Asu drug regulations in india

This is a good presentation for M.Pharm and B.Pharm students.

1. Regulatory Issues
Regulations in India (ASU DTAB, ASU
DCC), Regulation of manufacture of
ASU drugs-Schedule Z of Drugs &
Cosmetics Act for ASU drugs
ARAVIND R
ASST.PROFESSOR
DEPT.OF PHARMACOGNOSY

2. Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule T-GMP for the manufacture of ASU drugs
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
HERBAL DRUG TECHNOLOGY Aravind R

3. REGULATORY AGENCIES-INTRODUCTION
In the present scenario, pharmaceuticals-considered as the most highly regulated
industries worldwide.
The regulatory body ensures compliances in various legal and regulatory aspects of
a drug.
Every country has its own regulatory authority, which is responsible to enforce the
rules and regulations and issue the guidelines to regulate drug development
process, licensing, registration, manufacturing:
The major challenges of these regulatory bodies are
*To promote public health and protect the public from harmful and dubious drugs,
*To establish proper legalization covering all products with a medicinal claim and
all relevant pharmaceutical activities, whether carried out by the public or the
private sector.
*To increase worldwide regulatory growth to ensure safety of people., marketing
and labeling of pharmaceutical products.
3HERBAL DRUG TECHNOLOGY Aravind R

4. Regulatory agencies of
various country
COUNTRY NameofRegulatoryAuthority
USA FoodandDrugAdministration(FDA)
UK MedicinesandHealthcareProductsRegulatoryAgency(MHRA)
Australia TherapeuticGoodsAdministration(TGA)
India CentralDrugStandardControlOrganization(CDSCO),AYUSH(ASUDrugs)
Canada HealthCanada
Europe EuropeanMedicinesAgency(EMEA)
Denmark DanishMedicinesAgency
CostaRica MinistryofHealth
NewZealandMedsafe-MedicinesandMedicalDevicesSafetyAuthority
Sweden MedicalProductsAgency(MPA)
4HERBAL DRUG TECHNOLOGY Aravind R

5. HerbaldrugsareregulatedundertheDrugandCosmeticAct(DandC)
1940andRules1945inIndia,whereregulatoryprovisionsfor
Ayurveda,Unani,Siddhamedicineareclearlylaiddown.
DepartmentofAYUSHistheregulatoryauthorityandmandatethat
anymanufactureormarketingofherbaldrugshavetobedoneafter
obtainingmanufacturinglicense,asapplicable.
Effectivedrugregulationisrequiredtoensurethesafety,efficacy
andqualityofdrugsaswellasaccuracyandappropriatenessofthe
druginformationavailabletothepublic
5HERBAL DRUG TECHNOLOGY Aravind R

6. Theneedforpharmaceuticaldruganalysisisdrivenlargelyby
regulatoryrequirements.
AteamconsistingofR&D,QC,andQAunitmembersdevelops
thesequalityandcompliancesystems.
Itshouldbeoneofthehighestprioritiesoftopmanagementand
QAunitstodevelopandmonitorthesesystemstocomplywiththe
cGMPandGLPexpectations.
Compliancedocumentsareneeded,inadditiontotheregulatory
andresearchdocuments,todemonstratetheintegrityofthe
data.
CompliancedocumentsrefertothosereportsrequiredbyGMP
and/orutilizedduringthecourseofinspectionbyahealth
authority.
6HERBAL DRUG TECHNOLOGY Aravind R

7. Product registration (drug evaluation, authorization, and
monitoring of drug efficacy and safety);
Regulation of drug manufacturing, importation, and
distribution;
Regulation & Control of drug promotion and information.
Adverse drug reaction (ADR) monitoring.
Licensing of premises, persons and practices.
Main goal of drug regulation is to guarantee the safety,
efficacy and quality of drugs available to public.
7HERBAL DRUG TECHNOLOGY Aravind R

8. HerbaldrugsareregulatedundertheDrugandCosmetic
Act(D&C)1940andRules1945inIndia,where
regulatoryprovisionsforAyurveda,Unani,Sidha
medicineareclearlylaiddown.
DepartmentofAYUSHistheregulatoryauthorityand
mandatethatanymanufactureormarketingofherbal
drugshavetobedoneafterobtainingmanufacturing
license,asapplicable.
TheD&CActextendsthecontroloverlicensing,
formulationcomposition,manufacture,labelling,
packing,qualityandexport.
Schedule“T”oftheactlaysdownthegood
manufacturingpractice(GMP)requirementstobe
followedforthemanufacturingofherbalmedicines.
8HERBAL DRUG TECHNOLOGY Aravind R

9. The official Pharmacopoeias and formularies are
available for the quality standards of the medicines.
First schedule of the D & C Act has listed authorized
texts, which have to be followed for licensing any
herbal product under the two categories: ASU drugs &
Patent or proprietary medicines.
In India, traditional medicines are governed by the
Drugs and Cosmetics Act of 1940 and the Drugs and
Cosmetics Rules of 1945.
They regulate the import, manufacture, distribution
and sale of drugs and cosmetics.
9HERBAL DRUG TECHNOLOGY Aravind R

10. In1959,theGovernmentofIndiarecognizedthetraditionalIndian
systemofmedicineandamendedtheDrugsandCosmeticsActto
includedrugswhicharederivedfromtraditionalIndianMedicine.
Noproductsderivedfromtraditionalsystemsmaybemanufactured
withoutalicencefromtheStateDrugControlAuthorities.
Patentandproprietarymedicinesderivedfromthetraditionalsystems
mustcontainingredientswhicharementionedintherecognizedbooks
oftheabovesystems,asspecifiedintheDrugsandCosmeticsAct.
Thegovernmentinadvisedbyaspecialcommitteeandanadvisory
boardforAyurveda,SiddhaandUnanidrugs.
Pharmacopoeiacommitteeshavebeenconstitutedtoprepare
Pharmacopoeiasforallthesesystems.
ScheduleZoftheDandCact,1940wasamendedforregulationforthe
ClinicaltrialguidelinesforASUdrugs.
10HERBAL DRUG TECHNOLOGY Aravind R

11. The Central Government constitute a Board (to be
called the ASU-Drugs Technical Advisory Board) to
advise the Central Government and the State
Governments on technical matters arising out of the
administration of D&C, Act 1940
The Board shall consist of the following members:
11HERBAL DRUG TECHNOLOGY Aravind R

12. Director General of health Service(Chairman)
Drug Controller, India
Principle officer of ISM
Director of the Central drugs Laboratory, CDL
Government Analyst
Pharmacognocist
Phyto-chemist
4 person from ASU pharmacopeia committee
1 teacher in Dravyaguna& BhaishajyaKalpana
1 teacher in Ilmul-advia
1 teacher in Gunapadam
3 person from ASU drugs industry
3 practitioner of ASU medicine
12HERBAL DRUG TECHNOLOGY Aravind R

13. It advices matter related to Drugs.
The nominated and elected members of the Board
shall hold office for three years, but shall be
eligible for re-nomination and re-election. The
Board may, subject to the previous approval of the
Central Government, regulating its own procedure.
13HERBAL DRUG TECHNOLOGY Aravind R

14. ItisalsoanAdvisoryBodyconsistoftworepresentative
centralgovernmenttobenominatedbyGovernment.
OnerepresentativeofeachstateGovernmenttobe
nominatedbytheStateGovernment.
Function
DCCtoadvisetheCentralGovernment,theState
GovernmentsandtheASU-DTABonanymatterforthe
purposeofsecuringuniformitythroughoutIndiainthe
administrationofthisActinsofarasitrelatestoASU
drugs.
Itshallmeetwhenrequired.
Ithaspowertoregulateitsownprocedure.
14HERBAL DRUG TECHNOLOGY Aravind R

15. ❖Misbranded Drugs:-
•Ifitissocolored,coated,powderedorpolishedthatdamage
isconcealedorifitismadetoappearofbetterorgreater
therapeuticvalve.
•Ifitisnotlabelledintheprescribedmanner.
•Ifitslabelorcontaineroranythingaccompanyingthedrug
bearsanystatement,designordevicewhichmakesanyfalse
claimforthedrugorwhichisfalseormisleadinginany
particular
❖AdulteratedDrugs:-
•Ifitconsists,inwholeorinpart,ofanyfilthy,putridor
decomposedsubstance.
•Ifithasbeenprepared,packedorstoredunderinsanitary
conditionswherebyitmayhavebeencontaminatedwithfilth
orwherebyitmayhavebeenrenderedinjurioustohealth
15HERBAL DRUG TECHNOLOGY Aravind R

16. SCHEDULE T-GOOD
MANUFACTURING PRACTICE FOR
ASU DRUGS
By, ARAVIND R
ASST.PROFESSOR

17. OBJECTIVE
Rawmaterialsusedinthemanufactureofdrugs
areauthentic,ofprescribedqualityandarefree
fromcontamination.
Themanufacturingprocesswhichhasbeen
prescribedtomaintainthestandards.
Adequatequalitycontrolmeasuresareadopted.
Themanufactureddrugwhichisreleasedfor
saleisofacceptablequality.
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18. However
Under IMCC Act 1970(Indian Medicine Central Council
Act, 1970) registered Vaidyas, Siddhas and Hakeemswho
prepare medicines on their own to dispense to their
patients and not selling such drugs in the market are
exempted from the purview of G.M.P.
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19. SPECIFICATIONS
A Manufacturing Premises should have adequate space for all daily activity like:
Receiving and Storage of Herbs, Packaging material & other raw material
Production and Manufacturing Activity Area
Quality Control Section
Finished Goods Store
Office and Administration
Rejected Products/Drugs Store
Minimum area required for setting up Ayurveda, Siddha and Unani Medicine manufacturing
unit is 1200 square feet covered with separate cabins and partitions for each activity.
If unani medicines/ayurvedic medicineare manufactured along with other type of
medicine, additional 400 square feet area is required.
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20. PART 1-GENERAL REQUIREMENTS
1.LocationandSurroundings:ThefactorybuildingforAyurveda,
SidhaandUnaniMedicinemanufacturingshallbesituatedand
constructedtoavoidcontaminationfromopensewerage,drain,
disagreeableorobnoxiousodour,dustandsmokeetc.
2.Buildings:AbuildingformanufacturingunitforAyurvedic,Sidha
andUnaniMedicinesshallpermitworkunderhygienicconditions.It
shouldbefreefromanyinsects/rodents.Lightandventilation
facilityshouldbeadequate.Wallsandfloorshouldbefreefrom
cracksanddamp.Premisesshouldalsoconformitywithprovisionsof
factoryact.Itshallbelocatedsoastobe:
Buildingshouldcompatibleofothermanufacturingoperations
carriedoutinsamepremises.
SpaceshouldbeadequateforPlacementofequipmentandmaterials
toavoidmix-up/contaminationriskofdifferentdrugsand
components.
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21. GENERAL REQUIREMENTS
Design&constructiontobemaintainedtoprevententryofinsectsand
rodents.Interiorsurface(walls,floorsandceilings)shallbesmoothand
freefromcracksandpermiteasycleaninganddisinfection.Thewallsof
theroominwhichthemanufacturingoperationsarecarriedoutshallbe
impervioustoandbecapableofbeingkeptclean.Theflooringshallbe
smoothandevenandshallbesuchasnottopermitretentionor
accumulationofdustorwasteproducts.
Buildingshouldhaveaproperdrainagesystem.Sanitaryfittingandelectric
fixturesshallbeproperandsafe.
Burner/Bhattisectioncouldbecoveredwithtinroofandproperventilation
butcareshouldbedonetopreventfliesanddust.
Properfiresafetymeasuresandproperexistsshouldbethere.
Dryingspaceforrawmaterial,inprocessmedicinesshouldbeseparateand
measuresshouldbedonetopreventitfromflies/insects/dustetc.
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22. WaterSupply:Waterneededformanufacturingshouldbepureandof
potablequality.Adequateprovisionofwaterforwastingthepremisesshall
bemade.
4.DisposableofWaste:Properwastemanagementcareshouldbedone.
5.Container’sCleaning:Washing,cleaninganddryingsectionof
containerssuchasbottles,vialsandjarsshouldhaveadequate
arrangementandshouldbeseparatedfrommanufacturingoperations.
6.Stores:Storeshouldhaveadequatespaceforindependentlyand
separatelystorerawmaterial,packagingmaterialandfinishedproducts.
7.WorkingSpace:Manufacturingareashouldbeadequatefororderly
placementofequipment,machineryandmaterialusedduring
manufacturingoperationsandqualitycontroltofacilitateeasyandsafe
workingandtominimizeoreliminateanyriskofmix-upbetweendifferent
drugs,rawmaterialsandtopreventthecrosscontaminationduring
manufacturing,storageandhandlingoperations.
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23. 8.HealthClothing,SanitationandHygieneofWorkers:
9.MedicalServices:toemployees
10.MachineryandEquipment:detailsaboutmachineryandequipmentin
PartIIofScheduleT.
11.BatchmanufacturingRecords:
Eachbatchrecordshouldbemaintainedirrespectiveofproduct
manufactured(classicalpreparationsorpatentorproprietary
medicines).Manufacturingrecordsarerequiredtoprovideanaccount
ofthelistofrawmaterialsandtheirquantitiesobtainedfromthe
store,testsconductedduringthevariousstagesofmanufacturelike
taste,colour,physicalcharacteristicsandchemicaltestsasmaybe
necessaryorindicatedintheapprovedbooksofAyurveda,Siddhaand
UnanimentionedintheFirstScheduleoftheDrugsandCosmeticsAct.
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24. 12.DistributionRecord:Distributionrecord(Dispatchregister)
shouldbemaintainedtofacilitateprocessofpromptand
completerecallofthebatch.Distributionrecordshouldbe
maintainedtillexpiryofbatch.
Fordrugswhodon’thaveexpirydatelikeBhasma,Rasa,Asava-
arishthaetc,recordshouldmaintainuptofiveyearsofthe
exhaustingofstock.
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25. 13.RecordofMarketComplaints:Acomplainregistershouldmaintainto
recordallreportsofmarketcomplaintsreceivedregardingtheproductssold
inthemarket.Themanufacturershallenteralldatareceivedonsuchmarket
complaints,investigationscarriedoutbythemanufacturersregardingthe
complaintaswellasanycorrectiveactioninitiatedtopreventrecurrenceof
suchmarketcomplaintsshallalsoberecorded.Onceinaperiodofsix
monthsthemanufacturershallsubmittherecordofsuchcomplaintstothe
licensingauthority.TheRegistershallalsobeavailableforinspectionduring
anyinspectionofthepremises.
ReportsofanyadversereactionresultingfromtheuseofAyurvedic,Siddha
andUnanidrugsshallalsobemaintainedinaseparateregisterbyeach
manufacturer.Themanufacturershallinvestigateanyoftheadversereaction
tofindifthesameisduetoanydefectintheproduct,andwhethersuch
reactionsarealreadyreportedintheliteratureoritisanewobservation.
14.QualityControl:Amanufacturercanset-upownqualitycontrolsection
ortestingcouldbedonethroughgovernmentapprovedtestinglaboratory..
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26. PART-II
(A)
➢Listofrecommendedmachinery,equipmentandminimum
manufacturingpremisesrequiredforthemanufactureof
variouscategoriesofayurvedic,siddhasystemofMedicines.
➢Onemachineindicatedforonecategoryofmedicinecould
beusedforthemanufacturingofothercategoryofmedicine
also.Similarlysomeofthemanufacturingareaslike
powdering,furnace,packingofliquidsandAvaleha,Paks,
couldalsobesharedfortheseitems.
(B)
➢Listofmachinery,equipmentandminimummanufacturing
premisesrequiredforthemanufactureofvariouscategories
ofunanisystemofmedicines.
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27. Ayurvedic drug manufacturing license
approval:
(1)Approval of Plan ofPremises
(2)Submission of Application with documents toLA
for grant ofLicense
(3)Inspection of Premises by Inspector & reportingto
LA for takingaction
(4)Grant of license byLA
(5)Appeal in case of rejection ofapplication
(6) Renewal ofLicense
(7) Additional ProductPermission
(8) Addition of new Category inLicense
(9) Technical Personapproval
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28. Approval of plant of premises (area
requirement)
1)Manufacturing areas-As per Sch-T ( areas are insq.feets)
2)Office-100SFt
3)Workers Room-80 SFt/Eachsex
4)Raw material store-100SFt
5)Finish Product store-100SFt
6)Quarantine Room-100SFt
7)Packaging material store-100SFt
8)Bottle washing Room-100SFT
9)Bottle drying Room-100SFT
10)Packing & labeling Room-100SFt
11)Q.C.Laboratory-100-150 SFt-(Chemistry & CognosyLab.)
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29. For Public Testing Laboratory-800SFt-in
(i) Chemistry
(ii)Pharmacognosy,
(iii) Ayurveda, Siddha and Unani
(iv) Microbiology
(v) SampleRoom,
(vi) Office-cum-Record Room
Rule-160B-List of Equipmentgiven
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30. Submission of plant of premises to LA for
approval (documentrequired)
1)Forwarding letter address toLA
2)Original challan forFee-Rs.50
3)4 Copies of Plan-It includes thefollowing
-Key plan,
-plan,
-elevation,
-endview,
-Address of Premises & Signatureofa personhaving Authorisation.
4)Plan is scrutinized by Plan Committee & approved for
construction of premises.
5)Premisesistobeconstructedasper approved plan,Machineries
andequipmentsareto be installed, Technical Persons are to be
employed, all documents are to be prepared and thenapplication is
to be submitted to LA for issuingLicense.
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31. Application submission toLA
➢Forwarding letter address to LA for obtaining
LicenseinApplication Form. No.-24D dully
filled & signed by Auth. Person. Form of Firms
details dully filled & signed by Auth.Person
➢Original challan for lic. Fee as per requirements-Rs.1000/-
+Rs. 500/-GMP certi. Fee. Original plan of premises -1
copy
➢Document regarding possession of thepremises
➢Document regarding constitution of the Firm(P/D,MOAA,TDetc)
➢List of Products-category wise-4 copies along with product details Form-
with similarproduct
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32. Draft label of each product-3copies
List of
Machineries &
Equipments-1 copy
List of Laboratory
equipments-1copy
List of approved Technical persons with their degree & experience
certificates, appointment letter, acceptance letter, forms -4copies
Detail of method of analysis
of products & Raw materials
Consent letter of Public
TestingLaboratory
List ofSOP
Master Formula card of eachproduct
Xerox copy of Ref. Book for product’singredient
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33. Inspection of premises by inspector
and report toLA
Inspection of Premises by Inspector is carried out for
verificationof-
1)Areas ofPremises
Documents
Machineries & Equipments
Laboratories Equipments Technical
Personsrequirements
Other requirements if any as perlaw
2)
3)
4)
5)
6)
-Detail report of inspection is submitted to LA by Inspector along with his recommendations
for grant/rejection/compliance ofLicense.
-LA grant/reject application for License.(Lic.Form.No.-25D)
-License granted is valid for 5 years from the date ofgrant.
-License granted in Form No. 25D is to be renewed for another period of 5years.
-New License is to be obtained in case of change in constitution of the Firm within three
months.
-Separate License is to be obtain for change ofPremises.
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34. Procedure for addition of new category
in existinglicense
NewplanshowingoldandnewcategoryistobesubmittedforapprovaltoLA
asdiscussedearlier.FeeRs-20istobepaidbychallan.
❑Planisapprovedbyplancommittee.Premisesistobeconstructedfornew
categoryaspernewplan,Machineriesandequipmentsaretobeinstalled,
TechnicalPersonsaretobeemployed,alldocumentsaretobepreparedand
thanapplicationistobesubmittedtoLAforgrantingnewcategoryof
cosmetics.ThefollowingdocumentsaretobesubmittedtoLA.
1)ForwardingletteraddresstoLA
2)OriginalchallanforFeeofproductsasperrequirements-Nofeesatpresent
3)Originalnewplanofpremises-1copy
4)ListofProducts-categorywise-4copiesalongwithproductdetailsForm
5)Draftlabelofeachproduct-3copies
6)ListofMachineries&Equipments-1copy
7)ListofLaboratoryequipments-1copy
8)ListofapprovedTechnicalpersons-4copies
9)Detailofmethodofanalysisofproducts&Rawmaterials
10)CopyoforiginalLicensealongwithlistofproducts
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35. Procedure for additionalproduct
permission in existinglicense
For additional item –No fee isprescribed.
1)Application is to be made to LA forobtaining
permission for additional itemswith-
2)List of Products-category wise-4 copies along with
product detailsForm
3)Draft label of each product-3copies
4)Detail of method of analysis of products & Raw
materials
5)Copy of originalLicense
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36. Approval of technical person byLA
For getting approval of TP for particular sectionan
application along with documents is to be made to LAby
concern manufacturer if degree & experience is as per
Rules.
Documents are-(1) Appointment letter of TP (2)Acceptance
letter of TP (3) Copy of Degree Certificate ofTP
(4)Experience Certificate of TP (5) Forms of TP dully filled
with.
Verification of Degree , experience is carried out by an
Inspector & report is submitted toLA.
LA is approving TP for concern section if report isOK.
Approval given by LA is valid for all Manu. Units.HERBAL DRUG TECHNOLOGY Aravind R 36

37. Procedure for obtaining loanlicense
•ForwardingletteraddresstoLAforobtaining
License.Applicationform-24Ealongwithfee
Rs.600/-(challan)Form-1,2,3Properlyfilled&sign
byapplicant
•CopyofManu.licencesofownfirmalongwithlistofapproved
products.Listofloaneefirmstilldate.
•FormofFirmsdetailsdullyfilled&signedbyAuth.Person
•Documentregardingpossessionofthepremises-
•WholesaleLicence.
•DocumentregardingconstitutionoftheFirm(P/D,MOAA,TD
etc)
•MOAAmeans‘MedicalofficersAyurvedaAssociation’
•TD-adocumentthattransfersthelegaltitletopropertytoatrustee
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38. List of Products-category wise-4 copies along with product details
Draft label of each product-3copies
Detail of method of analysis of products & Rawmaterials
Consent letter of Public TestingLab
List ofSOP
MFR of each product
Documents regarding supervisorychemist
Validity of licenceIs for 5 years from the date ofgrant.
In case of any change in the constitution new license is to be obtained
within threemonths.
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39. Schedule Z -good clinical
practices (GCP) for clinical
trials on ASU medicines
DepartmentofAyushhasadoptedandformulatedthis
guidelinesbasedonCDSCOdocumentonGCPGuidelinesthat
wasreleasedin2001forclinicaltrialsonpharmaproducts.
HERBAL DRUG TECHNOLOGY Aravind R 39

40. •AlthoughtheASUsystemsareknownfortheirlonghistoryofsafeandeffective
use,yetvalidationofsafetyandefficacyusingscientificandevidence-based
methodologiesisneededforthepurposeofuniversalacceptability.
•Theargumentsofhavinglongstandinginthemedicalpracticeormarketare
oftenunconvincingandtherehasbeenpersistentandincreasingdemandof
documentedproofofclinicalsafetyandefficacyofASUmedicine.
•Inthisperspective,theclinicaltrialsinASUsystemsneedtobeguidedonthe
principleof‘GoodClinicalPractice’.
•Researchers,sponsorsanddrugmanufacturers,therefore,havetobewell
versedwiththestandardscientificproceduresthatarerequiredtobefollowed
whileconductingclinicaltrialswithASUinterventionstoachieveobjectiveand
reproducibleresults.
INTRODUCTION
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41. ➢GoodClinicalPracticeisasetofguidelineswhich
encompassesthedesign,conduct,termination,audit,
analysis,reportinganddocumentationofthestudies
involvinghumansubjects.
➢ThefundamentaltenetofGCPisthatinresearchonman,
theinterestofscienceandsocietyshouldnevertake
precedenceoverconsiderationsrelatedtothewellbeing
ofthestudysubject.
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42. •ThefundamentalobjectiveofGoodClinicalPracticeguidelinesforASU
medicineincludeprotectionofhumanrightsasasubjectinclinicaltrial.
•Italsoprovidesassuranceofthesafetyandefficacyofthenewly
developedaswellasconventionallyusedASUformulations.
•Theseguidelinesincludestandardsofhowclinicaltrialsshouldbe
conducted;anddefinetherolesandresponsibilitiesofclinicaltrial
sponsors,clinicalresearchinvestigators,monitorsetc.
•Theguidelinesonthewholeadoptthebasicprinciplesoutlinedbythe
CDSCOforengaginginGoodClinicalPracticealbeitwithnecessary
modificationstosuittheASUprinciplesandtreatmentmethodologies.
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43. AYUSHGCP guide line
AYUSH guideline contains GCP guideline forthe
ayurvedic, unani and siddhadrugs.
It containsfollowings:
➢Introduction
➢Definitions
➢Pre-requisites for thestudy
➢Protocol
➢Ethical and safetyconsideration
➢Informed consentprocess
➢Compensation forparticipation
➢Responsibilities of sponsor, monitor andinvestigator
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44. ➢Record keeping and datahandling
➢Qualityassurance
➢Statistics
➢Specialconcerns
➢Appendix I: guideline for evaluation ofayurvedic,
unani and siddhamedicine
➢Appendix II: ethicalissues
➢Appendix III: investigator’sbrochure
➢Appendix IV: essentialdocument
HERBAL DRUG TECHNOLOGY Aravind R 44

45. 2.3.1 Relevant components of Protocol
2.3.1.1 General information
a.Protocoltitle,protocolidentifyingnumberanddate.
b.Name,address&contactdetailsofthesponsorandthemonitor/CRO
c.Nameanddesignationofthepersonsauthorizedtosigntheprotocoland
theprotocolamendmentsforthesponsor
d.Name,title,addressandcontactdetailsofthesponsor’smedicalexpert
forthestudy
e.Name(s),title(s),address(es)anddetailsoftheinvestigator(s)whois/
areresponsibleforconductingthestudy,alongwiththeirconsentletter(s)
f.Name(s),address(es)anddetailsoftheinstitution(s)-clinical
laboratoriesand/orothermedicalandtechnicaldepartmentsalongwiththe
particularsofthehead(s)oftheinstitution(s)andtherelevant
department(s)
g.DiseaseReview,whichincludesprevalence,economicalburden,historical
aspects,clinicalfeatures,existingdiagnosticsandtreatmentincludingthe
detailsofadversedrugreactions(ADRs)asdescribedinrespectiveASU
systemalongwithrelatedinformation(s)inmodernsystem(ifavailable).
h.ASUdrug/PatentorProprietaryMedicinesreview,whichincludesof
detailsofingredientswithsupportingrelevantscientificstudyandpublished
papers(ifavailable).HERBAL DRUG TECHNOLOGY Aravind R 45

46. 2. Pre-requisites for the Study
2.1InvestigationalASUDrug/PatentorProprietaryMedicines:Physical,chemical
(whereveravailable),pharmaceuticalpropertiesandtheformulationofthe
InvestigationalASUdrug/PatentorProprietaryMedicinesmustbedocumented
topermitappropriatesafetymeasurestobetakenduringthecourseofastudy.
Instructionsforthestorageandhandlingofthedosageformshouldbe
documented.
2.2Pre-clinicalsupportingdataTheavailablepre-clinicaldataandclinical
informationontheInvestigationalASUdrug/PatentorProprietaryMedicines
shouldbeadequateandconvincingtosupporttheproposedstudyasper
guidelines.
2.3Protocol-Awelldesignedstudyreliespredominantlyonathoroughly
considered,well-structuredandcompleteprotocol.
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47. 2.3.1.2 Objectives and Justification
a.Aim and objectives of the study, indicating the Phase to which the study
corresponds
b.Name and description of the investigational product(s)
c.A summary of findings from non-clinical studies (if any) that potentially have
clinical significance and from clinical studies that are relevant to the study and
bibliographic references.
d. Summary of the known and potential risks and benefits, if any, to human subjects
e. Description of and justification for the route of administration, dosage regimen
and treatment periods for the ASU drug / Patent or Proprietary Medicines being
studied and the product being used as control. Dose-response relationships should
be considered and stated if required.
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48. 2.3.1.3 Ethical Considerations
2.3.1.4 Study design
2.3.1.5 Inclusion, Exclusion & Withdrawal of Subjects
2.3.1.6 Handling of the Product(s)
2.3.1.7 Assessment of Efficacy
2.3.1.8 Assessment of Safety
2.3.1.9 Statistics
2.3.1.10 Data handling and management
2.3.1.11 Quality control and quality assurance
2.3.1.12 Finance and Insurance
2.3.1.13 Publication policy
2.3.1.14 Evaluation
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49. REFERENCE
Drug and cosmetic act 1945
AYUSH GCPguidelines
General Guidelines For Drug Development Of
Ayurvedic Formulations, CENTRAL COUNCIL
FOR RESEARCH IN AYURVEDIC SCIENCES
Ministry Of AYUSH, Government Of India New
Delhi
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50. HERBAL DRUG TECHNOLOGY Aravind R 50