Legislations of pharmacy in india

This is very useful slide presentation for B.Pharm,Pharm Dand D.Pharm students not only for University exam but also job oriented exam like pharmacist, Drug inspector, GPAT etc.

1. Pharmaceutical
Legislation In
India
ARAVIND R
MPHARM

2. Before 1940
Establishment of Bengal Chemicals and Pharmaceutical
works at Calcutta-1901, by Acharya P C Ray
Parel factory -1903 in Bombay by Prof. Gajjar
Alembic Chemical work in Baroda in 1907
Spirit of Swadeshi movement gaintedthe momentum for
the development.
Manufacture of surgical dressings, sera and vaccines.

3. Resolution of 1927 under the leadership of Sir Haroon
Zafferfor recommending the Governor General to take
immediate steps to control the standardization, manufacture
and sale of drugs.
He pointed out the presence of many unscrupulous traders
with drugs and chemicals of defective strength and impure
quality.

4. What is the purpose of
Pharmaceutical legislation ?
Toensurethatthepatientsreceivedrugs:
❑ofrequiredquality
❑testedandevaluatedforsafetyandefficacyfor
theirintendedresult.

5. Drug Enquiry Committee
ThegovernmentofIndiapursuanceto
theresolution,in1927appointeda
committeeknownasDrugEnquiry
CommitteewithCol.Ramnatha.N.
Chopraasitschairmanin1928.
KnownasCHOPRACOMMITTEE

6. ReasonsforformationofChopraCommittee
1.UnitsinIndiawerenotsufficienttofulfilthe
requirementsofIndianPublic.
2.DrugswereimportedformUK,Germanyand
France.
3.Duringfirstworldwarcheaperdrugswere
importedintoIndia,whichincreasedthe
demandforindigenousdrugs.
4.UnhealthycompetitiongrewupandIndian
marketwasfloodedwithinferiorqualitydrugs.

7. 5.Publicpressurizedgovernmenttointroduce
effectivelegislationtocontrolimport,
manufacture,distributionandsaleofdrugs.
6.Therewasnolegalandeffectivecontrolon
pharmacyprofession.
7.Hencetohaveacomprehensivelegislation,the
Indiangovernmentappointeda‘DrugEnquiry
Committee’underthechairmanshipofCol.R.N.
Choprain1931.thiswasformallyknownasChopra
Committee.

8. What were the
recommendations of Drug
Enquiry Committee?
1.FormationofCentralPharmacyCouncilandState
PharmacyCouncil.(PCI)
2.CreationofDrugControlMachinery.(DCM)
3.EstablishmentofwellequippedCentralDrug
Laboratory,andStateDrugLaboratory.(CDL)
4.Acentrallawtocontroldrugandpharmacyprofession.
5.Appointmentofadvisoryboardtoadvicethe
governmentinmakingrulestocarryouttheobjectives
oftheact.

9. Recommendations of Chopra commitee
6.Setting up the course for training of pharmacist and
prescribe minimum qualification for the registration as the
pharmacist.
7.Registration of every pattern and proprietary medicine
manufacture in India or imported from outside country.
8.Bringing of crude single drug as well as compounded
medicine used in the indigenous system of treatment under
control.
9.Development of the drug industry in India.
10.Gradual reduction of manufacturing in medical stores.
11.Completion of an Indian Pharmacopoeia.

10. Implementations:-
❑DuetoSecondWorldWarin1939,there
wasdelayinintroductionofthelegislation.
❑Governmentwasreluctanttoimplement
therecommendationsofDEC,andthe
publicwaspressurizingthegovernment.
❑FinallyanImportofDrugBillwas
introducedin1937.
❑Thisbilldealtwithonlyimportofdrugsand
manufacturingandsaleofdrugswasnot
included.

11. HEALTH SURVEY AND
DEVELOPMENT COMITTEES

12. BHORE COMMITTEE
In1943,IndianGovernmentappointed
acommitteeunderthechairmanshipof
sirJosephBhoretomakeasurveyof
existingpositioninrespecttothe
healthcaredeliveryorganizationin
India
Andtomakerecommendationfor
futuredevelopments.

13. Recommendations of Bhorecommittee
1.Setting up of Central drug laboratory.
2.Establishment of all India Pharmaceutical
council
3.Establishment of a provincial Pharmaceutical
Council representing the pharmaceutical
trade, education.

14. (4)Starting of revised courses of study for:
(a)Licentiate Pharmacist
(b)Pharmaceutical Technologist
(c)Graduate Pharmacist
(5)Rigid enforcement of the Drugs and cosmetic
act, 1940 through country.

15. Bhatia Committee
GovernmentofIndiain1953appointedacommitteeunder
thechairmanshipofMajorGeneralS.L.Bhatia
Tomakecomprehensiveenquiryintotheworkingof
Pharmaceuticalindustry
TorecommendwhatstepstheGovernmentshouldtaketo
establishitonsoundlinesintheinterestofthecountry‘s
health care delivery and economy.

16. MudaliarCommittee
➢MudaliarCommitteewasformedintheyear,1962
➢Limitedtothedevelopmentofthehealthservices
infrastructureandthehealthcareattheinprimary
level.
➢Itfeltthegrowthofinfrastructureneededradical
transformationandfurtherinvestment.
➢Campaignagainstcommunicablediseasesintensified.
➢Alsopointedoutincreaseinthepopulationbecamea
majorworryandwasseenasahurdletothe
developmentprocess.

17. Hathi Committee
IndianGovernmenthassetupHathicommittee
underthechairmanshipofJaysukhlalHathiin
1975
totakecomprehensivelookintothedrugindustry
andtoenquiryintothevariousfacetsofdrugsin
India.
Thereportofthiscommitteecoveredallaspects
rangingfromlicensing,Pricecontrol,Imports,role
offoreignsectorandqualitycontrol.
Itencouragedthedevelopmentofindigenous
industries.
Italsofurthercontrolledpriceofalargenumber
ofdrugsintheinterestoftheconsumer.

18. Scope and objective
Drugbillwasintroducedin1940inlegislativeassembly,
andDrugBill1940waspassed,whichcametoforcein
1947.sincethendrugactwasamendedmanytimesandat
presentitcoverstheprovisionsrelatedtoDrugs,Cosmetics,
Ayurvedic,includingUnaniandHomeopathicmedicines.
ThepresentDrugandCosmeticActisanimprovedversion
oftheDrugAct,1940.themainobjectiveofthisactwasto
regulatetheimport,manufacture,distributionandsaleof
drugsandcosmeticsinIndia.
TheCentralGovernmentmadeseveralrulesentitledthe
DrugandCosmeticRules1945.Theseactandruleswere
amendedfromtimetotime

19. ThePharmacyact1948waspassedwiththemain
objectivetoregulatetheprofessionofPharmacyin
India.
In1954theDrugandMagicRemediesActwas
passedwiththemainaimtocontrolcertaintypes
ofadvertisementsrelatedtodrugandtoprohibit
certaintypesofadvertisementsrelatedtomagic
remedies.
MedicinalandToiletPreparations(Exciseduty)
Act,1955waspassedprovidingforthelevyand
collectionofdutiesofexciseonmedicinaland
toiletpreparationscontainingalcohol,opium
Indianhemporothernarcoticdrugs.

20. CentralgovernmentimplementedDrug
PriceControlorder1987.
In1985theNarcoticandPsychotropic
SubstanceAct,waspassed.Themain
objectiveofthisactwastoconsolidateand
amendthelawsrelatingtonarcoticdrugs
andPsychotropicsubstance.

21. Other acts included were:-
PreventionoffoodAdulterationact,1954andrules.
TheIndustries(DevelopmentandRegulations)Act,1951.
TheIndustrialEmployment(Standingorder)Act1946and
rules.
IndustrialDisputeAct,1947.
FactoryAct,1948.
TheIndianPatentandDesignAct1970.
TheTradeandMerchandiseMark,1958.
TheEpidemicDiseaseAct,1897.
ShopsandEstablishmentactsofrespectivestates.