challenges and issues related to regulation of traditional medicine

8/3/2019 Challenges and Issues Related to Regulation of Traditional Medicine

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CHALLENGES AND ISSUESCHALLENGES AND ISSUES

RELATED TO REGULATION OFRELATED TO REGULATION OF

TRADITIONAL MEDICINETRADITIONAL MEDICINE

Prof. Dr. K. R. Kohli

Director of Ayurveda,

Maharashtra


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The sum total of all the knowledge and practices,

whether explicable or not, used in diagnosis, prevention

and elimination of physical, mental or social imbalance and

relying exclusively on practical experience and

observation handed down from generation to generation,whether verbally or in writing.

y Ayurveda

y

Yoga & Naturopathyy Unani

y Siddha

y Homeopathy


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POSSIBLE REGULATORY CATEGORIES FORPOSSIBLE REGULATORY CATEGORIES FOR

HERBAL MEDICINESHERBAL MEDICINES

1. Prescription medicines: medicines/drugs thatcan only be purchased with a prescription (i.e. aphysicians order). In some countries, the legalframework allows traditional practitioners to

prescribe medicines.

2. Over the counter medicines: medicines/drugsthat can be purchased without a prescription from

a physician.

3. Self medication only: medicines/drugspermitted for self medication purposes only.


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POSSIBLE REGULATORY CATEGORIESPOSSIBLE REGULATORY CATEGORIES

FOR HERBAL MEDICINESFOR HERBAL MEDICINES

4. Dietary supplements: A dietarysupplementisasubstancewhichcontains,forinstance,avitamin,amineral,aherborotherbotanicaloranaminoacid.Adietarysupplementmaybeintendedtoincreasethetotaldailyintakeofaconcentrate,metabolite,constituent,extractorcombinationoftheseingredients.

5. Health food: healthfoodscouldbeproductsthatarepresentedwithspecifichealthclaimsandtherefore

regulateddifferentlyfromotherfoods.

6. Functional foods: likehealthfoods,functionalfoodsmaybeproductswhichareofferedwithspecifichealthclaimsandthereforeregulateddifferentlyfromotherfoods.


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Ayurvedic Products Herbal Products

1. Based on sound fundamental 1. Emperical andprinciples, well documented Experimental base

2. Time tested on human beings 2. Products based on in-vivo

for safety & efficacy and in-vitro trials

3. Based on wholesome 3. Isolated or extracted

ingredients material is used

4. Simple procedures of 4. Sophisticated procedures

processing and for new molecules

manufacturing

5. Holistic and comprehensive 5. Generalized or Empirical use

approach of use for health

Contd

NEED OF DIFFERENTIATIONNEED OF DIFFERENTIATION

BETWEENBETWEEN


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Ayurvedic Products Vs. Herbal Products

6. The product is developed and 6. The product is developedtested in the manner and tested on the

it is used basis of analytical

parameters

7. Psychophysical 7. No such consideration,

characteristics of fragmented approachpatients are taken of treatment

into consideration,

hence holistic

approach

NEED OF DIFFERENTIATIONNEED OF DIFFERENTIATION

BETWEENBETWEEN


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REGULATION/REGISTRATIONREGULATION/REGISTRATION

OF TRADITIONAL MEDICINESOF TRADITIONAL MEDICINES


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MEMBER STATES REPORTING HAVINGMEMBER STATES REPORTING HAVING

REGULATIONS OR LAWS GOVERNINGREGULATIONS OR LAWS GOVERNING



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TYPE OF LAW ORTYPE OF LAW OR

REGULATION ON HERBALREGULATION ON HERBAL

MEDICINESMEDICINES


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MANUFACTURING:MANUFACTURING:

REGULATORY REQUIREMENTSREGULATORY REQUIREMENTS


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REGULATORY STRUCTURESREGULATORY STRUCTURES

y The regulatory structure governing ASU products in India is divided

between the regulation of the products themselves and the

regulation of the institutions which either train the personnel in

charge of training doctors in AYUSH, or are concerned with delivery

ofAYUSH healthcare or in some cases, both.

y Chapter IV A of the Drugs and Cosmetics Act, 1940 (the

Act) governs these products and they are defined in the Act as

including all medicines intended for internal or external use for or in

the diagnosis, treatment, mitigation or prevention of disease or

disorder in human beings or animals and manufactured exclusively inaccordance with the formulae described in, the authoritative books

of Ayurvedic, Siddha and Unani (Tibb) systems of medicine specified

in the First Schedule to the Act.


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REGULATORY STRUCTURESREGULATORY STRUCTURES

y Though the Act classifies AYUSH products as medicinal

products for regulatory convenience (regulating

manufacture on a commercial scale as well as regulating

sale through pharmacies against a prescription), many of

these products are not only used as medicines, but also

as food supplements, or health foods, or OTC products.

y However,theeffectofthelegislationisthatanyproduct

whichismanufacturedforcommercialsalewithouta

licenseasrequiredunderthe Actisnotan AYUSH

product.


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TECHNICAL IMPLEMENTATION / ENFORCEMENTTECHNICAL IMPLEMENTATION / ENFORCEMENT

RELATED EVALUATION OF AYUSH MEDICINESRELATED EVALUATION OF AYUSH MEDICINES

y Ayurveda,Siddha,Unani DrugsTechnical Advisory Board

(ASUDTAB whichadvisesthegovernmentondrug

relatedissues)

y Ayurveda,Siddha,Unani DrugsConsultativeCommittee

(ASUDCC whichadvisesthegovernmenton

implementationissues)

y State licensing authorities whoactuallylookafterthe

testingprocessofAYUSHdrugstoascertaintheirpurity,

safetyetc.


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Manufacturing ProcessManufacturing Process

In India Schedule M of the Drugs and

Cosmetics Act includes the Good

Manufacturing Practices that are applicable tothe pharmaceutical industry and these have

come into effect from the 1st of July, 2005


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WHY REGULATION?WHY REGULATION?

1. Growing Popularity

2. Newer Communities using the TMs

3. Increase in the awareness

4. Availability of sophisticated equipments & Laboratoryequipments.

5. Use of toxic substances and metals in traditions

6. Depleting RM resources & fear of adulterations andadjustments.

7. Concerns on Safety of the medications of TMs.


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WHY REGULATION?WHY REGULATION?

8. MultiplicityofusagesasFood, DietSupplement,Medicine

etc.

9. Varietyofprescribers: fromaNaturaltraditionalhealerto

Degreeholders.10. Owingtoverylowliteracylevels,manyquacksmake

inroadsintopracticeofAyurvedicandHerbalmedicine.

11. Uncontrolledadvertising andagreedtomakequick

buck(MUSLIPOWER).

12. Unethicalpracticeslikeadulterationofproductswith

westernmedicines,peddlingofproductswithno

therapeuticbenefits,makingunsubstantiatedmedicinal

claims.


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WHY REGULATE ?WHY REGULATE ?

Protect consumer interests unsubstantiatedproduct claims

Protect product integrity- evaluation parameters

Maintain requisite standards batch to batchconsistency

Ensure public safety not compromised toxicities

Are safe, effective, beneficial Products, practices lead to positive clinical

outcomes.


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TRADITIONAL MEDICINE REGULATION:TRADITIONAL MEDICINE REGULATION:

CHALLENGESCHALLENGES--11

1. Traditionalmedicines&practicesbeingadoptedbynewerpopulations

2. International diversity:Traditionalmedicinepracticeshavebeen

adoptedindifferentculturesandregionswithouttheparalleladvance

ofinternationalstandardsandmethodsforevaluation.

3. National policy and regulation: Notmanycountrieshavenational

policiesfortraditionalmedicine.Regulatingtraditionalmedicine

products,practicesandpractitionersisdifficultduetovariationsin

definitionsandcategorizationsoftraditionalmedicinetherapies.A

singleherbalproductcouldbedefinedaseitherafood,adietarysupplementoranherbalmedicine,dependingonthecountry.This

disparityinregulationsatthenationallevelhasimplicationsfor

internationalaccessanddistributionofproducts.


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TRADITIONAL MEDICINE REGULATION:TRADITIONAL MEDICINE REGULATION:

CHALLENGESCHALLENGES--22

y Safety, effectiveness and quality: Scientific evidence from

testsdonetoevaluatethesafetyandeffectiveness of

traditionalmedicineproductsandpracticesis limited.While

evidenceshowsthatacupuncture,someherbalmedicinesandsomemanualtherapies(e.g.massage)areeffectivefor

specificconditions,furtherstudyofproductsandpractices

isneeded.Requirementsandmethodsforresearchand

evaluationarecomplex.Forexample,itcanbedifficultto

assessthequalityoffinishedherbalproducts.Thesafety,effectivenessandqualityoffinishedherbalmedicine

productsdependonthequalityoftheirsourcematerials

(whichcanincludehundredsofnaturalconstituents),and

howelementsarehandledthroughproductionprocesses.


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REGULATION:CHALLENGESREGULATION:CHALLENGES--33

Knowledge and sustainability: Herbalmaterialsforproductsarecollectedfromwildplantpopulationsandcultivatedmedicinalplants.Theexpandingherbalproductmarketcoulddriveover-harvestingofplantsandthreatenbiodiversity.Poorlymanagedcollectionandcultivationpracticescouldleadtotheextinctionofendangeredplantspeciesand

thedestructionofnaturalresources.Effortstopreservebothplantpopulationsandknowledgeonhowtousethemformedicinalpurposesisneededtosustaintraditionalmedicine.

Patient safety and use: Manypeoplebelievethatbecausemedicinesareherbal(natural)ortraditionaltheyaresafe(orcarrynoriskfor

harm).However,traditionalmedicinesandpracticescancauseharmful,adversereactionsiftheproductortherapyisofpoorquality,oritistakeninappropriatelyorinconjunctionwithothermedicines.Increasedpatientawarenessaboutsafeusageisimportant,aswellasmoretraining,collaborationandcommunicationamongprovidersoftraditionalandothermedicines.


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CHALLENGES RELATED TO THE REGULATORYCHALLENGES RELATED TO THE REGULATORY

CONTROL OF TRADITIONAL MEDICINESCONTROL OF TRADITIONAL MEDICINES

1. Brand Names: DifferencesinOpinionofapprovingbrandnamesindifferentstates.

2. Lack of interest in Implementation ofrulesand

regulationsbystateregulatoryauthorities (Example-samplesofAyurvedic/herbalmedicines containheavymetals,steroids..etc.)

3. Shortageofstaffduetolessimportancebeinggivento

Regulation

4. LeniencyinpunishingtheGuiltyofbypassingtherules(LethargyorCorruption??)

5. Thewidespreaduseofmultilevelmarketingfor

alternativetherapiesisanadditionalethicalchallenge.


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ASSESSMENT OF SAFETY ANDASSESSMENT OF SAFETY AND

EFFICACYEFFICACY

y Lackofeducation/informationleadstobelievethatTraditionaldrugsare

safe,buttherearecertain herbs which causes adverse effect onthe

bodye.g.Chitrak , Bhallatak.

y Adverse drug reactions ofthedrugsarenotrecordedproperly

(Pharmacovigilance)y Mostofthemanufacturersarenotinterestedinevaluationofsafetyand

efficacyoftheherbalmedicines.(not ready to spend time & money on

quality)

y Eachproductmaycontainseveral different plants and potentially

hundreds of chemical constituents,someofwhichmaybepresentinverylowconcentrations;thesefactorscombinetomakelaboratory

investigationbothcomplicatedandexpensive.

y Infrastructure for testing safety of the drugs isnotadequate

y

Inadequacy of trained staffforevaluationofsafetyofherbaldrugs


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ISSUES ON QUALITY CONTROL OFISSUES ON QUALITY CONTROL OF


1. The source and quality of the raw material

are variable.

2. The methods of harvesting, drying, storage,

transportation, and processing (for example, mode of

extraction and polarity of the extracting solvent, instability of

constituents, etc.) have an effect.


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ISSUES ON QUALITY CONTROL OFISSUES ON QUALITY CONTROL OF


1. LackofadequatestudiestoprovesafetyofmanyofthetraditionalmedicinalcategorieslikeHerbo-mineralpreparations,poisonousplantsetc.

2.Lack

of

Price

control

mechanism.

3. LackofadequatedataonresourcingoftheRM

4. Complexityoftraditionaldrugs;metalswithminerals,mineralswithherbs,metals,minerals&herbs,Animalmaterial,Herbsalone

5. Thewidespreaduseofmultilevelmarketingforalternativetherapiesisanadditionalethicalchallenge.


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PHARMACOPOEIA COMMISSION FORPHARMACOPOEIA COMMISSION FOR

INDIAN SYSTEM OF MEDICINEINDIAN SYSTEM OF MEDICINE

Govt.ofIndiahaspublishedstandardson 540singledrugsand101compoundformulation.

Stillthereareabout2000singledrugsandaboutequalnumberofcompoundedformulationwherestandardsaretobedeveloped.

Theemphasisonlimitingundesirableimpuritiesinbulkdrugsandformulations.

Thereisfastprogressinevolutionofmoreandmoresophisticatedmethodsofanalysis.Theserapiddevelopmentsshouldbereflectedinsuccessiveeditionsofpharmacopoeiawhichmustperforcebebroughtoutmorefrequentlythanitisdoneatpresent.

A wellorganizedindependentbodymaybeabletoassurethis,andfurthermorethestandardsembodiesinmonographscanbefullyunbiased.


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Stronger pharmacovigilenceStronger pharmacovigilence

y A strongerpharmacovigilenceby AYUSH

departmentneedstobeimplemented.

y Knowledge

of

existence

of

Pharmacovigilence

and

itsroletobemadepopular.

y Actnotonlyatthetimeofproblembutmakea

habitofmakingitasroutine.

y AtleaststartincentivisingcompaniesforClinicalTrials&PhaseIVstudies


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ISSUES RELATED TO MEDICINES PREPARED BYISSUES RELATED TO MEDICINES PREPARED BY

TM PRACTITIONERTM PRACTITIONER

GMP registration is mandatory for industry but exemption

has been given to registered ayurvedic practitioner and

teaching institutions that prepare medicines for their

patients.

There is no system available to check quality of the herbal

medicines prepared byVaidyas or the Institutions.

There are occasions when self made medicines contain

heavy metal, mixtures of synthetic drugs, steroids etc.

Adverse reactions owing to the use of such drugs are

usually not communicated to the regulatory authorities.


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RECOMMENDATIONSRECOMMENDATIONS

There is a strong need to hasten the process of

preparing Ayurvedic pharmacopoeia for established

drugs and constituents.

Quality assurance is a significant demand of AYUSH

importers and should help in establishing credibility of

AYUSH products. Therefore, a quality certification for

AYUSH products exported from India would establishquality credentials of these products, and is strongly

recommended. (AYUSH & QCI)


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Stringent and Quick Penalty for manufacture/sale of drugs in

contravention of the Act.

Penalty for subsequent offences needs to be more severe.

Availability of specific analysts for traditional products.

Standardize methods of testing and analysis.

Establish and rope in more Laboratories for Testing and

Analysis of Drugs

Schedule - E of Drug Act prescribe list of poisonous material

used in ASU drugs require special safeguards

IMPORTANT PROVISIONS OF INDIAN DRUGS &IMPORTANT PROVISIONS OF INDIAN DRUGS &

COSMETICS ACT RELATING TO AYURVEDICCOSMETICS ACT RELATING TO AYURVEDIC

MEDICINESMEDICINES


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WHO PERCEIVES CHALLENGESWHO PERCEIVES CHALLENGES

IN REGULATIONIN REGULATION

y AccordingtotheWHOglobalsurveyonthenationalpolicyandregulationofTM,commondifficultiesandchallengesinregulation:

1. Lackofinformationsharing

2. Lackofsafety

3. Monitoringforherbalmedicines

4. Lackofmethodstoevaluatetheirsafetyandefficacy


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RECOMMENDATIONS OF THERECOMMENDATIONS OF THE

WHO COMMITTEEWHO COMMITTEE

MemberStatesshould:

1. Worktostrengthentheregionalnetworkinallpossible

aspectsofherbalmedicines,particularlywithregardtotheirsafety,efficacyand ADR;

2. Developandstrengthenherbalmedicineeducationand

training,practiceandresearch;

3. Workatfacilitatingharmonizationamongthosecountries

thathavecommonsystemsofherbalmedicine


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RECOMMENDATIONS OF THERECOMMENDATIONS OF THE

WHO COMMITTEEWHO COMMITTEE

MemberStatesshould:4. Establishanationaladvisorycommitteeforherbal

medicines

5. Adoptrequirementsfortheregistrationofherbalmedicines.

6. EstablishcoordinationagenciestoimplementGACP;

7. Establishan ADRmonitoringcentreandsystemfor

conventionalmedicinesandherbalmedicines,anddevelopnecessarylinkageswithother ADR

monitoringcentersintheRegionandwithWHO

collaboratingcenters;


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DRUG MAGIC REMEDIES ACT.DRUG MAGIC REMEDIES ACT.

A strong implementation of the MagicRemedies Act (MRA) needs to be done for

AYUSH products right from the point ofproviding license by the state FDAs tomonitoring marketing of these products.Rampant use of herbal medicines is done

today by offering cure for diseases like cancer,HIV etc.


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TEACH REGULATORY NORMS INTEACH REGULATORY NORMS IN

CIRRICULUMCIRRICULUM

y REGULATIONSFORMANUFACTURING,SALES,

QUALITYCONTROLETCAND THEVARIOUSLAWS

SHOULD BETAUGHT ATTHEGRADUATION/POSTGRADUATIONLEVELOFTHE AYUSHCIRRICULUM.

y THISINFORMATIONWILLLEAD TO DEVELOPING

BETTER AND RESPONSIBLEPRACTITIONERSTOSERVETHESOCIETY.


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GMP Implementation for AYUSH productsGMP Implementation for AYUSH products

y Implementation of GMP to AYUSH

manufacturing is a real challenge due to

varied reasons ranging from Rawmaterials, to process standardization,

testing methods etc. A separate and

unique method needs to be developedfor implementation of Schedule M for

AYUSH products manufacturing .


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Use of AYUSH medicines by theUse of AYUSH medicines by theunorganised sectorunorganised sector

y RampantuseofAYUSHmedicinesisdoneinthe

unorganisedmarketbyquacks,retailshopsselling

thesemedicines.Needstrictregulationsonthese

butthechallengeisitsfallbackonthepopularityof

suchmedicinesandnonavailabilityissues.

y Educationthroughmassmediadiscouragingsuch

practicesneedstobedone.


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Lack of price control mechanismLack of price control mechanism

y Unlikethe DPCO(DrugPriceControlOrder)forpharmaceuticalpreparations,absenceofanysuchordermakesthe

wholebusinessofmanufacturingandselling AYUSHproductsamoneymakingbusinesswithoutanycontrolonthequality.

y A simpleoilusedforrelievingpainofArthritiscouldthusbesoldatRs.1200.00forabottleof100ml.


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Notification dated July 9, 2008 to allow use of excipients,

additives, preservatives, anti-oxidants, coloring agents, flavouringagents, alternate sweeteners permitted in the IndianPharmacopoeia/Prevention of Food Adulteration Act, 1954 (NEW)

Notification GSR NO.893(E) of 170 Guidelines for evaluation ofAy. Siddha & Unani Drugs.

Grant ofAyurvedic licenses to soaps, shampoos, hair tonicsand antacid products(New)

Clarification with regarding to use of prefix and suffix inclassical and patent ASU medicines.(New)

Supplementary guidelines formanufacturing of Rasaushadhies/Rasamarunthukal / Kushtajat (Herbo-mineral-metallic compounds).

REGULATION:REGULATION:

A CONTINUOUS NEED BASED PROCESSA CONTINUOUS NEED BASED PROCESS


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AYUSH MARKAYUSH MARK VOLUNTARY CERTIFICATEVOLUNTARY CERTIFICATE

SCHEME (VCS) FOR AYUSH PRODUCTSSCHEME (VCS) FOR AYUSH PRODUCTS

TheschemehasbeenstartedsinceOct,2009,

whichhastwolevelsofcertification an AYUSH

StandardMarkformeetingfordomesticregulatory

requirementandan AYUSHPremiumMarkformeetinginternationalnormssuchasthosesetby

WHOorregulationofimportingcountries.Thiswill

gounderanindependentthirdpartyassessment

systemandwouldresultin Qualitysealbeingawarded.Tillnow 125 Premium Marks and95

StandardMarkshasbeenawardedto ASUproducts.


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WAY FORWARDWAY FORWARD

REGULATIONIS A

CONTINUOUS

PROCESSWHICH

WILL KEEP ASKINGFORMORE


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challenges and issues related to regulation of traditional medicine

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