project mahesh

7/25/2019 Project Mahesh

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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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13/90

+%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

1(


17/90

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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18/90

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

1*


19/90

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

1+


20/90

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


21/90

;%der the 6ro4isio%s o! this act the


22/90

/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


23/90

/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%$

23


24/90

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-/


25/90

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


26/90

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(


27/90

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

2)


28/90

/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

2*


29/90

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


30/90

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


31/90

&ver time often 3


32/90

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

32


33/90

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

33


34/90

Cu%itrae6am oh$6%o

Dissociati4e a%esthetics Ketami%e Ketaar SV

-6ioids a%d mor6hi%e


35/90

/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

3'
http://www.jabfm.org/cgi/content/full/21/1/45#R19http://www.jabfm.org/cgi/content/full/21/1/45#R19


36/90

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

&1
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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

&3
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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

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4. "ACK2!OUND

2.1 # E0S or5a%isatio%s are reAuired to ha4e a% #ccou%tabe -?cer !or


46/90

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


47/90

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


48/90

Auick$ to sto6 the 5e%era 6ractitio%er co%ti%ui%5 to 6rescribe


49/90

'.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


50/90

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


51/90

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


52/90

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


53/90

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


54/90

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


55/90

/he oca 6er!orma%ce ma%a5eme%t or decisio% maki%5 5rou6 ma$

wish to co%sut E


56/90

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

'(


57/90

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

')


58/90

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+

'*


59/90

+%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

'+


60/90

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

(,


61/90

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


62/90

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


63/90

METHODOLOGY

(3


64/90

!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

(&


65/90

>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$-ecially in treating dia!ete$

('


66/90

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

((


67/90

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

()


68/90

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

(*


69/90

Pue$tion 2

>%at are t%e different ty-e$ of -atient do you $ee in your day today

-racticeJ

An$


70/90

%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

),


71/90

$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


72/90

)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


73/90

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


74/90

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

)&


75/90

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

)'


76/90

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

)(


77/90

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

))


78/90

+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

)*


79/90

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

)+


80/90

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


81/90

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


82/90

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


83/90

&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


84/90

CONCLUSIONS

#& +FE S:#E; )+

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