Regulatory Issues for ASU.ppt by Dr.U.Srinivasa

Useful for B.Pharm students

1. REGULATORY ISSUES IN INDIA FOR
ASU (Ayurveda, Siddha and Unani )
DRUGS
Dr.U.Srinivasa, M. Pharm., M.Phil., Ph.D.
Professor and Head, (Dept. of
Pharmacognosy)
Srinivas college of pharmacy, Mangalore.
Email. [email protected]

2. INTRODUCTION
Drugsplayanimportantroleinthehealthofbothpeople
andtheeconomyofacountry.
Pharmaceuticaldrugsareavailablefromalargenumber
ofsources.
PeopleandGovernmentswillingtospendmoneyon
drugsformanyreasonsso,itmustbesafe,effectiveand
goodqualityandusedappropriately.

3. INTRODUCTION
Thismeans,inturn,thatdevelopment,production,
importation,exportationandsubsequentdistributionof
drugsmustberegulatedtoensurethattheymeet
prescribedstandards.
Therefore,effectivedrugregulationisrequiredtoensure
thesafety,efficacyandqualityofdrugsaswellas
accuracyandappropriatenessofthedruginformation
availabletothepublic.

4. Regulatory requirements
Inanidealworld,theneedforanalysisshouldbe
drivenbythedesiretoassurethequalityofadrug
product.However,intherealworldtheneedfor
pharmaceuticaldruganalysisisdrivenlargelyby
regulatoryrequirements.
AteamconsistingofR&D,QC,andQAunitmembers
developsthesequalityandcompliancesystems.

5. Regulatory requirements
•Itshouldbeoneofthehighestprioritiesoftop
managementandQAunitstodevelopandmonitor
thesesystemstocomplywiththecGMPandGLP
expectations.
•Compliancedocumentsareneeded,inadditiontothe
regulatoryandresearchdocuments,todemonstratethe
integrityofthedata.
•Compliancedocumentsrefertothosereportsrequired
byGMPand/orutilizedduringthecourseofinspection
byahealthauthority

6. Functions of regulatory agencies
•Productregistration(drugevaluationandauthorization,
andmonitoringofdrugefficacyandsafety);
•Regulationofdrugmanufacturing,importation,and
distribution;Regulation&Controlofdrugpromotionand
information.
•Adversedrugreaction(ADR)monitoring.
•Licensingofpremises,personsandpractices.

7. Goal of drug regulation
•Main goal of drug regulation is to guarantee the safety,
efficacy and quality of drugs available to public

8. Regulations in India
HerbaldrugsareregulatedundertheDrugandCosmetic
Act(D&C)1940andRules1945inIndia,whereregulatory
provisionsforAyurveda,Unani,Siddhamedicineareclearly
laiddown.
DepartmentofAYUSHistheregulatoryauthorityand
mandatethatanymanufactureormarketingofherbaldrugs
havetobedoneafterobtainingmanufacturinglicense,as
applicable.
.

9. Regulations in India
TheD&CActextendsthecontroloverlicensing,
formulationcomposition,manufacture,labelling,
packing,qualityandexport.
Schedule“T”oftheactlaysdownthegood
manufacturingpractice(GMP)requirementstobe
followedforthemanufacturingofherbalmedicines

10. Regulations in India
TheofficialPharmacopoeiasandformulariesareavailable
forthequalitystandardsofthemedicines.Firstschedule
oftheD&CActhaslistedauthorizedtexts,whichhaveto
befollowedforlicensinganyherbalproductunderthetwo
categories:ASUdrugs&Patentorproprietarymedicines.
InIndia,traditionalmedicinesaregovernedbytheDrugs
andCosmeticsActof1940andtheDrugsandCosmetics
Rulesof1945.

11. Regulations in India
Theyregulatetheimport,manufacture,distributionandsale
ofdrugsandcosmetics
In1959,theGovernmentofIndiarecognizedthetraditional
IndiansystemofmedicineandamendedtheDrugsand
CosmeticsActtoincludedrugswhicharederivedfrom
traditionalIndianMedicine.
Noproductsderivedfromtraditionalsystemsmaybe
manufacturedwithoutalicencefromtheStateDrugControl
Authorities

12. Regulations in India
•Patentandproprietarymedicinesderivedfromthe
traditionalsystemsmustcontainingredientswhichare
mentionedintherecognizedbooksoftheabove
systems,asspecifiedintheDrugsandCosmeticsAct.
•Thegovernmentinadvisedbyaspecialcommitteeand
anadvisoryboardforAyurvedic,SiddhaandUnani
drugs.
•Pharmacopoeiacommitteeshavebeenconstitutedto
preparePharmacopeias'forallthesesystems.

13. DRUG TECHNICAL ADVISORY BOARD
(ASU DTAB)
TheCentralGovernmentconstituteaBoard(tobecalled
theDrugsTechnicalAdvisoryBoard)toadvisethe
CentralGovernmentandtheStateGovernmentson
technicalmattersarisingoutoftheadministrationofD&C,
Act1940.
TheBoardshallconsistofthefollowingmembers,

14. DRUG TECHNICAL ADVISORY BOARD
MEMBERS
•Director General of health
•Drug Controller, India
•Principle officer of ISM Director of the Central drugs
Laboratory
•Government Analyst
•Pharmacognocist
•Phyto-chemist
•4 Person from ASU pharmacopeia committee
•1 Teacher in Dravaguna
•1 Teacher in Ilmul-advia
•1 Teacher in Gunapadam
•3 Person from ASU drugs industry
•3 Practitioner of ASU medicine

15. Activities and responsibilities
ItadvicesmatterrelatedtoDrugs.
ThenominatedandelectedmembersoftheBoard
shallholdofficeforthreeyears,butshallbeeligiblefor
re-nominationandre-election.
TheBoardmay,subjecttothepreviousapprovalof
theCentralGovernment,regulatingitsownprocedure

16. DRUG CONSULTATIVE COMMITTEE
(ASU DCC)
TheBoardshallconsistofthefollowingmembers,
It is also an Advisory Body consist of two
representative central government to be nominated by
Government .
One representative of each state Government to be
nominated by the State Government.

17. Functions
DCCtoadvisetheCentralGovernment,theState
GovernmentsandtheASU-DTABonanymatterforthe
purposeofsecuringuniformitythroughoutIndiainthe
administrationofthisActinsofarasitrelatestoASU
drugs.
Itshallmeetwhenrequired.
Ithaspowertoregulateitsownprocedure