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Project Report on
PERFORMANCE EVALUATION OF PRESCRIPTION
DRUG OF BOEHRINGER INGELHEIM
SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENT OF
DEGREE OF MASTERS OF MARKETING MANAGEMENT (MMM
FROM THE UNIVERSIT! OF MUMBAI
SUBMITTED B!
MAHESH S" VISH#AKARMA
MARKETING
$%&'$%&)
UNDER THE GUIDANCE OF
PROF" MANGESH KASBEKAR
N L DALMIA INSTITUE OF MANAGEMENT STUDIES AND RESEARCH
MIRA ROAD (EAST*
MUMBAI '%&&%'
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Content+
Sr no Top,c P- no
1 Certificate 3
2 Declaration 4. Acknowledgment 5
4 Executive Summary 6
5 ro!lem Statement "
6 #e$earc% &!'ective (
L,ter/t0re Re1,e2
" )ndian %armaceutical )ndu$try *
( +rend$ in %arma )ndu$try 1,
* Drug$ and Act$ 1"
1, re$cri-tion And &ver t%e Counter Drug 23
11 .icen$ing 36
12 )nve$tigating concern$ a!out t%e re$cri-tion of Controlled
Drug$ in /eneral ractice
42
13 )ntroduction to 0oe%ringer )ngel%eim 54
14 )ntroduction to Dia!ete$ 56Met3o4o5o-6 o7 St046
15 #e$earc% De$ign 61
16 Data Analy$i$ 63
1" inding$ of t%e #e$earc% (1
1( Conclu$ion (3
1* #ecommendation (4
2, A--endice$ (5
21 !i!ilogra-%y (*
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Certificate
TOPIC:+o Study t%e -erformance evaluation of re$cri-tion Drug$ of
0oe%ringer )ngel%eim Com-any in t%e region of ort%ern um!ai
NAME OF THE STUDENT: Mr. Mahesh S Vishwakarma
+%i$ i$ to certify t%at r a%e$% S i$%wakarma $tudent of .Dalmia )n$titute of anagement Studie$ and #e$earc% %a$ carried out
t%e -ro'ect on t%e c%o$en to-ic under our $u-ervi$ion and guidance a$
-artial fulfillment of re7uirement$ of o$t /raduate Di-loma in 0u$ine$$
anagement 8arketing9 um!ai :niver$ity for t%e Academic ;ear
2,14 < 2,16
________________ _________________
Prof. Mangesh Kasbekar
Project Guide Director
Place:Mumbai
Dae:
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DECLARATION
) r a%e$% S i$%wakarma of . Dalmia )n$titute of anagement
Studie$ and #e$earc% of %ere!y declare t%at ) %ave com-leted
t%e ro'ect on Per7or8/nce E1/50/t,on o7 Pre+cr,pt,on Dr0- o7
Boe3r,n-er In-e53e,8 a$ -artial fulfilment of re7uirement$ of degree of
ma$ter$ of marketing management 89 in t%e Academic ;ear 2,,14
< 2,16 +%e information $u!mitted i$ true and original to t%e !e$t of my
knowledge
Pro!. P. ". #r$a Mahesh SVishwakarma
Director Stude%t
Date: ________________
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AC=&>.ED/E+
) take great -lea$ure in $u!mitting my -ro'ect re-ort and ) would like to ex-re$$ my
$incere t%ank$ to all t%o$e w%o %el-ed me in t%e com-letion of my -ro'ect
+%e -ro'ect titled 9Per7or8/nce e1/50/t,on o7 pre+cr,pt,on 4r0- o7 :oe3r,n-er
,n-e53e,8;i$ t%e -roduct of t%e $u--ort and guidance extended !y t%e in$titute )t
i$ not 'u$t t%e attem-t to enric% my$elf wit% t%e la$t learning ex-erience wit% t%e
in$titute a$ a -art of t%e curriculum !ut to do 'u$tice to my mentor?$ effort$ in
grooming me a$ a -rofe$$ional $-anning over two year$ of my cour$e
) take t%i$ o--ortunity to extend my %eartfelt gratitude to our Director
rof . Aryaw%o %a$ !een t%e ma'or driving force for t%e $tudent$ to $trive for
excellence and not $ettle for anyt%ing !ut t%e !e$t
+%e -at% to $ucce$$ i$ not ac%ieved unle$$ you are -rovided wit% timely advice
w%ic% wa$ alway$ availa!le t%roug% my -ro'ect guide rof ange$% =a$!ekar
) al$o ex-re$$ my gratitude toward$ t%e $taff of t%e li!rary and t%e com-uter center
t%at %a$ !een very co@o-erative during t%e endeavor
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P!O"#EM STATEMENT
+o Study t%e -erformance evaluation of re$cri-tion Drug$ 8+ra'enta9 of0oe%ringer )ngel%eim Com-any in t%e region of ort%ern um!ai
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!ESEA!CH O"$ECTI%E
+o $tudy t%e -erformance evaluation of re$cri-tion drug of 0oe%ringer )ngel%eim
$-ecifically in term$ of efficacy and $afety -rofile
+o $ugge$t way$ to com-any to im-rove on marketing $trategy to -romote t%e
re$cri-tion drug$
*
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LITERATURE REVIE#
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In4,/n P3/r8/ce0t,c/5 In40+tr6
)ndia?$ -%armaceutical $ector %a$ $een unwavering growt% in t%e -a$t few year$ going u- to 23
!illion :SD in 2,12 from 23 !illion :SD in 2,,2 ariou$ indu$try re-ort$ $ugge$t t%at t%e-%armaceutical $ector in )ndia %a$ !een growing con$i$tently at t%e rate of 13@14 every year
$ince t%e la$t five year$ According to t%e con$ulting firm c=in$ey Com-any )ndia?$
-%armaceutical $ector will touc% 55 !illion :SD !y 2,2, and generic$ are ex-ected to continue
to dominate t%e market w%ile -atent@-rotected -roduct$ are likely to con$titute 1, -er cent of t%e
market till 2,15
)ndian -%armaceutical indu$try com-anie$ can !roadly !e cla$$ified a$ dome$tic com-anie$ and
foreign com-anie$ 8C$9 Some of t%e ma'or -layer$ include /laxoSmit%=line Ci-la Dr
#eddy?$ .a!oratorie$ #an!axy fiBer etc inancial year 2,13 wa$ c%allenging on t%e dome$tic
front and witne$$ed $luggi$% growt% owing to acute com-etition from unli$ted -layer$ and $o on/rowt% in t%e $ector i$ ex-ected to !e !oo$ted t%i$ year due to increa$ing con$umer $-ending
ra-id ur!aniBation et al
+%ere %a$ !een a -aradigm $%ift in t%e attitude of -eo-le in )ndia toward$ %ealt%care Alarming
ri$e in ca$e$ of cardiova$cular -ro!lem$ nervou$ $y$tem di$order$ dia!ete$ and many ot%er
di$ea$e$ a$ well a$ di$order$ %a$ created more awarene$$ in t%e growing -o-ulation a!out t%e
need of im-rovement in medical $ector +%erefore t%ere i$ a great need for -%armaceutical
com-anie$ to inve$t t%eir time and re$ource$ in re$earc% and develo-ment of new efficient and
co$t effective drug$
)ndia %a$ an organiBed -%armaceutical market of it$ own w%ic% i$ !eing con$idered a$ a
-otential -artner !y ot%er countrie$ +%e )ndian %arma arket i$ ranked num!er 3 in term$ of
volume and 1,t% in term$ of market value )ndian -%arma com-anie$ are al$o -roving to !e
glo!al leader$ in -roduction of generic$ and vaccine$
According to a re-ort !y t%e De-artment of )ndu$trial olicy and romotion 8D)9 )ndia %a$
attracted Direct oreign )nve$tment of :S 113*1,3 million from A-ril 2,,,@2,13 and will $ee
an u-$urge in t%e year$ to come 0io-%armaceutical$ i$ al$o increa$ingly !ecoming an area of
intere$t given t%e com-lexity in manufacture and limited com-etition
According to a re-ort !y )S Fealt% t%e dome$tic -%armaceutical market %a$ $een a growt% of
135 and recorded total $ale$ of #$ 6((3 crore 8:S 112 !illion9 in t%e mont% of Guly 2,13
+%e ma'or rea$on$ for t%i$ growt% can !e attri!uted to continual growt% in -rolonged t%era-ie$
increa$ing $ale$ of generic medicine$ and $trengt%ening %old over rural market$
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TRENDS IN PHARMA INDUSTR!
A %ig%ly fragmented indu$try t%e )ndian -%armaceutical indu$try i$ e$timated to %ave over
1,,,, manufacturing unit$ a$ given !y t%e &rganiBation of %armaceutical roducer$ of )ndia
+%e organiBed $ector account$ for 'u$t 5 of t%e indu$try wit% around 3,, -layer$ w%ile a %uge
*5 i$ in t%e unorganiBed $ector A large num!er of -layer$ in t%e unorganiBed $egment are
$mall and medium enter-ri$e$ and t%i$ $egment contri!ute$ 35 of t%e indu$try?$ turnover
)n calendar year 8C;9 2,,5 turnover of t%e organiBed $ector com-anie$ aggregated to #$ 3,2 !n
of w%ic% 1* came from C$ w%ile t%e remaining (1 wa$ contri!uted !y )ndian com-anie$
+urnover of -layer$ in t%e unorganiBed $egment t%oug% difficult to a$$e$$ i$ e$timated to !e
around #$ 16, !n
+%e )ndian -%armaceutical indu$try con$i$t$ of manufacturer$ of !ulk drug$ and formulation$
0ulk drug$ include t%e active -%armaceutical ingredient$ 8A)$9 w%ic% are u$ed for t%e
manufacture of formulation$ According to e$timate$ t%e -ro-ortion of formulation$ and !ulk
drug$ i$ in t%e order of "525 +%ere are !elieved to !e over 6,,,, formulation$ manufactured in
)ndia in more t%an 6, t%era-eutic $egment$ ore t%an (5 of t%e formulation$ -roduced in t%e
country are $old in t%e dome$tic market )ndia i$ largely $elf@$ufficient in ca$e of formulation$
t%oug% $ome life $aving new@generation@tec%nology@!arrier formulation$ continue to !e
im-orted
Among t%e t%era-eutic $egment$ t%e anti@infective$ to- dome$tic -roduction in volume$ )n
2,,5 t%e c%ronic t%era-y $egment accounted for around 26 of t%e dome$tic formulation
!u$ine$$ growing at a rate of 1,H fa$ter t%an t%e acute t%era-y $egment +%e c%ronic t%era-y
$egment include$ anti@dia!etic$ cardiac and neuro@-$yc%iatry formulation$
0ulk drug manufacturing i$ largely concentrated in And%ra rade$% w%ic% account$ for more
t%an one@t%ird of t%e country?$ total !ulk drug -roduction followed !y /u'arat +%e )ndian !ulk
drug indu$try %a$ lately !een gaining $ignificant -re$ence in t%e glo!al market a$ foreign and
multinational com-anie$ are looking to $ourcing A)$ and intermediate$ from )ndian
manufacturer$ actor$ favouring t%e indu$try are a va$t re$ource of tec%nical -eo-le $tateof@
t%e@art manufacturing facilitie$ low co$t and t%e advantage of t%e Engli$% language A$ -art of
government?$ $u--ort to increa$e ex-ort$ duty free Bone$ %ave !een $et u- and $everal
manufacturer$ of !ulk drug$ %ave !een $%ifting t%eir facilitie$ to t%e$e area$ A$ a re$ult t%e
diver$e $-read %a$ now $tarted getting con$olidated and concentrated in certain region$ acro$$t%e country
)ndia %a$ a $ignificant $%are in t%e glo!al generic$ market and i$ ranked t%ird )n recent year$
t%i$ $egment %a$ !een facing $tiff com-etition w%ic% make$ t%e $cale of -roduction im-ortant to
im-rove -rofita!ility )ndia %a$ -re@dominantly !een a generic -layer and %a$ t%e -otential to
gain a glo!al -re$ence for t%e following key develo-ment$
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ulti-le !randed drug -atent ex-iration$ in t%e $%ort term According to )S Fealt% in 2,,6
and 2,," a total of :S 2( !n and :S 2, !n re$-ectively of !randed $ale$ were likely to
!ecome $u$ce-ti!le to t%e entry of generic e7uivalent$
)ncrea$ing confidence of con$umer$ in generic$ in t%e develo-ed market$
A -ro@generic $entiment from %ealt%care aut%oritie$ driven !y t%e -re$$ure of containing ri$ing
%ealt%care co$t$
An aging -o-ulation acro$$ t%e world leading to increa$ing demand for low co$t t%era-ie$
/lo!al %ealt%care cri$i$ like A)DS in t%e develo-ing world nece$$itating afforda!le medication
for t%e ma$$e$
Pro40ct,on /n4 Tr/4e
+%e dome$tic !ulk drug and formulation indu$try %a$ !een a!le to largely meet t%edome$tic demand for t%e$e -roduct$ 0e$ide$ it al$o ex-ort$ to $everal region$ including
t%e E: and :S Ex-ort$ currently con$titute nearly 4( of t%e indu$try?$ turnover and
%ave !een growing at an average 22 annually $ince 1**4 )n ;,6 ex-ort$ grew !y an
im-re$$ive 21 touc%ing #$ 215( !n
+%e growing demand from t%e dome$tic market and increa$ed manufacturing activitie$
%a$ led to ri$ing im-ort$ during t%e -a$t few year$ )n ;,6 im-ort$ were wort% #$ 452
!n a$ again$t #$ 31" !n in ;,5 +%e nature of im-ort$ %a$ undergone a $ignificant
c%ange over t%e year$ from fini$%ed do$e$ im-orted -rior to t%e 1*",$ to largely !ulk
drug$ today
Dome$tic demand %a$ !een $%owing $ignificant growt%H t%e ri$e in con$um-tion !eing
-rimarily attri!uted to t%e ri$ing -o-ulation ri$e in income level$ and increa$ing %ealt%
awarene$$ among -eo-le ew -roduct launc%e$ !y t%e )ndian and multinational
com-anie$ %ave al$o catalyBed market demand oreover t%e favoura!le regulatory
environment increa$ed ex-enditure on #D and im-roved tec%nical $kill$ in t%e field of
c%emical $ynt%e$i$ %a$ al$o -layed an im-ortant role
+%e increa$ing alliance$ and tie@u-$ of )ndian com-anie$ wit% glo!al -layer$ %a$ furt%er
given a !oo$t to )ndian ex-ort$
Ke6 Dr,1er+ 7or t3e P3/r8/ce0t,c/5 In40+tr6
/rowing orientation toward$ #e$earc% and Develo-ment 8#D9
+%e introduction of -roduct -atent in )ndia %a$ !roug%t $ome fundamental c%ange$ in
$trategie$ of )ndian -%armaceutical com-anie$ wit% focu$ $%ifting more toward$ #D
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+%e original )ndian -atent law w%ic% recogniBed only -roce$$ -atent gave )ndian
com-anie$ t%e o--ortunity to -roduce -roduct$ under -atent in over$ea$ market$
-articularly regulated market$ !y ado-ting new -roce$$e$ Con$e7uently com-anie$
were in advantageou$ -o$ition to -roduce drug$ t%roug% rever$e engineering at relatively
very low co$t t%at %el-ed t%e dome$tic indu$try to grow fa$ter during t%e initial $tage$ of
develo-ment &n t%e ot%er %and t%i$ di$couraged multinational com-anie$ from
launc%ing t%eir new -roduct$ in )ndia fearing du-lication of t%eir new drug di$covery
t%roug% rever$e engineering A$ a re$ult C$? market $%are declined from ", -rior
to 1*"2 to 2, at -re$ent
+%e introduction of -roduct -atent %a$ led t%e dome$tic indu$try toward$ ex-loring new
avenue$ of drug develo-ment w%ic% would re7uire %ig%er ca-ital inve$tment in #D
and greater t%ru$t toward$ innovation Current trend$ indicate t%at #D ex-enditure of
to- dome$tic com-anie$ %a$ increa$ed from a mere 2 of total turnover in C;,, to
nearly 4 in C;,5 +%oug% t%i$ i$ t%e average for t%e indu$try to-@line -layer$ %ave$-ent in t%e range of (@1, during ;,6 +%i$ level of ex-enditure i$ %owever low
com-ared wit% t%e $-ending of 12@16 of turnover on #D !y international leader$
#D !y )ndian -%armaceutical com-anie$ i$ !acked !y a favoura!le -olicy environment and
availa!ility of $ur-lu$ $killed tec%nical worker$ at low co$t$ +%i$ i$ to t%e advantage of t%e
$ector and will $ee a $ignificant t%ru$t in coming year$
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Le1er/-,n- CRAM+ opport0n,t,e+
+%e glo!al -%armaceutical indu$try i$ increa$ingly facing co$t -re$$ure$ on variou$ count$ and
#D -roductivity of t%e$e -layer$ %a$ gone down $ignificantly in recent year$ under ri$ing
man-ower co$t$ and %ig%er regulatory ri$k )n fact t%e -roce$$ of getting a--roval of new
-roduct$ in regulated market re7uire$ $trict com-liance of 7uality norm$ w%ic% i$ $tringent and
i$ al$o $u!'ect to %ig% legal ri$k +%i$ factor i$ forcing C$ to out$ource -art of t%eir #D
and manufacturing activitie$ to low co$t de$tination$ like )ndia and C%ina
)ndia i$ emerging a$ t%e glo!al %u! for contract re$earc% and manufacturing $ervice$ 8C#A$9
due to it$ low co$t advantage and world cla$$ 7uality $tandard$ +%e )ndian -%arma indu$try
-o$$e$$e$ world $tandard manufacturing facilitie$ a$ -er t%e / norm$ w%ic% are a--roved !y
variou$ regulatory agencie$ acro$$ t%e glo!e +%e diver$e di$ea$e -rofile and a!undance of
-atient$ in )ndia -rovide$ !etter ground for clinical trial$ )ndia %a$ leveraged t%i$ advantage to
attract clinical trial$ -roce$$ out$ourced !y t%e com-anie$ involved in innovation
a'ority of t%e contract manufacturing deal$ relate to -roduction of active -%armaceutical
ingredient$ 8A)$9 and intermediate$ in w%ic% )ndia -o$$e$$e$ com-etence ic%ola$ iramal
S%a$un C%emical$ Divi?$ .a! Di$%man %arma Cadila Fealt%care .u-in atrix .a! and
Auro!indo %arma are $ome of t%e com-anie$ w%ic% %ave witne$$ed im-re$$ive growt% in
revenue$ from t%eir C#A$ !u$ine$$ under variou$ tie@u-$ wit% glo!al -%armaceutical ma'or$
Gro2,n- e=port+
Ex-ort$ %ave !een t%e ma'or growt% ena!ler of t%e )ndian -%armaceutical indu$try in recentyear$ )ndia ex-ort$ -%armaceutical -roduct$ A)$ and intermediate$ to more t%an 2,, countrie$
acro$$ t%e world +raditionally #u$$ia /ermany igeria and )ndia?$ neig%!oring countrie$ like
Sri .anka e-al and t%e iddle Ea$t were t%e ma'or market$ for )ndian -%armaceutical
ex-ort$ o$t of t%e$e market$ are not %ig%ly regulated and are con$idered to !e low@value
market$
#emarka!ly t%e -ro-ortion of ex-ort$ in dome$tic turnover %a$ !een increa$ing over t%e year$
de$-ite t%e growing dome$tic demand Currently ex-ort$ con$titute 4( of e$timated turnover
of t%e indu$try a$ com-ared to nearly 35 during C;,2
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E=p/n4,n- pre+ence ,n re-05/te4 8/r>et
&ver t%e year$ )ndia %a$ $%own !etter regulatory awarene$$ and $u-erior tec%nical $kill$ w%ic%
%a$ ena!led )ndian com-anie$ to -enetrate t%e %ig%@value market$ like t%e :S and E: Ex-ort$
of -%armaceutical -roduct$ 8fini$%ed -roduct$ a$ cla$$ified under %eading 3, of )+C@FS code9
to t%e :S grew !y an im-re$$ive 33 to #$ 23 !n and !y a w%o--ing 62 to #$ 35 !n to t%e
E: during ;,4@;,6 #egulated market$ t%oug% difficult to -enetrate due to $tringent
regulation$ are known to give !etter value and margin to ex-orter$
+%e increa$ing -re$ence in %ig%@value market$ like t%e :SA and Euro-e %a$ $trongly !oo$ted
t%e overall growt% of t%e )ndian -%armaceutical indu$try Fowever wit% com-etition getting
$tiffer in t%e regulated market$ and t%e con$e7uent -re$$ure on margin$ )ndian -layer$ are al$o
ex-anding t%eir geogra-%ical reac% to %ig%@growt% region$ $uc% a$ t%e C)S and .atin American
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countrie$ Alt%oug% con$idered a$ low@value market$ t%e$e market$ are witne$$ing im-re$$ive
growt% and t%erefore it -rovide$ great o--ortunity for )ndian -layer$
R,+e ,n ne2 pro40ct 5/0nc3e+
)n t%e -%armaceutical indu$try new -roduct launc%e$ create new demand After t%e introduction
of -roduct -atent in )ndia t%e dome$tic indu$try %a$ witne$$ed a fre$% $-ell of new -roduct
launc%e$ ew -roduct$ launc%ed $ince 2,,5 accounted for around 12 of t%e overall market
growt% +%e$e launc%e$ %ave !een done !y !ot% dome$tic and international -layer$ and $ome of
t%em are fir$t time launc% of new c%emical entity 8CE9
T3e Re-05/tor6 Contro5 o7 t3e P3/r8/ce0t,c/5 In40+tr6
Ke6 ,++0e+ 7/c,n- t3e P3/r8/ce0t,c/5 In40+tr6
Some of t%e i$$ue$ t%e dome$tic indu$try i$ facing are a$ under
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Incre/+,n- +p/n o7 pr,ce contro5
+%e draft ational %armaceutical$ olicy 2,,6 currently underway and awaiting a--roval
from t%e arliament intend$ to !ring 354 drug$ under -rice control w%ic% i$ in addition to t%e
"4 !ulk drug$ already notified under -rice control +%e -rice control a$ -ro-o$ed in t%e olicy i$
likely to cover at lea$t 5,@6, of t%e dome$tic market under -rice control +%e -ro-o$ed control
on -rice$ i$ $et to im-act t%e indu$try margin $ignificantly e$-ecially t%o$e -layer$ %aving only
local o-eration$ Fowever to $ecure t%e -rofita!ility firm$ will %ave to increa$e t%eir $cale of
-roduction
+%e num!er of drug$ under -rice control %ad come down from nearly 4,, in t%e 1*",$ to "2 in
1**5 and furt%er reduced to 2* in 2,,2 +%i$ deci$ion wa$ %owever $talled !y t%e Su-reme
Court a$king t%e De-artment of ertiliBer$ and C%emical$ /o) to identify t%e e$$ential and life
$aving drug$ t%at need to continue remaining under -rice control +%e De-artment li$ted 354
item$ t%at it -urc%a$e$ for it$ %o$-ital$ called t%e ational .i$t of E$$ential edicine$ 8.E9+%e new draft -olicy con$i$t$ of t%e$e 354 drug$ t%at are likely to !e under t%e co$t !a$ed -rice
control
Pr,ce ero+,on ,n -ener,c+
)ndian generic$ market i$ witne$$ing a margin -re$$ure in mo$t of t%e -roduct categorie$ due to
two main rea$on$ t%e -ro-o$ed -rice control likely to !e im-o$ed !y t%e /overnment and t%e
$tiff com-etition among dome$tic -layer$ )n fact )ndia %a$ witne$$ed a fa$t ri$e in t%e num!erof -layer$ over a -eriod of time oreover t%e ex-an$ion of ca-acitie$ !y certain leading
-layer$ %a$ al$o fuelled com-etition in certain -roduct categorie$ w%ic% re$trict$ margin$ of t%e
$maller -layer$
+%e fall in -rice$ of generic drug$ are not limited to )ndia only +%e :S w%ic% i$ t%e world?$
large$t -%armaceutical market i$ al$o ex-eriencing a $%ar- reduction in -rice$ of generic drug$
due to $tiff com-etition Some ot%er develo-ed countrie$ like t%e := and /ermany %ave al$o
witne$$ed t%e $ame $cenario +%e ero$ion in -rice$ i$ to t%e extent of *, in $ome ca$e$ )ndian
-layer$ w%ic% %ave !een o-erating in t%e$e market$ %ave al$o witne$$ed ero$ion in margin$ in
certain t%era-eutic $egment$
Lo2 R?D pro40ct,1,t6
De$-ite t%e increa$ing ex-enditure on #D t%e introduction of new molecule$ !y )ndian -layer$
%a$ !een limited )t i$ in fact a %it@and@mi$$ $ituation in t%e field of di$covery and develo-ment$
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of new c%emical entity 8CE$9 w%ere mi$$e$ are more t%an %it$ ery few di$coverie$ reac% t%e
final $tage$ of a--roval$ and in mo$t of t%e ca$e$ t%e claim for -atent get$ $tuck in legal !attle$
)n $-ite of t%e ri$ing ex-enditure in #D t%e level of inve$tment in #D i$ $till low at average
4 a$ com-ared to t%e glo!al -ractice of $-ending 12@16 of $ale$ on #D
+%e c%anging glo!al -%armaceutical indu$try %a$ tran$formed -ro$-ect$ of )ndian
-%armaceutical com-anie$ +%e leading %arma com-anie$ in )ndia %ave !een actively extending
t%e frontier$ of $cientific knowledge and going glo!al t%roug% merger$ and ac7ui$ition$ )n 2,,5
ac7ui$ition$ !y t%e )ndian -%armaceutical com-anie$ were t%e %ig%e$t wit% 2, !uyout$ a!road
A $imilar trend wa$ o!$erved during 2,,6 w%ic% include Dr #eddy?$ !uyout of /ermany?$
0eta-%arm and #an!axy?$ -urc%a$e of #omania?$ +era-ia Euro-e %a$ emerged a$ t%e mo$t
-referred de$tination for ac7ui$ition$ !y )ndian com-anie$
+%e Euro-ean generic$ market %a$ emerged a$ a ma'or attraction for ac7ui$ition$ !y )ndian
com-anie$ According to re-ort$ margin ero$ion in Euro-e i$ muc% le$$ com-ared to t%e :Sw%en a drug or formulation !ecome$ generic
Con$olidation i$ inevita!le and i$ ex-ected to !ring in economie$ of $cale and -rovide acce$$ to
newer geogra-%ie$ to regional -layer$ +%e /overnment %a$ e$timated t%at !y year 2,1, t%e
indu$try %a$ t%e -otential to ac%ieve a $iBe of :S 2( !n
Dr0-+ /n4 Act+
)n t%e !eginning of t%e current century Drug )ndu$try wa$ -ractically non@exi$tent in )ndia and
-%armaceutical$ were !eing im-ortant from a!road +%e ir$t >orld >ar c%anged t%e $ituation
and not only were fini$%ed and c%ea- drug$ im-orted in increa$ing volume t%e demand for
indigenou$ -roduct$ al$o were voiced from all $ide$ >it% t%e clamour for $wade$%i good$
manufacturing concern$ !ot% )ndian and oreign $-rang u- to -roduce -%armaceutical$ at
c%ea-er rate$ to com-ete wit% im-orted -roduct$ aturally $ome of t%e$e were of inferior
7uality and %armful for -u!lic %ealt% +%e /overnment wa$ t%erefore called u-on to take noticeof t%e $ituation and con$ider t%e matter of introducing legi$lation to control t%e manufacture
di$tri!ution and $ale of drug$ and medicine$
+wo of t%e law$ +%e oi$on$ Act and t%e Dangerou$ Drug$ Act were -a$$ed in 1*1* and 1*3,
re$-ectively +%e &-ium Act wa$ 7uite old %aving !eing ado-ted a$ early a$ 1("( 0ut to %ave a
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com-re%en$ive legi$lation w%ic% t%e ra-id ex-an$ion of t%e -%armaceutical -roduction and drug
market re7uired !y t%e end of t%e $econd decade for it$ control t%e )ndian /overnment
a--ointed in 1*31 a Drug$ En7uiry Committee under t%e C%airman$%i- .t Col # C%o-ra
w%ic% wa$ a$ked to make $ifting en7uirie$ into t%e w%ole matter of drug -roduction di$tri!ution
and $ale !y inviting o-inion$ and meeting concerned -eo-le +%e Committee wa$ a$ked to make
recommendation$ a!out t%e way$ and mean$ of controlling t%e -roduction and $ale of drug$ and
-%armaceutical$ in t%e intere$t of -u!lic %ealt% +%e C%o-ra Committee toured all over t%e
country and after carefully examining t%e data -laced !efore it $u!mitted a voluminou$ re-ort to
government $ugge$ting creation of drug control mac%inery at t%e centre wit% !ranc%e$ in all
-rovince$ or an efficient and $-eedy working of t%e controlling de-artment t%e committee al$o
recommended t%e e$ta!li$%ment of a well@e7ui--ed Central Drug$ .a!oratory wit% com-etent
$taff and ex-ert$ in variou$ !ranc%e$ for data $tandardiBation work :nder t%e guidance of t%e
Central .a!oratory it wa$ $ugge$ted $mall la!oratorie$ would work in t%e -rovince$ or t%e
training of young men and women t%e Committee recommended t%e -ermi$$ion of Central
%armacy Council and t%e rovincial %armacy Council$ wit% regi$trar$ w%o would maintain
t%e li$t$ containing name$ and addre$$e$ of t%e licen$ed -%armaci$t$
+%e out!reak of t%e Second >orld >ar in 1*3* delayed t%e introduction of legi$lation on t%e
line$ $ugge$ted !y t%e C%o-ra Committee w%ic% t%e )ndian government contem-lated and
con$idered a$ urgent Fowever t%e Drug$ Act wa$ -a$$ed in 1*4, -artly im-lementing t%e
C%o-ra recommendation$ >it% t%e ac%ievement of inde-endence in 1*4" t%e re$t of t%e re7uired
law$ were -ut on t%e Statute 0ook )n 1*(5 t%e arcotic Drug$ and $yc%otro-ic Su!$tance$ Act
were enacted re-ealing t%e Dangerou$ Drug$ Act 1*3, and t%e &-ium Act of 1("(
At -re$ent t%e following Act$ and #ule$ made t%ere under t%at govern t%e manufacture $ale
im-ort ex-ort and clinical re$earc% of drug$ and co$metic$ in )ndia
I +%e Drug$ and Co$metic$ Act 1*4,
I +%e %armacy Act 1*4(
I +%e Drug$ and agic #emedie$ 8&!'ectiona!le Adverti$ement9 Act 1*54
I +%e arcotic Drug$ and $yc%otro-ic Su!$tance$ Act 1*(5
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I +%e edicinal and +oilet re-aration$ 8Exci$e Dutie$9 Act 1*56
I +%e Drug$ 8rice$ Control9 &rder 1**5 8under t%e E$$ential Commoditie$ Act9
S-M -/0 "#S
/here are some other aws which ha4e a beari%5 o% 6harmaceutica
ma%u!acture7 distributio% a%d sae i% 8%dia. /he im6orta%t o%es bei%5:
1. /he 8%dustries 9De4eo6me%t a%d e5uatio% #ct7 1+'1
2. /he /rade a%d Mercha%dise Marks #ct7 1+'*
3. /he 8%dia% Pate%t a%d Desi5% #ct7 1+),
1. Dru5s a%d cosmetics #ct71+&, a%d rues71+&'
/he object o! the #ct is to re5uate the im6ort7 ma%u!acture7 distributio% a%d
sae o! dru5s.
;%der the 6ro4isio%s o! this #ct7 the
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;%der the 6ro4isio%s o! this act the
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/he #ct makes it i%cumbe%t u6o% the State Go4er%me%ts to co%stitute State
Pharmac$ members eected !rom amo%5st themse4es b$ re5istered Pharmacists
o! the state.
b Ci4e members o! whom at east two sha be 6erso%s 6ossessi%5 a
6rescribed de5ree or di6oma i% Pharmac$ or Pharmaceutica
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/he Dru5s a%d Ma5ic emedies #ct 6rohibits a 6erso% !rom taki%5 6art i%
6ubicatio% o! a%$ ad4ertiseme%t re!erri%5 to a%$ dru5 which su55ests use
o! the dru5 !or:
a the 6rocureme%t o! miscarria5e i% wome% or 6re4e%tio% o! co%ce6tio%
i% wome% a%d
b the mai%te%a%ce or im6ro4eme%t o! the ca6acit$ o! the huma% bei%5
!or se>ua 6easure
cthe correctio% o! me%strua disorders i% wome%
d the dia5%osis7 cure7 miti5atio%7 treatme%t or 6re4e%tio% o! a%$ 4e%ereadisease. 8t is 6rohibited to direct$ or i%direct$ 5i4e a !ase im6ressio%
re5ardi%5 the true character o! a dru5 or make !ase caim !or it or to co%4e$
a%$ !ase or miseadi%5 i%!ormatio% i% a%$ materia 6articuar about it. Eo
6erso% sha im6ort i%to or e>6ort !rom 8%dia a%$ docume%t co%tai%i%5
ad4ertiseme%t o! this %ature.
hoe4er co%tra4e%es the 6ro4isio%s o! this #ct sha7 o% co%4ictio%7 be
6u%ishabe with im6riso%me%t which ma$ e>te%d to si> mo%ths7 with or
without @%e. 8% case o! subseAue%t co%4ictio%s the im6riso%me%t ca% be
e>te%ded to o%e $ear. /he docume%t7 artice or thi%5 which co%tai%s the
oFe%di%5 ad4ertiseme%t ca% be seied a%d co%@scated.
8! the 6erso% co%tra4e%i%5 a%$ o! the 6ro4isio%s o! the #ct is a com6a%$7
e4er$ 6erso% who at the time the oFe%ce was committed was i% char5e o!
the busi%ess o! the com6a%$ sha be deemed 5uit$.
/he 6rohibitio% u%der this #ct does %ot a66$ to: a a%$ si5%board or %otice
dis6a$ed b$ a re5istered medica 6ractitio%er i%cudi%5 the treatme%t !or
a%$ o! the disease7 b a%$ treaties or book deai%5 with a%$ o! the matters
!rom a bo%a@de scie%ti@c sta%d6oi%t7 c a%$ ad4ertiseme%t reated to a%$
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dru5 se%t co%@de%tia$ to a%$ re5istered medica 6ractitio%ers or to
chemists !or distributio% amo%5 re5istered medica 6ractitio%ers or to a
hos6ita or aborator$7 a%d d Go4er%me%t ad4ertiseme%ts.
&. /he Earcotic Dru5s a%d Ps$chotro6ic Substa%ces #ct7 1+*'
/his is a% #ct to co%soidate a%d ame%d the aw reati%5 to Earcotic Dru5s7 to
make stri%5e%t 6ro4isio%s !or the co%tro a%d re5uatio% o! o6eratio%s
reati%5 to Earcotic Dru5s a%d Ps$chotro6ic Substa%ces a%d !or matters
co%%ected therewith
Pre+cr,pt,on /n4 O1ert3eCo0nter Dr0-+
A drug i$ a c%emical t%at affect$ living t%ing$ A$-irin allergy medicine $lee-ing -ill$ and
ot%er medication$ are drug$ So are vitamin$ cigarette$ and alco%ol
edicine i$ a legal drug u$ed to treat an ailment or illne$$
-4erthecou%ter 9-/
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8% the ;%ited States7 the Cood a%d Dru5 #dmi%istratio% decides whether a
medici%e is sa!e e%ou5h to se o4erthecou%ter. /aki%5 -/< medici%es sti
has risks. Some i%teract with other medici%es7 su66eme%ts7 !oods or dri%ks.
-thers cause 6robems !or 6eo6e with certai% medica co%ditio%s. 8! $ouHre
6re5%a%t7 tak to $our heath care 6ro4ider be!ore taki%5 a%$ medici%es.
8t is im6orta%t to take medici%es correct$. More medici%e does %ot
%ecessari$ mea% better. Iou shoud %e4er take -/< medici%es o%5er or i%
hi5her doses tha% the abe recomme%ds. 8! $our s$m6toms do%Ht 5o awa$7
itBs a cear si5%a that itHs time to see $our heathcare 6ro4ider.
/he histor$ o! o4erthecou%ter medici%es has bee% a roercoaster. /he ose
case7 which cumi%ated i% a decisio% !rom the 0ouse o! "ords i% 1),&7
estabished that a6othecaries coud 6rescribe a%d dis6e%se medici%es7
breaki%5 the mo%o6o$ o! the
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is a cear 6ubic heath be%e@t to be 5ai%ed !rom maki%5 this im6orta%t
medici%e a4aiabe throu5h 6harmacies. 0owe4er7 the erciseB. #
s6okesma% !or the o$a %at i$ in t%e drugJ
I >%at do ) take t%e drug forJ
2(
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I Fow muc% $%ould ) takeJ
I >%at are t%e -o$$i!le $ide effect$J
I >%o $%ould not take t%e drugJ
I Fow long i$ it $afe to take t%e drugJ
#ESC#)+)& D#:/S
re$cri-tion drug$ are legal drug$ t%at can only !e ordered !y a doctor or a denti$t &nly a
licen$ed -%armaci$t can $ell -re$cri-tion drug$ >%en a drug i$ -re$cri!ed for you or your
c%ildren it i$ im-ortant to a$k
I >%at i$ t%e name of t%e drugJ
I >%at will it doJ
I Are t%ere any $ide effect$J
I >%en and %ow $%ould ) take t%e drugJ
I Are t%ere food$ and drink$ or ot%er drug$ to avoid w%ile ) am taking t%i$ medicineJ
I Can t%i$ -re$cri-tion !e refilledJ
I )$ t%ere a generic form of t%i$ drugJ
Side Effect$
Drug$ affect your w%ole !ody ot everyone re$-ond$ to drug$ in t%e $ame way )n addition to
treating t%e -art of your !ody t%at need$ t%e drug a drug may cau$e a reaction in ot%er -art$ of
t%e !ody +%e$e un-lanned reaction$ are called $ide effect$ Common $ide effect$ are nau$ea
%eadac%e$ and $lee-ine$$ Sometime$ $ide effect$ are cau$ed !y mixing a drug wit% certain
ot%er drug$ or food$ any drug$ $%ould not !e mixed wit% alco%ol +%e com!ination can !e
fatal )t i$ !e$t to not drink alco%ol w%en taking any kind of medication Dairy -roduct$ -revent
$ome anti!iotic$ from working &+C drug$ li$t $ide effect$ on t%e la!el )t i$ !e$t to a$k your
doctor or -%armaci$t a!out $ide effect$
Do$age
Fow muc% of a drug you take i$ called t%e do$e or t%e do$age 0ot% &+C and -re$cri-tion drug$
%ave t%e do$age on t%e !ottle or -ackage +oo muc% medicine i$ dangerou$ +aking too muc% of
a drug or taking it too often lead$ to an overdo$e An overdo$e can kill you
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/eneric v$ 0rand ame
Eac% com-any t%at make$ a drug can give it a !rand name >%en a new drug come$ out t%e
com-any t%at develo-$ it i$ t%e only com-any t%at can make it for 1" year$ After 1" year$ ot%er
com-anie$ can make t%at drug too A generic name i$ t%e c%emical name of t%e drug >%en
many com-anie$ can make a drug one com-any will u$ually $ell it under t%e generic name
/eneric drug$ are u$ually muc% c%ea-er t%an !rand@name drug$ A$k your -%y$ician to -re$cri!e
t%e c%ea-e$t form
&+C ED)CA+)& .)S+
De$cri-tion of &+C
on@ re$cri-tion medicine$ 8&+C medicine$9 t%e$e medicine$ can !e $old only at a -%armacy
8and not in any ot%er $%o-9 +%e$e need not !e di$-en$ed under t%e direct $u-ervi$ion of a
-%armaci$t +%e$e medicine$ can !e adverti$ed to t%e -u!lic !ut wit%out making tall claim$ or
mi$leading t%e -u!lic All adverti$ement$ $%ould al$o contain t%e >arning me$$age$
1 Do not u$e for more t%an a week wit%out con$ulting your doctor or -%armaci$t
2 All medicine$ %ave t%e -otential to %ave adver$e effect$ in any individual
)n addition to t%e 2 a!ove me$$age$ t%e la!el of t%e medicine $%ould
Al$o contain
1 Any contra@indication$ for u$e
2 )ndication$ do$age fre7uency of do$e
3 otential adver$e effect$ 8t%o$e w%ic% can !e ignored and t%o$e if $een !y t%e -atient %e
$%ould $to- taking t%e medicine )n addition it would !e of advantage if ). or ) 8-atient
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oriented information9 i$ enclo$ed in t%e -ackage containing more information of t%e medicine
8+%i$ ) or ). %a$ to !e a--roved !y t%e DC/)9 )t i$ -refera!le t%at $uc% information !e
mandatory
Exam-le of &+C edicine
A$-irin 3,,mg
A$cor!ic acid 1,,mg 5,,mg
errou$ $alt$ ta! e7 to 6,mg elemental iron
olic acid ta! 5,, mcg
itamin D3 4,, ): 8ca-$ule$9
Calamine .otion
Exam-le of re$cri-tion edicine
-#" #tro6i%e tab 1 m5
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Phe%irami%e0c tab 2'm57 1' m5'm
Prochor6erai%e tab 'm5
Promethai%e tab 1,m572'm5 S$ru6 'm5'm Q
Pro5ua%i tab 1,,m5
Pi6erai%e tab ',,m57 s$ru6 )',m5'm
P$ra%te6amoate tab 2', m57 sus6 2',m5'mQ
a%itidi%e tab 1',m5T/E#" 9"-ide "otio% or
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&ver time often 3
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ie5a %etwork o! dru5 saes7 but others !a i%to the tra6 o! tr$i%5 to he6
6eo6e as best the$ ca%. ece%t cam6ai5%s to treat 6ai% as a 4ita si5%
ao%5 with bood 6ressure7 6use7 res6irator$ rate7 a%d tem6erature make
it %ecessar$ !or 6ro!essio%as to treat 6ai% a55ressi4e$ a%d a66ro6riate$.
/he Cedera a%d state 5o4er%me%tsB cam6ai5% a5ai%st the iicit use o!
6rescri6tio% o6iates7 o% the other ha%d7 has made it di?cut at times !or
6atie%ts to obtai% reie! !or the 6ai% o! ca%cer or a debiitati%5 disease.
;%dertreatme%t o! 6ai% has aso become a 6robem amo%5 6rescribi%5
6h$sicia%s7 resuti%5 !rom !ears o! i%4esti5atio% b$ re5uator$ a5e%cies.
Ph$sicia%s ha4e !ou%d themse4es !ear!u o! 5o4er%me%t sa%ctio%s i! the$
6rescribe these medicatio%s. Parado>ica$7 some 6atie%ts re!use to take
o6iates a%d other medicatio%s !or 6ai% co%tro at the e%d o! their i4es !or
!ear o! becomi%5 addicted.
Pro!essio%as who 6rescribe or work arou%d co%troed dru5s aso are at
risk o! abusi%5 readi$ a4aiabe medicatio%s a%d becomi%5 addicted. Part
o! the 6robem is that %ot o%$ do the 6ro!essio%as di4ert medicatio%s !or
their ow% use7 but7 i% some cases7 the$ rob 6atie%ts o! %ecessar$
medicatio%s.
De6e%de%ce o% Medicatio% a%d Pseudoaddictio%
/here are cear diFere%ces betwee% the 6h$sica de6e%de%ce o%
medicatio%7 acti4e addictio%7 addictio% i% remissio%7 a%d 6seudo
addictio%. /he de6e%de%ce o% medicatio% ma$ be thera6eutic re5ardess
o! the cass to which it beo%5s. Ph$sica de6e%de%ce o! a thera6eutic
dru5 ma$ occur7 resuti%5 i% withdrawa s$m6toms i! the medicatio% is
sudde%$ sto66ed. /his is a 6h$sioo5ic res6o%se to the chro%ic use o! a
medicatio%7 just as sto66i%5 a bood 6ressure medici%e sudde%$ ca%
cause h$6erte%sio%7 heart attack7 or stroke. Dru5seeki%5 beha4ior7
actio%s to obtai% dru5s either b$ a 6rescri6tio% or otherwise7 ma$ i% some
6eo6e reUect %ot addictio% but rather di?cut$ i% obtai%i%5 a66ro6riate
medicatio%s because the$ are abeed as addicts. Some 6eo6e with a
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histor$ o! addictio% to iicit dru5s ma$ aso ha4e a chro%ic 6ai% s$%drome
that woud be%e@t !rom a66ro6riate o6iate 6ai% medicatio%. # 6erso%
reco4eri%5 !rom dru5 addictio% ma$ %eed a stimua%t !or %arcoe6s$ or a
tra%Auiier !or a%>iet$. 8! these 6robems are u%dertreated because o!
6h$sicia% !ear7 a s$%drome o! 6seudoaddictio% ma$ occur7 i% which the
6erso% e%5a5es i% dru5seeki%5 beha4ior sim6$ to obtai% a thera6eutic
a%d eFecti4e dosa5e e4e o! a medicatio%.
Patie%ts i% dru5addictio% reco4er$ ma$ be e4e% more 4i5ia%t tha% the
6h$sicia%. /he$ are acute$ aware o! the co%seAue%ces o! rea6se a%d do
%ot wa%t to e>6erie%ce the 6robems o! addictio% a5ai%. Cor that reaso%7
some 6eo6e i% reco4er$ ma$ !or5o o6ioid medicatio%s e4e% i% the !ace o!
se4ere trauma.
#bused Prescri6tio% Dru5s
$codo%e. Deto>i@catio% a%d withdrawa !rom a%$ o! the medicatio%s
ma$ be 6robematic a%d ma$ reAuire i%6atie%t treatme%t a%d
a66ro6riate 6harmacoo5ica su66ort.
Co&&onl' Use( Prescr)*)on Dr+gs ,)h Poen)al for Ab+se
am6es
Sedati4es =arbiturates #m$ta7 Eebuta
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Cu%itrae6am oh$6%o
Dissociati4e a%esthetics Ketami%e Ketaar SV
-6ioids a%d mor6hi%e
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/he 8%ter%et is a major source o! 6rescri6tio% dru5s that are used !or
%o%medica uses. # 2,,( sur4e$ docume%ted that *+o! sites sei%5
co%troed 6rescri6tio% dru5s ha4e %o 6rescri6tio% reAuireme%ts7 a @5ure that
is dow% !rom +& i% 2,,&. -! the11 o! sites
that reAuired a 6rescri6tio%7 ), o%$ reAuired a 6rescri6tio% be !a>ed7
aowi%5 a customer to easi$ !or5e 6rescri6tio%s or !a> the same 6rescri6tio%
to se4era 8%ter%et 6harmacies. /here has aso bee% a tre%d toward o%i%e
co%sutatio% i% ieu o! a 6rescri6tio%. 8% 2,,(7 ++ eb sites oFered such a
ser4ice.
Se(a)-es
=arbiturates are t$6ica$ used as a sedati4e a%d a%tico%4usa%t7 but the$ha4e a% eAua roe as the mea%s to decrease the ikeihood o! seiures a%d
other s$m6toms i% acoho7 heroi%7 a%d other t$6es o! dru5 withdrawa. /his
cass o! medicatio%s is easi$ abused as a h$6%otic a%d o4erdose is commo%7
resuti%5 i% death throu5h res6irator$ de6ressio%. /he$ are addicti4e but
toera%ce ca% occur a withdrawa s$%drome e>ists7 co%sisti%5 o! a5itatio%7
headaches7 6s$chomotor retardatio%7 co%!usio%7 a%d 6ossibe seiures.
#ddicts ma$ seek out barbiturates as a see6 aid a%d as a method o! se!
deto>i@catio% i! the$ k%ow that a De6artme%t o! /ra%s6ortatio% dru5 test is
%eari%5.1+
O*)o)(s an( Mor*h)ne Der)-a)-es
ists about the use o! o6ioids !or the treatme%t o!
chro%ic 6ai% %ot ori5i%ati%5 !rom ca%cer a%d the resuti%5 i%crease i%
medicatio%s a4aiabe !or di4ersio% to iicit use. ;%dertreatme%t o! 6ai% has
aso become a 6robem amo%5 6h$sicia%s because o! !ears o! i%4esti5atio%
b$ re5uator$ a5e%cies. -%e res6o%se to u%dertreatme%t has bee% the
a66eara%ce o! dru5seeki%5 beha4ior amo%5 6eo6e with e5itimate %o%
ca%cer 6ai%. M$riad state a%d Cedera aws a%d 6oices 6ro4ide 6h$sicia%s
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with a co%!usi%5 6icture o! whe% a%d to whom these medicatio%s ca% be
6rescribed.
# rece%t sur4e$ o! 6h$sicia%s re5ardi%5 dru5 abuse showed that doctors
6ercei4e the & mecha%isms o! di4ersio% to be 91 doctor sho66i%5 to @%d a
coo6erati4e 6ro!essio%a 92 obtai%i%5 co%troed substa%ces !rom muti6e
doctors 93 6atie%t dece6tio% or ma%i6uatio% o! doctors a%d 9& !or5ed or
atered 6rescri6tio%s. # @!th source7 %ot we "erenson A. P@er Stirs troam6hetami%e or
meth$6he%idate. -! 4isits to the emer5e%c$ de6artme%t !or atte%tio% de@cit
h$6eracti4it$ disorder medicatio% 6robems7 &* were !or %o%medica use o!
the medicatio%s7 3& were ad4erse reactio%s associated with medica use7
1, were accide%ta i%5estio%7 a%d * were suicide attem6ts. /he rates
were hi5her !or the 12 to 1)$earod a5e 5rou6 tha% !or 6atie%ts a5ed 1* or
oder. -4er two thirds 9(*o! the 4isits i%4o4ed %o%medica use o! these 2
dru5s a%d a%other substa%ce7 such as acoho7 a% iicit dru57 or a
6harmaceutica.
Tran/+)l)0ers an( M+scle !ela1ers
=e%odiae6i%es are commo%$ di4erted !or %o%medica uses. /he$ are
t$6ica$ 6rescribed as see6 aids or as a%tia%>iet$ medicatio%s. /he$ are
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aso use!u i% deto>i@catio% !rom acoho or other substa%ces a%d are use!u
i% the treatme%t o! co%4usi4e disorders. -4erdose ca% cause res6irator$
de6ressio%7 es6ecia$ whe% used with other sedati4e medicatio%s or acoho.
/here is a s$%drome o! 6arado>ica disi%hibitio% that resuts i% i%creased
e>citeme%t7 irritabiit$7 a55ressio%7 hostiit$7 a%d im6usi4it$. 8% rare cases7
these co%ditio%s ca% ead to attacks o! ra5e or 4ioe%ce or other a%tisocia
beha4iors. /oera%ce ca% de4eo6 with the use o! these medicatio%s. 0i5h
be%odiae6i%e doses are used b$ addicts to e%ha%ce the eu6horia eFects o!
o6ioids boost methado%e or heroi% @>es tem6er cocai%e hi5hs au5me%t
the eFects o! acoho or ease the eFects o! withdrawa !rom heroi%7
methado%e7 a%d other dru5s.
Musce rea>a%ts ca% aso be addicti%5. a%t sod u%der the %ame o! Soma7 is a% e>am6e. 8ts acti4e
metaboite is me6robamate7 a cass 8V substa%ce a%d a hi5h$ addicti4e a%d
6ote%t sedati4eh$6%otic. 8%5estio% ca% cause addictio% a%d a mid se%se o!
eu6horia. 0i5her doses cause eu6horia a%d im6aired ha%de$e coordi%atio%
a%d baa%ce. /oera%ce e>ists a%d there is a withdrawa s$%drome o! a%>iet$7
tremor7 musce twitchi%57 i%som%ia7 auditor$ a%d 4isua hauci%atio%s7 a%d
biarre beha4ior
LICENSING
Com-ul$ory .icen$ing Effect$ on t%e )ndian %armaceutical arket
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many maintain t%at t%e com-ul$ory licen$ing -rovi$ion )ndia enacted effectively %a$ no teet%
+%e Act allow$ a c%allenge to t%e -atent a--lication !ut t%e c%allenging -roce$$ it$elf i$ very
$low +%i$ many are worried will tie u- t%e licen$e$ for year$ !efore t%ey can !e u$ed to $ave
live$ in ot%er countrie$ a$ well a$ in )ndia
Additionally com-ul$ory licen$ing term$ are vague making it more difficult to u$e t%e
-rovi$ion
>it% fewer com-ul$ory licen$e$ and fewer generic medicine$ availa!le many fear t%e -rice of
drug$ will ri$e /eneric medicine$ %ave reduced t%e -rice$ of antiretroviral$ 8A#$9 !y *( and
)ndian com-anie$ %ave !een crucial in t%at effortDr ;u$uf Famied C%airman and anaging
Director of Ci-la t%e large$t )ndian generic drug -roducer announced at an A)DS meeting in
Se-tem!er 2,,, t%at %e would $ell A#$ at le$$ t%an one@tent% t%e -rice of ot%er drug
com-anie$ +%i$ move %el-ed !ring !rand@name com-anie$L -rice$ down +%erefore an increa$e
in -rice -otentially would !e detrimental to countrie$ counting on low -rice$ for treatment$ like
A#$
Anot%er -otential -ro!lem wit% t%e com-ul$ory licen$ing law i$ t%at it re$trict$ t%e ex-ort of
medicine$ to countrie$ w%ere t%ey are -atented +%i$ exclude$ a large -ortion of t%e -o-ulation
from gaining acce$$ to t%e drug$ DrFamied %a$ $tated t%at even t%oug% countrie$ %ave t%e
a!ility to u$e com-ul$ory licen$ing t%ey are not doing $o >%ile Ci-laL$ -rice i$ greatly reduced
from t%at of t%e !rand@name drug manufacturer$L -rice it i$ $till not reduced enoug% to reac% t%e
-oore$t nation$ +%e re7uirement$ for im-orting or ex-orting al$o make it difficult to u$e and
-er%a-$ co$t -ro%i!itiveH even Canada %ad to im-ort mo$t of it$ drug$ $u--lied !y com-ul$ory
licen$e +%e im-ortKex-ort -roce$$ i$ -ur-o$efully legally cum!er$omeH two com-ul$ory licen$e$
are nece$$ary in mo$t circum$tance$ and t%e >+& can 7ue$tion t%e grant of $uc% licen$e$
any are worried t%at t%e revi$ed Act will adver$ely affect t%e re$t of t%e t%ird world E$-ecially
in Africa one $ingle viru$ can wreak %avoc on t%e economy +%o$e concerned a!out acce$$ to
medicine$ for t%e +%ird >orld name -u!lic %ealt% a$ t%e total welfare goal >it% t%i$ in mind t%e
revi$ed ActL$ re$triction$ on com-ul$ory licen$ing allow t%at goal to !e to$$ed a$ide +%e Do%a
Declaration doe$ allow -u!lic %ealt% to !e t%e num!er one concern !ut t%e )ndian arliament in
enacting t%e revi$ed Act -it$ # D and !u$ine$$ concern$ again$t -u!lic %ealt%
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+%e tec%nology ga- !etween develo-ing and >e$tern countrie$ i$ %i$torically wide !ut t%e
increa$e in -atent -rotection in develo-ing countrie$ -artially clo$e$ t%i$ ga- Develo-ing
countrie$ %ave !een de-endent on >e$tern economie$ and tec%nologie$ for muc% of t%e twentiet%
century 0ecau$e -roducer$ in >e$tern countrie$ %ave gained from %aving -ro-erty rig%t$ t%ey
%ave more incentive to -roduce ew $tronger -ro-erty rig%t$ %ave given t%e )ndia Contract
#e$earc% &rganiBation 8C#&9 $ector a !oo$t a$ well &ne al!eit o-timi$tic e$timate i$ t%at t%e
$ector will tri-le in t%e next five year$ A$ t%e ma'or drug -i-eline $low$ t%e C#&$ are -oi$ed to
$te- in and %el- manufacture Mme@tooM drug$ and -romote more clinical re$earc% +%e c%allenge
for t%at $ector will !e to kee- it$ co$t$ low enoug% to attract cu$tomer$ w%ile al$o im-roving
7uality +%e )ndian government recogniBe$ t%e need to $u--ort indu$try@@for exam-le t%e
De-artment of 0iotec%nology will $-end a$ muc% a$ 25 of t%eir !udget on $-urring innovation
in t%e $mall and medium@$iBed re$earc% indu$try
+%e -otential -ro!lem i$ t%at t%e +#)S remuneration -rovi$ion u$e$ t%e co$t of !ringing t%e
drug to market a$ a !a$i$ for calculating t%e remuneration +%i$ a$$e$$ment $%ould factor in t%e
additional co$t of $tringent re7uirement$ !y t%e -atent owner$ to o!tain a com-ul$ory licen$e for
t%e develo-ing country
0logger G att%ew 0uc%anan -atent attorney in t%e :nited State$ goe$ even furt%er and $ee$
t%e com-ul$ory licen$ing -rovi$ion a$ a direct t%reat to t%e integrity of t%e new-atent -rovi$ion$
in )ndia Fe cite$ t%e vague language allowing com-ul$ory licen$ing
and t%e fact t%at )ndia already %a$ a com-ul$ory licen$ing -rovi$ion in ca$e a -atent %a$ not !een
MworkedM in )ndia a$ -ro!lem$ Fe argue$ t%e exi$ting -rovi$ion wa$ enoug% and t%e recent
c%ange$ allow too muc% room for t%e -rovi$ionL$ u$e
&ne of t%e -rovi$ion$ to t%e revi$ed Act i$ t%at !ot% -roduct -atent and -roce$$ -atent
a--lication$ are now acce-ted in )ndia Some are concerned t%at )ndiaL$ -%armaceutical market
will follow t%e :S market and !ecome overrun wit% -atent$ for new do$age$ and new u$age$
rat%er t%an new drug$ +%e o--ortunity to gain -atent -rotection for a -roduct could Mdi$courage
generic com-anie$ from trying to develo- a com-etitive -roductM !ecau$e t%at market would !e
$aturated wit% co-ycat$ An already $aturated generic market would not !ring down -rice$
+%e mail!ox -rovi$ion could %ave %uge -rice im-lication$ due to t%e volume of -atent
a--lication$ collected in t%e -a$t ten year$ Some generic drug$ mig%t not !e availa!le if old
medicine$ receive -atent$ !ut mo$t !elieve t%e )ndian Controller of atent$ will take a
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con$ervative a--roac% to granting -atent$ >it% )ndia com-eting more wit% develo-ed nation$ in
t%e develo-ment of medicine$ for -atent control ot%er develo-ing nation$ wit%out a -atent
regime could face a toug%er !attle to o!tain medicine$ A!!ott $tate$ t%at t%e availa!ility of
com-ul$ory licen$ing w%ic% %a$ !een in -lace $ince t%e $y$temL$ ince-tion M%a$ not undermined
t%e $y$temM and $%ould !e ke-t
&n t%e one %and acce$$ remain$ a -ro!lem in )ndia even w%en low -rice$ exi$t :nion ini$ter
for Science and +ec%nology in )ndia =a-ilSi!al contend$ t%at Meven wit% over 1,,,,
manufacturer$ -roducing million$ of do$e$ of e$$ential drug$ at t%e lowe$t -rice$ in t%e world for
t%e la$t $everal year$ acce$$ continue$ to remain a!y$mally low at a!out 35 -er cent N$icOM +%i$
unfortunately mean$ t%at even w%ile )ndian manufacturer$ %ave t%e ca-a!ility to u$e com-ul$ory
licen$ing and -roduce c%ea-er medicine$ afforda!ility doe$ not $olve t%e greate$t -ro!lem in
)ndia acce$$ Com-ul$ory licen$ing i$ likewi$e a !alance !etween greater acce$$ to medicine and
t%e in$i$tence on intellectual -ro-erty rig%t$ -rotection a$ -romoted to a large extent !y t%e
:nited State$
&n t%e ot%er %and com-ul$ory licen$ing i$ a good attem-t to $olve $ome of t%e acce$$ -ro!lem$
+%e direct effect i$ t%at more -eo-le can acce$$ medicine$ !ecau$e t%ey are a c%ea-er generic
form licen$ed from a -atent %older /eneric drug$ co$t le$$ to -roduce !ecau$e t%ey %ave few
$unk co$t$@@t%at i$ no # D re$-on$i!ility@@and can !e $old at a lower -rice>%en com-anie$
$ell more generic$ or ot%er c%ea- $u!$titute$ t%e -atented medicine$ lo$e market $%are
/overnment$ in turn can u$e t%eir !argaining -ower to !uy in !ulk and furt%er reduce -rice$@@
for exam-le w%en -urc%a$ing for -eo-le in edicaid -rogram$ Com-ul$ory licen$ing allow$
many countrie$ not only t%o$e wit% more wealt% or t%o$e wit% manufacturing ca-acity to
-urc%a$e drug$ for t%eir citiBen$
Alt%oug% acce$$ remain$ a -ro!lem $ome grou-$ in )ndia are o-timi$tic a!out t%e future of
-%armaceutical$ due to t%e revi$ed Act &) write$ t%at t%e revi$ed Act $ignal$ t%e $tart of a new
era for t%e %armaceutical )ndu$try in )ndia M+%e new Act will !oo$t # D and will %el- to
!ring in foreign direct inve$tment in t%e indu$try and contri!ute to im-roved %ealt%careM
or &) t%e im-ortance of t%e revi$ed Act $eem$ to lie in t%e new -erce-tion of )ndia a$ a
$u--orter of -atent rig%t$ &) !elieve$ t%e revi$ed Act i$ $till not $trong enoug% !ut t%at it
$%ould al$o eliminate -re@grant o--o$ition cur! t%e com-ul$ory licen$ing -rovi$ion$ and
$trengt%en mail!ox -rovi$ion$ S-ecifically &) want$ to re$trict com-ul$ory licen$e$ to
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national emergencie$ -u!lic %ealt% cri$e$ and antitru$t $ituation$ rat%er t%an t%e current vague
language t%at goe$ !eyond t%e Do%a Declaration 0ut &) contend$ t%e revi$ed Act will %ave
little effect on drug -ricing ot only will few drug$ !e affected !ut &) cite$ $everal $tudie$
t%at demon$trate $trengt%ening intellectual -ro-erty rig%t$ %a$ little effect on exi$ting drug$
82,*9 )ndia will -rofit !y attracting foreign inve$tment creating o--ortunitie$ for )ndian talent to
rever$e t%e M!rain drainM and incentivi$ing creativity and t%e creation of wealt% 821,9 &)L$
$tatement$ im-ly t%at com-ul$ory licen$ing may not !e a$ im-ortant a$ creating a $y$tem to
-romote indu$try
)n addition to foreign confidence in t%e )ndian $y$tem -atent -rotection $-ur$ individual
confidence )ncrea$ed -atent -rotection $to-$ free rider$%i- !y encouraging new re$earc% and it
remove$ t%e !urden of -roving infringement from t%e -atent owner +%o$e -rai$ing t%e revi$ed
Act often dwell on t%e !oo$t to indu$try and do not even com-lain a!out t%e com-ul$ory
licen$ing -rovi$ion
+%e $ucce$$ of t%e colla!oration !etween t%e -%armaceutical indu$try and -u!lic %ealt%
advocate$ t%erefore $eem$ to de-end on -erce-tion Since t%e -rovi$ion wa$ enacted )ndia %a$
!arely u$ed it$ com-ul$ory licen$ing -rovi$ion t%e way t%at indu$try fear$ ;et t%e -o$$i!ility of
giving it u- created u-roar in t%e international community At t%e $ame time -%armaceutical
com-anie$ were reluctant to inve$t in )ndia !ecau$e of t%e com-ul$ory licen$ing -rovi$ion and
lack of full -atent -rotection a$ re7uired !y t%e +#)S Agreement ow t%at !ot% element$@@full
-atent -rotection and t%e com-ul$ory licen$ing -rovi$ion@@are incor-orated into t%e -atent
regime !ot% -u!lic %ealt% advocate$ and indu$try -erceive t%ey %ave a $take in t%e regime
Sale of re$cri-tion Drug$ under Su-ervi$ion of %armaci$t
Drug$ Co$metic$ Act govern t%at H if any licen$ee 8 $%o- owner -o$$e$$ing Drug .icen$e9
i$ found $elling Sc%edule F drug$ 8drug$ re7uired to !e $old only on t%e -re$cri-tion of a
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#egi$tered edical ractioner9 M wit%out t%e direct $u-ervi$ion of a %armaci$t M t%e violation
committed i$ #ule 65 829 of t%e Drug$ Co$metic$ rule$ 1*45
Drug$ de-artment i$ engaged in conducting $-ecial raid$ exclu$ively for verification of
availa!ility of %armaci$t$ in t%e edical $%o-$ !y way of engaging +eam of in$-ector$ and
conducting $ur-ri$e raid$ oreover Every one i$ aware t%at under #+) Act t%e -erformance ofany Drug$ )n$-ector can t%e$e day$ !e o!tained o$tly de-artmental action$ like warning$
$u$-en$ion of licen$e for certain -eriod$ cancellation of licen$e are taken u- A$ a .a$t $tringent
ea$ure ro$ecution$ in t%e Court$ are al$o launc%ed
ro$ecution$ for t%i$ violation re7uire collection of evidence ere a!$ence of %armaci$t in t%e
$%o-$ doe$ not con$titute any offence Sale of on $c%edule F drug$ 8u$ually referred a$ &+C
drug$ ot%er t%an !y %armaci$t in t%e a!$ence of -re$cri-tion
doe$ not con$titute offence :Kr 65 829 of t%e Drug$ Co$metic$ rule$ 1*458any a time$ $%o-kee-er$ take -lea t%at %armaci$t %ad gone out for eating etc9 +%e $ignature column in t%e !ill
!ook M$ignature of %armaci$t M i$ u$ually $cri!!led a$ initial$ $imilar to t%e $ignature of t%e
%armaci$t and w%en %armaci$t$ are 7ue$tioned $u!$e7uently %armaci$t$ are found
acce-ting t%e $ignature$ to !e t%eir $ignature$ +%e Drug$ De-artment andate$ di$-lay of t%e
%armaci$t certificate and t%e Drug$ .icen$e con$-icuou$ly for t%e awarene$$ of t%e con$umer
o$tly t%e ca$e$ filed are S:& &+& a$ no con$umer come$ com-laining t%at a $c%edule F
drug wa$ $old to %im K %er wit%out t%e direct $u-ervi$ion of a #egi$tered %armaci$t
any a time$ Drug )n$-ector$ -erform mock -urc%a$e$ of $c%edule F drug$ to identify erring
licen$ee$
1>%en %armaci$t$KPualified -er$on$ in olden day$ were not $ufficiently availa!le in )ndia
-eo-le w%o were ex-erienced were given certificate w%ic% are called C certificate$ and D
certificate$ even Com-ounder certificate$ were in -ractice $u!$e7uently t%e D%arm %older$
are -rovided A2 certificate$ !y t%e %armacy council w%ile t%e A1 certificate$ are %eld !y t%e
0%arm %older$8$till we %ave C D Com-ounder certificate$ in o-eration w%ic% were
given in and around 1*5* 1*6,
2+%e Drug De-artment in A in many di$trict$ 8 Mnot all Ma$ it i$ not andatory9 H i$ giving $ale
licen$e$ only to t%o$e H only w%en %armaci$t i$ included a$ artner and Agreement on 0ond
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-a-er to t%i$ effect i$ $u!mitted to t%e office +%i$ i$ to fix lia!ility on t%e %armaci$t in ca$e t%e
%armaci$t confine$ to 'u$t $elling K renting %i$ certificate
3 )n ca$e$ w%en %armaci$t i$ cited a$ em-loyee in $%o- in all ca$e$ invaria!ly -%armaci$t
declaration i$ $ecured w%erein t%e -%armaci$t $ign$ give$ in writing an undertaking t%atM%eK$%e $%all devote t%eir w%ole time to $u-ervi$e t%e $ale of $c%edule % drug$ in t%e $%o- and
$%all al$o !e re$-on$i!le for t%e conduct of !u$ine$$ a$ -er rule$ and al$o would !e re$-on$i!le
for t%e maintenance of t%e regi$ter$ or ca$% memo$ a$ -er t%e -rovi$ion$ of t%e act
+%e two $ide$ of t%e $ame coin 1 Commi$$ion of offence w%ile t%e ot%er 2 &ffence cau$ed due
to omi$$ion )n t%i$ -articular ca$e t%e S%o- kee-er commit$ offence !y $elling $c%edule F drug$
in t%e a!$ence of direct $u-ervi$ion of %armaci$t +%e ot%er $ide of t%e coin would !e
%armaci$t not devoting and making %im$elf a!$ent unavaila!le in t%e $%o- 8 +%e a!$ence of
%armaci$t mig%t !e $tated to !e due to many of t%eir own cited and well ex-lained rea$on$
>ould E#E a!$ence of -%armaci$t make t%e -%armaci$t lia!leJ +%e an$wer would !e &Q 9
4 Drug$ )n$-ector$ routine in$-ection$ Goint raid$ Con$umer awarene$$ -rogramme$ al$o
form -art and -arcel to ake %armaci$t $u-ervi$e t%e $ale of t%e Sc%edule F drug$
5 A$ -er t%e rovi$ion$ of t%e Act it i$ not andatory to wear a w%ite a-ron in t%e edical $%o-
yet $-ecial drive$ are conducted !y drug$ de-artment in A w%ere w%ite a-ron$ are made to !e
worn t%i$ drive i$ 'u$t to rai$e a concern in t%e con$umer t%at a 7ualified -er$on !y name
M-%armaci$t M w%o u$ually wear$ a w%ite a-ron need to !e -re$ent in t%e $%o- and $%ould
di$-en$e -re$cri-tion drug$ to %im
ic%ael Gack$on could !e t%e late$t $tar to %ave died from an accidental overdo$e of -re$cri-tion
medication$ According to .ife StyleGack$on wa$ Rtaking a cocktail of u- to $even
-re$cri-tion drug$ in t%e mont%$ !efore %i$ deat% including t%e anti@anxiety drug$ Tanax and
Uoloft and t%e -ainkiller Demerol +%e Gack$on
IN%ESTI2ATIN2 CONCE!NS A"OUT THE P!ESC!IPTION OF
CONT!O##ED D!U2S IN 2ENE!A# P!ACTICE
3. INT!ODUCTION
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1.1. 8% the $ear #u5 2,,* to #u5 2,,+7 (7,+*7*1( 6rescri6tio%s !or Schedue
2 co%troed dru5s were issued. Schedue 2 o! the Misuse o! Dru5s
e5uatio%s 2,,1 i%cudes dru5s such as diamor6hi%e7 subject to the !u
co%troed dru5 reAuireme%ts reati%5 to 6rescri6tio%s7 sa!e custod$ 9e>ce6t
!or secobarbita a%d the %eed to kee6 re5isters.
1.2 /he majorit$ o! 6rescri6tio%s issued are e%tire$ a66ro6riate a%d7 i%
5e%era7 most e>am6es o! u%usua 6atter%s o! 6rescribi%5 are e>6ai%ed b$
e>ce6tio%a 6atie%t %eed rather tha% b$ 6oor ci%ica 6er!orma%ce7 !raud or
crimi%a beha4iour. 0owe4er7 this e>6a%atio% shoud be acce6ted o%$ a!ter
the ess commo% causes ha4e bee% e>cuded.
1.3 /his 6a6er outi%es the 6rocesses !or i%4esti5atio% o! a66are%t$
idios$%cratic 6rescribi%5 o! co%troed dru5s i% 5e%era 6ractice a%d su55ests
wa$s i% which the ess commo% causes o! 6oor 6ro!essio%a 6er!orma%ce7
!raud a%d crimi%a beha4iour ma$ be ide%ti@ed.
1.& /here are cear ad4a%ta5es to !oowi%5 sta%dard 6rocesses i%
i%4esti5ati%5 co%cer%s: the$ ca% be 6ubished i% ad4a%ce so that those
subject to them ca% comme%t o% them a%d be aware o! the 6rocess that wi
be !oowed a%d o! the 6ossibe %eed !or
Secrec$ i% the ear$ sta5es o! a% i%4esti5atio%. /he$ wi he6 to e%sure that
the P
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4. "ACK2!OUND
2.1 # E0S or5a%isatio%s are reAuired to ha4e a% #ccou%tabe -?cer !or
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Cos of CD *rescr)b)ng o% a% i%di4idua 6rescri6tio% or set a5ai%st a
com6arator 5rou6
7+an)' of CDs *rescr)be( a66are%t$ e>cessi4e amou%ts o% a%
i%di4idua 6rescri6tio%
%ol+&e of CDs *rescr)be( set a5ai%st a com6arator 5rou6 o!
6ractitio%ers7 6ractices or P
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E1cess)-e sock or(er)ng b' a *rac)ce or *rac))oner;
#ocal *ol)ce )nfor&a)on e.5. a% i%crease i% street a4aiabiit$
Oher so+rces fro& ,)h)n he PCT *rescr)b)ng ea& e.5. 6ractice
6harmacists or ocums
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Auick$ to sto6 the 5e%era 6ractitio%er co%ti%ui%5 to 6rescribe
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'.1 8! the dis6e%si%5 6harmac$ is k%ow% it ma$ be 6ossibe to retrie4e the
6rescri6tio%s that 5a4e rise to the cause !or co%cer%. 8% co%ti%ui%5 their
i%4esti5atio% P#s ma$ %eed to re4iew:
The *rescr)*)on?
co%sider the com6ete 6athwa$ !rom the 6re6aratio% a%d si5%ature o!
the 6rescri6tio% throu5h to the dis6e%ser a%d the reci6ie%t o! the dru5s
The *rescr)ber?
does the oca 6er!orma%ce decisio% maki%5 5rou6 ha4e a%$ other
co%cer%s about the i%di4idua doctor or 6racticeO
The /+an)'>
6rescri6tio%s !or
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o /he 6atie%t %eeds hi5h dose treatme%t e.5. 4ia a s$ri%5e
dri4er
o /he 6atie%t 5oi%5 o% hoida$ a%d reAuiri%5 u%usua$ ar5e
amou%ts
o /he 6atie%t has a 4er$ hi5h toera%ce to o6iates a%d he%ce
reAuires ar5e doses
o 8! the 6atie%t is tra4ei%5 home to die.
The (r+g > -!te% it is the choice o! dru5 which wi draw atte%tio% to the
ci%icia%. /here are a %umber o! co%troed dru5s that whe% used i%
6rimar$ care ma$ be a% i%dicatio% that the ci%icia% is mo4i%5 awa$
!rom estabished ci%ica 6ractice a%d that hisher 6rescribi%5 %eeds
!urther i%4esti5atio%. /he !oowi%5 is %ot a com6rehe%si4e ist a%d the
P# a%d #- shoud be aert to a%$ u%usua
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Summary of use/
potential misuse of
controlled drugs
Examples of drugs
->$codo%e
Pethidi%e
Dru5s that are used b$
5e%eraist 6ractitio%ers
u%der shared care
arra%5eme%ts
Methado%e Mi>ture 1m5m
=u6re%or6hi%e i% the !orm o! hi5h
dose
Subute> 9this is not the same as
temgesic) shared care only
Dru5s that shoud o%$be used a!ter i%itiatio%
or co%sutatio% with a
s6eciaist 6ractitio%er
a%d i% the co%te>t o!
o%5oi%5 shared care
Methado%e tabets 'm5
Meth$6he%idate
Diamor6hi%e 3,m57 1,,m57
',,m5
Dru5s that shoud
rare$ be 6rescribed i%
6rimar$ care
Di6i6a%o%e
'1
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Summary of use/
potential misuse of
controlled drugs
Examples of drugs
Diamor6hi%e ree!ers
De>edri%e !or 6ur6ose o! addictio%
De>tromoramide !or the treatme%t
o! addictio%
Metham6hetami%e
#%$ =arbiturate !or the treatme%t o!
addictio%
Methado%e
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The *a)en an( h)s@her con())on ?
8t ma$ be %ecessar$ to reco%cie the i%dicatio%s !or the 6rescri6tio% with
the 6atie%t a%d their medica record. /his wi reAuire the P
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eth%o5ra6hic issues bee% co%sidered e.5. ar5e %umbers o! si%5e
homeess or sicke ce 6atie%tsO
Docors8 beha-)o+r sk)lls an( kno,le(ge> e.5. is the 5e%era
6ractitio%er a GPS8 i% dru5 misuse7 6aiati4e care7 chid a%d adoesce%t
me%ta heathO # GP !or a hos6ice7 homeess hoste or care home or a ead
!or a% addictio% ser4iceO
B. !E%IEIN2 THE SITUATION
).1 Coowi%5 !urther i%4esti5atio% the P# wi re6ort to the #-7 who wi
decide i! the resuts o! the i%4esti5atio% merit re!erra to the DMG. >ce6t i%
the case o! sus6ected !raud or crimi%ait$ the 6ractitio%er shoud be i%!ormed
that co%cer%s ha4e bee% raised a%d i%4esti5ated.
. ACTIN2 ON THE OUTCOME OF THE IN%ESTI2ATION
Possibe outcomes are:
Concerns are no s+bsan)ae(a%d the 6ractitio%erBs 6rescribi%5 o!
6a%atio% o! wh$ there has bee% a% i%4esti5atio% a%d the reaso%s
wh$ the 6ractitio%erBs 6rescribi%5 was i%itia$ a cause !or co%cer% shoud
be made to the 6ractitio%er. 8! there are e>ce6tio%a circumsta%ces
ide%ti@ed the% the P
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/he oca 6er!orma%ce ma%a5eme%t or decisio% maki%5 5rou6 ma$
wish to co%sut E
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The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Still
headquartered in Ingelheim, it operates globally with !" affiliates and more than !#,#00 employees.
Since it was founded in $$%, the family&owned company has been committed to researching, deeloping,
manufacturing and mar(eting noel products of high therapeutic alue for human and eterinary medicine.
Boehringer Ingelheim is a full member of the )uropean *ederation of +harmaceutical Industries and
ssociations )*+I.
The corporate logo of Boehringer Ingelheim depicts a styli-ed rendition of the central section of the imperial
palace of harlemagne.
The company's (ey assets of interest are/
respiratory diseases,
metabolism,
immunology,
oncologyand central nerous system.
TIITI)S 1* B1)3I45)3 I45)6)I7 8BI9
0oe%ringer )ngel%eim work$ in %uman-%armaceutical$ animal %ealt%and!io-%armaceutical$
+%e grou- con$i$t$ of 146 affiliated com-anie$ wit% 4""43 em-loyee$ in 2,14 in all continent$
#e$earc% and develo-mentfacilitie$ were in five $ite$ and 2, -roduction -lant$ in 13 countrie$
+%e re$earc% and develo-ment facilitie$ are located in #idgefield ienna =o!eand ilan
&ver (,,, em-loyee$ work for 0oe%ringer )ngel%eim in re$earc% and develo-ment
A#ARDS
)n 2,15 t%e +o- Em-loyer$ )n$titute awarded t%e com-any a$ to- em-loyer
in Au$tria C%inaand /ermany w%ic% demon$trate$ %ig%e$t $tandard$ of em-loyee offering$ and
forward@t%inking %uman re$ource$-rogramme$ and initiative$
)n addition t%e com-any wa$ recogniBed !y Science agaBine for t%e tent% con$ecutive year a$a to- com-any to work for in t%e -%armaceutical and !iotec%nology indu$trie$
0oe%ringer )ngel%eim?$ trainee@-rogramme wa$ %onoured a$ a career@en%ancing and fair
-rogramme !y A!$olventa
+%e com-any wa$ ranked num!er 1 in t%e Rraktikanten$-iegel a $urvey among$t "5,, intern$
for em-loyer 7uality in t%e -%armaceutical indu$try
'(
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0oe%ringer )ngel%eim %a$ !een awarded wit% t%e certificate R0eruf und amilie 8Go! and
amily9 for !eing a family@oriented com-any )ngel%eim
KE! PRODUCT LINE
Prescription Medicine:
Actily$e 8alte-la$e9
Aggrenox 8di-yridamoleKacetyl$alicylic acid9
A-tivu$ 8ti-ranavir9
lomax 8tam$ulo$in9
/ilotrifK/iotrif 8afatini!9
GentaduetoK+ra'entaDuo 8linagli-tinKmetformin9
etaly$e 8tenecte-la$e9
icardi$ 8telmi$artan9
radaxa 8da!igatran etexilate9
+ra'entaK +rad'enta 8linagli-tin9
Consumer Health Care:
Anti$tax 8red vine leaf extract9
0i$olvon 8!rom%exine9
0u$co-anK0u$ca-ina 8%yo$cine !utyl!romide9
Dulcolax 8!i$acodyl9
Uantac 8ranitidine9V"5 and 15, mg ta!let$H 3,, mg ta!let$ $yru- and
$olution for in'ection are manufactured !y /laxoSmit%=line
ucoanginKuco$olvan 8am!roxol9
Silomat 8dextromet%or-%an9
+%oma-yrin 8acetyl$alicylic acid -aracetamol caffeine9
Animal Health:
Circo.ET 8-orcine circoviru$ vaccine ty-e 2 killedBaculovirusvector9
')
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Duramune 8a line of -et vaccine$9
etacam 8meloxicam9
yco.ET 8Mycoplasma hyopneumoniae!acterin9
etmedin 8-imo!endan9
DIABETES
Dia!ete$ mellitu$ de$cri!e$ a grou- of meta!olic di$ea$e$ in w%ic% t%e -er$on %a$ %ig% !lood
gluco$e 8!lood $ugar9 eit%er !ecau$e in$ulin -roduction i$ inade7uate or !ecau$e t%e !odyL$
cell$ do not re$-ond -ro-erly to in$ulin or !ot%
atient$ wit% %ig% !lood $ugar will ty-ically ex-erience -olyuria 8fre7uent urination9 t%ey will!ecome increa$ingly t%ir$ty 8-olydi-$ia9 and %ungry 8-oly-%agia9
+%ere are t%ree ty-e$ of dia!ete$
+y-e 1
+y-e 2
/e$tational dia!ete$
T6pe & D,/:ete+ 8e55,t0+
+%e !ody doe$ not -roduce in$ulin Some -eo-le may refer to t%i$ ty-e a$ in$ulin@de-endent dia!ete$ 'uvenile dia!ete$ or early@on$et dia!ete$
eo-le u$ually develo- ty-e 1 dia!ete$ !efore t%eir 4,t% year often in early adult%ood or
teenage year$
+y-e 1 dia!ete$ i$ now%ere near a$ common a$ ty-e 2 dia!ete$
Appro=,8/te56 &%@ o7 /55 4,/:ete+ c/+e+ /re t6pe &"
atient$ wit% ty-e 1 dia!ete$ will need to take in$ulin in'ection$ for t%e re$t of t%eir life+%ey mu$t al$o en$ure -ro-er !lood@gluco$e level$ !y carrying out regular !lood te$t$
and following a $-ecial diet
T6pe $ D,/:ete+ 8e55,t0+
'*
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+%e !ody doe$ not -roduce enoug% in$ulin for -ro-er function or t%e cell$ in t%e !ody do
not react to in$ulin 8in$ulin re$i$tance9
Appro=,8/te56 %@ o7 /55 c/+e+ o7 4,/:ete+ 2or542,4e /re t6pe $"
Some -eo-le may !e a!le to control t%eir ty-e 2 dia!ete$ $ym-tom$ !y lo$ing weig%t
following a %ealt%y diet doing -lenty of exerci$e and monitoring t%eir !lood gluco$e
level$
Fowever ty-e 2 dia!ete$ i$ ty-ically a -rogre$$ive di$ea$e @ it gradually get$ wor$e @ and
t%e -atient will -ro!a!ly end u- %ave to take in$ulin u$ually in ta!let form
&verweig%t and o!e$e -eo-le %ave a muc% %ig%er ri$k of develo-ing ty-e 2 dia!ete$
com-ared to t%o$e wit% a %ealt%y !ody weig%t eo-le wit% a lot of vi$ceral fat al$o
known a$ central o!e$ity !elly fat or a!dominal o!e$ity are e$-ecially at ri$k 0eingoverweig%tKo!e$e cau$e$ t%e !ody to relea$e c%emical$ t%at can de$ta!iliBe t%e !odyL$
cardiova$cular and meta!olic $y$tem$
Ge+t/t,on/5 D,/:ete+ Me55,t0+
+%i$ ty-e affect$ female$ during -regnancy Some women %ave very %ig% level$ of
gluco$e in t%eir !lood and t%eir !odie$ are una!le to -roduce enoug% in$ulin to tran$-ort
all of t%e gluco$e into t%eir cell$ re$ulting in -rogre$$ively ri$ing level$ of gluco$e
Diagno$i$ of ge$tational dia!ete$ i$ made during -regnancy
+%e ma'ority of ge$tational dia!ete$ -atient$ can control t%eir dia!ete$ wit% exerci$e and
diet 0etween 1, to 2, of t%em will need to take $ome kind of !lood@gluco$e@
controlling medication$ :ndiagno$ed or uncontrolled ge$tational dia!ete$ can rai$e t%e
ri$k of com-lication$ during c%ild!irt% +%e !a!y may !e !igger t%an %eK$%e $%ould !e
Co8p5,c/t,on+ 5,n>e4 to :/456 contro55e4 4,/:ete+
0elow i$ a li$t of -o$$i!le com-lication$ t%at can !e cau$ed !y !adly controlled dia!ete$
E6e co8p5,c/t,on+@ glaucoma cataract$ dia!etic retino-at%y and $ome ot%er$
Foot co8p5,c/t,on+@ neuro-at%y ulcer$ and $ometime$ gangrene w%ic% may re7uire
t%at t%e foot !e am-utated
'+
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S>,n co8p5,c/t,on+@ -eo-le wit% dia!ete$ are more $u$ce-ti!le to $kin infection$ and
$kin di$order$
He/rt pro:5e8+@ $uc% a$ i$c%emic %eart di$ea$e w%en t%e !lood $u--ly to t%e %eart
mu$cle i$ dimini$%ed
H6perten+,on@ common in -eo-le wit% dia!ete$ w%ic% can rai$e t%e ri$k of kidney
di$ea$e eye -ro!lem$ %eart attack and $troke
Ment/5 3e/5t3@ uncontrolled dia!ete$ rai$e$ t%e ri$k of $uffering from de-re$$ion
anxiety and $ome ot%er mental di$order$
He/r,n- 5o++@ dia!ete$ -atient$ %ave a %ig%er ri$k of develo-ing %earing -ro!lem$
G08 4,+e/+e@ t%ere i$ a muc% %ig%er -revalence of gum di$ea$e among dia!ete$ -atient$
G/+trop/re+,+@ t%e mu$cle$ of t%e $tomac% $to- working -ro-erly
Keto/c,4o+,+@ a com!ination of keto$i$ and acido$i$H accumulation of ketone !odie$ and
acidity in t%e !lood
Ne0rop/t36@ dia!etic neuro-at%y i$ a ty-e of nerve damage w%ic% can lead to $everal
different -ro!lem$
Nep3rop/t36@ uncontrolled !lood -re$$ure can lead to kidney di$ea$e
PAD (per,p3er/5 /rter,/5 4,+e/+e@ $ym-tom$ may include -ain in t%e leg tingling and
$ometime$ -ro!lem$ walking -ro-erly
(,
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Stro>e@ if !lood -re$$ure c%ole$terol level$ and !lood gluco$e level$ are not controlled
t%e ri$k of $troke increa$e$ $ignificantly
Erect,5e 46+70nct,on@ male im-otence
In7ect,on+@ -eo-le wit% !adly controlled dia!ete$ are muc% more $u$ce-ti!le to
infection$
He/5,n- o7 2o0n4+@ cut$ and le$ion$ take muc% longer to %eal
Ho2 to 4eter8,ne 23et3er 6o0 3/1e 4,/:ete+* pre4,/:ete+ or ne,t3er
Doctor$ can determine w%et%er a -atient %a$ a normal meta!oli$m -redia!ete$ or dia!ete$ in
one of t%ree different way$ @ t%ere are t%ree -o$$i!le te$t$
T3e A&C te+t
@ at lea$t 65 mean$ dia!ete$
@ !etween 5" and 5** mean$ -redia!ete$
@ le$$ t%an 5" mean$ normal
T3e FPG (7/+t,n- p5/+8/ -50co+e te+t
@ at lea$t 126 mgKdl mean$ dia!ete$
@ !etween 1,, mgKdl and 125** mgKdl mean$ -redia!ete$
@ le$$ t%an 1,, mgKdl mean$ normal
An abnormal reading following the FPG means the patient has impaired fasting glucose
(IFG)
T3e OGTT (or/5 -50co+e to5er/nce te+t
@ at lea$t 2,, mgKdl mean$ dia!ete$
@ !etween 14, and 1*** mgKdl mean$ -redia!ete$
@ le$$ t%an 14, mgKdl mean$ normal
Dr0- t3er/p,e+ /1/,5/:5e 7or t3e tre/t8ent o7 4,/:ete+ 8e55,t0+
(1
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CLASS DRUGS
0iguanide$ etformin
Sul-%onyl urea?$ /lim-eride
eglitinide$ #e-aglinide
+%iaBolidinedione$ ioglitaBone
Al-%a gluco$ida$e in%i!itor$ Acar!o$e
D--4 in%i!itor$ +ra'enta
TRAENTA (LINAGLIPTIN.inagli-tin i$ an in%i!itor of t%e enByme D4 8di-e-tidyl -e-tida$e@49 w%ic% i$ involved in t%e
inactivation of t%e incretin %ormone$ /.@1 and /) 8glucagon@like -e-tide@1 gluco$e@
de-endent in$ulinotro-ic -oly-e-tide9
.inagli-tin gluco$e@de-endently increa$e$ in$ulin $ecretion and lower$ glucagon $ecretion t%u$
re$ulting in an overall im-rovement in t%e gluco$e %omoeo$ta$i$
.inagli-tin i$ a once@daily ta!let t%at i$ u$ed along wit% diet and exerci$e to im-rove glycaemic
control in adult$ wit% +y-e 2 Dia!ete$
.inagli-tin $%ould not !e u$ed in -atient$ wit% +y-e 1 Dia!ete$ or for t%e treatment of dia!etic
ketoacido$i$ 8increa$ed ketone$ in t%e !lood or urine9
(2
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METHODOLOGY
(3
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!ESEA!CH DESI2N:
+%e #e$earc% de$ign followed i$
1 Ex-loratory #e$earc%
2 De$cri-tive #e$earc%
E=p5or/tor6 Re+e/rc3 Ex-loratory re$earc% i$ a ty-e of re$earc% conducted !ecau$e a -ro!lem
%a$ not !een clearly defined Ex-loratory re$earc% %el-$ determine t%e !e$t re$earc% de$ign datacollection met%od and $election of $u!'ect$ /iven it$ fundamental nature ex-loratory re$earc%
often conclude$ t%at a -erceived -ro!lem doe$ not actually exi$t )n our ca$e we fir$t wanted to
make certain a$-ect$ of t%e $tudy clear !efore actually de$cri!ing t%e -ro!lem +%e -rimary
re$earc% too %a$ %el-ed u$ ac%ieve $ome clarity
De+cr,pt,1e Re+e/rc3 +%i$ re$earc% i$ t%e mo$t commonly u$ed and t%e !a$ic rea$on for
carrying out de$cri-tive re$earc% i$ to identify t%e cau$e of $omet%ing t%at i$ %a--ening
De$cri-tive re$earc% al$o known a$ $tati$tical re$earc% de$cri!e$ data and c%aracteri$tic$ a!out
t%e -o-ulation or -%enomenon !eing $tudied De$cri-tive re$earc% an$wer$ t%e 7ue$tion$ w%o
w%at w%ere w%en and %ow +%e de$cri-tion i$ u$ed for fre7uencie$ average$ and ot%er
$tati$tical calculation$ &ften t%e !e$t a--roac% -rior to writing de$cri-tive re$earc% i$ to
conduct a $urvey inve$tigation Pualitative re$earc% often %a$ t%e aim of de$cri-tion and
re$earc%er$ may follow@u- wit% examination$ of w%y t%e o!$ervation$ exi$t and w%at t%e
im-lication$ of t%e finding$ are
(&
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>e %ave u$ed t%i$ re$earc% along wit% ex-loratory re$earc% or carrying out de$cri-tive re$earc%
we %ave u$ed a 7ue$tionnaire t%i$ 7ue$tionnaire would !e admini$tered to 1,, re$-ondent$ and
t%i$ would %el- u$ to identify t%e variou$ factor w%ic% will %el- u$ to $tudy t%e $ati$faction level
of cu$tomer$ toward$ mo!ile $ervice -rovider$
C/0+/5 Re+e/rc3
+%i$ met%od i$ conducted to identify cau$e and effect relation$%i- among varia!le$ w%en t%e
re$earc% -ro!lem %a$ !een narrowed to >%ere concomitant variation$ i$ not met t%ere i$ no
relation$%i- !etween varia!le$ t%i$ met%od$ i$ t%e mo$t fea$i!le
De+,-n U+e4 In T3e Project
A de$cri-tive re$earc% $eek$ to determine an$wer$ to w%o w%at w%ere and %ow 7ue$tion$ t%at
i$ it de$cri!e$ t%e c%aracteri$tic$ of a -%enomenon +%e de$cri-tion i$ u$ed for fre7uencie$
average$ and ot%er $tati$tical calculation$ &ften t%e !e$t a--roac% -rior to writing de$cri-tive
re$earc% i$ to conduct a $urvey inve$tigation Pualitative re$earc% often %a$ t%e aim of
de$cri-tion and re$earc%er$ may follow@u- wit% examination$ of w%y t%e o!$ervation$ exi$t and
w%at t%e im-lication$ of t%e finding$ are
) %ave u$ed t%i$ re$earc% along wit% ex-loratory re$earc% or carrying out de$cri-tive
re$earc% i %ave u$ed a 7ue$tionnaire t%i$ 7ue$tionnaire would !e admini$tered to 5, re$-ondent$
and t%i$ would %el- me to identify t%e variou$ factor w%ic% will %el- to $tudy t%e -erformance of
-re$cri-tion drug$ of 0oe%ringer )ngel%eim e$-ecially in treating dia!ete$
('
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DATA ANA#6SIS
1 Data Collection et%od
Survey
2 Data Collection )n$trument
Pue$tionnaire
3 Communication et%od
er$onal )nterview
4 Sam-ling $trategy) +arget -o-ulation +%e -o-ulation con$i$t of 5, Doctor$ from t%e region of
nort%ern um!ai
)) Sam-ling met%od Convenience $am-ling met%od i$ ado-ted
))) Sam-ling rocedure Sim-le random $am-ling -rocedure i$ ado-ted
((
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Deter8,ne S/8p5e S,e
+%e $am-le $iBe i$ given !y t%e formula
n (
$
p E$
w%ere- denote$ -ro!a!ility of $ucce$$7 denote$ -ro!a!ility of failureU denote$ $tandard normal variationE denote$ $tandard errorn denote$ $am-le $iBe
()
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DATA ANALA!SIS
Q0e+t,onn/,re
Pue$tion 1
AreaJ
Area
=ori4ai
Ka%di4ai
Maad to #%dheri
+%e Doctor$ w%o were $urveyed in t%e $urvey were mo$tly from
nort%ern -art of um!ai And in nort%ern -art al$o 23 of doctor$ were
from 0orivali 1" from =andivali and 1, doctor$ were from !etween
alad to ile -arle
(*
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Pue$tion 2
>%at are t%e different ty-e$ of -atient do you $ee in your day today
-racticeJ
An$
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%aving ot%er di$ea$e like coug% n cold urinary tract infection !one
related -ro!lem
Pue$tion 3
Do you $ee Dia!etic -atient often in your day today -racticeJ
;e$
o
D)abe)c Pa)en
Ies
Eo
+%e entire re$-ondent$ were %aving dia!etic?$ -atient vi$iting to t%em
for follow u- or treatment of dia!ete$ +%i$ $%ow$ t%at t%e $am-le
),
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$elected for t%e $urvey wa$ very good a$ t%e $urvey involve evaluation
of Anti dia!etic Drug
Pue$tion 4
>%at are t%e ty-e of drug$ do you -refer to treat dia!etic -atientJ
An$
Met!ormi% Gime6ride D66& /ds 8%sui%
,
1,
2,
3,
&,
',
(,
Dr+gs +se(
Dru5s used
Almo$t all t%e Doctor$ were u$ing metformin a$ t%e fir$t line drug for
treating dia!etic$ and after t%at glim-eride a$ t%e $econd c%oice $ome
al$o u$e gli!enclamide ery low -ercent of Doctor$ u$ed D--4
)1
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)n%i!itor$ mo$tly !ecau$e of %ig% co$t &t%er commonly u$ed drug$
were in$ulin and +%iaBolidinedione$ and in t%at al$o mo$tly
ioglitaBone
Pue$tion 5
Fave you ever tried +ra'enta in your Dia!etic atient to control 0/
levelJ
An$
6es@No
Ies
Eo
&ut of t%e total -o-ulation $urveyed *, of t%e doctor$ %ave tried
+ra'enta in t%eir dia!etic -atient to control t%eir 0/ level
)2
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Pue$tion 6
>%at do you t%ink a!out efficacy of +ra'enta viB a viB ot%er !rand$ youu$eJ
An$
Ecac' %ers+s Ohers
=est
Good
Medium
"ow
Almo$t 65 of Doctor$ u$ing +ra'enta found efficacy of +ra'enta to !e
!e$t among ot%er drug$ Around 15 doctor$ $aid it$ good e$-ecially in
)3
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renal com-romi$ed -atient and 14 doctor$ $aid it$ com-ara!le to ot%er
drug$ availa!le in market and around 6 doctor$ $aid it$ lower t%an
ot%er D--4 )n%i!itor$
Pue$tion "
>%at do you t%ink a!out F!A1c #eduction o!tained wit% +ra'enta
com-ared to ot%er$ drug$ availa!leJ
An$
HbA3c !e(+c)on
-6timum
=etter
Good
"ower /ha% other
)&
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Doctor$ u$ing +ra'enta found to !e more efficaciou$ t%an commonly
u$ed drug$ like metformin and glim-eride Fowever $ome doctor$ al$o
$aid it i$ lower t%an ot%er d--4 in%i!itor$ like $itagli-tin and
vildagli-tin
Pue$tion (
>%at i$ your &-inion a!out t%e Safety a$-ect$ of +ra'entaJ
An$
Safe'
Sa!e
Data Eot a4aiabe
)'
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All t%e doctor$ w%o %ave tried +ra'enta in t%eir dia!etic -atient feel$
+ra'enta i$ t%e $afe$t molecule com-ared to all e$-ecially related to ckd
8C%ronic =idney Di$ea$e9 -atient
Pue$tion *
Fave you encountered any $ide effect$ after -re$cri!ing +ra'enta to you
-atientJ
An$
S)(e eec
Ies
Eo
)(
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Doctor$ u$ing +ra'enta till date %ave not encountered any $eriou$ $ide
effect$ a$$ociated wit% t%e drug )t clearly denote$ t%at +ra'enta i$ $afer
to -re$cri!e in any kind of -atient irre$-ective of %i$ co mor!idcondition
Pue$tion 1,
>%at i$ your o-inion a!out drug to drug interaction a$$ociated wit%
+ra'entaJ
An$
D o D Inerac)on
Ies
Eo
))
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+ra'enta doe$ not $%ow any drug to drug interaction w%en -re$cri!ed t%e
doctor$ w%o were $urveyed +%i$ data al$o $ugge$t $trong $afety -rofile
of +ra'enta ver$u$ ot%er$
Pue$tion 11
>%at i$ your o-inion a!out t%e education -rovided !y 0oe%ringer
)ngel%eim a!out +ra'entaJ
An$
Kno,le(ge
Good
=etter
Poor
)*
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o$t of t%e doctor$ find t%e educational -rogram$ of 0oe%ringer
)ngel%eim to !e good and u$eful in t%eir day today -ractice ew doctor$
al$o found t%e lecture to !e of -oor 7uality w%ic% mig%t !e t%e rea$onfor not u$ing +ra'enta !y t%e doctor$ in t%eir -atient
Pue$tion 12
Are you $ati$fied !y t%e literature -rovided !y 0) for t%e -roductJ
An$
#)era+re
Ies
Eo
More
)+
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any doctor$ were $ati$fied !y t%e literature and -roduct information
given !y t%e com-any re-re$entative %owever t%ere were few doctor$
w%o re7uired more u-dating on regular !a$i$ to know a!out current
information a!out t%e re$earc% molecule
Pue$tion 13
Any $ugge$tion you would like to give to im-rove t%e -roduct
-erformance in term$ of cmeJ
An$
Sim6e
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o$t of t%e doctor$ $ugge$ted t%at t%e cme $%ould !e $im-le and it
$%ould %ave late$t content to %ave intere$t for t%e doctor$ to learn Some
al$o $ugge$t c%oo$ing good 7uality $-eaker$ for t%e -rogramme w%o %a$good knowledge of t%e $u!'ect And many doctor$ $ugge$ted it $%ould !e
timed -ro-erly to avoid time lo$$
CONCLUSIONS
*1
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FINDIN2S OF THE !ESEA!CH:
+%e finding$ of t%e re$earc% were a$ follow$
&S+ & +FE D&C+S A#E :S)/ +#AGE+A +& +#EA+D)A0E+ES
&S+ & +FE D&C+S A#E SA+)S)ED 0; +FE E)CA;
& +FE D#:/
A; D&C+S +F)= :S)/ +#AGE+A AS A SEC&D
.)E +F#EAF; )S A /&&D &+)& C&A#ED +&
/.)E#)E
&S+ & +FE D&C+S #EE# :S)/ +#AGE+A )
#EA. C&)SED A+)E+
*2
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&S+ D&C+S A#E SA+)S)ED >)+F F0A1C
#ED:C+)& SF&> 0; +#AGE+A
S&E D&C+S A.S& S://ES+ED F0A1C #ED:C+)&
& :+& 2
A.. D&C+S >E#E E#; :CF SA+)S)ED >)+F +FE
SAE+; #&).E & +#AGE+A
& D&C+S &:D A; #E.A+ED :#E.A+ED
S)DE EEC+S ASS&C)A+ED >)+F +#AGE+A D:#)/+F)E# C.))CA. #AC+)CE
& D#:/ +& D#:/ )+E#AC+)& >E#E #E+ED
>)+F +#AGE+A ) A; A+)E+ 0; A; D&C+S
A#+)C)A+)/ ) +FE S:#E;
ED:CA+)&A. #&/#AS C&D:C+ED 0;
0&EF#)/E# )/E.FE) )S /&&D
*3
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CONCLUSIONS
#& +FE S:#E; )+