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Case study of Neem-
• The Neem tree Azadirachta lndica is a tropical evergreen tree native to
India and is also found South East cou ntries the seeds, bark and leaves
conta ins compounds with an antiseptic, antiviral, antipyretic, anti-
inflammatory, antiulcer and antifungal properties.
• In 1971, US Timber importer 'Robert Harson' observed that trees
usefulness in India and began importing Neem seeds to his company
headquarters, he conducted safety and performance test of neem.
• Three years later, he sold his invention to the US department of
agriculture and multinational chemical Corporation WR Grace and co.
• In 1992, The WR Grace and co secured it's right to the formula that used
the emulsion from the Neem trees, seeds to make powerful fungicidal.
• In applying for the patent, the company had argued that it had uspd and
extract of trees seed to make a new fungicide but th~ Indians clai~ that
its patent was not sufficiently novel, as Indian rrhers have used tJS J
fungicide for decades. f
_ a ,_ ~ ~A
• The Indians and Members of Green party in Europeal
□
Union opposed the patent because they believed tha'"
the rights of poor farmers in developing countries will be
harmed.
• The name patent become a first to challenge European
and US patents on grounds of biopiracy.
• The Indian scientist argued that Indians have known a
medicinal properties of Neem long back ago.
• The European patent office accepted the arguments
offered by Indian scientist and rejected the order of US
patent office to our the patent to WR Grace and co.
• The victory is the result of 4 year long efforts by \
Research Foundation for science, tec~nology ~nd
environment. r ~
• The CSIR claimed that documentary evidence of (:]
Traditional knowledge including ancient Sanskrit text
and paper published in 1953 in the Journals of Indian
Med ical Association.
• Un ited States Patent and Trade mark Office (USPTO)
investigated the validity of the patent.
• In 1997, USPTO upheld the CSIR objection and
cancelled the patent due to lack of novelty.
Case study of Curcuma -

• Turmeric is a tropical herb grown in east India. Turmeric

powder is deep distinct color and bitter in taste.
• It is used as dye, cooking ingredient, litmus in chemical tests
and for medicinal purpose.
• A United states Patent on turmeric was awarded to the
University of Mississipi Medical centre in May 1995,
specifically for Use of turmeric in Wound healing.
• Two years later, a complaint was filed by India's council of
scientific and industrial research. (CSIR)
• CSIR argued that turmeric has been used in India from\
thousands of years for healing wounds ar\d rashes, ther fore
Patent on its medicinal use was not a ~ el invention .

"' }.
9.2.2. Objectives
The objective of WHO and [CH guidelines is to put forward a basic criteria for
evaluating the quality. safely and efficacy of herbal medicines. and to assist
national reg ulmory auchorities. scientific organisations and manufacturers to
evaluate the documentation/submissions/dossiers in respect of such products. As
a genera[ rule. traditional experience means that long -term use and medical,
historical and ethnological background of those products should be considered.

210 Herbal Drug Technology

The defi nition of long -term use may differ for different countries and should be
111 least several decades old. Therefore. the evaluation should take into account a
description in the medicnVphnrmaceuticaJ I iterature or similar sources. or a
documentation of knowledge on the application of an herbal medicine without a
clearly defined time limitation. Marketing authorisations for similar products
should be taken into account.

These g111idclines aim to provide:

I) Gu.iding principle for evaluating the quality with respect to the safety of
herbal medicines with specific reference to contaminants and residues.
2) Model criteria For using whiJe identifying possible contnmin11nts and residues.
3) Example of met.hods and techniques. and
4) Exumple of practical procedures for controlling the quality of finished herbal
products.
9.2.4. Assessment of Safety
This should cover all relevant aspects of lhc safc1y asscssmem of a medicinal
produc1. A principle that if the produc1 bu.:. been 1ruditionally used wi1bou1
demonstrated harm. no &p?cilic restrictive regulatory action should be 1nken unless
new evidence demands u revised riskbenCJfil u.,scssmenl !.hould be foll owed.
A review of the relevant literulure should be provided wilh original articles or
references to the originnl articles. Rcfcremces cun be made 10 the existing o flicinl
monograph/review resultsLoog-term use \vithout any evidence of risk may indicate
1h01 u medicine is harmless: however. ii i111nccnuin how lo ng o ne cun re ly on Ion~
tenn ust1ge to assure the harmlessness of mdicinc in the light of concern e,i;presscd
in recent years over the long-term huards of .some herbRI medicines. TI1e reported
side effects shou ld be documcn1ed nccorclli ng 10 normal phunnucovigiluncc pruc1ices.
 Bio piracy
• Biopiracy is defmed as, "the illegal
appropriation of life - micro-organisms, plants
and animals (including humans) and the
traditional knowledge that accompanies it,,
• M·ultinational corporations (MNCs) have been
searching for rich natural resources
everywhere to make out a product along with
the traditional knowledge prevailing there,
then patent it and mint money out of it.
 WHAT IS BIOPROSPECTING?
• Exploration of biodiversity for commercially
valuable genetic and biochemical resources
- Eisner 1989'1 l{eid et al. 1993
• The systematic search for genes, natural
compounds, designs and whole organisms in
wild life ,vith a potential for product
development by biological observation, and
biophysical, biochemical and genetic
methods without disruption to nature.
- Nicolas Mateo et al., 2001

What is Bioprospecting?
• Bioprospecting, also known as biodiversity
prospecting. is the exploration of biological
material for commercially valuable genetic and
biochemical properties.
• In simple terms this means the investigation of
living things to see how they can be
commercially useful to humans .
 Why is it needed?
• The underlying aim of bio prospecting is to find new
resources and products from nature that can be
used by humans.
• Improving human health, through both medicine and
better nutrition are key focal areas.
• It plays a dominant role in discovering leads for drug
development, since existing/known compounds for
developing drugs for human use are limited .

• •

ii Phase 1 COLLECTION
l • Collection of samples

~
• Cultivation

Phase 2 PREPARATION
• Isolation, identification and
characterisation of compound

Phase 3 SCREENING

01 II •
· • Screening for potential use
Confirmation of bioactivity

Phase 4 COMMERCIALISATION
• Product development and testing
• Commercialisation
.41
 11.1 PATENT
► 1\ pa lcnl refers to an exclusive right which is granted to ;in invento r The pe rsc,n w h,>
h,1-; be,·n ~r,1n ted paten t is c,1lled "Piltcntee".
;. )';ite nt is a lcg,11 d ocument th,1t g1v('S patent hc,lder exclusive right to implemenl
de~cnb11d invention commercially The word patent is n lo1 tin term " I'ATERE" which
,n,...111 , lu l,1y open ,1r o pen letter.
; A pnl.-nl is ,1 form of 111tl'lk-ctual property, 11 gives its owner the right to ,·, clud l.'
,11h,•rs from milking, uslni;. selling ;ind importing an in venhor1 for a limited pt•nod o f
lime 11su,1lly 20 years. If ,, n m,,enhon 1s p,1ten ted, it implies that no o ther person cnn
cnmmt'rn,1llv benefit from makmg. us ing, selling o r distributing it
; A pnl(•nt is ,i n ~xclus1vc monopoly granted by a govl'mment to an inventor over hb
invenliun for ., limited penod of time. The purpose of this system is to e ncour.1gc
lnvl.'nl'ions by promoting their pro tl!ction and invention so as to contnbutc to
dcvdop indus tries which in tum provides better utility to the SOC1cty.
 ,_ . '-" '"JO/
80 °{/y

11.3 FARMERS RIGHT

;. This i~ the rifth l ,11.1v<'n lo f,umers for the in1provem ent. conservation a nd ll\ak1n
,1vail.1ble of pl,1111 )1.en<'hC rl'50ur,"l.'5 (PGR) so that formers need not i;o to lhl' bre,.'dt~
evt•ry lBme
► The protection of plant variety and farmers right act 20CJI (PPV~ FR act) 1s an art of Iii,
p nrh,,ml'nl of India that was l'nacted to provide for the cstabhshme n I of an effl'\'1,\·~
system for protectio n or plant vaneues.
;.. The right!! or thl' farmer.1 and pla nt breeders are to encourage the devl'lopmcnt an,J
cultiva l iun of new varieties of plants.
► The rrv & FR act 200 I was enactt.-d to gran t antcllectual property rights to pl ant brCt',:Jl'I\
fl!St.'arc hcrs ,ind fomwrs who have develo ped any new or ('Xl"inct plant variety. ·
 nt r r' Ri h
•:• Plant variety protection provides legal
protection of a plant variety to a
breeder in the form of Plant breeder's
rights.
•:• Plant breeders' rights (PBR), also
known as plant variety rights (PVR),
are rights granted to the breeder of a
new variety of plant that give them
exclusive control over the propagating
material (including seed, cuttings,
divisions, tissue culture) and
harvested material (cut flowers, fruit,
foliage) of a new variety for a number
 12 2 THE AYURVEDIC. SI DDH,\ t\NI> UNJ\NI [)IHl(;s f ECIINICt\L Afl\llSO({Y
HOARD (,\SU l>TAH)
1bll central govemmenr shall constitute a board by 111'\tlfylng In lhe official! gn1.ette. The
t,c)lrd sh,lll arlvl(:l! lht;: ccnlrnl iU well U St.lie govtmlllftlb (II\ l«MiCAI ITUllters 11rlsing out
or the section 33-C of the Drugs and Cosmetic act and carry nthtt functions Hl>lgned 10 ii by
ih:ls cllapt:er.
Al Constitution of the board
n,, board s hall consi~I o f the fo llowing fflffl\bers.
1. The director general of health services, ex officio.
2. Tht: drugs controller. e:-i: (lffido.
3. The dil'L'Clor or Central Drugs Laboratory. Calcutta. ex officio.
4. One govemmenl .tnalyst nominated by the Cl'lltnl board.
5. One Pharmacognodsl no mlNl.e d by the Cl'lltral government.
6. One phytochemis I nomin.11ed by the central government
7. Pour persons nominated by central govemfflffll, among which two horn lhe
members of Ayurvedic pharmacopoeia rommitta- and one each from Unani and
Siddha pharmacopoeia committee.
8. One teacher in Dravyaguna and Bhaishajya kalpana lo be nominated by a!ntral
government.
9. One teacher from Dmul-Advia and Taklis-wa-Oawasv.i to be nominated by Cffltral
government.
10. One teacher in Gunapadam to be nominated by tt.ntral government.
'fil,.Three persons, one each represent the Ayurvedic. Siddm and Onani drug industry
~ be no.m inated by central government.
•12.1Three persons, one each &om alllOflpt the pr., lilioorrs o1 Aymvedic, Siddha and
Unani! n,t, syslems of medicine to~ uuWDlllled by,...,,,..,
gowu YkPN!ffl
B) Funmnninr nf the board
> The ce.ntral government shall appoint a ~ frrm' ~- · SI' Is ~
•

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