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Ethics in Pharmaceutical Industry Presented By: Namita Amale 01 Hitesh Jadhav 10 Amey Kadam 13 Milind P atil 27 Siddhesh Sonawane 29 Subodh !!an"a# 3$

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Ethics in Pharmaceutical

IndustryPresented By:

Namita Amale 01

Hitesh Jadhav 10Amey Kadam 13

Milind Patil 27

Siddhesh Sonawane 29

Subodh !!an"a# 3$

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PHARMACEUTICS

• Pharmaceutical industry

• Sales practices

• Guidelines and regulatins

1% &u#o'ean (ede#ation o) Pha#ma*euti*al+ndust#ies and Asso*iations%

2% Pha#ma*euti*al ,esea#*h and Manu)a*tu#e#so) Ame#i*a%

•. Indian perspecti!e1% Amon- to' .ve 'ha#ma*euti*al eme#-in-

ma#"ets%

2% Hi-hly )#a-mented indust#y with

20/000#e-iste#ed units%

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•  o's the *ha#ts amon-st +ndias s*ien*e basedindust#ies with new te*hnolo-y and d#u-manu)a*tu#in- '#o*esses%

• +ndia is e'e*ted to be the thi#dla#-est -lobal -ene#i*

a*tive 'ha#ma*euti*al in-#edient 4AP+5 me#*hant

ma#"et by 201$/ with a 7%2 'e# *ent ma#"et sha#e%

•  +n 2012/ d#u- *om'anies )#om +ndia .led 9 'e# *ento) the ove#all d#u- maste# .lin-s 48M(s5 in the S%

• +ndian sta#tu's )o*usin- on the d#u- dis*ove#y

business%• +ndia loo"in- at 'oli*y #e-ulation shi)t in 'ha#ma*y

se*to#%

• ove#nment o) +ndia to b#in- all 'ha#ma*y #elatedde'a#tments unde# one #oo)%

Current scenari in India

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Ethics in Pharmaceutical

Industry: Ethical "eha!ir

• +nte-#ity

• +n)o#mation sha#in-

• A**u#ate '#es*#i'tion• #ans'a#en*y

• :b!e*tivity

• (ai#ness

• ;a#e )o# and about 'eo'le

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Ethics in pharmaceutical

industry: Unethical "eha!ir

• Misleadin- adve#tisements

• Pe#sonal inte#est

• Mis-uidin- '#es*#i'tion• Sub!e*tivity

• Pa#tiality

• Sellin- o) sam'les to 'ubli*

• n*ont#olled testin-

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Re!enue # Indian

Pharmaceutical Industry he +ndian 'ha#ma*euti*als ma#"et is e'e*ted toe'and at a ;A, o) 23%9 'e# *ent to #ea*h S< ==

billion by 2020%%

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Mar$et Shares # Tp Indian

Cmpanies

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Histry # the cmpany

 Gla%Smith&line plc (GS&) is a Britishmultinatinal pharmaceutical* "ilgics* !accines andcnsumer healthcare cmpany+

• As # March ,-./* it 0as the 0rld1s si%th2largest

pharmaceutical cmpany+

• The cmpany 0as esta"lished in ,--- "y the merger# Gla% 3ellcme and Smith&line Beecham plc+

• As # , May ,-./ it had a mar$et capitalisatin #456 "illin+

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3hat 0ent 0rng7+8•  Pail and >ellbut#in )o# una''#oved uses and )ailin-

to #e'o#t sa)ety data about Avandia%

• +n July 2012 SK 'leaded -uilty to *#iminal *ha#-esand a-#eed to a 'ay <3 billion to settle the *#iminal

*ha#-es%

• SK 'aid <1 billion to settle the *#iminal *ha#-es%

• he #emainin- <2 billion we#e 'a#t o) the *ivilsettlement ove# una''#oved '#omotion and 'ayin-"i*"ba*"s%

• ?#ibin- do*to#s/

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3hy8

H08

3hen8

9inalerdict ;

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E< Sur!ey

• At &@/ they have *ondu*ted a su#vey amon- health*a#e '#o)essionals 4H;Ps5 and 'ha#ma*euti*al*om'anies to unde#stand thei# 'e#s'e*tive o) the

Medi*al ;oun*il o) +ndias 4M;+5 -uidelines and the8e'a#tment o) Pha#ma*euti*als 48oP5 ma#"etin-*ode%

• ;a##ied out a two'a#t su#vey/ in whi*h 100#es'ondents 'a#ti*i'ated%

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&ey =ndings # the sur!ey

• A#ound twothi#d o) the #es'ondents )elt that theim'lementation o) the uni)o#m *ode o) 'ha#ma*euti*alma#"etin- '#a*ti*es 4;PMP5 would *han-e the manne# inwhi*h 'ha#ma '#odu*ts a#e *u##ently ma#"eted in +ndia%

• A**o#din- to the su#vey/ mo#e than =0 o) the#es'ondents a#e o) the o'inion that the ;PMPs -uidelinesmay lead to mani'ulation in #e*o#din- o) a*tual sam'lin-a*tivity%

• Mo#e than =0 o) the #es'ondents indi*ated that theeBe*tiveness o) the *ode will be ve#y low in the absen*e o)le-islative su''o#t '#ovided to the ;PMP *ommittee%

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• An ove#whelmin- ma!o#ity o) the #es'ondents 4905

)elt that Pha#ma *om'anies in +ndia should )o*us onbuildin- a #obust inte#nal *ont#ols system )o# ensu#in-*om'lian*e with the ;PMP%

• A#ound 72 o) the #es'ondents )elt that the M;+ wasnot st#in-ently en)o#*in- its medi*al ethi*s -uidelines%

• And only 3$ o) the #es'ondents )elt that the M;+s

-uidelines would have an im'a*t on the ove#all saleso) Pha#ma *om'anies%

 

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Suggestins

•Prmtin # prescriptin drugs shuld"e made a legal matter+

•Sa#ety data shuld "e reprted t the

cncerned "dy and must "e updatedn a regular "asis+

•Prmtin # nly licensed medicinesshuld "e carried ut+

•Ethical practices t "e carried ut "ycmpanies and their representati!es+i+e+ "ri"ing dctrs must "e a!ided+

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Cnclusin

&thi*s in the a#ea o) 'ha#ma*euti*als whi*h *on*e#n the'ha#ma*ist as a 'e#son and the 'ha#ma*euti*al *om'anyas a *o#'o#ate body is e'e#ien*in- evolution/ whe#e'ha#ma*y '#a*ti*e is diBe#ent today than it was

'#eviously% Pha#ma*euti*al innovation and te*hnolo-yadvan*ement has sha'ed the 'ha#ma*euti*al indust#y and

'ha#ma*ists themselves and the need o) solid st#on- ethi*sto be embedded into the 'ha#ma*ist as an individual whi*hwill then )o#m the o#-aniCation o) 'ha#ma*euti*al with hi-h

ethi*al values% &thi*s and 'ha#ma*y at la#-e must be

sensitive and #es'onsive to an unavoidably

*han-in- envi#onment%

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