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5/12/2017 TelemedicineInIndiaLegalAnalysisFood,Drugs,Healthcare,LifeSciencesIndia

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India: Telemedicine In India Legal Analysis


LastUpdated:12February2013
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ArticlebyVijayPalDalmia,Partner ConnectionsatFirm
VaishAssociatesAdvocates
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ArticlebyVijayPalDalmia,AdvocateDelhiHighCourtandSupremeCourtofIndia
Partner,VaishAssociatesAdvocates,NewDelhi,India,vpdalmia@vaishlaw.com

Theconceptoftelemedicineandwebbasedmedicalservicesarederivedfromtheexchangeortransmissionofmedical
knowledgeorinformationthroughelectronicformatsandmediums,soastocutacrosstimeandspaceacrosstheworldforthe
benefitofmedicaladvancement.Medicalinformationiscommunicatedthroughelectronicmediaininteractiveformatssuchas
audiovisualmedia,telephonicconferences,satellitecommunication,internetetc.formedicalconsultation,examinationor
remotemonitoring/medicalprocedurepurposes.Themodelhaspopularizedsinceitlinksisolatedcommunitiesto
advancedmedicalservicesandprovidesspeedydeliveryofmedicalexpertise.Certifiedmedicalpractitionersworldoverhave
startedtakingadvantageofthetelemedicineconcept,expandingtheirservices.TheUnitedStateslicensurelawspromotethe
modelwhilerequiringapractitionerfollowingtheformattoobtainafulllicenseacrossstatestodelivertelemedicinehealthcare
servicesacrossstatelines.InIndiapractitionersandmedicalsocietieshavebeenteletransmittingmedicalinformationand
remotemonitoringhealthservicessinceasearlyas1975.Themediumofteleapplicationsandwebinterfacebasedsystems
linkingpatientsandmedicalpractitionersthroughtelemedicineservicesmayusewirelessdiagnosticstoolslikestethoscopes
bloodpressure,temperatureandinsulinmonitors,andultrasoundsenablingremotediagnosis,treatment,advancedhealthcare
andmedicalservices.

TheMedicalCouncilofIndiaregulatesuniformstandardsofhigherqualificationsinmedicineandrecognitionofmedical
qualificationsinIndiaandabroad.Officialregistrationofdoctorswithrecognizedmedicalqualificationsiscontrolledbythe
council,andprocedureshavebeenlaidoutundertheIndianMedicalCouncilAct1956andIndianMedicalDegreeAct1916.
Althoughtherearenolegalconstraintsspecificallydealingwithmethodologyofexecutingordispensingmedicalservicesin
India,variouslawsincludingtheDrugsandCosmeticsAct,1940definenegligencecriminalintentsale,manufactureand
distributionofdrugsetc.,whilejudicialprecedentandcaselawsdeterminemedicalnegligenceonacasebycasebasis.The
healthcareserviceprovideradoptingtelemedicinemethodsofmedicalpracticemustensurethatmedicalconsultation,
prescriptions,treatmentanddrugsaredispensedonlyinaccordancewithlegalprovisionsandguidelinesregulatingthe
medicalandhealthcaresectorinIndia.

UnderthepresentlawsrelatingtotheaboveinIndia,afullyautomatedprocesssolelybasedonanartificialintelligence
programmaynotbelegallyfeasible,asitisabasicrequirementthatonlymedicalpractitionersregisteredbeforethe
MedicalCouncilofIndiaandotherrelevantlawsareallowedtoprovidemedicalconsultation,prescriptionsand
treatment.ForunderstandingthelegalpropositioninregardtothetelemedicineinIndia,onehastounderstandthe
implicationsofsomeimportantlegalprovisionsrelatingtomedicalhealthcareanddrugsinIndia,asunder:

A*"Registeredmedicalpractitioner"hasbeendefinedunderSection2(ee)oftheDrugsandCosmeticsRules,1945of
Indiaasaperson

i.holdingaqualificationgrantedbyanauthorityspecifiedornotifiedunderSection3oftheIndianMedicalDegrees
Act,1916(7of1916),orspecifiedIntheSchedulestotheIndianMedicalCouncilAct,1956(102of1956)or
ii.registeredoreligibleforregistrationinamedicalregisterofaStatemeantfortheregistrationofpersonspracticing
themodernscientificsystemofmedicineexcludingtheHomoeopathicsystemofmedicineor
iii.registeredinamedicalregister,otherthanaregisterfortheregistrationofHomoeopathicpractitioner,ofaState,who
althoughnotfallingwithinsubclause(i)orsubclause(ii)declaredbyageneralorspecialordermadebytheState

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Governmentinthisbehalfasapersonpracticingthemodernscientificsystemofmedicineforthepurposesofthis
Actor
iv.registeredoreligibleforregistrationintheregisterofdentistsforaStateundertheDentistsAct,1948(16of1948)or
v.whoisengagedinthepracticeofveterinarymedicineandwhopossessesqualificationapprovedbytheState
Government.

A"Drug"hasbeendefinedunderSection3(b)oftheDrugsandCosmeticsAct,1940andincludes

i.allmedicinesforinternalorexternaluseofhumanbeingsoranimalsandallsubstancesintendedtobeusedfororin
thediagnosis,treatment,mitigationorpreventionofanydiseaseordisorderinhumanbeingsoranimals,including
preparationsappliedonhumanbodyforthepurposeofrepellinginsectslikemosquitoes
ii.suchsubstances(otherthanfood)intendedtoaffectthestructureoranyfunctionofhumanbodyorintendedtobe
usedforthedestructionof(vermin)orinsectswhichcausediseaseinhumanbeingsoranimals,asmaybespecified
fromtimetotimebytheCentralGovernmentbynotificationintheOfficialGazette
iii.allsubstancesintendedforuseascomponentsofadrugincludingemptygelatincapsulesand
iv.suchdevicesintendedforinternalorexternaluseinthediagnosis,treatment,mitigationorpreventionofdiseaseor
disorderinhumanbeingsoranimals,asmaybespecifiedfromtimetotimebytheCentralGovernmentby
notificationintheOfficialGazette,afterconsultationwiththeBoard.

Theterm"prescribed"asperSection3[(i)]oftheDrugsandCosmeticsAct,1940meansprescribedbyrulesmade
undertheAct.

Prescriptionsmadeagainstmedicalconsultationanddiagnosisservicesundertelemedicineformatsshouldsatisfy
legalrequirementsgivenbelowsoastobeavalidlegalprescriptionunderthelawsofIndia.TheDrugsandCosmetics
Rules,1945specifythetypeofdrugsthatrequirevalidmedicalprescriptionsforretailpurchase,classifyingthemunder
SchedulesappendedtotheRules.

"Prescriptiononlydrugs"aredefinedunderSection65(9)oftheDrugsandCosmeticsRules,1945,whichstatesthat

a.SubstancesspecifiedinScheduleHorScheduleXshallnotbesoldbyretailexceptonandinaccordancewiththe
prescriptionofaRegisteredMedicalPractitioneronly.

Further,inthecaseofsubstancesspecifiedinscheduleX,theprescriptionsshallbeinduplicate,onecopyofwhich
shallberetainedbythelicenseeforaperiodoftwoyears.
b.ThesupplyofdrugsspecifiedinScheduleHorScheduleXtoRegisteredMedicalPractitioners,Hospitals,
DispensariesandNursingHomesshallbemadeonlyagainstthesignedorderinwritingwhichshallbepreserved
bythelicenseeforaperiodoftwoyears

Theaboveprovisiondealsonlywiththedispensingofmedicineandsupplyofacertaincategoryofmedicine.However,
irrespectiveofthescheduleinwhichamedicinemayfall,prescriptionofamedicinecanbemadeonlybya
registeredmedicalprofessionalaspertheRules.Sincetherearenolegalprovisionsdescribingthemanneroftreating
apatient,prescriptionsinstructingapatienttoconsumeanydrugsareveryimportantdocumentaryevidenceofnegligence
orlackofitonthepartofamedicalpractitionerwhiletreatingapatient.TheRuleshavedefinedtheimportantcomponents
thatconstituteavalidlegalprescription,forallmedicalpracticepurposes.

A"prescription"hasbeendefinedunderSection65(10)oftheDrugsandCosmeticsRules,1945soastohavethe
followingcomponents

a.beinwriting**andbesigned***bythepersongivingitwithhisusualsignatureandbedatedbyhim
b.specifythenameandaddressofthepersonforwhosetreatmentitisgiven,orthenameandaddressoftheownerof
theanimalifthedrugismeantforveterinaryuse
c.indicatethetotalamountofthemedicinetobesuppliedandthedosetobetaken.

Forallmedicaltreatmentsthroughtelemedicineorwebinterfaceformat,itisimportanttoensurethattheprescriptions
mustsatisfytheaboverequirementsofbeinginwritingandsignedbyaregisteredmedicalpractitioner,withoutwhichthe
prescriptionwillbeinvalidintheeyesofthelaw.

DuetotherecognitionofelectronicdocumentsundertheInformationTechnologyAct,2000,aprescriptioninanelectronic
formatmaybevalidatedasalegalprescriptionifitisasecureelectronicrecordaffixedwithasecuredigitalsignatureas
prescribedundertheInformationTechnologyAct,2000ofIndia.TheInformationTechnologyAct,2000providesfor
authenticationofsecureelectronicrecordsandaffixingofdigitalsignaturessoastoensurethelegalvalidityofthesame.

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Section4,mentionedhereinbelow,oftheInformationTechnologyAct,2000whichrecognizeselectronicrecordsis
importantforunderstandingabove:

"whereanylawprovidesthatinformationoranyothermattershallbeinwritingorinthetypewrittenorprintedform,
then,notwithstandinganythingcontainedinsuchlaw,suchrequirementshallbedeemedtohavebeensatisfiedif
suchinformationormatteris

a.Renderedormadeavailableinelectronicform,and
b.Accessiblesoastobeusableforsubsequentreference."

Section3oftheInformationTechnologyAct,2000dealswithauthenticationofelectronicrecordsasunder:

1.Subjecttotheprovisionsofthesectionanysubscribermayauthenticateanelectronicrecordbyaffixinghisdigital
signature.
2.Theauthenticationoftheelectronicrecordshallbeeffectedbytheuseofasymmetriccryptosystemandhash
functionwhichenvelopandtransformtheinitialelectronicrecordintoanotherelectronicrecord.

DigitalsignaturesarelegallyrecognizedunderSection5oftheInformationTechnologyAct,2000,whichstatesasunder:

"whereanylawprovidesthatinformationoranyothermattershallbeauthenticatedbyaffixingthesignatureorany
documentshallbesignedorbearthesignatureofanypersonthennotwithstandinganythingcontainedinsuchlaw,
suchrequirementshallbedeemedtohavebeensatisfied,ifsuchinformationormatterisauthenticatedbymeansof
digitalsignatureaffixedinsuchmannerasmaybeprescribedbytheCentralGovernment."

Automatedartificialintelligencebasedtelemedicineformatscontrolledbyaregisteredmedicalpractitionercanformulate
legalprescriptionsintheformofanelectronicrecord,providedthesamecanbeattributed,underSection11ofthe
InformationTechnologyAct,2000,totheoriginator

a.ifitwassentbytheoriginatorhimself
b.byapersonwhohadtheauthoritytoactonbehalfoftheoriginatorinrespectofthatelectronicrecordor
c.byaninformationsystemprogrammedbyoronbehalfoftheoriginatortooperateautomatically.

Section14oftheInformationTechnologyAct,2000,definesasecureelectronicrecord,whereinanysecurityprocedure
hasbeenappliedtoitataspecificpointoftime,afterwhichsuchrecordshallbedeemedtobeasecureelectronicrecord
fromsuchpointoftimetothetimeofverification.

UnderSection15oftheInformationTechnologyAct,2000,asecuredigitalsignaturebyapplicationofasecurityprocedure
agreedtobythepartiesconcerned,canbeverifiedtobeadigitalsignature,atthetimeitwasaffixed,ifitwas

a.uniquetothesubscriberaffixingit
b.capableofidentifyingsuchsubscriber
c.createdinamannerorusingameansundertheexclusivecontrolofthesubscriberandislinkedtotheelectronic
recordtowhichitrelatesinsuchamannerthatiftheelectronicrecordwasalteredthedigitalsignaturewouldbe
invalidated.

Sincetelemedicineformatsofmedicalpracticeareessentiallybasedonmediumsoftechnology,themedicalpracticemodel
mayusetheabovelegalprovisionstotheiradvantagewithrespecttopreparationofvalidlegalelectronicprescriptions.

'OTCDrugs'(OverTheCounterdrugs)aredrugslegallyallowedtobesold'OverTheCounter',i.e.withouttheprescriptionofa
RegisteredMedicalPractitioner.InIndia,thoughthephrasehasnolegalrecognition,alldrugsnotincludedinthelistof
'prescriptiononlydrugs'undertheDrugsandCosmeticsAct,1940maybeconsideredasnonprescriptiondrugs(orOTC
drugs).Aproposalforalistofoverthecounter(OTC)drugshasbeenunderthegovernment'sconsiderationandacommittee
appointedforthepurposehasbeenworkingonit.TheDrugControllerGeneralofIndiaisexpectedtolaydownaseparateset
ofrulesorguidelinesforOTCmarketingoncethelistisofficial.

Inascenariowhereadviceisprovidedelectronicallythroughatelemedicineinterface,whichismannedbycertifiedmedical
practitionersand/oranartificialintelligencesystemvalidatedbymedicalpractitionersentitledtopracticemedicineinIndia,the
guidelinesissuedbytheMedicalCouncilofIndiaundertheCodeofEthicsRegulations,2002alsoapply.Someguidelines,
whichmayapplytoatelemedicinesystemarelistedbelow:

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5/12/2017 TelemedicineInIndiaLegalAnalysisFood,Drugs,Healthcare,LifeSciencesIndia

Section1.4oftheCodeofEthicsRegulations,2002statesthatregistrationnumbersofmedicalpractitioners/doctors
accordedbytheStateMedicalCouncil/MedicalCouncilofIndiamustbedisplayedintheclinicandinall
prescriptions,certificates,moneyreceiptsgiventopatients.

UnderSection6.1.1oftheCodeofEthicsRegulations,2002theactofsolicitingpatientsdirectlyorindirectlyisunethical,
byaphysicianoragroupofphysicians,institutionsororganizations.Althoughnolegalprovisiondealswiththemannerof
communicationbetweenamedicalpractitionerandpatientwithrespecttodiagnosisandtreatment,therearenumerous
legalprovisionsdealingwithethicalconducttobefollowedbymedicalpractitionerswhiledispensingspecializedmedical
services.

2013,VaishAssociates,Advocates,
AllrightsreservedwithVaishAssociates,Advocates,10,HaileyRoad,FlatNo.57,NewDelhi110001,India.

Thecontentofthisarticleisintendedtoprovideageneralguidetothesubjectmatter.Specialistprofessionaladviceshouldbe
soughtaboutyourspecificcircumstances.Theviewsexpressedinthisarticlearesolelyoftheauthorsofthisarticle.

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