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Pharmaceutical jurisprudence

1. MedicinalandToiletPreparation
Act–1955
Content
•Objectives
•Definitions
•Licensing
•ManufactureInbondandOutsidebond
•Exportofalcoholicpreparations
•ManufactureofAyurvedic,Homeopathic,Patent&
ProprietaryPreparations.
•OffencesandPenalties.

2. ObjectivesoftheAct
Thecollectionoflevyanddutiesofexciseonmedicinaland
toiletpreparationscontainingalcohol,opium,Indianhemp
orothernarcoticdrugs.
Toprovideuniformityintherulesandratesofexciseduty
leviableonsuchmedicinalandtoiletpreparation.
Excisedutyisaformoftaximposedongoodsfortheir
production,licensingandsale.

3. Definitions
ABSOLUTEALCOHOL
BONDEDMANUFACTORY
NON-BONDEDMANUFACTORY
DENATURATEDALCOHOL[SPRIT]
SPIRITSTORE
MEDICINALPREPARATIONS
TOPLETPREPARATIONAS
RECTIFIEDPREPARATION
RECTIFIEDSPIRIT

4. Licensing:Procedureforobtaininglicense
Applyinwritingforanewlicenseor
fortherenewalofanexistinglicense
fromthelicensingauthority
Theapplicationalongwith
licensingfeeshouldbesubmitto
ExciseCommissioner
Theapplicationshallcontainnameandaddressoftheapplicantandhis
designation,.Iftheapplicantisacompanythenameandtitleofeachofits
directorsalongwiththeiraddresses
Theapplicationshouldalsostatecapitalproposedtobeinvest,proposeddate
ofcommencementofmanufacture.
Requirethefulltimeservicesofanexciseofficer.
hewouldbeprovidedaccommodationinthemanufacturingpremises.

5. Theapplicationshouldbeaccompaniedbysiteand
elevationplansofthemanufacturingfacilities
Alistofallpreparationswhichtheapplicantproposesto
manufactureand/orthosemanufacturedduringthe
precedingyearshowingthepercentageorproportionof
alcoholinalcoholpreparation
GrantofLicense
Onreceivingtheapplicationthelicensingauthorityshallverifythe
detailsmentionedintheapplicationandmakenecessaryinquires
wherevertheneedisfelt.Oncetheauthorityissatisfiedthatallthe
conditionsarefulfilleditshallgrantanappropriatelicense

6. ManufactureInbondandOutsidebond
BONDEDLABORATORY:
Idealrequirements:abondedlaboratoryshouldconsist
following
Aspiritstore
Aroomformanufactureofmedicinalpreparations
Roomsforstorageoffinishedmedicinalpreparations.
Aseparatemanufactureroomandstorageroomfortoilet
preparations.
Accommodationwithnecessaryfurnitureforexciseofficerin
charge.

7. STEPSOFMANUFACTUREINBOND
Obtainingthespirit
Verificationandstorageofreceivedspirit
Issueofspiritfromspiritstoretomanufacturer
Wastageofspiritinmanufacture
StorageOfFinishedProduct

8. MANUFACTUREOUT-SIDEBOND
Obtainingthespirit
Manufacture,storageandsale
Sampling
Returns
Employees
Inspection

9. In-bond Outsidebond
Licenseisrequired Licenseisrequired
bondedlaboratoryrequired Non-bondedlaboratory
required
Excisedutypayableon
removalofgoodsfrombonded
laboratory
Excisedutypayableatthetime
ofspiritpurchase
Bondedlaboratoryshould
workedundersupervisionof
excisestaff
Noexcisestaffrequired
Forlargescale Forsmallscale

10. ExportofAlcoholicPreparations
MethodofExport
Examinationofgoodspriortoexport
Goodsunderbond
Dutypaidgoods
Verifyingapplication
Examinationattheplaceofexport
Presentationofclaimforrefund

11. MANUFACTUREOFAYURVEDIC,HOMEOPATHICANDPATENT
PROPRIETARYPREPARATIONS
AyurvedicPreparations
Ayurvedicpractitionersregisteredunderanylawfor
thetimebeingareallowedtomanufactureanddispense
selfgeneratedalcoholicpreparationsfreeofduty.
Practitionersshouldallowexciseofficertotake
samples.
Practitionersshouldmaintainrecordofquantitiesof
preparationsmanufacturedanddispensed,together
withnameandaddressofpatients.

13. HomeopathicPreparations:AllHomeopathicPreparationscontainingalcoholare
classifiedaspreparationscapableofconsumptionasordinaryalcoholic
beveragesandaresubjectedtodutiesprescribedforsuchclassofpreparations.
PatentproprietaryPreparations:
Allallopathicpreparationscontainingalcoholcanbeputintotwocategories
I]Officialpreparationsmadeaccordingtotheformulaprescribedin
Pharmacopoeia.
II]Non-officialallopathicpreparationsarealsoknownaspatentproprietary
preparations.
Theofficialandnon-officialpreparationswhicharecapableofbeing
consumedasordinaryalcoholicbeveragesknownasrestrictedpreparations.
Manufacturerwanttomanufacturealcoholicproprietarypreparationshasto
submittwosampleswithitsreceipttostategovernment.Stategovernment
willdeclarewhetherthesampleistobeclassedasrestrictedoras
unrestrictedpreparations.

14. OFFENCES-PENALTIES
OFFENCES PENALTIES
Failuretoobserveconditionsoflicense
ortopaydutyormanufacturedutiable
goodswithoutlicenseorsupplyfalse
information
SixmonthsimprisonmentorRs.2000fine
orboth
Anyowneroroccupieroflandwho
willfullyconnivesatthecommissionof
anoffence
SixmonthsimprisonmentorRs.500fine
orboth
Anypersonwhowillfullyandmaliciously
givefalseinformation
TwoyearsimprisonmentorRs.2000fine
orboth
Anypersonwhomakesfalseentriesor
tearoutpagesfromstockbook
FineuptoRs.2000
Dutiablegoodsnotstoredinorderly
mannerasdirected
FineuptoRs.1000
Dutiablegoodsnotwrapperorlabeledas
prescribed
FineuptoRs.1000
Apersonauthorizedtoexportdutiable
goodsunderbondfailstofurnishproof
DutyplusfineuptoRs.2000

15. OFFENCES PENALTIES
•Openlockordoorofwarehouse.
•Makeanyalterationinwarehouse
•Removeanygoodsincontravention
oftherules
FineuptoRs.2000
Anyofficerofexcisedepartmentwho
unnecessarilydetains,seizesany
property
FineuptoRs.2000
Anyexciseofficerwhorefusestodo
hisduty
Threemonthsimprisonmentorfineor
both
Ifanyexciseofficerdiscloses
informationacquiredinthecourseof
hisduty
FineuptoRs.1000