Vasantha_Muthuswamy

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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



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



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



!odes of trans#ission

' Se8ual contact ------------- 9:.7/

' Blood and Blood products ; /./

' ID<s -------------------------- /./2

' 3erinatal trans#ission ------ (.):

' =ters ------------------------- 2.+



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



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





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





>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>%



>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$,(++(



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



' 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



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



4HAN5 M=<

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