimals,is
knownaspharmaceuticallegislation.
Intheearlypartofthe20
th
century,therewaspracticallyno
legislativecontrolondrugsaswellasontheprofessionof
pharmacyinIndia.AlthoughtheOpiumAct1878,thePoison
Act1919andtheDangerousDrugsAct1930wereinforce,
thesewerespecificinnatureandapproximatelyinadequate
incontrollingtheextremelydisorganizedconditions
predominantatthattime
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4. In1927resolutionwaspassedbythecouncilofstates
torecommendtotakeimmediatestepstocontrol
unsystematicuseofdrugsandtolegislateforthe
standardizationofthepreparationandsaleofdrugs.The
governmentofIndiainpursuancetotheresolution
appointedacommitteeknownastheDrugsEnquiry
Committeein1928.
GovernmentofIndiaon11
th
August1930,appointeda
committeeunderthechairmanshipofLateCol.R.N.
ChopratoseeintotheproblemsofPharmacyinIndiaand
recommendthemeasurestobetaken.This
committeepublisheditsreportin1931.
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5. RecommendationsoftheDrugEnquiryCommittee
TheformationoftheCentralPharmacyCouncilandState
PharmacyCounciltolookintotheeducationandtraining
ofprofessionals.
Thecommitteesuggestedthecreationofa
departmenttocontroldrugsatthecentrallevelwith
branchesinvariousstates.
TheestablishmentofaCentralDrugLaboratoryto
checkthequalityandefficacyofthedrugsbeing
producedandsoldinthecountry
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6. ChronologyofEventsinPharmaceuticalLegislation:
TheoriginsofPharmaceuticalLegislationcanbebrieflytraced
throughthefollowingchronology:
1937:GovernmentofIndiabrought‘ImportofDrugsBill’;laterit
waswithdrawn.
1940:Govt.brought‘DrugsBill’toregulatetheimport,
manufacture,saleanddistributionofdrugsinBritishIndia.ThisBill
wasfinallyadoptedas‘DrugsActof1940’.
1941:ThefirstDrugsTechnicalAdvisoryBoard(D.T.A.B.)underthis
actwasconstituted.CentralDrugsLaboratorywasestablishedin
Calcutta.
1945:‘DrugsRuleundertheDrugsActof1940’wasestablished.
1945:Govt.broughtthePharmacyBilltostandardizethePharmacy
EducationinIndia
1946:TheIndianPharmacopoeialListwaspublishedunderthe
chairmanshipoflateCol.R.N.Chopra.Itcontainslistsofdrugsin
useinIndiaatthattimewhichwasnotincludedinBritish
Pharmacopoeia.
1948:PharmacyAct1948published
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7. 1948:IndianPharmacopoeialCommitteewasconstituted
underthechairmanshipoflateDr.B.N.Ghosh.
1949:PharmacyCouncilofIndia(P.C.I.)wasestablished
underPharmacyAct1948.
1954:EducationRegulationhascomeinforceinsome
states.
1954:DrugsandMagicRemedies(Objectionable
Advertisements)Act1954waspassedtostopmisleading
advertisements(e.g.Cureallpills)
1955:MedicinalandToiletPreparations(ExciseDuties)Act
1955wasintroducedtoenforceuniformdutyforallstates
foralcoholproducts.
1955:FirstEditionofIndianPharmacopoeiawaspublished.
1985:NarcoticandPsychotropicSubstancesActhasbeen
enactedtoprotectsocietyfromthedangersofaddictive
drugs.
Govt.ofIndiacontrolsthepriceofdrugsinIndiabyDrugs
PriceOrderchangedfromtimetotime.
7

8. BriefOverviewoftheMajorPharmaceutical
LegislationsinIndia
8
Year Legislation ScopeandObjective
1940
TheDrugand
CosmeticsAct.
Theactcoversprovisionsrelatedtodrugs,cosmetics,
AyurvedicincludingUnaniandhomoeopathicmedicines.
ThemainobjectiveofthisActistoregulatetheimport,
manufacture,distributionandsaleofdrugsandcosmetics.
1948PharmacyAct
Theobjectiveofthisactistoregulatetheprofessionof
pharmacyinIndia.
1954
TheDrugsandMagic
Remedies
(Objectionable
Advertisements)Act
Theobjectiveofthisactistocontrolcertaintypesof
advertisementsrelatedtodrugsandtoprohibitcertain
kindofadvertisementsrelatedtomagicremedies.
1985
NarcoticDrugsand
Psychotropic
SubstancesAct
Themainobjectiveofthisactistoconsolidateandamend
lawsrelatingtoNarcoticdrugsandtomakestringent
provisionsforthecontrolandregulationofsuchdrugs.
1987
Drugs(PriceControl)
Act
Themainobjectiveofthisactistocontrolthepricesof
drugs.

9. HealthSurveyandDevelopmentCommittee
TheHealthSurveyandDevelopmentCommittee,popularlyknownas
theBhoreCommitteewassetbytheGovernmentofIndiain1943with
SirJosephBhoreasChairman.Tosurveytheexistingpositionregarding
thehealthconditionsandhealthorganisationinthecountryandto
makerecommendationsforfuturedevelopment.In1946itsubmitted
report.
developmentofanationalprogrammeofhealthservices
SomeoftheimportantrecommendationsoftheBhoreCommitteewere:
Theincorporationofpreventiveandtherapeuticservicesatall
administrativelevels.
TheCommitteevisualisedthedevelopmentofprimaryhealthcentresin2
stages:
(a)ashorttermplanitwasproposedthateachprimaryhealthcentrein
theruralareasshouldmakeavailabletoapopulationof40,000with
asecondaryhealthcentretoserveasasupervisory,coordinatinginstitution.For
eachprimaryhealthcentretwomedicalofficers,fourpublichealth
nurses,fourmidwives,twosanitaryinspectors,twohealthassistants,
onepharmacistandfifteenotherClassworkerswererecommended.
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10. Alongtermplan(alsocalledtheThreeMillionPlan)ofsettingupprimaryhealthunits
with75beddedhospitalsforeach10,000to20,000populationandsecondaryunitswith
650beddedhospitals,againreorganisedarounddistricthospitalswith2500beds.
Threemonth'straininginpreventiveandsocialmedicinetoprepare'socialphysicians'.
HathiandMudaliarCommittee
HathiCommittee:
TheIndianGovernmentkeepinginmindthelargescaleexpansionofthedrugsand
pharmaceuticalindustryconstitutedtheHathiCommittee.TheHathiCommitteewas
formedintheyear1974undertheChairmanshipofShriJaisukhaiHathiwithaviewto
ensuretheregulatedandrapidgrowthofdrugsmanufactureandtoensurethatall
essentialdrugsaremadeavailabletotheconsumersatareasonableprice.
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11. Theobjectives:
Toenquireintotheprogressmadebytheindustryandthe
statusachievedbyit.
Tosuggestmeasuresthatthepublicsectorattainsaleadership
roleinthemanufactureofbasicdrugsformulationandinresearch
anddevelopment.
Tomakerecommendationsforprocessingtherapidgrowthof
thedrugsindustry.
Toexaminethepresentarrangementfortheflowofnew
technologyintotheindustry.
Torecommendmethodsforeffectivequalitycontrolofdrugs.
Torecommendmeasuresforprovidingessentialdrugsand
commonhouseholdremediestothegeneralpublicespeciallyin
theruralsector.
Toensureequitabledistributionofbasicdrugsandrawmaterial
especiallytotheSmallScaleSector.
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12. TheHathiCommitteesubmitteditsreportinApril1975
Primaryrecommendations
Toreemphasizetheleadershippositionofthepublicsectorinthe
pharmaceuticalindustry.
SettingupofNationalDrugAuthority
PreferencetoIndianSectorovertheforeignsector
Indigenousproductionofrawmaterials.
Selectivepricecontrolonpricesofdrugs.
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13. THEOTHERRECOMMENDATIONSOFTHECOMMITTEEARE:
Restrictedlistofessentialdrugs
Measurestobeimplementedtoensuretheir
production
Gradualshiftbemade frombrandnamestogeneric
names
Pricecontrolmeasuresbeeffectedwiththeaimof
makinglife-savingdrugsandessentialdrugs
affordable
Publicsectorshouldplayaleadingroleindrug
production
Certaindrugsshouldbereservedtoencouragethe
growthofIndiandrugcompanies
Eliminationofirrationaldrugs.
13

14. MUDALIARCOMMITTEE
TheMudaliarCommitteealsoknownasthe“Health
SurveyandPlanningCommitteewassetupintheyear
1959undertheleadershipofDr.A.L.Mudaliar.
Theprimaryobjectivesbehindthesettingupofthe
committeewere:
Toassesstheperformanceofthehealthsectorsincethe
submissionoftheBhoreCommitteereport.
Tomakerecommendationsforthefuturepathof
developmentinthehealthsector.
ThecommitteefoundtheconditionsinPublicHealth
Centres(PHC’s)tobeunsatisfactoryasmostofthem
wereunderstaffedandnurseswereinchargeofthe
centres.
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15. RECOMMENDATIONS
Thegovernmentshouldconsolidatetheprogressthat
hasbeenachievedthroughthefirsttwotofiveyear
plans.
Thestrengtheningofthedistricthospitalswith
specialistservices.
Ineachstatebetweentheheadquartersandthedistrict
centrethereshouldbeRegionalorganizationswhichis
leadbyregionaldirectorsorassistantdirectors.Each
ofthesedirectorsshouldsupervise2or3district
medicalorhealthofficers.
EachPublicHealthCentreshouldnotservemorethan
40000population.
Combinationofmedicalandhealthservices.
ConstitutionofanAllIndiaHealthService.
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16. CODEOFPHARMACEUTICALETHICS
Theword“Ethics”isderivedfromtheGreekword
“ ”meaningwayoflife.Ethicsisthatbranchof
philosophywhichisconcernedwithhumanbehaviour.
Ethicsstudieswhatismorallyrightorwrong.
Ethicsmaybedefineasthestudyof“whatisrightor
goodinhumanbehaviour”
Ethicsisrelatedtoissuesofrightnessandwrongness.
Whatisrightisethicalandwhatiswrongisunethical.If
itisethical,itisright,proper,fair.Ethicsisamatterof
practicalconcern.Ittriestodeterminethegoodandright
thingtodo;choicesregardingrightandwrong,good
andevil.Ethicsistoconsiderthepracticeofdoingright
actions.
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17. Ethicsincludesthefundamentalrulesbywhichweliveourlives.
ThereisadifferencebetweenLawandEthics;
Lawpertainstorulesthatgovernhumaninasocietywhileethicsare
unwrittenrulesbywhichprofessionalsregulatetheiractions.
Valueswhichguidehowwemusttobehaveareconsidered
moralvalues,e.g.,valuessuchasrespect,honesty,equality,
responsibility,etc.Statementsaroundhowthesevaluesare
appliedarecalledethics.
Thus,ifalawisbrokentheviolatorissubjecttopunishmentas
prescribedinthelawhoweverincaseofviolationofethical
rulestheviolatorisnotsubjecttopunishmentunderanylaw
butmaybesubjecttopunishmentprescribedbytheprofessional
bodythatoverlooksthatparticulartrade.Codeofethicsset
standardsofprofessionalconductwhichdifferfromthelaws
thatgovernthatprofession.
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18. PHARMACEUTICALCODEOFETHICS
ThecodeofethicsframedbythePharmacyCouncilofIndiais
meanttoguidetheIndianPharmacistinrelationshipwith
patient,healthprofessionalsandsociety.
ProfessionofPharmacyisanobleprofessionasitisdirectly
healingthepatienttogetwellwiththehelpofmedical
practitioners.
GovernmenthasrestrictedthepracticeofPharmacytoonly
ProfessionPharmacistsi.e.registeredPharmacistunderthe
PharmacyAct1948.PCIframedthefollowingethicsfor
IndianPharmacists,whichmaybecategorizedunderthe
followingheadings:
1.Pharmacistinrelationtohisjob.
2.Pharmacistinrelationtohistrade.
3.Pharmacistinrelationtomedicalprofession.
4.Pharmacistinrelationtohisprofession.
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19. PHARMACISTINRELATIONTOHISJOB
PharmaceuticalServices:
Apharmacistshouldprovideefficientandcomprehensiveservices.through
hisregisteredmedical/drugshop.
Emergencymedicinesandcommonmedicinesshouldbesuppliedtothe
patientswithoutanydelay.
Thepharmacistshouldensurereadystockofallemergencysupplies
Pharmacy/DrugStore:
Thepharmacy/drugstoreshouldbeoperatedbyaqualifiedpharmacist.In
theshoptheremustbecleanliness,properstorageanddistributionof
drugs.
ThePharmacistshouldensurethatthereisnoaccidentalcontaminationin
thepreparation,dispensingandsupplyofmedicines.
Theappearanceofthepharmacyshouldreflecttheprofessionalattitudeof
thepharmacyinthemindofthecustomer.
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20. Prescription:
Apharmacistshouldnotcommentontheprescriptionreceived.
Nopartoftheprescriptionshouldbechanged(addition,deletionor
substitution)withouttheconsentoftheprescriber.
Itisdutyofthepharmacisttosupplythedrugsaspertheprescriptionand
notmakeanypersonalsuggestions
Incasethepharmacistfeelsthatthereisanerroronthepartofthe
prescriberheshouldrefertheprescriptionbacktotheprescriber.
PracticalTraining:
Aregisteredpharmacistshouldstartpracticingpharmacyafter
completionofpracticaltrainingunderanexperiencedpharmacists.
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21. PHARMACISTINRELATIONTOHISTRADE
PriceStructure:
Thepricechargedtothecustomershouldbe
fairandshouldnotbetakinganyundue
advantageofhisrequirement.
FairTradePractice:
Fairpracticeshouldbeadoptedbya
pharmacistinthetradewithoutany
attempttocaptureotherpharmacist’s
business.
Thepharmacistshouldnotadoptunhealthy
practicesofofferingdiscountsandgiftsto
customers.
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22. HawkingandHoardingofDrugs:
Hoardingwhichmeansoverstockingwiththeintentof
creatingartificialshortageofanyproductsshouldnotbe
doneunderanycircumstances.
AdvertisementandDisplay:
Thepharmacistshouldnotadvertiseinanyformthe
servicesprovidedbythem.
Advertisementshouldnot:
Bemisleading
Makeexaggeratedclaims
Guaranteetherapeuticefficacy
Offerrefundincaseoffailuretocure
Appealtofear
Havereferencetoword‘cure 22

23. PHARMACISTINRELATIONTOMEDICALPROFESSION:
Theprofessionalactivityofthemedicalpractitioneraswell
asthepharmacistsshouldberestrictedtotheirownfield
only.Medicalpractitionersshouldnotpossessdrugsstores
andpharmacistsshouldnotdiagnosediseasesand
prescriberemedies.
Apharmacistshouldnevermakerecommendationsofany
particularphysicianandsimilarlyaphysicianshouldnever
recommendanypharmacist.
Apharmacistshouldavoidfromanyformofarrangement
withanyphysicianwhereinthephysicianrecommendsthe
pharmacistinreturnforcommissionorgifts.
23

24. Apharmacistshouldalwaysmaintainproperlink
betweenphysiciansandpeople.Heshouldadvise
thephysiciansonpharmaceuticalmattersand
shouldeducatethepeopleregardinghealthand
hygiene.
Apharmacistshouldsharehisknowledgeof
medicinesandlatestdevelopmentinthefieldof
pharmacywiththephysicians.
Anyinformationacquiredbyapharmacistduringhis
professionalactivitiesshouldnotbedisclosedto
anythirdpartyuntilandunlessrequiredtodosoby
law 24

25. PHARMACISTINRELATIONTOHISPROFESSION
Aprofessionalpharmacistmustkeepingcarefulwatch
forpossibledangerordifficultiesduringpracticeof
profession.Apharmacistmustabidebythe
pharmaceuticallaws.
Thepharmacistsshouldhaveafairknowledgeofthe
lawsofthecountrypertainingtofood,drug,pharmacy,
health,sanitationetc.
TomaintainrelationshipwithProfessional
Organizationsapharmacistshouldbeactivelyinvolved
inprofessionalorganization’sactivities.
25

26. Apharmacisthastomaintainandupdateknowledge
ofnewmedicines,devices,andtechnologies
becomeavailable.
Apharmacistshouldavoidactivitiesthatwillbring
disrespecttothepharmacyprofession.
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