Case Study Case Study Case Study Case Study

Case Study

1. CASE STUDY OF NEEM
TheneemtreeAzadirachtaindicaisatropicalevergreentreenative
toIndiaandisalsofoundinothersoutheastcountries.

2. ThetreeisreferencedinIndianoldtextsformorethan2000yearsagoand
hasbeenconnectedforcenturiesinagricultureasaninsectandpest
repellent,veterinarymedicine,cosmeticsandtoiletries.
Neemextractscanbeusedagainsthundredsofpestsandfungaldiseases
thatattackfoodcrops;theoilextractedfromitsseedscanbeusedtocure
coldandflualsomixedinsoap,itprovidesrelieffromskindiseases,
malariaandmeningitisaswell.

3. ❖Theseeds,barkandleavescontaincompoundswithprovenantiseptic,
antiviral,antipyretic,anti-inflammatory,anti-ulcerandanti-fungal
properties.
❖In1971,UStimberimporter“RobertHarson”observedthatthetrees
usefulnessinIndiaandbeganimportingneemseedstohiscompany
head-quarters.

4. ❖Heconductedsafetyandperformancetestofneem.
❖ThreeyearslaterhesoldhisinventiontotheUSDepartmentof
agriculturalandmultinationalchemicalcorporationWRGraceandco.
❖In1992theWRGraceandco.secureditsrighttotheformulathatused
theemulsionfromtheneemtreesseedstomakeapowerfulfungicide.

5. ❖Inapplyingforthepatent,thecompanyhadarguedthatithad
usedanextractofthetreesseedtomakeanewfungicide
In1994,EuropeanPatentOffice(EPO)grantedapatenttotheUS
CorporationW.R.GraceCompanyandUSDepartmentofAgriculturefora
methodforcontrollingfungionplantsbytheaidofhydrophobic
extractedNeemoil.

6. ❖In1995,agroupofinternationalNGOsandrepresentativesofIndian
farmersfiledlegaloppositionagainstthepatent.Indiansclaimthatits
patentwasnotsufficientlynovelasIndianfarmershaveusedthis
fungicidefordecade.
❖TheIndiansandmembersofthegreenpartyintheEuropeanunion
opposedthepatentbecausetheybelievedthattherightsofthepoor
farmersindevelopingcountrieswillbeharmed.
❖TheneempatentbecamethefirsttochallengeEuropeanpatentson
groundsofbiopiracy.

7. TheIndianscientistsarguedthattheIndianshaveknownthemedicinal
propertiesofneemlongback.
Indiansscientistsubmittedevidencethatthefungicidaleffectofextracts
ofneemseedshadbeenknownandusedforcenturiesinIndian
agriculturetoprotectcrops,andtherefore,wereunpatentable.

8. ❖TheEuropeanPatentOfficeEPOacceptedtheargumentsofferedbyIndian
scientists
❖In1999,theEPOdeterminedthataccordingtotheevidenceallfeaturesof
thepresentclaimweredisclosedtothepublicpriortothepatentapplication
andthepatentwasnotconsideredtoinvolveaninventivestep.
❖InMay2000EPOrevokedthepatentwhichwasgrantedforneem.
❖Thevictoryisaresultoffouryearlongeffortbytheresearchfoundations
forscience,technologyandenvironment.

9. CASE STUDY OF CURCUMA

10. •TurmericisatropicalherbgrownineastIndia.Turmericpowderhasa
deepdistinctcolorandbittertaste.
•ThetropicalherbturmerichasbeenusedinIndiaforthousandsofyears
andisusedasamedicineandasaspices,cookingingredient,forflavouring
theIndiancooking.
•Turmericisalsousedincosmeticsanddyes.
•Turmerictraditionallyisusedasamedicineforcenturiestohealwounds
anduseasanantisepticforskininfections

11. AUnitedStatespatentonturmericwasawardedtotheuniversityof
Mississippimedicalcentreinmay1995,specificallyfortheuseofturmeric
inwoundhealing.
•Twoyearslater,anapplicationforre-examinationagainstthepatentgranted
totheUniversitywasfiledbyTheCouncilofScientific&Industrial
Research(CSIR)ofIndiawithsufficientdocumentedevidenceoftheprior
arttoUSPTO.

12. CSIRarguedthatturmerichasbeenusedinIndiaforthousandsofyearsfor
healingwoundsandrashesandthereforethepatentonitsmedicalusewasnot
anovelinvention.
•TheCSIRclaimwassupportedbydocumentaryevidenceoftraditional
knowledgeincludes32referenceswrittenindifferentlanguagessuchas
ancientsanskrittext,UrduandHindiandpaperpublishedin1953inthe
journalsofIndianMedicalAssociation.
•Unitedstatespatentandtrademarkoffice(USPTO)investigatedthevalidity
ofthepatent.

13. In1997despiteanappealmadebythepatentholders,
USPTOupheldtheCSIRobjectionandrevokedthepatent
andsaidthatuseofturmericwasknowntoIndiafor
thousandsofyearsandhencecancelledthepatentdueto
lackofnovelty.
ThetraditionalknowledgeofIndiawasprotectedinthis
case.

14. HERBALDRUGREGULATIONS ININDIA
ProvisionsrelatingtothemanufactureandcontrolofAyurvedic,Siddhaand
Unani(ASU)drugshavebeenprescribedintheDrugsandCosmeticsact.
ThisactsdescribestheformationofDrugsTechnicalAdvisoryBoard
(DTAB),WhichconsistsofvariousnominatedmembersandtheDrugs
ConsultativeCommittees(DCC).

15. TheAyurvedic,SiddhaandUnaniDrugsTechnicalAdvisory
Board(ASU-DTAB)
Thecentralgovernmentshallconstituteaboardbynotifyinginthe
officialgazette.
Theboardshalladvicethecentralaswellasstategovernmentson
technicalmattersarisingoutofthesection33-CoftheDrugsand
Cosmeticsactandcarryotherfunctionsassigned.

16. A) Constitution of the board
The board shall consist of the following members.
1. The Director general of Health services, Ex officio
2. The Drugs controller, Ex officio
3. The Director of Central Drugs laboratory, Calcutta, Ex officio
4. One Government analyst nominated by the central board.
5. One Pharmacognocistnominated by the Central Government.
6. One Phytochemistnominated by the Central Government.

17. 7.FourpersonsnominatedbythecentralGovernment,amongwhichtwo
fromthemembersofAyurvedicpharmacopeiacommitteeandoneeach
fromUnaniandSiddhapharmacopeiacommittee.
8.OneteacherinDravyagunaandBhaishajyaKalpanatobenominatedby
theCentralGovernment.
9.OneteacherfromIlmul-Adviaandtaklis-wa-Dawasaitobenominated
bytheCentralGovernment.

18. 10.OneteacherinGunapadamtobenominatedbytheCentral
Government.
11.Threepersons,oneeachrepresenttheAyurvedic,SiddhaandUnani
drugindustrytobenominatedbytheCentralGovernment.
12.Threepersons,oneeachfromamongstthepractitionerofAyurvedic,
SiddhaandUnani,Tibbsystemsofmedicinetobenominatedbythe
CentralGovernment

19. B) Functioning of the board
• The Central Government shall appoint a chairman from amongst its members
• The nominated members of the board shall hold office for three years but shall
be eligible for renomination.
• The board may make bye laws to regulate its functioning and conduct of all
activities.
• The central government shall appoint a secretary of the board and shall
provide the board with such clerical and other staff.

20. TheAyurvedic,SiddhaandUnaniDrugsConsultative
Committee(ASU-DCC)
TheCentralGovernmentmayconstituteanadvisorycommitteeas
mentionedinthesection33-DoftheDrugsandCosmeticsAct.
Thiscommitteemayadvisethecentralandstategovernmentsandthe
Ayurvedic,SiddhaandUnanidrugstechnicaladvisoryboard
(ASU-DTAB)onanymatterforthepurposeofsecuringuniformity
intheadministrationofthisact(section33-D)throughoutIndia.

21. ConstitutionandFunctioningofASU-DCC
•TheASU-DCCshallconsistoftwopersonsnominatedbycentral
governmentandonepersonfromthestategovernmentactas
representativeoftherespectivegovernments.
•TheASU-DCCshallmeetwhenrequiredtodosobythecentral
governmentandshallregulateitsownactivitiesaspertheir
requirements.

22. REGULATIONS FOR THE MANUFACTURE OF AYURVEDIC,
SIDDHA AND UNANI (ASU) DRUGS
Thesection33-EEBoftheDrugsandCosmeticsactdescribesthe
regulationforthemanufactureandsaleofASUdrugs.TheActhasset
somestandardsrelatedtothehygienicconditions,factorypremises,
prohibitionofmanufactureandsaleofcertaindrugsandpenaltiesfor
contraventionofthisact.

23. Requirements of factory premises and hygiene Conditions
As per the act, it is mandatory to maintain proper hygienic conditions in the factory premises
along with the following requirements.
• Factory or industry involved in the manufacture of ASU drugs should not be situated adjacent to
open sewage, drain, public lavatory or any other factory which produces obnoxious odour, large
quantities of waste, dust or smoke
• The premises of manufacturing unit shall be clean, hygienic and free from insects, rodents and
other contamination.

24. Note:AllthesectionsfallundertheScheduleZoftheDrugs&CosmeticsAct
•Thewallsandfloorofmanufacturingroomsshouldbesmooth,easilycleanablewith
waterandshouldnotaccumulatedustorwasteproducts
•Thewaterusedinthemanufactureshallbepureanddrinkingquality.Itshouldbefree
frompathogenicorganisms.Adequatefacilityshouldbeprovidedtoprocessesthe
containersandclosuresforwashing,cleaning,drying,etc.,andit
shouldbeseparatedfromthemanufacturingunit.
•Suitablearrangementsshallbeprovidedfordisposingwastewaterandother
materialsinamannerthatitdoesnotaffectthehealthofpeopleinthe
surroundingarea.
•Personnelworkinginthefactoryshouldbefreefromcontagiousdiseases.

25. B. Prohibition of manufacture and sale of certain ASU
drugs
The act prescribes some criteria to prohibit the manufacture
and sale of certain ASU
drugs which are not manufactured or sold in accordance of
the rules.
The following categories of ASU drugs can be prohibited
from manufacture and sale.
• Any misbranded, adulterated or spurious ASU drugs.

26. Any proprietary or patented medicine which does not
display
the list of all
ingredients on the label of the container.
• The selling, stocking and distribution of any ASU drug
which has been
manufactured in contravention of the provision of this act.