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Developing Guidelines for HIV-
AIDS in IndiaConcerns,Needs,Bottlenecks, Solutions
Dr.Vasanta !utus"a#$
Senior Deput$ Director General, Indian Council of !edical %esearc
Ne" Deli,India
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HIV& AIDS in INDIA
' (nd #ost populous nation in te "orld
' !ore tan ) *illion people
' +. of Indian population are HIV
' IN actual nu#*er ----- /.0 #illion cases
' 1 ) of general population in 2 states -----
!aarastra,A.3.,4a#il Nadu, 5arnataka,!anipur,Nagaland
%est of te countr$ 6 ) of general population
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Concerns
' !oved fro# ig risk to general population
' !en are victi#s in 1 7 cases
' 4rans#ission route is se8ual in 1 97 cases
' Significant variations a#ong and "itin states
Based on annual surveillance data collected
from 232 sites
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!odes of trans#ission
' Se8ual contact ------------- 9:.7/
' Blood and Blood products ; /./
' ID<s -------------------------- /./2
' 3erinatal trans#ission ------ (.):
' =ters ------------------------- 2.+
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N>>DS
' Continuous surveillance
' A"areness progra##es
' Increased ealt care allocations
' Identification of ig risk groups
' Access to treat#ent for all' %e#oval of stig#a and discri#ination
' Developing appropriate guidelines
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Develop#ent of guidelines
' NAC= ----- 4reat#ent Guidelines, Blood safet$guidelines,A"areness progra##es,4rainin*g
#odule for Blood *ank,S4D clinics,ANC clinics' IC!% ------ >tical guidelines for Bio#edical
researc, )09+,(+++,>tical guidelines for
HIV&AIDS researc,(++)' NAC=- IAVI-?a"$er@s collective ---- HIV&AIDSlegislation,HIV vaccine trial guidelines
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Callenges
' Disse#ination of national and international guidelines
' 4raining "orksops for different stakeolders
'Appropriate legislations for co#pliance as guidelines are not#andator$- "ill *e read$ *$ end of (++/.Draft legislation ofetical guidelines is "it te !=H .
' Beavioural studies for risk reduction
' 3ro#otion of access to drugs as all A%Vs are availa*le in te
open #arket *ut not in te National progra##e on AIDS control.' ?arge nu#*er of clai#s fro# traditional practioners ; tere are 2
recognised 4%! practices
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>tical 3rinciples
' Beneficence - Do no Har#@- 3u*lic ealt concerns are
not placed over individual rigts
' ustice - Vulnera*les to *e identified and protected' Autono#$ ; Infor#ed consent in difficult settings ;
illiterac$,overcro"ding,#uti linguistic societ$,fa#il$ and
co##unit$ consultation
' >nsure etical revie" ; training of I>C&I%B #e#*ers-
>%CI& >%CA3& SIDC>%
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>8isting ?egislations
' Drugs and Cos#etics Act )0:+ ,(++(
' GC3 India guidelines ,(++)
' !CI guidelines, )072,(++(onl$ applica*le to#odern #edicine practionersJ
' Social science researc guidelines,(+++
' National AIDS polic$,National Healtpolic$,National ealt researc polic$, (++(
' Draft *ill for *io#edical researc autorit$,(++(
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So#e tougts
' <nifor# etical guidelines are ideal as all are
*orn eKual and are guided *$ te *asic u#an
rigts.; Is it feasi*le in a "orld of uneKuals
; Is it possi*le "ere Govt. 3olicies are different
; Is it acieva*le "ere no capacit$ e8ists
' Is it rigt to i#pose stricter standards L
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' E 3rotection of u#an su*ects in HIV&AIDS researc
entails a clear de#arcation of responsi*ilities and
lia*ilit$ in te conduct of researc.Issues suc asInfor#ed consent,provision of insurance,#edical
care,availa*it$ of follo"up care and
#edication,co#pensation and #etods of deter#ining
te sa#e reKuire legislation *efore researc can *eper#itted.3articipants sould *e a"are of te legal
lia*ilit$ for ar# and co#pensation F
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Case stud$
' Clinical trial of A44 "it A%4 drugs in HIVcases "o are also positive for 4u*erculosis
; irst ti#e trial; Single dose A%4 "it D=4 terap$- also first ti#e
; A%4 for ( $ears and ten National polic$
; o decides, o" long,"o *ears te cost; Counselling for HIV as "ell as A44 trial
; 3rivac$ and confidentialit$ issues
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4HAN5 M=<
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