An introduction to standard institutions and regulatory authorities such as ICH, WHO, USFDA, MHRA, TGA, BIS, ASTM, ISO, CDSCO

An Introduction to Standard Institutions and Regulatory Authorities
such as ICH, WHO, USFDA,
MHRA, TGA, BIS, ASTM,
ISO, CDSCO

1. such as
ICH, WHO, USFDA,
MHRA, TGA, BIS, ASTM,
ISO, CDSCO.
Mr. Hemant Alhat

2. ICH : International Council for Harmonisation

TheInternationalCouncilforHarmonisationofTechnical
RequirementsforPharmaceuticalsforHumanUse (ICH)is
uniqueinbringingtogethertheregulatoryauthoritiesand
pharmaceuticalindustrytodiscussscientificandtechnical
aspectsofpharmaceuticalsanddevelopICHguidelines .
Sinceitsinceptionin1990,

ICHhasgraduallyevolved,torespondtoincreasinglyglobal
developmentsinthepharmaceuticalsectorandtheseICH
ICHhasgraduallyevolved,torespondtoincreasinglyglobal
developmentsinthepharmaceuticalsectorandtheseICH
guidelinesareappliedbyagrowingnumberofregulatory
authorities.

ICH'smissionistoachievegreaterharmonisationworldwide
toensurethatSafe,Effective&HighQualityMedicines are
developed,andregisteredandmaintained inthemost
resourceefficientmannerwhilstmeetinghighstandards.Since
itsannouncementoforganisationalchangesinOctober2015,

ICHhasgrownasanorganisationandnow includes17Members
and32Observers.
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3. ICH’sMission

WithICH’sestablishmentasaninternationalnon-profit
AssociationunderSwisslawonOctober23,2015,

ICH’smissionhasbeenembodiedinitsArticlesofAssociationas
follows:

Tomakerecommendationstowardsachievinggreater
harmonisationintheinterpretationandapplicationof
technicalguidelinesandrequirementsforpharmaceutical
harmonisationintheinterpretationandapplicationof
technicalguidelinesandrequirementsforpharmaceutical
productregistrationandthemaintenanceofsuch
registrations;

Tomaintainaforumforaconstructivedialogueon
scientificissuesbetweenregulatoryauthoritiesandthe
pharmaceuticalindustryontheharmonisation ofthe
technicalrequirementsforpharmaceuticalproducts;

Tocontributetotheprotectionofpublichealthinthe
interestofpatientsfromaninternationalperspective;
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4. ICH’s Mission

Tomonitorandupdateharmonisedtechnicalrequirements
leadingtoagreatermutualacceptanceofresearchanddevelopment
data;

Toavoiddivergentfuturerequirementsthroughharmonisation of
selectedtopicsneededasaresultoftherapeuticadvancesandthe
developmentofnewtechnologiesfortheproductionofmedicinal
products;
Tofacilitatetheadoptionofneworimprovedtechnicalresearch

Tofacilitatetheadoptionofneworimprovedtechnicalresearch
anddevelopmentapproacheswhichupdateorreplacecurrentpractices;

Toencouragetheimplementationandintegrationofcommon
standardsthroughthedisseminationof,thecommunicationof
informationaboutandcoordinationoftrainingon,harmonised
guidelinesandtheiruse;and

TodeveloppolicyfortheICHMedicalDictionaryforRegulatory
ActivitiesTerminology(MedDRA)whilstensuringthescientificand
technicalmaintenance,developmentanddisseminationofMedDRAas
astandardiseddictionarywhichfacilitatesthesharingofregulatory
informationinternationallyformedicinalproductsusedbyhumans.

https://www.ich.org/page/mission
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5. World Health Organization (WHO)

World Health Organization (WHO), the United Nations’
specialized agency for Health was founded in 1948.

Itsheadquartersare situated inGeneva, Switzerland.

There are 194MemberStates, 150country offices, six
regional offices.regional offices.

It is an inter-governmental organization and works in
collaboration with its member states usually through
the Ministries of Health.

The WHO providesleadershipon global health matters,
shapingthe health research agenda, settingnorms and
standards, articulatingevidence-based policy options,
providing technical support to countries and monitoring
and assessing health trends.

It began functioning onApril 7,1948–a date now being
celebrated every year asWorld Health Day.
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6. World Health Organization (WHO)

Objectives

To act as thedirectingand coordinatingauthority on
international health work.

To establishand maintaineffective collaboration with
the United Nations,specialized agencies, governmental
To establishand maintaineffective collaboration with
the United Nations,specialized agencies, governmental
health administrations, professional groups and such other
organizations as may be deemed appropriate.

Toprovide assistanceto the Governments, upon
request,in strengthening health services.

Topromotecooperation among scientific and
professional groupswhich contributeto the
advancement of health.
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7. WHO’s Contribution to World

The country offices are WHO’s primary contact
points with governments.

They providetechnical support on health matters,
share relevant global standards and guidelines, and
relay government requests and requirements to other relay government requests and requirements to other
levels of WHO.

They also inform and follow up with the host
government on reports of disease outbreaks outside the
country.

They provide advice and guidance on public health
to other UN agency offices in-country.
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8. WHO and India

India became a party to the WHO on 12 January 1948.

Regional office for South East Asia is located in New Delhi.

Smallpox

In 1967 the total number of smallpox cases recorded in India
accounted for nearly 65% of all cases in the world. Of this 26,225
cases died, giving a grim picture of the relentless fight that lay
accounted for nearly 65% of all cases in the world. Of this 26,225
cases died, giving a grim picture of the relentless fight that lay
ahead.

In 1967, the WHO launched the Intensified Smallpox
Eradication Programme.

With a coordinated effort by Indian government with the World
Health Organization (WHO), smallpox was eradicated in 1977.
https://www.drishtiias.com/important-institutions/drishti-
specials-important-institutions-international-institution/world-
health-organization-who
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9. USFDA

TheU.S.FoodandDrugAdministration(FDA) is
composedofsevenCentersresponsibleforensuring
thetobaccoproducts,Safety,Efficacy,Oversight
AndSecurityOfTheNation'sHumanAndAndSecurityOfTheNation'sHumanAnd
VeterinaryDrugs,biologicalproducts,medical
devices,food,cosmeticsandproductsthatemit
radiation.
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10. WhatisUSFDA?

ThegovernmentoftheUnitedStatesestablishedtheU.S.Food
andDrugAdministration(USFDA)astheREGULATORYBODY
thatREVIEWS,APPROVES&REGULATESmedicalproducts,
includingpharmaceuticaldrugsandmedicaldevices.

ProductstheUSFDARegulates

Withthisinmind,the agencyismainlyresponsible for
protectingpublichealthbyregulatingthefollowing-protectingpublichealthbyregulatingthefollowing-

Humandrugsandbiologics

Animaldrugs

Medicaldevices

Tobaccoproducts

Food(includinganimalfood)

Cosmetics

Electronicproductsthatemitradiation
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11. Regulatory Process of USFDA
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12. Responsibilities of the USFDA-

Theregulationresponsibilitiesofthebodyinclude-

ProtectingpublichealthbyensuringtheSAFETY,EFFICACY,AND
SECURITYofhumanandveterinarydrugs,medicaldevices,vaccines,
andbiologicalproducts.

toensuretheyusemedicalproductsandfoodswithsafety.
Empoweringthepublicbygivingthemaccurate,science-based
informationinformation

ENSURINGTHESAFETY offoodbyproperlylabelingthem.

Protectingpublichealthbymanufacturing ,marketingand
distributingtobaccoproductsandprovidingcautionarymeasures
toreducetobaccousebyminors.

Ensuringpublicsafetyfromradiationreleasedbycertain
electronicproducts.

Advancingpublichealthbyspeedingupinnovationsthatmake
medicalequipmentmoreeffective,safer,andmoreaffordable.

FulfillstheroleofNation’scounterterrorismcapabilitybyensuring
food

https://www.pristyncare.com/blog/know-about-usfda/
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13. MHRA
Medicines And Healthcare Products Regulatory Agency

TheMedicinesandHealthcareproductsRegulatoryAgency
regulatesmedicines,medicaldevicesandbloodcomponentsfor
transfusionintheUK.

RecognisedGLOBALLY asanauthorityinitsfield,theagencyplaysa
leadingroleinprotectingandimprovingpublichealthand
supportsinnovationthroughscientificresearchandsupportsinnovationthroughscientificresearchand
development.

Theagencyhas3centres:

theClinicalPracticeResearchDatalink(CPRD ),adataresearch
servicethataimstoimprovepublichealthbyusing
anonymisedNHSclinicaldata

TheNationalInstituteforBiologicalStandardsandControl
(NIBSC),agloballeaderinthestandardisationandcontrolof
biologicalmedicines

theMedicinesandHealthcareproductsRegulatoryAgency
(MHRA),theUK’sregulatorofmedicines,medicaldevicesand
bloodcomponentsfortransfusion,responsibleforensuringtheir
safety,qualityandeffectiveness
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14. Responsibilities

Theagencyisresponsiblefor:

Ensuringthatmedicines,medicaldevicesandbloodcomponents
fortransfusionMEETapplicableSTANDARDSofsafety,qualityand
efficacy

Ensuringthatthesupplychain formedicines,medicaldevicesand
bloodcomponentsisSAFEANDSECUREbloodcomponentsisSAFEANDSECURE

Promotinginternationalstandardisationandharmonisation to
assuretheeffectivenessandsafetyofbiologicalmedicines

Helpingtoeducatethepublicandhealthcare professionalsabout
therisksandbenefitsofmedicines,medicaldevicesandblood
components,leadingtosaferandmoreeffectiveuse

Supportinginnovationandresearchanddevelopment that’s
beneficialtopublichealth

InfluencingUK,EUandinternationalregulatoryframeworks so
thatthey’rerisk-proportionateandeffectiveatprotectingpublichealth

https://www.gov.uk/government/organisations/medicines-and-
healthcare-products-regulatory-
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15. Therapeutic Goods Administration (TGA)

TheTGAisresponsibleforRegulatingthesupply,
import,export,manufacturingandadvertisingof
therapeuticgoods.

TheARTG(AustralianRegisterofTherapeutic

TheARTG(AustralianRegisterofTherapeutic
Goods)containstherapeuticgoodsthatcanbe
lawfullysuppliedinAustralia.

TheTGAisapartoftheAustralianGovernment
DepartmentofHealth.
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16. The role of the TGA

Evaluatetherapeutic goods before they are supplied

Focuson SAFETY, QUALITY AND PERFORMANCE

Monitorproducts once they are on the market
Allowfor access to unapproved goods in certain

Allowfor access to unapproved goods in certain
circumstances

We do not make decisions based on value for
money or make decisions about which products
receive Government subsidy
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17. https://www.tga.gov.au/role-
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18. BIS
Bureau of Indian Standards

BureauofIndianStandards (hereinafterreferredto
as‘BIS’)isastatutorybodyestablishedunderthe
BureauofIndianStandardsAct ,2016(hereinafter
referredtoasthe‘Act’).referredtoasthe‘Act’).

BISprescribesthestandardsforcoveringgoods
andsystemsunderthestandardizationregime.

BIShasbeenidentifiedasthe‘NationalStandards
BodyofIndia’andisregulatedundertheMinistry
ofConsumerAffairs,Food&PublicDistribution,
andGovernmentofIndia.
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19. Functions of BIS

BISthroughitscoreactivitiesofstandardizationandconformity
assessment,hasbeenbenefitingtheeconomyby providingsafe
andreliableandqualitygoods;minimizinghealthhazardsto
consumers;

protectingtheenvironment,promotingexportsandimports
substitute;

controllingproliferationofvarietiesetc.

ThestandardsandcertificationschemeofBISapartfrom

ThestandardsandcertificationschemeofBISapartfrom
benefittingtheconsumersandindustryalsosupportvarious
publicpoliciesespeciallyinareasofproductsafety,consumer
protection,foodsafety,environmentprotection,buildingand
construction,etc.
[1]

BIScarriesoutvariousactivitieslikethatofstandardsformulation,
productcertification,hallmarking,laboratoryservices,training
services,etc.

However,theprimaryandmostrecognized objectiveofBISisto
formulateandprescribethestandardsforproductsfortheir
certification.

BISalsoensurestheharmoniousdevelopmentoftheactivities
ofstandardization,markingandqualitycertificationofgoods.
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20. Schemes of certification
are covered under BIS

The following schemes of certification are covered under BIS

Product Certification Scheme–Applicable for tangible
products; with some products classified under compulsory
certification.

System Certification Scheme–Applicable for systems/
process

System Certification Scheme–Applicable for systems/
process

Foreign Manufacturers Certification Scheme -Applicable for
foreign manufacturers who are engaged in the sale of their
products in India.

Hallmarking–Applicable for articles made from precious
metals like gold and silver

ECO Mark Scheme–Applicable for products affecting or
related to the environment

https://www.lexology.com/library/detail.aspx?g=9e0c0900-
8a29-4a0d-88d8-32c8652dc3e0
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21. ASTM
American Society for Testing and Materials

ASTMInternational,formerlyknownasAmericanSocietyfor
TestingandMaterials ,isan internationalstandards
organizationthatdevelopsandpublishesvoluntary
consensustechnicalstandardsforawiderangeofmaterials,
products,systems,andservices.

Some12,575ASTMvoluntaryconsensusstandardsoperate

Some12,575ASTMvoluntaryconsensusstandardsoperate
globally.

Theorganization'sheadquartersisinWestConshohocken,
Pennsylvania,about5mi(8.0km)northwest
ofPhiladelphia.

Foundedin1898astheAmericanSectionof
theInternationalAssociationforTestingMaterials (see
alsoInternationalOrganizationforStandardization),

ASTMInternationalpredatesotherstandardsorganizationssuch
as the British
StandardsBSI(1901),IEC(1906),DIN(1917),ANSI(1918),AFNOR
(1926),andISO(1947).
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22. 
ASTMInternationalhasnoroleinrequiringorenforcingcompliance
withitsstandards.Thestandards,however,maybecomemandatorywhen
referencedbyanexternalcontract,corporation,orgovernment.
[5]

IntheUnitedStates,ASTMstandardshavebeenadopted,byincorporation
orbyreference,inmanyfederal,state,andmunicipalgovernment
regulations.

TheNationalTechnologyTransferandAdvancementAct, passedin1995,
requiresthefederalgovernmenttouseprivatelydevelopedconsensusstandards
wheneverpossible.TheActreflectswhathadlongbeenrecommendedaswheneverpossible.TheActreflectswhathadlongbeenrecommendedas
bestpracticewithinthefederalgovernment.

Othergovernments(localandworldwide)alsohavereferencedASTM
standards.
[8]

CorporationsdoinginternationalbusinessmaychoosetoreferenceanASTM
standard.

AlltoyssoldintheUnitedStatesmustmeetthesafetyrequirementsofASTM
F963,StandardConsumerSafetySpecificationforToySafety,aspartof
theConsumerProductSafetyImprovementAct of2008(CPSIA).Thelaw
makestheASTMF963standardamandatoryrequirementfortoyswhilethe
ConsumerProductSafetyCommission(CPSC)studiesthestandard's
effectivenessandissuesfinalconsumerguidelinesfortoysafety.
[9]
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23. ISO
International Organization for Standardization

The InternationalOrganizationfor
Standardization(ISO)isaninternationalstandard-
settingbodycomposedof representativesfrom
variousnationalstandardsorganizations.variousnationalstandardsorganizations.

Foundedon23February1947 ,theorganization
promotesworldwideproprietary,industrial ,and
commercialstandards.ItisheadquarteredinGeneva,
Switzerland,
[3]
andworksin164countries.
[1]

Itwasoneofthefirstorganizationsgrantedgeneral
consultativestatuswiththeUnitedNationsEconomic
andSocialCouncil.
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24. ISO
International Organization for Standardization

TheISOisanindependent,non-governmentalorgan ization,the
membersofwhicharethestandardsorganizationsofthe164
membercountries.
[1]

Itistheworld'slargestdeveloperofvoluntaryinternational
standardsanditfacilitatesworldtradebyprovidingcommon
standardsamongnations.

Morethan20thousandstandardshavebeenSET,covering

Morethan20thousandstandardshavebeenSET,covering
everythingfrommanufacturedproductsandtechnologytofoodsafety,
agriculture,andhealthcare.
[3]

Useofthestandardsaidsinthecreationofproductsandservices
thataresafe,reliable,andofgoodquality.

Thestandardshelpbusinessesincreaseproductivity while
minimizingerrorsandwaste.Byenablingproductsfromdifferent
marketstobedirectlycompared,they facilitatecompaniesin
enteringnewmarketsandassistinthedevelopmentofglobal
tradeonafairbasis.

ThestandardsAlsoServeToSafeguardConsumers andtheend-
usersofproductsandservices,ensuringthatcertifiedproducts
conformtotheminimumstandardssetinternationally .
[3]
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25. Structure ISO

ISOisavoluntaryorganizationwhosemembersare
recognizedauthoritiesonstandards, eachone
representingonecountry.Membersmeetannually ata
GeneralAssemblytodiscussthestrategicobjectivesofISO.GeneralAssemblytodiscussthestrategicobjectivesofISO.
Theorganizationiscoordinatedbyacentralsecretariat
basedinGeneva.
[9]

Acouncilwitharotatingmembershipof20member
bodiesprovidesguidanceandgovernance ,including
settingtheannualbudgetofthecentralsecretariat.
[9][10]

Thetechnicalmanagementboardisresponsiblefor
morethan250technicalcommittees, whodevelopthe
ISOstandards.
[9][11][12][13]
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26. CDSCO
Central Drugs Standard Control Organisation

TheCentralDrugsStandardControl
Organisation(CDSCO)underDirectorateGeneralof
HealthServices,MinistryofHealth&Family
Welfare,GovernmentofIndia istheNational
RegulatoryAuthority(NRA)ofIndia.

ItsheadquarterislocatedatFDABhawan,KotlaRoad,

ItsheadquarterislocatedatFDABhawan,KotlaRoad,
NewDelhi110002andalsohassixzonaloffices,foursub
zonaloffices,thirteenPortofficesandsevenlaboratories
spreadacrossthecountry.

TheDrugs&CosmeticsAct,1940andrules1945 have
entrustedvariousresponsibilitiestocentral&state
regulatorsforregulationofdrugs&cosmetics.

Itenvisages/foreseeuniformimplementationofthe
provisionsoftheAct&Rules madethereunderfor
ensuringthesafety,rightsandwellbeingofthe
patientsbyregulatingthedrugsandcosmetics.
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27. 
CDSCOisconstantlythrivingupontobringouttransparency,
accountabilityanduniformityinitsservicesinorderto
EnsureSafety,EfficacyAndQualityOfTheMedicalProduct
manufactured,importedanddistributedinthecountry.

UndertheDrugsandCosmeticsAct,CDSCO is
RESPONSIBLEforApprovalofDrugs,ConductofClinical
Trials,layingdownthestandardsforDrugs,controloverthe
CDSCO
Central Drugs Standard Control Organisation
Trials,layingdownthestandardsforDrugs,controloverthe
qualityofimportedDrugsinthecountryandcoordination
oftheactivitiesofStateDrugControlOrganizationsby
providingexpertadvicewithaviewofbringaboutthe
uniformityintheenforcementoftheDrugsandCosmeticsAct.

FurtherCDSCOalongwithstateregulators, isjointly
responsibleforgrantoflicensesofcertainspecialized
categoriesofcriticalDrugssuchasbloodandbloodproducts,I.
V.Fluids,VaccineandSera.
https://cdsco.gov.in/opencms/opencms/en/About-
us/Introduction/
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28. 
WithintheCDSCO, theDrugControllerGeneralofIndia(DCGI)
REGULATESpharmaceuticalandmedicaldevices ,underthe
gamutofMinistryofHealthandFamilyWelfare.TheDCGIis
ADVISEDbytheDrugTechnicalAdvisoryBoard(DTAB)andtheDrug
ConsultativeCommittee(DCC).Itisdividedintozonalofficeswhich
dopre-licensingandpost-licensinginspections,post-market
surveillance,andrecallswhenneeded.
[3][4]
Manufacturerswhodeal
CDSCO
Central Drugs Standard Control Organisation
surveillance,andrecallswhenneeded.Manufacturerswhodeal
withtheauthorityarerequiredtonameanAuthorizedIndian
Representative(AIR)torepresenttheminalldealingswiththe
CDSCOinIndia.
[5]

ThoughtheCDSCOhasa goodtrackrecordwiththeWorldHealth
Organization,
[6]
ithasalsobeenaccusedofpastcollusionwith
independentmedicalexpertsandpharmaceutical
companies.
[7]
CDSCOplanstoopeninternationalofficesinBeijing,
China.
[8]

https://en.wikipedia.org/wiki/Central_Drugs_Standard_Control_Orga
nisation
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29. 
What do GMP, ISO and QSR mean, and how do they differ?

Posted onbyTriLinkBioTech

GMP stands for Good Manufacturing Practices, and refers to a system of
manufacturing that guarantees reproducibility of product quality to set
specifications. cGMPis simply Current Good Manufacturing Practices and
refers to compliance with current regulations. It can be considered redundant
since to be GMP compliant you must comply with current GMP regulations
anyways. The requirements differ depending on what type of product is being
manufactured and whether it is for pharmaceutical or diagnostic purposes. ISO
stands for International Organization for Standardization, which offers a
standard for operating a firm from management through manufacturing. It is standard for operating a firm from management through manufacturing. It is
more encompassing than GMP. QSR stands for Quality Systems Regulation,
which are GMP standards described by the FDA for the manufacture of
products for the diagnostic industry. The ISO and QSR systems each describe
specific GMP standards. The ISO system pays more attention to the
management of the firm and places a number of reporting loops in the firm to
ensure attention to issues. The QSR system is more focused on the
manufacturing systems, and the validation of those systems. Although neither
standard is required to maintain GMP facilities, it is essential that a firm
satisfies the requirements of the client’s quality system. Generally, this means
conforming to ISO or QSR standards. Every product made at TriLinkis
manufactured under GMP. We are compliant with ISO 9001.
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