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'lWT II-<SI"1lS 3-~-<SI"1lS (i)

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PUBLISHED BY AUTHORITY

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,

4 THE GAZETTE OF INDIA: EXTRAORDINARY [PARTII-SEC. 3(i)]

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cnW ~ ~ "4G - 31'Vl&1;

['IWI II-~ 3(j)] 5

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--- ----- . - - ---- -- -- ----------------------------

6 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II-SEC. 3(i»)

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['q]T( II -lSl1IS 3(i)] 7

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~\8 THE GAZETTE OF INDIA: EXTRAORDINARY [PARTII-SEC. 3(i)]

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'tf PlA~Rild ~ <1ft ~ ~ 'iIffi'IT t : (3{'RT f.IcI;c Offill ~ m ~~ PlA~Rild ~ ~ 1l 'U(Ijl{ 'U (Ijl{ eft <1ft \)j::lSliiifilld 'SI'fmrt ~) :

• ~/~m~o3l'R~~~~3l'R~ .

3l'R / <IT

• lffiGRIT ~ ~~, ~ ~ cBt ~, fclm;f WIT ~ .

3l'R / <IT

• ~~~,~~cBt~,~mm ..

3l'R / <IT

• ~ ~ ~O (tR') ..3l'R / <IT

3l'R / <IT

• "C!ft1 ~ cB- ~~ q;) ~ ~ S1Z ~ 3l'R ~ CIiT 3Rr ~

(<Y) ~ ~ ~ / ~ ~ cB- ~a:r 'ffi1l.T fcmn S3lT fcrcrrg cBt ~ cBt ~ ~ ~ 'f.rcr;c~. CIiT 1:[Cl? 'ffi1I.T ~

(1T) ~~

(tl') fcrcrrg cBt ql{~i~ClJt113l'R ~ q;) ~ ~ ~ 'lW1. ~ ~/t1g'(-\)('1C;I~/mWIT ~/~ ~ CIiT ~ I

1l ~'16l11f.l0(31~ ~ ~ /~ ~ 3l'R ~ ~~ ~ fcp l'fRCf WT ~~, 1994 (1994 CIiT 42) ~ mxr 2,

mxr 9 3l'R mxr 19 ~ ((ffi tT ~ -g 3l'R 1l ~ ~ ~ fcp :

1. tl mxr3lT ~ ~ ~ ~ cBt ~ q;) WlWIT W~ ~ I


2. ~ ~ ctt 'affi31T "4 ~ q;f <IT q;f <fiT ~ <fiT ~ -;ffl f<l?m 7fm ~ <IT ~ <IT fcnx:fi 3Rl ~q;) -;ffl f<l?m ~ I

3. ~ fcnx:fi ~ q<mr ~ <IT >flITCI <IT ~ $" 311Rt ~ ~ ~ m (3M) q;) ~

"G!R$"~~31'R~~m~ I

4. ~ ~ (3M) $" ~ "G!R"4 f.rfm1 ff1fcBH=T1q >@;m ctt ~ 31'R~ ~ f.rfm1 <:rn1 q;) ~:~ <1'R"~ 7fm ~ I <rg f<l:; '(:qoilCfi~OI. (~fG1'(~'l'd ff1FcnH=T1q ~ <fiT '1J1'T) aRT ~1Tm ~ I

5. tl ~ ~ aRT ~ \RI ff1Rt>H11q >@;m ctt ~ 31'R~ ~ ~ ~ <:rn1 q;) ~ ~ I

6. tl ~ ~ f<l:; tl ~ ftI;m ~ ~ ~ fcnx:fi ~ ~ 3M q;) ~ "G!Rctt 311Rt ~ q;) Cf11ffT B "'(1"Cfi"ffi WB~~I

7. tl ~ ~ W~ ~ f<l:; ~ "4 ~ aRT ~ ~ ~fM~qi ~ m'l "4 "'('I('<l 3tR ~ -g 3tR gm ~ ~ aRT jUqrm-;ffl 7fm ~ I

~ : ~ ~ vIT \RI ~ 3lj>l"1lfilld <1'R"m ~, $" "(11'11\1 ~~ B<n 3tR ~ cRrn f<l:; ~ ~"tR~/~"tR mmaR<1'R"~Bm~ ~~ I

'$ffitT 3f.rcl;c vftfcm ~ ~ 3Rl imT 3FT <IT \JmcI) <l'R $" ~

(~ aRT WI f<l:;m vm:;)(f.!<r:l 3, 5(3) (en) 31'R5(3)(~ W')

......................................................................................................................

GfdT <fiT -q;'rc)(~$"~~~aRT -q;'rc) q;) ~ S'I 31j>l"1 Ifilldm-:ft ~)

.................................................................................................................................................

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["IT'! II-~ 3(i)] 17

• m/~ m~O 31'R vrR\ ~ q\t ~ 31'R ~FL .

31'R / <IT

• lffiGR!T ~ l1?I msm. vrR\ ~ q\t~. fcl<TA ~ ~ .

31'R / <IT

• ~~msm. vrR\~q\t~. ~~ .

31'R / <IT

• ~ ~ ~O (tPr) .31'R / <IT

• 3lmR~O

tf fill?t>ctl', 11 ~ cf; ~ 31tRT WT (WT/i3i'ffCP em 1TI'I)~ cf; ~ ~ 1TI'I ~ ~ VPl'I (fG;1/lffiI/~) q;) S3!Tm ~ ~ RI~I~l1i f.!+:;r m~. f.rcIm;) vrR ~ ~ ~ ~ 31'R ~ ~ ~ :

>fT1<f ~ ~ em tp)c)(~cf;~~~&RT~em~~ ~'jl'lSjlftJld ~ ~)

• m/\31l~ m ~O 31'R vrR\ ~ q\t ~ 31'R ~·lr-L .(cp'iclCf)lQ1 ~)

31'R / <IT

• lffiGR!T ~ 1:['31 msm. vrR\ ~ q\t~. fcl<TA ~ ~ .

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• ~ ~ msm. vrR\ ~ q\t~. ~ ~ .(cplclCf)14l ~)

18 THE GAZETTE OF INDIA: EXTRAORDINARY [PARTII-SEC. 3(j)]

3fR / <IT

• ~ ~ ~O (t-l) ..3fR / <IT

• 3TTtm' ~O

4 {1~if.1t:Qi ~ mmrr ~ /'CfRCfi ~ 3fR ~ ~;CfRCfi ~ fcI;" 'I1T'fC! 3M ~~. 1994 (1994 CfiT 42) $t tTRI2.

tTRI 9 3fR tTRI19 ~ iTffi ~ lTt -g- 3fR 4 ~ ~ ~ fcI;" :

1. 4 tmr31't <l f.rm ~ 311RItIT $t >icpft1<!iT ~ W~ ~ I

2. ~ ~ c5t tmr31't <l <l'~ tR <IT tR CfiT ~ CfiT ~ ~ fcI;"m 'l'fllT ~ <IT ~ <IT frRfi 3RT 'CZl'fcffiq;1 ~ fcI;"m ~ I

3. ~ frRfi ~ ~ ~ <IT )['l1TC[ <IT ~ ~ ~ ~ ~ ~ :3J'lR (3M/\'mfCI) CfiT"IT"I) q;1 ~ VIR ~~~ 3fR~~m~ I

4. ~ ~ (3M/\'mfCI) CfiT "IT"I) ~ ~ VIR <l ~ ~RI>6(t14 ~ c5t >icpft13fR ~ ~ ~'ffiR1 q;1 ~: ~ 'CI'iX ~ 'l'fllT ~ I '45 fcI;" f4oe'lqo;~Oi (~F\>t'<{ltcl ~RI>f<114~ CfiT"IT"I) &RT ~ nzrr ~ I

5. 4 ~ ~ &RT <r~ ~ ~RI>~4 ~ c5t >icpft13fR ~ ~ ~ ~ 'ffiR1 <!iT ~ ~ I

6. 4 ~ ~ fcI;" 4 WRr fu;m ~ ~ ~ frRfi 'W11l ~ 3M <!iT ~ VIR c5t ~ ~ q;1 CfT'CR'I ~ ~ W~~~I ..

7. 4 ~ ~ W'CfRCfi ~ fcI;" m <l ~ &RT ~ lTt frlrM~4i ~ ~ <l ~ 3fR ~ -g- 3fR W't9 ~ ~ GRT fOOm~'l'fllT~1

~ : ~ ~ vn ~ 'W11l 31j)~'1ij'aicl 'CI'iX m ~. ~ ~a-T ~ WIT 3fR ~ crR-tn fcI;" ~ ~ tR

~/~ tR ~aR'CI'iX~ ~ m 'CZl'fcffi crtt ~ I

~ <mTT <t ~Fcli6(ft4 'lI)Tm:rr <t Sj+uuftCb,(Ui <t ~('(F\>t~q;d ~ ~ em ~ UITq')

[f.r4;:r 5(3)(<9) CfiT ~ ~]

4. ~ ~ ~ ~ ~ GRT 9'ill'~ tR ~ ~ ~ ~ '11 ~F\>t{~cpcl. '45 >fl'ITfUra ~ ~ fcI;" ~~/~/~ CfiT/c5t T-f/Tft/~ 3mJ CfiT/c5t ~ ~ 3M(3M CfiT "IT"I) ~ ~ ~/~~ q;1 vn GRn CfiT f.rcI;c~/GRn ~ f.rq;c ~ ~ ~ ~ 3fR vn ~ ~/~F\>tx~tcl ~ ~ ~ ~ ~ CfiT ~(<r~) GRT ~ ~ om \3Cffi GRn ~ ~ c5t <rnT $p ~ 3fR 3M ~ VIR c5t ~ ~ 3l<lR ~ ~ ~RlRli6t1qo;~"4Tn! ~ I

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['qfTT II -~ 3(i) ] 19

cmrr emm(~RPct1<t>aRT 3t'jl'lJilf1lld)

"l<f1<iq;-ffi em ~(~FcI>ct1<t>aRT 3t'jl'lJilf1lld)

'cmrr cf; ~ w:1 ~ 3TT~ ~ ctr ~ .q ~ ctr c;m.q, xf\1l«\.)<fd ~fcpct1<t>cmrr em f.lita-TUT Ji1~~FcPct1<t>aRT ~~I

'SfI'Ca ~ ~ cf; 'UM ~ GTffi <1ft ~1'jqi~IQi ~ cf; l'I'lluftQi'(OI cf; ~(~ q;) ~ ~ ~ ~ l'I'!l~'I~II<'I1cf; :wtWf aRT 'lffl ~)

[~5(3)("'1) 3l'R 18(3) ~]

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3fR"""""""""""""""."""."" .• "l<f1<i~ ~ <imfT ~ fcp ~/~/~"""""""""""""'vIT 'lfi/~ em;ctr:!?I/~ftR'1T"""""""""".~ em/ctr"""""."cmrr 3fR 'lfi/~""""""""""."""""vIT 'lfi/~ ctr/em~/~/~"""""""."".~ <m/ctr ~ \3CRl cmrr aRT ~ ~ ~ 3trr em 'x=i~ ~, ~ 3fCA ~ cf; ~31M'!.q ~/~l'::lTdl/~/~/~, ~, ~. 1:Itrr 3fR 1:I'rnt w:1.q ~ t I ~ ~ <m 1Wll'fl'1"fl ~ ~ ~"d"<t> 6fl1..q~i.ffI cf; ~ ~ cf; ~ \ii't'tr cf; ~ ~ ~ m 7J<l1 ~/"'ltl S3TT t; I cRta-run cf; ~ ~ t I

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'lfi"".." """" "".""." "."".".~.""."""." "." ,,."..".~." em f.1crRft 3fR~ """ .. " "" ~-:;ft/~ " .. " 3TT7j" .. " "ctr ~ ~ ~ ~ ~ cf; ~ 31M'! .q ~

20 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II-SEC. 3(i)]

-qRt tow \3Cffi ~/~ m- mR ~ 3M ~ vrr:t ~ ~ Pil'OlfMtm "IDam &RT ~ ~ cB'r~ CR ~~~ (~~~~\iffit~m) I

~ 13fc;;:;Jf{gd ~/~ cB'r ~ ~ cB'r ~ ~, vh ~ ~ ~ fcI; ~ ~ ~ CfWfI czmr4 ~ ~, m~ "IDam 1R tt ..rnm fcnm \il1'f'TT (zrgt ~ "IDam q;r ~

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<51. fcrcTrg m- ~IT. ~ vr.r ~ &RT ~ q;r 1:RJlffl ~ <mT (fcrcTrg cB'r~ ~ ~ cB'r 'V!l"q')

U. ~cB'r ~ 3fR~ OW~'VI'*I~

~ ~~~

~ ..~ ..• ~ <IT R1R1>M'll13ltfra1cP <IT ~ ~ <IT ~ 3M ~~, 1994 (1994 q;r 42) m- f.r<r:IT m- ~ <1m

~'l3Wrm-~~~cB'r~~ I~7

3{lT 'lIT '\JiffCO f1'R<ft m~~(18 'Cj1:f <ITm '3m m- ~ &RT 'IRf 'V!l"q')

[f.Iw:r 5(4) (CI» ~]3{lT (3ftTI) 3TR '\JiffCO (~) GRIT ~

(aR ~ ~ 'IRT ~)

~~'t{l'fd ~ (~ ~ mr 'RCIR f$m ~) ..

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(Pil'OlrBftld ~ q;) ~ ~ ~ m- ~ ~ ~m- ~ '1fT 0/1 fcnm \ifT ~ ~)

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[\1TI1 II-~ 3(i)] 21

-q?[ ~ em t111r.. .

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4. ~ ~ ~ RlRhH1C!i &RT ~ ~ ~ ~ $T ll't 1:Rfl'M ~ ~ ~ mofr ~ I

5. ~~, <1ft~~~m~~-qiTxm~m~~~~, <:RIl~~~'!>!fQ'C!i~

~ BR mc;IT ~ ~ 3tR 31m ~ ~ m&<l' ~ m~ I ~ -mq; fcnm 'l'fm ~ fop 31m ~ fcrcRuft ~ ~ q;'r

~ ~ ~ 31m'CIiTm&<l' l1'AT~, ~~ ~~fopfcR:fi ~ -q ~~~ G'f1R~ ~xm m I

6. ~, 'fI'rq fcrrl'N ~ ~ ~ ~I ~ ~ ~ ~ ~~, <1ftzrg ~ ~ ~ ~ ~ 3tR fcR:fi

~<:IT~-q\3lR~~~-q~~~m~q;'r~l'fA~~~~1

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~ ~ ~. ('1'«' ~ <:RIl q '!>!fQ'C!i~ ~ ~ ~ ~ '!>I<lTvR ~ ('1t5f1l('1GI~<:IT~ ~, ~ ~ 20 ~

~ <:RIll '!>!fQ'C!i~ ~ ~ Wf11lT-'l?i 'CIiTmmtR ~ I ~/<:RIlI '!>!fQ'C!i~ ~ ~ Wf11lT'l?i 'C!iT mmtR ~ I

~ I ~I ~ (~) Vffi'i ~ fcnm \i!RT ~ $T ~ ~ &RT ~ ~ ~ 'tR fcrrl'N ~ I ~

'!>f'CI?R 'CIiTmmtR Wf11lT'l?i ~ ~ ~ ~ ~-~ 3PTI $T ~ ~ (\ill <f;crc;r ~ ~ -q ~ • ~)

-q~~~ I

~:

['IWT II-~ 3(i)] 27

JRjq 123Rlffiffi &m '<4i044it't ~ ~ WT q '\3acO q;r ~ ~ ~ '<~,(~1l1'1 ~ ~

("I'iwA ~ lIaR &m ~ ~)(~24(1) ~)

3trr~~~ .

(~mtm~~)

~ 3trr ~ ~ ~ ~ ~ c5 ~ ~ l1RR!T ~ c5 ~ ~.~ t I ~ ~ ~ "Wtm3l'f c5 ~~

~ ~ APlfC>1ft1d ~

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9. ~3TA~~

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1. ~q5t~ .

2. ~ Cjj4i1IR~G ~ q5t ~ ~ ~ ~ .

3. ~ C:f;4i1IR~G~ q5t ~ ~ ~ ~ .

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2. ~ Cjj4i1IR~G ~ q5t ~ ~ ~ ~ .

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5. ~ c5 ~ ~ ~ CZl"fcffi(cprm ~ c5 3trr ~ ~ .

6. ~ m~ l"J1Z 3trr ~ 31"~ q5t ~ .

•

28 THE GAZETIE OF INDIA: EXTRAORDINARY [PARTII-SEC. 3(i))

(t) f.rffiRT ~1. ~ Cf>4'GIRqc:; ~ q5t ~ ~ ~ ~ ..

2. ~ Cf>4'GIRqc:; ~ q5t ~ ~ ~ ~ .

3. fcn1:; ~ ~ ftnm31't ~ -;;p:[ 31'R~ ~ .

4. ~ ~ ~ -;;p:[ 31'R ~ ~ .

5. ~ 1l ~ ftnm-~ q5t ~ ~ .

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(13) lWf ~ m r:;q;Cfi/ ~ WI ~ ~1. lWf ~ m r:;q;Cfi / ~ WI r:;q;Cfi ~ fcrw:wr ~ .

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dCf>~l)la'1 .

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(17) l'I<l~ll~II&11~ :

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2. ~ Cf>4'GIRqc:; q5t ~ ~ ~ ~ .

3. fcMr1T 1l fcn1:; ~ ~ ~ -;;P:[ I

4. ~~~-;;P:[31'R~~ I

(~) ~~ :

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3. fcMr1T 1l fcn1:; ~ ~ ~ -;;P:[ I

4. ~ ~ ~ -;;P:[31'R~ ~ I

(311)WR~~ :

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2. ~ Cf>4'GIRqc:; q5t ~ ~ ~ ~ .

3. fcl'lWT 1l ~ ~ ~ ~ -;;P:[ I

4. ~~~-;;P:[31'R~~ I

m "1tf ..(3t) :Slll&1IRi'<'l ~ m "1tf .

(~6) ~ ~ (~~ ~ ~ 1l ~ q~ll1~C;II'1I) :

['11fT! II-l91IS 3(i)] 29

ID -;;@ .

1. ~~~ ID/-;;@2. ~~ IDP®3. ~~ ~fcpffiCfi ID/-;;@4. ~~ ID/-;;@5. vfi.~.~ ~fcpR~Cfi ID/-;;@6. ~~~ IDf-;;@7. ~~~ ID/-;;@8. ~~ ID/-;;@9. ~&n~ ID/-;;@10. ~~~ ID/-;;@11. 3f'iq" .•........... ID/-;@

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JRijIJ 13-;hr/"Cfi'I'f.fuT ~:~ U f1Ft Wr/~ ~:~ "* ~ ~ "* '(~«flCfi'(UI "* ~ ~(~ "* ~ &m 1'1'<1 ~)

(f.rwf 24(1) ~)

~ : :ff:~ ~fcpR~I<'1ql em ~ ~ ~ "* 311m'<" "4"'< ~ ~ VfT ~ i 3tR ~ ~ &RT :ff:~~rmffil<'1101 "* ~ -B ,<F\1i'<..;)CP\ifcI;m VIT ~ i I

3f1T~"*~~~ .("'<fVi!i ZIT "'<'i<I "'<fVi!iaf.;f)

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~ ID -;@~ ID -;@

~ ID -;@

6. W<'1~~7. ~fcpffil<'1q -B ~ "* ""fl1'T


8. ~ <fVIC :9. ~~/~:

1. ~$t~:2. ~ cf; ~ ~ Cl?4ilIRqc: $t ~3. ~ cf; ~ ~ Cl?4ilIRqc: ctt ~ :4. ~ ctt 'Tt ~ ftlxrr31'!ctt ~ :5. T1":m cf; ~ ~ ~ ~ (rpqm T1":m cf; ~ WI 3lR/<1T\RfCl? ~ ~

("IT) ~~:1. ~$t~:2. ~ cf; ~ ~ Cl?4ilIRqc: ctt ~3. ~ cf; ~ ~ Cl?4ilIRqc: $t ~ :4. ~~~:5. T1":m cf; ~ ~ ~ ~ (rpqm T1":m cf; ~ WI 31'R/<1T\RfCl? ~ ~6. ~ ~ fcI;tz lTC! <T'BR 3ITEffi'I ~ $t ~7. ~~~~31'!ctt~ I

(El) ~icwm;~olfcMA :1. ~ cf; ~ ~ Cl?4ilIRqc: ctt ~:2. ~ cf; ~ ~ Cl?4ilIRqc: $t ~ :3. ~ $t 'Tt ~ ftlxrr31'!$t ~ :4. ~ ~ "Cl?T ";f1l1 3lR ~O :5. RI fc!;f{i I('Ill -q ~ ftIxrr "Cl?&ll $t ~ ~O :

6. 3lT'mi ~ ftIxrr "Cl?aTI ctt ~O :

7. '!~ T1":m ~ ftIxrr "Cl?aTI ctt ~O :

(61 3i1W.~.~/-c;q.~.~ ~ :1. 3i1W.~.~/-c;q.~.~ ~ : ~ ~ ~ .2. 3i1W.~.~.31'R --c;q.~.~. ~ $t ~O3. ~:-

'Rl:eCAl~llI1:

4. 3i1W.~.~ -q ~ "Cl?T ";f1l1

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('tJ1) >lql'I~II('I1 ~~ :1. ~ cf; ~ ~ =Cl?-&.4il=IRF.l-:1b·C:ctt ~ :2. ~ cf; ~ ~ Cl?4ilIRqc: ctt ~ :3. ~ -q fcI;tz lTC! ~ cf; ";f1l1:

4. ~ ~ "Cl?T ";f1l1 31'R~O :

('012) ~~~:1. ~ cf; ~ ~ Cl?4ilIRqc: $t ~ :2. 'lG1Tll cf; ~ ~ Cl?qilIRqc: ctt ~ :3. ~ -q fcI;tz lTC! ~ cf; "11+1 :4. ~ ~ "Cl?T ";f1l1 31'R~O :

['lI'1 II -"&US 3( i)] 31

('<13)

1. 11G-WI cf; ~ ~ q;4~IR1c: cBt ~ :2. 11G-WI cf; ~ 3mmft q;4~IR1c: cBt -msm:3. fclwT ~ fcnq" l"J"C; ~ cf;""fTI'T :4. ~~·cpr""fTI'T3fR~O:

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men :~:~:

5. \3idCP GA cf; ~ ~, fir&n 3fR ~6. \3idCP *" cpr ]:I'Q"i"R' : weT ~/~/-ey.n

2. RlRPR1q:;'itdq;.,~~lq1~ cf; ""fTI'T,. 3fR'tffi, '\ill \3idCP ~(~ 'fic;rq)


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i. ~ ~R!·;'1:gfQ;~lq~ r.rr<m:I ~ 1 ~ 2 m/~ii. Mcl~~~ <ft r.rr<m:I-~ ~ ~iii. Mcl~~~ ~ r.rr<m:I - ~iv. ~fQ;~~~ - cMt~

T[ <rtG~, -aT ~ ~ ~ c;ff11 \3OT<n ~ ? cpqm ~ cnr m/~'1Jl1 ~ "Q"ffi <l"fUrn C!R I

u \RfCl?"$ ~$1 ~ x-i~<;'1~C;!i91"$ ~ ~tn I m/~

3RT CI5'rt ~

\3q~fuli9 ~ ~~ mR"$ ~~ ~ ~~ ~ ~ &RT m~ ctt ~8:lT 1l CI5'rt ~ ~ ~ I1000/-"ffi (-:w ,<f\11~{IcWI"$ ~) ~ 5000/-"ffi (~"$ ~) cnr ~ WR"~ "$ "4"a1' 1l ~ ~ I

JR1itf 15l'fR'CI" 3iTT ~ ~ "* ~ ~ ~. ~ ~I <R:". ~ 'Tf:~ cAr"* ,<~,<{lqHOI "* ~ ~

(~24(1)~)1.~~:

['lWT II-~ 3(i)] 33

2.11"ffi3. ~/f.r\;fi/~4.~/1R-~5. ~<wr,*~~

3TT. ~ <ffi;rq;' f.1cfm;r;n 3fR ~1.. ~ ~ <IT ~ ~ '* ~ ~ ~ 3fR' ~'''<nl''<n; cBT ~ ~t/"f@(<ltRr ~ CFR)2. ~ <n.,-q"~i« '* "fTl1, ~ 3fR «<) vIT ~ ~/~ ~ I (<ltRr m/"f@~~3. ~an ~ Pt"'1~Rlli'1 cBT ~ : m/"[email protected] \3?i'1CP ~'Cl '* ~ xrn 'T1TI ~ cnTf.fm ~ ~ '* ~ ~RBC'{iCfi~~S31T I<:9.~~~1 m/"f@(~~~ ...............)'1. ~~;f'j[~~~ct~~~ m/"f@<1'. 3f!lan ~ ~ ~/~ ~ ct ~ ~ 'CfiT ~ m/"f@~. ~ ct ~;f'j[ ~/~ ct ~ ct ~ ~ ct ~ ~ ~ I m/"f@'q.~~~ m/"f@'tP. ~ ~RBffilll ~ ~ m/"f@VI. ~ fcrgi'1' • m/;ffil'

~. ~1. 'l1miT'ClC!>/~ (~ ~ ~)2. ~ ~ eCM1~lll'1-23. ~ Qql"'l'llqli'11(~)-2 md ~ ~31R1ft (~RBct\IC'1llcnTf.fm T1:~cnTf.fm ~) ~, vIT ~ ~ 1:R ~ m I4. (~ Cfi4i:II~~Gj-2

t ~ ~ ct ~ ~ cBT ~an (~ 400 Cf1T ~) m/;ffil'\'l. ~

1.~m,*~~ m/;ffil'2. ~(cIT'1CI>i'1fait '* qftl~Cfiqol ~ i3Qll~f7Ii'111WIt m '* ~ ~ m/"f@3.~~'i'1'mmct~~ m/;ffil'

\3i. ~:1. ~ c:fq "1<'< "llllor>""17I~-1 m/;ffil'2. ~ ~ ct ~ ~ "llllor>l't'I7I~-13. ~ ~ (crt 2)-14. ~I ~t:>I"~ (~-~ <IT "II"'C~'I~'~)5. ~ ~/~-1 ct ~ ct ~ I'fI'Q'l1R ~ ct ~ ~

~. ' ~>llllll~IIC'11

1. 1013l$ft, "~Cllilc~,;ft 3fR ~ W1ffUT '* ~ ~ I m/;ffil'2. ~ "f@, m 3l11A C!>ID ~ 'C'lT'l1 \'lOT<lT ~ ? cpq<n ~ 'CfiT "fTl1 3fR 11"fficrfUri9'CFRI3. cnTf.fm ~ ff<T '* ~ ~ ~~~q'1~ftC'1i'11'* ~ ~ I m/;ffil'

\[. qftl~Cfiqol 'CfiT ~

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-

I I


3. ~/f.!G;fi/~4.~/tR~5. ~ ~ ct ~~, ~an 31'R~ ~6. iRI ~ ~ qfr 1'l"I R;rn-fr ~3fffift ~ i I

31T. ~~~31'R~1. ~: ~ ~/~ ~ ct ~ ~ ~ 3fR 3ffi~(~~CiR)en. 'lfN mucn/~-1~. di'fif.'t~I,,"H-1'T. ~ i'fi4i1IRqc:2.~~ctm~~~(<iT~)

~. cnf1Wt ct 1'l"I, • 31'R tffi vr'T cn'ff.r<:rr ~/~ (~~ CiR)t f.'t'"'1~ltJd qfr ~ :

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3. ~ >I«1I~I'iUI ~

31' 1. ~ ~/~FcPf<1IC'1q cnr 1'l"I2. 11m :3. ~/f.!G;fi/~4.~/tR-~5. ~·~ct~~: m/~6. i.Rfi'fi ~ ~ ct ~ xftlx~CPd ~ ~ cnr 1'l"I

31T i'fi4i1IRqc:~:1. ~ i'fi4i1IRqc:~ qfr ~ ~ ct ~ ~O (~: ~ m;<l

~FcPrui'fi cnr ~ : ~/~~~&r ct ~ 'ilR 11m)2. ~ ct ~ ~ i'fi4i1IRqc:3. ~~<?il(>1I:R131'R ~ ~ ct ~ ~ -c.qfcffi ~ own 31'R.31'T ct ~ : 2 (~ ct ~ xffi 'R ~ ~ ~~1~~FcP('{,i'fi m-n~)

~ ~ : R(;rc~, ~f.'ti'fiC'l ~ ~~<?il(>1I:R1<iT~~ ~~ 31'Itt ~\3' ~~~i3i ~ xftl~Cfi~ol 31'R 3J'TT"R?[ ~3Rr~

\3q~f{gd ~ '*~ W<f ct ~ ~ i 31'R ~ ~ ~ aRT ~ -wmn qfr ~an -q ~ 3l'J'tIffr ~ i I1000/-~ ('1'C1 ~R1I~i'fixOIct~) 31'R 5000/-~ (~ct~) 'CfiT ~ 9JQ'C/~ ct 't1'1H'# ~ i I

["lJ11 II-~ 3(i)] 3S

~163trr/~ Slt<lI,<~qOI/'fl':~ &R/m ~ ~ 'd; ~ '(~{{lCb'(OI 'Cbl 'SI'lIfOT'C!?l'

(f.mlf 24(2) ~)

~ ~ fc!;-m "VITffi ~ fcI> "!R ~ ~FcI>fHl6111/\RfCfitlcn Cf>T f.Rt~ q)'{ mlfllT ~ 31'R 1'fPICI 3i<T ~ ~.1994(1994 cpr 42) * ~ ~'""1~ftlC'l 3i<T(.rr)/\RfCfi(<m) (~ Cf>T CfOf.1 ~3i<T/\mCPTf:~/~/~ *~ ~F\1i{<;)Cb~OI cpr W'iTOTQ"')I ~ fc!;-m "VITffi ~ :-1.2.3.4.

~ ~F\1i{{jq;Xol Cf>T W'iTOTQ"')I ~ ~ CIfr ~ ~ 'I:!tq ~ CIfr ~ *~ ~ ~I

~ ~ ~ ~ "!R -ij ~ ~ 'Wlm3l't 31'R Cb4't11~'lG * ~ ~ vrr ~ ~ I Cb4't11~'lG 31'R/m 'Wlm -ij~ Cj)ljt ~ffit CIfr ~ -ij ~ ~ ~ I

~~*~a:R" .~ .

~ .~ .

xF\1i{{jCbxOI cpr 1(IHCbxol W'iTOTQ"')I

(~h"!R ~ ~ WI JfGA fc)my ~)[~25(2) ~]

~ 1'fPICI 3i<T~ ~. 1994 (1994 Cf>T 42) * GltfA 3i<T (wn)/i3i'C'ICP(~) cf; ~/~ ~/<l'Cb-ij m cf; ~ xF\1i{{jCbxOI * W'iTOTQ"')I * ~ * ~ (~/i3i'C'ICP <l'Cb Cf>T ~) ~ ~ ~ q-;;r.~ *~-ij~1

~ ~. ~ ~/i3i'C'ICP <l'Cb CIfr 'Wlm3l't 31'R ~ "!R ~ ~ * ~. ~ ~/i3i'C'ICP <l'Cb* "r.{F\1i....,{{j~CbxmrOIW'iTOTQ"')I 'I:!tq ~ CIfr ~ *~ ~ ~ ~I

<:rg ~ ~ ~ ><ffi -ij c:ffri; ~ 'Jfcltn3l't 3fR Cb4't11~~G cf; ~ >rGR fc!;-m vrr '<m ~ I Cb4tn~~G31'R/<n 'Wlm -ij ~ ~ ~ Gl~ffit cf; t1lR -ij ~ ~ ~ I

~ .~ .

~~*~a:R" .1JSIT.....•..•..........

~18

vrgt ~ fc!;-m VIT1T ~ crm ~ CIfr ~ ~ (~ ~ ~ ~ ~ "'f@ ~ ffi ~~ CIfr~~) &RT W'iTOTQ"')I

(~ "!R ~ fc!;-m ~)[~16 &R~23~]

~ fcnm "VITffi ~ fcI> GmT 3fR~. ~ ~ 3fRm~ ~ 3fR ~ ~ 'd; ~ ~ ~ 7]1;[ t.&RT 4il ~ 1'fPICI 3i<T~~. 1994 (1994 Cf>T 42) cf; ~ f.1q;c ~ ~ c:R ~/"f[~ ~


~ ~ ~ ~ ~ ~ (3flT/\1('f(fj' em-n=) ~ ~ ~ ~ ~ 10 '# ~ ~ ~ ~ tR~ q:;) ~ ~ '# ~ ~ &RT 'ffi1J. ~ ~ ~ ~ ~ ~ (~ ~Rnct!flq ~ ~ m~~\ilR~~~~~~m~~~~fcnm11mm I

-::rfl1 .~ .~ .f'i«!TI 1lfu em-::rfl1 ..

-::rfl1 .~ .~ ..f'i«!TI 1lfu em-::rfl1 .

1:1'ffi . 1:1'ffi .

~ xftr. X:f .. ~xftr. X:f ..

~~~~em~ .

D D(~~~ $t m~aITtf~ ~~~ ~ ~ ~ m~~ ~~),

~~ ~ $t ~ ~ ~ 31:f!Rm~~~ CfiRUT~ ~ $t ~>RR $t ~~~>WlCIlCfm~~~~~~~~~~tR~~m~~~ I

f.'I'""1R:iftll1 ~ ................................................................. ~~~\ilR'\1CI>~~~'l'fif~ I

f.'I'""1R:if(911 ~ .......................................................... ~~>RR~$t'l'fif~ I

('~,G~)~~m11'if.'l~~Ic;'i

(~)~ _".fI""'cllf.'lF">'~~~I=Cfjm11'if.'l~~Id1-::rfl1~'I:I'G1'll'f

~~~ .

JR;tJ 191lfu zn ~ ~ ~ ~ f.rcI;c ~ ~ ~ ~ ~ '# [f.n:r:l 2(Tf) '# <mr~] (1lfu m ~ ~ $t Gm '# ~

6 'ffi1J. m-rn)(~ 5(3) (Tf) ~)

("ar>! ~ ~ ~ ~ ~~)

['IWT II-~ 3(i)] 37

~ fcnm \iITffi ~ fcp ~ 31'R.>Il"Q'"CP, ~ ~ 3fR m 'i3"'fCf; ~ 3fR ~ ~ cf; ~ ~ ~ ~ -g,&RT q;) ~ lfT'lCl' 3M 1'IC'<II~qol~, 1994 (1994 cnl 42) cf; 3!'ifA vfl'fcre ~ vfr >Il"Q'"CP cnl f.rc!;c: ~ ~~ (3M/'i3CfCl'7cnl "fIl'I) cf; ~ cf; ~ >rffi 11 ~ ~ cf; ~ ~ 1R~ q;) ~ ~~ ~&11'1 ~ &RT ~ 31'R>Il"Q'"CP (<1ft ~f(lk{:flll ~ ~ m~ ~ 'VIl'l cf; ~ ~ ~) cf; ~ m~ cf; ~~ fcnm 1'flI1 m I

"fIl'I .

~ .~ .fi«n/ 'Y'ft1 cnl "fIl'I .

"fIl'I .

~ .~ .fi«n/ 'Y'ft1 cnl "fIl'I ..

1:fffi .. 1:fffi .

~~.~ . ~~.~ .

(:I'I'T1icP31'R~~m~~~~31'R~cf;~m~~~~)

~ cf; ~ ~ ~ ~ cf; ~ ~ f.rc!;c: ~ ~ cf; 'CI>RUT GA ~ ~ ~ >[ey1' ~ ~ ~ 3fR:I'I'T1icP~~cf;~~~~~~3fR~1R~c:<TTCl''lIT~~~ I

f.i"'1f&ftl('1 ~ ......................................................................... cf;~~'VIT"IdCfi~-mn~~~ I

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3R'DT <$.11U\SI'.~ ~MINISTRY OF HEALTH AND FAMILY WELFARE

NOTIFICATIONNew Delhi, the 27th March, 2014.

G.S.R. 218 (E).- In exercise of the powers conferred by section 24 of the Transplantation of Human OrgansAct, 1994 (42 of 1994) and in supersession of the Transplantation of Human Organs Rules, 1995, except as respectsthings done or omitted to be done before such supersession, the Central Government hereby makes the following rules,namely:-I.Short title and commencement - (1) These rules may be called the Transplantation of Human Organs and TissuesRules, 2014.(2) They shall come into force on the date of their publication in the Official Gazette.2. Definitions: - In these rules unless the context otherwise requires,-

(a) "Act" means the Transplantation of Human Organs Act, 1994;(b) "cadaver(s)", "organ(s)" and "tissue(s)" means human cadaver(s), human organ(s) and human tissue(s),

respectively;


(c) "competent authority" means the Head of the institution or hospital carrying out transplantation orcommittee constituted by the head of the institution or hospital for the purpose;

(d) "Form" means a Form annexed to these rules;(e) National Accreditation Board for Testing and Calibration Laboratories (NABL) means the autonomous

body established under the aegis of Department of Science and Technology, Government of India withthe objective to provide Government, Regulators and Industry with a scheme of laboratoryaccreditation through third-party assessment for formally recognising the technical competence oflaboratories and the accreditation services are provided for testing and calibration of medicallaboratories in accordance with International Organisation for Standardisation (ISO) Standards;

(f) "the technician who can enucleate cornea" means the technician with any of the followingqualifications and experience who can harvest corneas (enucleate eyeballs or excise corneas), namely:(i) Ophthalmologists possessing a Doctor of Medicine (M.D) or Master of Surgery (M.S) in

Ophthalmology or Diploma in Ophthalmology (D.O.); and(ii) registered Doctors from all recognised systems of medicine, Nurses, Paramedical Ophthalmic

Assistant, Ophthalmic Assistant, Optometrists, Refractionists, Paramedical Worker or MedicalTechnician with recognised qualification from all recognised systems of medicine, provided theperson is duly trained to enucleate a donated cornea or eye from registered, authorised andfunctional eye Bank or Government medical college and, the training certificate should mentionthat he has acquired the required skills to independently conduct enucleation of the eye or removalof cornea from a cadaver;

(g) words and expressions used and not defined in these rules, but defined in the Act, shall have the samemeanings, respectively, assigned to them in the Act.

3. Authority for removal of human organs or tissues.-Subject to the provisions of Section 3 of the Act, aliving person may authorise the removal of any organ or tissue of his or her body during his or her lifetime asper prevalent medical practices, for therapeutic purposes in the manner and on such conditions as specified inForm 1,2 and 3.

4. Panel of experts for brain-stem death certification.-For the purpose of certifying the brain-stem death, theAppropriate Authority shall maintain a panel of experts. in accordance with the provisions of the Act, to ensureefficient functioning of the Board of Medical Experts and it remains fully operational.

S. Duties of the registered medical practitioner.- (1) The registered medical practitioner of the hospital havingIntensive Care Unit facility, in consultation with transplant coordinator, if available, shall ascertain, aftercertification of brain stem death of the person in Intensive Care Unit, from his or her adult near relative or, ifnear relative is not available, then, any other person related by blood or marriage, and in case of unclaimedbody, from the person in lawful possession of the body the following, namely:-

(a) whether the person had, in the presence of two or more witnesses (at least one of who is a near relativeof such person), unequivocally authorised before his or her death as specified in Form 7 or in documentslike driving license, etc. wherein the provision for donation may be incorporated after notification ofthese rules, the removal of his or her organ(s) or tissue(s) including eye, after his or her death, fortherapeutic purposes and there is no reason to believe that the person had subsequently revoked theaforesaid authorisation;

(b) where the said authorisation was not made by the person to donate his or her organ(s) or tissue(s) after hisor her death, then the registered medical practitioner in consultation with the transplant coordinator, ifavailable, shall make the near relative or person in lawful possession of the body, aware of the option toauthorise or decline the donation of such human organs or tissues or both (which can be used fortherapeutic purposes) including eye or cornea of the deceased person and a declaration or authorisation tothis effect shall be ascertained from the near relative or person in lawful possession of the body as perForm 8 to record the status of consent, and in case of an unclaimed body, authorisation shall be made inForm 9 by the authorised official as per sub-section (I) of section 5 of the Act;

(c) after the near relative or person in lawful possession of the body authorises removal and gives consent fordonation of human organ(s) or tissue(s) of the deceased person, the registered medical practitionerthrough the transplant coordinator shall inform the authorised registered Human Organ Retrieval Centrethrough authorised coordinating organisation by available documentable mode of communication, forremoval, storage or transportation of organ(s) or tissue(s).

(2) The above mentioned duties shall also apply to the registered medical practitioner working in an IntensiveCare Unit in a hospital not registered under this Act, from the date of notification of these rules.(3) The registered medical practitioner shall, before removing any human organ or tissue from a living donor,shall satisfy himself -(a) that the donor has been explained of all possible side effects, hazards and complications and that the donor

has given his or her authorisation in appropriate Form I for near relative donor or Form 2 for spousaldonor or Form 3 for donor other than near relative;

['qflJ IJ-~ 3(i)] 41

(b) that the physical and mental evaluation of the donor has been done, he or she is in proper state of healthand it has been certified that he or she is not mentally challenged and that he or she is fit to donate theorgan or tissue:Provided that in case of doubt regarding mentally challenged status of the donor the registered medicalpractitioner may get the donor examined by a psychiatrist and the registered medical practitioner shall signthe certificate as prescribed in Form 4 for this purpose;

(c) that the donor is a near relative of the recipient, as certified in Form 5, and that he or she has submittedan application in Form 11 jointly with the recipient and that the proposed donation has been approved bythe competent authority as defined at rule 2(c) and specified in Form 19 and that the necessary documentsas prescribed and medical tests, as required, to determine the factum of near relationship, have beenexamined to the satisfaction of the registered medical practitioner and the competent authority;

(d) that in case the recipient is spouse of the donor, the donor has given a statement to the effect that they areso related by signing a certificate in Form 2 and has submitted an application in Form 11 jointly with therecipient and that the proposed donation has been approved by the competent authority under theprovisions of sub-rule (2) of rule 7;

(e) that in case of a donor who is other than a near relative and has signed Form 3 and submitted an applicationin Form II jointly with the recipient, the permission from the Authorisation Committee for the saiddonation has been obtained;

(f) that if a donor or recipient is a foreign national, the approval of the Authorisation Committee for the saiddonation has been obtained;

(g) living organ or tissue donation by minors shall not be permitted except on exceptional medical grounds tobe recorded in detail with full justification and with prior approval of the Appropriate Authority and theState Government concerned.

(4) A registered medical practitioner, before removing any organ or tissue from the body of a person after his or herdeath (deceased donor), in consultation with transplant coordinator, shall satisfy himself the following, namely:-(a) that caution has been taken to make inquiry, from near relative or person in lawful possession of the body of a

person admitted in Intensive Care Unit, only after certification of Brain Stem death of the person that thedonor had, in the presence of two or more witnesses (at least one of whom is a near relative of suchperson),unequivocally authorised before his or her death as specified in Form 7 or in documents like drivinglicense etc. (wherein the provision for donation may be incorporated after notification of these rules), theremoval of his or her organ(s) or tissue(s) after his or her death, for therapeutic purposes and it has beenascertained that the donor has not subsequently revoked the aforesaid authorisation, and the consent of nearrelative or person in lawful possession of the body shall also be required notwithstanding the authorisationbeen made by deceased donor:Provided that if the deceased person who had earlier given authorisation but had revoked it subsequently andif the person had given in writing that his organ should not be removed after his death, then, no organ or tissuewill be removed even if consent is given by the near relative or person in lawful possession of the body;

(b) that the near relative of the deceased person or the person lawfully in possession of the body of the deceaseddonor has signed the declaration as specified in Form 8.

(c) that in the case of brain-stem death of the potential donor, a certificate as specified in Form 10 has beensigned by all the members of the Board of Medical Experts referred to in sub-section (6) of section 3 of theAct:Provided that where a neurologist or a neurosurgeon is not available, an anesthetist or intensivist who is notpart of the transplant team nominated by the head of the hospital duly empanelled by Appropriate Authoritymay certify the brain stem death as a member of the said Board;

(d) that in the case of brain-stem death of a person of less than eighteen years of age, a certificate specified inForm 10 has been signed by all the members of the Board of Medical Experts referred to in sub-section (6) ofsection 3 of the Act and an authority as specified in Form 8 has been signed by either of the parents of suchperson or any near relative authorised by the parent.

6. Procedure for donation of organ or tissue in medicolegal cases.- (I) After the authority for removal of organs ortissues, as also the consent to donate organs from a brain-stem dead donor are obtained, the registered medicalpractitioner of the hospital shall make a request to the Station House Officer or Superintendent of Police or DeputyInspector General of the area either directly or through the police post located in the hospital to facilitate timelyretrieval of organs or tissue from the donor and a copy of such a request should also be sent to the designated postmortem doctor of area simultaneously.

(2) It shall be ensured that, by retrieving organs, the determination of the cause of death is not jeopardised.(3)The medical report in respect of the organs or tissues being retrieved shall be prepared at the time of retrieval by

retrieving doctor (s) and shall be taken on record in postmortem notes by the registered medical practitionerdoing postmortem.


(4) Wherever it is possible, attempt should be made to request the designated postmortem registered medicalpractitioner, even beyond office timing, to be present at the time of organ or tissue retrieval.

(5) In case a private retrieval hospital is not doing post mortem, they shall arrange transportation of body alongwith medical records, after organ or tissue retrieval, to the designated postmortem centre and the post mortemcentre shall undertake the postmortem of such cases on priority, even beyond office timing, so that the body ishanded over to the relatives with least inconvenience.

7 Authorisation Committee.-(l) The medical practitioner who will be part of the organ transplantation team forcarrying out transplantation operation shall not be a member of the Authorisation Committee constituted under theprovisions of clauses (a) and (b) of sub-section(4) of section 9 of the Act.(2) When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or

otherwise, the Authorisation Committee shall consider all such requests and the transplantation shall not bepermitted if the recipient is a foreign national and donor is an Indian national unless they are near relatives.

(3) When the proposed donor and the recipient are not near relatives, the Authorisation Committee shall,-(i) evaluate that there is no commercial transaction between the recipient and the donor and that no

payment has been made to the donor or promised to be made to the donor or any other person;(ii) prepare an explanation of the link between them and the circumstances which led to the offer being

made;(iii) examine the reasons why the donor wishes to donate;(iv) examine the documentary evidence of the link, e.g. proof that they have lived together, etc.;(v) examine old photographs showing the donor and the recipient together;(vi) evaluate that there is no middleman or tout involved;(vii) evaluate that financial status of the donor and the recipient by asking them to give appropriate evidence

of their vocation and income for the previous three financial years and any gross disparity between thestatus of the two must be evaluated in the backdrop of the objective of preventing commercial dealing;

(viii) ensure that the donor is not a drug addict;(ix) ensure that the near relative or if near relative is not available, any adult person related to donor by

blood or marriage of the proposed unrelated donor is interviewed regarding awareness about his or herintention to donate an organ or tissue, the authenticity of the link between the donor and the recipient,and the reasons for donation, and any strong views or disagreement or objection of such kin shall alsobe recorded and taken note of.

(4) Cases of swap donation referred to under subsection (3A) of section 9 of the Act shall be approved byAuthorisation Committee of hospital or district or State in which transplantation is proposed to be done and thedonation of organs shall be permissible only from near relatives of the swap recipients.

(5) When the recipient is in a critical condition in need of life saving organ transplantation within a week, thedonor or recipient may approach hospital in-charge to expedite evaluation by the Authorisation Committee.

8. Removal and preservation of organs or tissues.-The removal of the organ(s) or tissue(s) shall be permissiblein any registered retrieval or transplant hospital or centre and preservation of such removed organ(s) or tissue(s)shall be ensured in registered retrieval or transplant centre or tissue bank according to current and acceptedscientific methods in order to ensure viability for the purpose of transplantation.

9. Cost for maintenance of cadaver or retrieval or transportation or preservation of organs or tissues.- Thecost for maintenance of the cadaver (brain-stem dead declared person), retrieval of organs or tissues, theirtransportation and preservation, shall not be borne by the donor family and may be borne by the recipient orinstitution or Government or non-Government organisation or society as decided by the respective StateGovernment or Union territory Administration.

10. Application for living donor transplantation.- (I) The donor and the recipient shall make jointly anapplication to grant approval for removal and transplantation of a human organ, to the competent authority orAuthorisation Committee as specified in Form I I and the papers for approval of transplantation would beprocessed by the registered medical practitioner and administrative division of the Institution for transplantation.(2) The competent authority or Authorisation Committee shall take a decision on such application in accordancewith the rule 18.(3) If some State wants to merge Form II with Form I, Form 2 or Form 3, they may do so, provided the contentof the recommended Forms are covered in the merged Form and the same is approved by the State Governmentconcerned.

11. Composition of Authorisation Committees.-(I) There shall be one State level Authorisation Committee.(2) Additional Authorisation Committees in the districts or Institutions or hospitals may be set up as per norms

given below, which may be revised from time to time by the concerned State Government or Unionterritory Administration by notification.

(3) No member from transplant team of the institution should be a member of the respective AuthorisationCommittee.

['I1fIT II-~ 3(i)] 43

(4) Authorisation Committee should be hospital based if the number of transplants is twenty five or more in ayear at the respective transplantation centres, and if the number of organ transplants in an institution orhospital are less than twenty-five in a year, then the State or District level Authorisation Committee wouldgrant approval(s).

12. Composition of hospital based Authorisation Committees.- The hospital based Authorisation Committee shall,as notified by the State Government in case of State and by the Union territory Administration in case of Unionterritory, consist of,-(a) the Medical Director or Medical Superintendent or Head of the institution or hospital or a senior

medical person officiating as Head - Chairperson;(b) two senior medical practitioners from the same hospital who are not part of the transplant team -

Member;(c) two persons (preferably one woman) of high integrity, social standing and credibility, who have served

in high ranking Government positions, such as in higher judiciary, senior cadre of police service orwho have served as a reader or professor in University Grants Commission approved University or areself-employed professionals of repute such as lawyers, chartered accountants, doctors of IndianMedical Association, reputed non-Government organisation or renowned social worker - Member;

(d) Secretary (Health) or nominee and Director Health Services or nominee from State Government orUnion territory Administration - Member.

13. Composition of State or District Level Authorisation Committees.- The State or District LevelAuthorisation Committee shall, as notified by the State Government in case of State and by the Union territoryAdministration in case of Union territory, consist of,-(a) a Medical Practitioner officiating as Chief Medical Officer or any other equivalent post in the main or

major Government hospital of the District - Chairperson;(b) two senior registered medical practitioners to be chosen from the pool of such medical practitioners

who are residing in the concerned District and who are not part of any transplant team- Member;(c) two persons (preferably one woman) of high integrity, social standing and credibility, who have served

in high ranking Government positions, such as in higher judiciary, senior cadre of police service orwho have served as a reader or professor in University Grants Commission approved University or areself-employed professionals of repute such as lawyers, chartered accountants, doctors of IndianMedical Association, reputed non-Government organisation or renowned social worker - Member;

(d) Secretary (Health) or nominee and Director Health Services or nominee from State Government orUnion territory Administration-Member:

Provided that effort shall be made by the State Government concerned to have most of the members' ex-officioso that the need to change the composition of Committee is less frequent.

14. Verification of residential status, etc.-When the living donor is unrelated and if donor or recipient belongs toa State or Union territory, other than the State or Union territory where the transplantation is proposed to beundertaken, verification of residential status by Tehsildar or any other authorised officer for the purpose with acopy marked to the Appropriate Authority of the State or Union territory of domicile of donor or recipient fortheir information shall be required, as per Form 20 and in case of any doubt of organ trafficking, theAppropriate Authority of the State or Union territory of domicile or the Tehsildar or any other authorisedofficer shall inform police department for investigation and action as per the provisions of the Act.

15. Quorum of Authorisation Committee.- The quorum of the Authorisation Committee should be minimumfour and the quorum shall not be complete without the participation of the Chairman, the presence of Secretary(Health) or nominee and Director of Health Services or nominee.

16. Format of approval of Authorisation Committee.- The format of the Authorisation Committee approvalshould be uniform in all the institutions in a State and the format may be notified by the respective StateGovernment as per Form 18.

17. Scrutiny of applications by Authorisation Committee.- (1) Secretariat of the Authorisation Committee shallcirculate copies of all applications received from the proposed donors and recipients to all members of theCommittee along with all annexures, which may have been filed along with the applications.

(2) At the time of the meeting, the Authorisation Committee should take note of all relevant contents and documentsin the course of its decision making process and in the event any document or information is found to beinadequate or doubtful, explanation should be sought from the applicant and if it is considered necessary thatany fact or information requires to be verified in order to confirm its veracity or correctness, the same beascertained through the concerned officer(s) of the State Government or Union territory Administration.

18. Procedure in case of near relatives.- (1) Where the proposed transplant of organs is between near relativesrelated genetically, namely, grandmother, grandfather, mother, father, brother, sister, son, daughter, grandsonand granddaughter, above the age of eighteen years, the competent authority as defined at rule 2(c) orAuthorisation Committee (in case donor or recipient is a foreigner) shall evaluate;(i) documentary evidence of relationship e.g. relevant birth certificates, marriage certificate, other

relationship certificate from Tehsildar or Sub-divisional magistrate or Metropolitan Magistrate or


Sarpanch of the Panchayat, or similar other identity certificates like Electors Photo Identity Card orAADHAAR card; and

(ii) documentary evidence of identity and residence of the proposed donor, ration card or voters identitycard or passport or driving license or PAN card or bank account and family photograph depicting theproposed donor and the proposed recipient along with another near relative, or similar other identitycertificates like AADHAAR Card (issued by Unique Identification Authority of India).

(2) If in the opinion of the competent authority, the relationship is not conclusively established after evaluating theabove evidence, it may in its discretion direct further medical test, namely, Deoxyribonucleic Acid (DNA)Profiling.

(3) The test referred to in sub-rule (2) shall be got done from a laboratory accredited with National AccreditationBoard for Testing and Calibration Laboratories and certificate shall be given in Form 5.

(4) If the documentary evidences and test referred to in sub-rules (I) and (2), respectively do not establish a geneticrelationship between the donor and the recipient, the same procedure be adopted on preferably both or at leastone parent, and if parents are not available, the same procedure be adopted on such relatives of donor andrecipient as are available and are willing to be tested, failing which, genetic relationship between the donor andthe recipient will be deemed to have not been established.

(5) Where the proposed transplant is between a married couple the competent authority or Authorisation Committee(in case donor or recipient is a foreigner) must evaluate the factum and duration of marriage and ensure thatdocuments such as marriage certificate, marriage photograph etc. are kept for records along with the informationon the number and age of children and a family photograph depicting the entire family, birth certificate ofchildren containing the particulars of parents and issue a certificate in Form 6 (for spousal donor).

(6) Any document with regard to the proof of residence or domicile and particulars of parentage should be relatableto the photo identity of the applicant in order to ensure that the documents pertain to the same person, who is theproposed donor and in the event of any inadequate or doubtful information to this effect, the CompetentAuthority or Authorisation Committee as the case may be, may in its discretion seek such other information orevidence as may be expedient and desirable in the peculiar facts of the case.

(7) The medical practitioner who will be part of the organ transplantation team for carrying out transplantationoperation shall not be a competent authority of the transplant hospital.

(8) The competent authority may seek the assistance of the Authorisation Committee in its decision making, ifrequired.

19. Procedure in case of transplant other than near relatives.-Where the proposed transplant is between other than near relatives and all cases where the donor or recipient isforeign national (irrespective of them being near relative or otherwise), the approval will be granted by theAuthorisation Committee of the hospital or if hospital based Authorisation Committee is not constituted, then bythe District or State level Authorisation Committee.

20. Procedure in case of foreigners.-When the proposed donor or the recipient are foreigners;

(a) a senior Embassy official of the country of origin has to certify the relationship between the donor and therecipient as per Form 21 and in case a country does not have an Embassy in India, the certificate ofrelationship, in the same format, shall be issued by the Government of that country;

(b) the Authorisation Committee shall examine the cases of all Indian donors consenting to donate organs to aforeign national (who is a near relative), including a foreign national of Indian origin, with greater cautionand such cases should be considered rarely on case to case basis:Provided that the Indian living donors wanting to donate to a foreigner other than near relative shall not beconsidered.

21. Eligibility of applicant to donate.- In the course, of determining eligibility of the applicant to donate, theapplicant should be personally interviewed by the Authorisation Committee which shall be videographed andminutes of the interview shall be recorded.

22. Precautions in case of woman donor.-In case where the donor is a woman, greater precautions ought to be taken and her identity and independentconsent should be confirmed by a person other than the recipient.

23. Decision of Authorisation Committee.- (1) The Authorisation Committee (which is applicable only for livingorgan or tissue donor)should state in writing its reason for rejecting or approving the application of theproposed living donor in the prescribed Form 18 and all such approvals should be subject to the followingconditions, namely:-(i) the approved proposed donor would be subjected to all such medical tests as required at the relevant

stages to determine his or her biological capacity and compatibility to donate the organ in question;(ii) the physical and mental evaluation of the donor has been done to know whether he or she is in proper

state of health and it has been certified by the registered medical practitioner in Form 4 that he or she isnot mentally challenged and is fit to donate the organ or tissue:

.. ['WI II-~ 3(il] 45

Provided that in case of doubt for mentally challenged status of the donor the registered medicalpractitioner or Authorisation Committee may get the donor examined by psychiatrist;

(iii) all prescribed forms have been and would be filled up by all relevant persons involved in the process oftransplantation;

(iv) all interviews to be video recorded.(2) The Authorisation Committee shall expedite its decision making process and use its discretion judiciously and

pragmatically in all such cases where, the patient requires transplantation on urgent basis.(3) Every authorised transplantation centre must have its own website and the Authorisation Committee is required

to take final decision within twenty four hours of holding the meeting for grant of permission or rejection fortransplant.

(4) The decision of the Authorisation Committee should be displayed on the notice board of the hospital orInstitution immediately and should reflect on the website of the hospital or Institution within twenty four hoursof taking the decision, while keeping the identity of the recipient and donor hidden.

24. Registration of hospital or tissue bank.- (I) An application for registration shall be made to the AppropriateAuthority as specified in Form 12or Form 13or Form 14or Form 15, as applicable and the application shall beaccompanied by fee as specified below, payable to the Appropriate Authority by means of a bank draft, whichmay be revised, if necessary by the Central or State Government, as the case may be:-

0) for Organ or Tissue or Cornea Transplant Centre: Rupees ten thousand;(ii) for Tissue or Eye Bank: Rupees ten thousand;(iii) for Non-Transplant Retrieval Centre: Nil.

(2) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the applicant hascomplied with all the requirements, grant a certificate of registration as specified in Form 16 and it shall be validfor a period of five years from the date of its issue and shall be renewable.

(3) Before a hospital is registered under the provisions of this rule, it shall be mandatory for the hospital to appoint atransplant coordinator.

25. Renewal of registration of hospital or tissue bank.- (1) An application for the renewal of a certificate ofregistration shall be made to the Appropriate Authority at least three months prior to the date of expiry of theoriginal certificate of registration and shall be accompanied by a fee as specified below, payable to theAppropriate Authority by means of a bank draft, which may be revised, if necessary by the Central or StateGovernment, as the case may be,-(i) for Organ or Tissue or Cornea Transplant Centre: Rupees five thousand;(ii) for Tissue or Eye Bank: Rupees five thousand;(iii) for Non-Transplant Retrieval Centre: Nil.

(2) A renewal certificate of registration shall be as specified in Form 17 and shall be valid for a period of five years.(3) If, after an inquiry including inspection of the hospital or tissue bank and scrutiny of its past performance and

after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the applicant, since grantof certificate of registration under sub-rule (2) of rule 24 has not complied with the requirements of the Act andthese rules and the conditions subject to which the certificate of registration has been granted, shall, for reasonsto be recorded in writing, refuse to grant renewal of the certificate of registration.

26. Conditions and standards for grant of certificate of registration for organ or tissue transplantationcentres.- (1) No hospital shall be granted a certificate of registration for organ transplantation unless it fulfillsthe following conditions and standards, namely»

A. General manpower requirement specialised services and facilities:

(a) Twenty-four hours availability of medical and surgical, (senior and junior) staff;(b) twenty-four hours availability of nursing staff (general and specialty trained);(c) twenty-four hours availability of Intensive Care Units with adequate equipment staff and support

system, including specialists in anesthesiology and intensive care;(d) twenty-four hours availability of blood bank (in house or access) , laboratory with multiple discipline

testing facilities including but not limited to Microbiology, Bio-Chemistry, Pathology-Hematology andRadiology departments with trained staff;

(e) twenty-four hours availability of Operation Theater facilities (OT facilities) for planned and emergencyprocedures with adequate staff, support system and equipment:

(f) twenty-four hours availability of communication system, with power backup, including but not limitedto multiple line telephones, public telephone systems, fax, computers and paper photo-imagingmachine;

(g) experts (other than the experts required for the relevant transplantation) of relevant and associatedspecialties including but not limited to and depending upon the requirements, the experts in internalmedicine, diabetology, gastroenterology, nephrology, neurology, pediatrics, gynecology, immunologyand cardiology, etc., shall be available in the transplantation centre;


(h) one medical expert for respective organ or tissue transplant shall be available in the transplantationhospital; and

(i) Human Leukocyte Antigen (HLA) matching facilities (in house or outsourced) shall be available.B. Equipments:

Equipments as per current and expected scientific requirements specific to organ (s) or tissue (s) beingtransplanted and the transplant centre should ensure the availability of the accessories, spare-parts and back-up,maintenance and service support system in relation to all relevant equipments.

C. Experts and their qualifications:(a) Kidney Transplantation:

M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. training in a recognisedtransplant center in India or abroad and having attended to adequate number of renal transplantation asan active member of team;

(b) Transplantation of liver and other abdominal organs:M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. experience in the specialityand having one year training in the respective organ transplantation as an active member of team in anestablished transplant center;

(c) Cardiac, Pulmonary, Cardio-Pulmonary Transplantation:M.Ch. Cardio-thoracic and vascular surgery or equivalent qualification in India or abroad with at leastthree years' experience as an active member of the team performing an adequate number of open heartoperations per year and well-versed with Coronary by-pass surgery and Heart-valve surgery;

(d) the hospital registered under Clinical Establishment (Registration and Regulation) Act, 2010 (23 of 2010) shallalso follow the minimum standards prescribed in respect of manpower, equipment, etc., as prescribed under thatAct;

(e) the hospital registered shall have to maintain documentation and records including reporting of adverse events.(2) No hospital shall be granted a certificate of registration for tissue transplantation under the Act unless it fulfills

the following conditions and standards, namely.-(a) Cornea Transplantation:

M.D. or M.S. or Diploma (DO) in ophthalmology or equivalent qualification with three months post M.D. orM.S or DO training in Corneal transplant operations in a recognised hospital or institution;

(b) Other tissues such as heart valves, skin, bone, etc.:Post graduate degree (MD or MS) or equivalent qualification in the respective specialty with three monthspost M.D. or M.S training in a recognised hospital carrying out respective tissue transplant operations and forheart valve transplantation, and the qualification and experience of expert shall be MCh degree inCardiothoracic and Vascular Surgery (CTVS) or equivalent qualification with three months post MCh trainingin a recognised hospital carrying out heart valve transplantation;

(c) the Hospital registered under Clinical Establishment (Registration and Regulation) Act, 2010(23 of 2010) shallalso follow the minimum standards prescribed in respect of manpower, equipment, etc., as prescribed under thatAct;

(d) the Hospital registered shall have to maintain documentation and records including reporting of adverse events.27. Conditions and standards for grant of certificate of registration for organ retrieval centres.-

(1) The retrieval center shall be registered only for the purpose of retrieval of organ from deceased donors and theorgan retrieval centre shall be a hospital having Intensive Care Unit (ICU) facilities along with manpower,infrastructure and equipment as required to diagnose and maintain the brain-stem dead person and to retrieveand transport organs and tissues including the facility for their temporary storage.

(2) All hospitals registered as transplant centres shall automatically qualify as retrieval centres.(3) The retrieval centre should have linkages with nearby Government hospital designated for post-mortem, for

retrieval in medico-legal cases.(4) Registration of hospital for surgical tissue harvesting from deceased person and for surgical tissue residues, that

are routinely discarded, shall not be required.28. Conditions and standards for grant of certificate of registration for tissue banks.A. Facility and premises:(I) Facilities must conform to the standards and guidelines laid down for the purpose and the States and Union

territories may have separate registration fee and procedure to keep track of their tissue bank activities.(2) The respective State or Union territory Appropriate Authority may constitute an expert committee for advising on

the matter related to tissue specific standards and related issues.(3) The tissue bank must have written guidelines and standard operating procedures for maintenance of its premises and

facilities which include-(a) controlled access;(b) cleaning and maintenance systems;(c) waste disposal;

['IW1 II-~ 3(j)] 47

(d) health and safety of staff;(e) risk assessment protocol; and(0 follow up protocol.

(4) Equipments as per scientific requirements specific to tissue (s) being procured, processed, stored and distributed andthe tissue bank should ensure the availability of the accessories, spare-parts and back-up, maintenance and servicesupport for all equipments.

(5) Air particle count and microbial colony count compliance.shaHbe ensured for safety where necessary.

(6) Storage area shall be designated to avoid contact with chemicals or atmospheric contamination and any knownsource of infection.

(7) Storage facility shall be separate and distinguish tissues, held in quarantine, released and rejected.

B. Donor screening:(8) Complete screening of donor must be conducted including medical or social history and serological evaluation for

medical conditions or disease processes that would contraindicate the donation of tissues and the report of corneasor eyes not found suitable for transplantation and their alternate use shall be certified by a committee of twoOphthalmologists.

C. Laboratory tests:(9) Facility for relevant Laboratory tests for blood and tissue samples shall be available and testing of blood and tissue

samples shall begin at Donor Screening and continue during retrieval and throughout processing.D. Procurement and other procedures:(10) Procurement of tissue must be carried out by registered health care professionals or technicians having necessary

experience or special training.(11) Consent for the procurement shall be obtained.(12) Procurement records shall be maintained.(13) Standard operating procedure for following shall be followed, namely :

(a) procurement or Retrieval and transplantation;(b) processing and sterilisation;(c) packaging, labeling and storage;(d) distribution or allocation;(e) transportation; and(0 reporting of serious adverse reactions.

E. Documentation and Records:(14) A log of tissue received and distributed shall be maintained to enable traceability from the donor to the tissue and the

tissue to the donor and the records shall also indicate the dates and the identities of the staff performing specific stepsin the removal or processing or distribution of the tissues.

F. Data Protection and Confidentiality:(15) A unique donor identification number shall be used for each donor, and access to donor records shall be restricted.G. Quality Management:(16) The Quality Management System shall define quality control procedures that include the following, namely:

(a) environmental monitoring;(b) equipment maintenance and monitoring;(c) in -process controls monitoring;(d) internal audits including reagent and supply monitoring;(e) compliance with reference standards, local regulations, quality manuals or documented standard operating

procedures; and(0 monitoring work environment.

H. Recipient Information:(17) All tissue recipients shall be followed up and prompt and appropriate corrective and preventive actions taken in caseof adverse events.29. Qualification, role, etc., of transplant coordinator.- (1) The transplant coordinator shall be an employee of theregistered hospital having qualification such as:

(a) graduate of any recognised system of medicine; or(b) Nurse; or(c) Bachelor's degree in any subject and preferably Master's degree in Social work or Psychiatry or

Sociology or Social Science or Public Health(2) The concerned organisation or institute shall ensure initial induction training foJIowed by retraining at periodic

interval and the transplant coordinator shall counsel and encourage the family members or near relatives of the

48 THE GAZETTE OF INDIA: EXTRAORDINARY [PARTII-SEC. 3(i»)

deceased person to donate the human organ or tissue including eye or cornea and coordinate the process of donationand transplantation.

(3) The transplant coordinator or counselor in a hospital registered for eye banking shall also have qualificationspecified in sub-rule (I).

30. Advisory committee of the Central or State Government to aid and advise appropriate authority.- (1)The Central Government and the State Government, as the case may be, shall constitute by notification an AdvisoryCommittee under Chairpersonship of administrative expert not below the rank of Secretary to the State Government for aperiod of two years to aid and advise the Appropriate Authority and the two medical experts referred to in cIause(b) ofsub-section(2) of section l3A of the Act shall possess a postgraduate medical degree and at least five years' experiencein the field of organ or tissue transplantation.(2) The terms and conditions for appointment to the Advisory Committee are as under:

(a) the Chairperson and members of the Committee shall be appointed for a period of two years;(b) the Chairperson and members of the Committee shall be entitled to the air fare and other allowances to attend

the meeting of the Committee equivalent to the officer of the level of the Joint Secretary to the Government ofIndia;

(c) the Central Government or State Government or Union territory Administration shall have full powers toreplace or remove the Chairperson and the members in cases of charges of corruption or any other chargesafter giving a reasonable opportunity of being heard;

(d) the Chairperson and members can also resign from the Committee for personal reasons;(e) there shall not be a corruption or criminal case pending against Chairperson and members at the time of

appointment;(f) the Chairperson or any of the members shall cease to function if charges have been framed against him or her

in a corruption or criminal case after having been given a reasonable opportunity of being heard.31. Manner of establishing National or Regional or State Human Organs and Tissues Removal and StorageNetworks and their functions.- (1) There shall be an apex national networking organisation at the centre, as theCentral Government may by notification specify.(2) There shall also be regional and State level networking organisations where large number of transplantation of

organ(s) or tissue (s) are performed as the Central Government may by notification specify.(3) The State units would be linked to hospitals, organ or tissue matching laboratories and tissue banks within their

area and also to regional and national networking organisations.(4) The broad principles of organ allocation and sharing shall be as under,-

(a) The website of the transplantation center shall be linked to State or Regional cum State or Nationalnetworks through an online system for organ procurement, sharing and transplantation.

(b) patient or recipient may get registered through any transplant centre, but only one centre of a State orregion (if there is no centre in the State) and his or her details shall be made available online to thenetworking organisations, who shall allocate the registration number, which shall remain same even ifpatient changes hospital;

(c) the allocation of the organ to be shared, is to be decided by the State networking organization and by theNational networking organization in case of Delhi;

(d) all recipients are to be listed for requests of organs from deceased donors, however priority is to be givenin following order, namely:-(i) those who do not have any suitable living donor among near relatives;(ii) those who have a suitable living donor available among near relatives but the donor has refused in

writing to donate; and(iii) those who have a suitable living donor available and who has also not refused to donate in

writing;(e) sequence of allocation of organs shall be in following order: State list----Regional List-----National List---

Person of Indian Origin ----Foreigner;(f) the online system of networking and framework and formats of national registry as mentioned under rule

32 shall be developed by the apex networking organisation which shall be followed by the StatesGovernments or Union territory Administrations and the allocation criteria may be State specific whichshall be finalised and determined by the State Government, in consultation with the State level networkingorganisation, wherever such organisation exists:Provided that the organ sharing and networking policy of States or locations of hospitals shall not bebinding on the Armed Forces Medical Services (AFMS) and the armed forces shall be free to have theirown policy of organ or tissue allocation and sharing, and the Director General Armed Forces MedicalServices shall have its own networking between the Armed Forces Medical Services hospitals, who shallbe permitted to accept organs when available from hospitals with in their State jurisdiction.

['WI II-~ 3(i)] 49

(5) The networking organisations shall coordinate retrieval, storage, transportation, matching, allocation andtransplantation of organs and tissues and shall develop norms and standard operating procedures for suchactivities and for tissues to the extent possible.

(6) The networking organisations shall coordinate with respective State Government for establishing new transplantand retrieval centres and tissue banks and strengthening of existing ones.

(7) There shall be designated organ and tissue retrieval teams in State or District or institution as per requirement, tobe constituted by the State or Regional networking organisation.

(8) For tissue retrieval, the retrieval teams shall be formed by theState Government or Union territory Administration where ever required.

(9) Networking shall be e-enabled and accessible through dedicated website.(10) Reference or allocation criteria would be developed and updated regularly by networking organisations in

consultation with the Central or State Government, as the case may be.(11) The networking organisation(s) shall undertake Information Education and Communication (IEC) Activities for

promotion of deceased organ and tissue donation.(12) The networking organisation(s) shall maintain and update organ or tissue Donation and Transplant Registry at

respective level.32. Information to be included in National Registry regarding donors and recipients of human organ andtissue.- The national registry shall be based on the following, namely:-Organ Transplant Registry:(I) The Organ Transplant Registry shall include demographic data about the patient, donor, hospitals, recipient and donor

follow up details, transplant waiting list, etc., and the data shall be collected from all retrieval and transplant centers.(2) Data collection frequency, etc., will be as per the norms decided by the Advisory Committee which may preferably be

through a web-based interface or paper submission and the information shall be maintained both specific organ wiseand also in a consolidated format.

(3) The hospital or Institution shall update its website regularly in respect of the total number of the transplantations donein that hospital or institution along with reasonable detail of each transplantation and the same data should beaccessible for compilation, analysis and further use by authorised persons of respective State Governments andCentral Government.

(4) Yearly reports shall be published and also shared with the contributing units and other stakeholders and key events(new patients, deaths and transplants) shall be notified as soon as they occur in the hospital and this information shallbe sent to the respective networking organisation, at least monthly.

Organ Donation Registry:(5) The Organ Donation Registry shall include demographic information on donor (both living and deceased), hospital,

height and weight, occupation, primary cause of death in case of deceased donor, associated medical illnesses,relevant laboratory tests, donor maintenance details, driving license or any other document of pledging donation,donation requested by whom, transplant coordinator, organs or tissue retrieved, outcome of donated organ or tissue,details of recipient, etc.

Tissue Registry:(6) The Tissue Registry shall include demographic information on the tissue donor, site of tissue retrieval or donation,

primary cause of death in case of deceased donor, donor maintenance details -in case of brain stem dead donor,associated medical illnesses, relevant laboratory tests, driving license or any other document pledging donation,donation requested by whom, identity of counsellors, tissue(s) or organ(s) retrieved, demographic data about thetissue recipient, hospital conducting transplantation, transplant waiting list and priority list for critical patients, ifthese exist, indication(s) for transplant, outcome of transplanted tissue, etc.

(7) Yearly reports in respect of National Registry shall be published and also shared with the contributing units and otherstakeholders

Pledge for organ or tissue donation after death:(8) Those persons, who, during their lifetime have pledged to donate their organis) or tissue(s) after their death. shall

in Form 7 deposit it in paper or electronic mode to the respective networking organisationis) or institution wherethe pledge is made, who shall forward the same with the respective networking organisation and the pledger hasthe option to withdraw the pledge through intimation.

(9) The Registry will be accessible on-line through dedicated website and shall be in conformation to globallymaintained registry (ies), besides having national, regional and State level specificities.

(10) National or regional registry shall be compiled based on similar registries at State level.(II) The identity of the people in the database shall not be put in public domain and measures shall be taken to ensure

security of all collected information.(12) The information to be included shall be updated as per prevalent global practices from time to time.33. Appeal.- (1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of section 9or by an order of the Appropriate Authority under sub-section (2) of section 15 or sub-section (2) of section 16 of theAct, may, within thirty days from the date of receipt of the order, prefer an appeal to the Central Government in case ofthe Union territories and respective State Government in case of States.


(2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed against.FORM]

For organ or tissue donation from identified living near related donor(to be completed by him or her)

(See rules 3 and 5(3)(a))

My full name (proposed donor) is ..

Photograph of the Donor(Attested by Notary Publicacross the photo after affixing)

and this is my photograph To be affixed here.

My permanent home address is

..................................................................... Tel: ..

My present address for correspondence is

...................................................................... Tel: .

Date of birth (day/month/year)I enclose copies of the following documents: (attach attested photocopy of at least two of following relevantdocuments to indicate your near relationship):• RationlConsumer Card number and Date of issue and place: .

and/or• Voter's I-Card number, date of issue, Assembly constituency .

and/or• Passport number and country of issue .

and/or• Driving License number, Date of issue, licensing authority .

and/or• Permanent Account Number (PAN) ..

and/or• AADHAAR No ..

and/oridentity and• Any other valid proof of address reflecting near relationship

I authorise removal for therapeutic purposes and consent to donate my .(Name of organltissue) to my relative (Specify sonldaughter/father/mother/ brother/sister/grand-father/grand-mother/grand-sonlgrand-daughter), whose particulars are as follows and name is.. .. . .. .. .. . .. .. . .. . .. . .. ... .. .. . .. .. . .. .. .. .. . .. . .. .. .. . . . .. .. .. . .. .. ... and who was born on.................................... (day/month/year) :

To be affixed here.

Photograph of the Recipient(Attested by Notary Publicacross the photo after affixing)

The copies of following documents of recipient are enclosed (attach attested photocopy of at least two relevantdocuments to indicate your near relationship):• Ration/Consumer Card number and Date of issue and place: .

and/ or

['IWT II-~ 3(i)] 51

• Voter's I-Card number, date of issue, Assembly constituency .and/or

• Passport number and country of issue .and/ or

• Driving License number, Date of issue. licensing authority .and/or

• Permanent Account Number (PAN) .and/or

• AADHAAR No <Issuedby Unique Identification Authority of India).and/or

• Any other valid proof of identity and address reflecting near relationship

I solemnly affirm and declare that:

Sections 2, 9 and 19 of The Transplantation of Human Organs Act, 1994 have been explained to me and I confirm that:

I. I understand the nature of criminal offences referred to in the sections.

2. No payment as referred to in the sections of the Act has been made to me or will be made to me or any other

person.

3. I am giving the consent and authorisation to remove my (name of organ/tissue) of

my own free will without any undue pressure, inducement, influence or allurement.

4. I have been given a full explanation of the nature of the medical procedure involved and the risks involved for

me in the removal of my (name of organ)/tissue). That explanation was given by

.......................................... (name of registered medical practitioner).

5. I understand the nature of that medical procedure and of the risks to me as explained by that practitioner.

6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takesplace.

7. I state that particulars filled by me in the form are true and correct to the best of my knowledge and belief and

nothing material has been concealed by me.

Date Signature of the prospective donor(Full Name)

Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing theaffidavit(s) signs(s) on the Notary Register, as well.

FORM 2For organ or tissue donation by living spousal donor

(To be completed by himlher)(See rules 3, 5(3)(a) and 5(3)(d))

My full name (proposed donor) is ..and this is my photograph

Photograph of the Donor(Attested by Notary Public

across the photo after affixing)

To be affixed here

My permanent home address is


........................................................................... Tel: .

My present address for correspondence is .

................................................................................................ Tel: .

Date of birth (day/month/year)

I authorize removal for therapeutic purposes and consent to donate my (Name of organ) tomy husband/wife.................... whose particulars are as follows and full name is·. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and who was born on.................................... (Day/month/year):

Photograph of the Recipient(Attested by Notary Publicacross the photo after affixing)

To be affixed here

I enclose copies of the following documents (attach attested photocopy of at least two of following relevantdocuments to indicate the spousal relationship):• Ration/Consumer Card number and Date of issue and place: .

and/or• Voter's Identity-Card number, date of issue, Assembly constituency .


and/or• Driving License number, Date of issue, licensing authority .

and/or• Permanent Account Number (PAN)......................................................................................................

• AADHAAR No. (issued byand/or

Uniqu~ Identification Authority of India)

• Any other proof of identityand/orand address establishing spousal relationship

I submit the following as evidence of being married to the recipient-

(a) A certified copy of a marriage certificate

OR

(b) An affidavit of a 'near relative' confirming the status of marriage to be sworn before Class-I MagistratelNotary

Public.

(c) Family photographs

(d) Letter from Head of Gram Panchayat / Tehsildar / Block Development OfficerlMember of Legislative

Assembly/Member of Legislative Council (MLC)lMember of Parliament with seal certifying factum and status

of marriage.

OR

(e) Other credible evidence

I solemnly affirm and declare that sections 2, 9 and 19 of the Transplantation of Human Organs Act, 1994 (42 of 1994),have been explained to me and I confirm that

I. I understand the nature of criminal offences referred to in the sections.

['q!11 II-~ 3(i)] 53

2. No payment of money or money's worth as referred to in the Sections of the Act has been made to me or will be

made to me or any other person.

3. I am giving the authorisation to remove my (organ) and consent to donate the same

,of my own free will without any undue pressure, inducement, influence or allurement.


me in the removal of my.................. ...... ........ (organ). That explanation was given by


5. I understand the nature of that medical procedure and of the risks to me as explained by that practitioner.

6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takes

place.

7. I state that particulars filled by me in the form are true and correct to to the best or my knowledge and nothing

material has been concealed by me.

Signature of the prospective donor Date(Full Name)

Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing theaffidavit(s) signs(s) on the Notary Register, as well

FORM 3For organ or tissue donation by other than near relative living donor

(To be completed by himlher)(See rules B, 5(3)(a) and 5(3)(e))

My full name is .and this is my photograph

Photograph of the Donor(Attested by Notary Publicacross the photo after affixing)

To be affixed here

My permanent home address is............................................................................................. Tel: ..

My present address for correspondence is .

............................................................................................... Tel: .

Date of birth (day/month/year)

I enclose copies of the following documents: (attach attested photocopy of at least two of following relevantdocuments to prove your identity):• Ration/Consumer Card number and Date of issue and place: .

(Photocopy attached)and/or

• Voter's I-Card number, date of issue, Assembly constituency ..(Photocopy attached)



• Driving Licence number, Date of issue, licensing authority .(Photocopy attached)

and/or• PAN .


and/or• AADHAAR No .

and/or• Other proof of identity and address , , , .

Details of last three years income and vocation of donor (enclose documentary evidence)..................................................................................................................................................................................................................................................................

I authorize removal for therapeutic purposes and consent to donate my (Name oforgan/tissue) to a person whose full name is and who was born on.................................... (day/month/year) and whose particulars are as follows:

Photograph of the Recipient(Attested by Notary Public across the To be affixedPhoto after affixing) here

(attach attested photocopy of at least two relevant documents to prove identity ofrecipient)

• Ration/Consumer Card number and Date of issue and place: .(Photocopy attached)

and/or• Voter's I-Card number, date of issue, Assembly constituency .


• Passport number and country of issue .(Photocopy attached)

and/or• Driving Licence number, Date of issue, licensing authority .


• PAN .and/or

• AADHAAR No .and/or

• Other proof of identity and address .I solemnly affirm and declare that sections 2, 9 and 19 of the Transplantation of Human Organs Act, 1994 (42 of 1994),have been explained to me and I confirm that

I. I understand the nature of criminal offences referred to in the Sections.

2. No payment of money or money's worth as referred to in the Sections of the Act has been made to me or will be

made to me or any other person..3. I am giving the consent and authorisation to remove my (name of organ/tissue) of

my own free will without any undue pressure, inducement, influence or allurement.


me in the removal of my (name of organ/tissue). That explanation was given by


5. I understand the nature of that medical procedure and of the risks to me as explained by the practitioner.

6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takes

place.7. I state that particulars filled by me in the form are true and correct to the best of my knowledge and nothing

material has been concealed by me.

Signature of the prospective donor(Full Name)

Date

['qfTJ IJ-~ 3(i)] 55

Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing theaffidavit(s) signs(s) on the Notary Register, as well.

FORM 4

For certification of medical fitness of living donor

(To be given bv the Registered Medical Practitioner)

[See proviso to rule 5(3)(b)]I, Dr. possessing qualification of registered as medical

practitioner at serial no. by the Medical

Council, certify that I have examined Shril Smt.! Km. S/o, Dlo, W/o Shri.................................... aged who has given informed consent for donation of his/her

.................................. (Name of the organ) to Shri/Smt.!Km who is a 'near

relative' of the donor/other than near relative of the donor and has been approved by the competent authority or

Authorisation Committee (as the case may be) and it is certified that the said donor is in proper state of health, not

mentally challenged * and is medically fit to be subjected to the procedure of organ or tissue removal.

Place: .

Date: .Signature of Doctor

Seal

To be affixed(pasted) here To be affixed

(pasted) here

Photograph of the Donor(Attested by doctor)

Photograph of the recipient(Attested by the doctor)

The signatures and seal should partially appear on photograph and document without disfiguring the face in photograph

* In case of doubt for mentally challenged status of the donor, the Registered Medical Practitioner may get the donorexamined by psychiatrist.

FORMSFor certification of genetic relationship of living donor with recipient(To be filled by the head of Pathology Laboratory certifying relationship)

[See rules S(3)(c) and 18(3)]I, Dr.lMr.lMrlMiss. . working as . .. .. at

...... and possessing qualification of certify that Shril Smt.! Km.

...... S/o, Dlo, W/o Shril Smt. .

aged the donor and Shril Smt. S/o, Dlo, W/o

Shri/Smt.. aged the prospective recipient of the organ to be donated by the said

donor are related to each other as brotherlsister/mother/fatherlsonldaughter, grandmother, grandfather, grandson and

granddaughter as per their statement. The fact of this relationship has been established / not established by the results of

the tests for DNA profiling. The results of the tests are attached.


Signature(To be signed by the Head of the Laboratory)

SealPlace .

Date .

FORM 6For spousal living donor

(to befilled by competent authority * and Authorisation Committee,of the hospital or district ur state in case offureigners)

[See rule 18(2)]

I, Dr.lMr.lMrs/Miss : possessing qualification of .registered as medical practinoner at serial No. .. by the.............................................................. Medical Council, certify that-

Mr S/o aged resident of and Mrs D/o,W/o aged resident of.............................................................. are related to each other as spouse according to the statement givenby them and their statement has been confirmed by means of following evidence before effecting the organ removal fromthe body of the said ShrilSmt/ (Applicable only in the cases where considerednecessary).

OR

In case the Clinical condition of Shri/Smt mentioned above is such that recording ofhis/her statement is not practicable, reliance will be placed on the documentary evidence(s). (mention documentaryevidence(s) here) .

a.Marriage certificate indicate date of marriage

b.Marriage photographs

c.Date when transplantation was advised by the hospital ( to be compared with duration of marriage):

d.Number and age of children and their birth certificates

e.Any other document

Signature of competent authority*IAuthorisation committee in case offoreigners along with Seal/Stamp

Place ..

Date ..*Director or Medical Superintendent or In Charge of the hospital or the internal committee of the hospital formed for thepurpose.as defined under the rules of Transplantation of Human Organ Act, 1994(42 of 1994).

. FORM 7 .For organ or tissue pledging

(To be filled by individual of age 18year or above)[See rule 5(4)(a)]

ORGAN(S) AND TISSUE(S) DONOR FORM(To be filled in triplicate)

Registration Number (To be allotted by Organ Donor Registry) .J. S/o,D/o,W/o aged .

.... and date of birth .................................................... resident of

............................................................ in the presence of persons mentioned below hereby unequivocally

authorise the removal of following organ(s) andlor tissue(s), from my body after being declared brain stem dead by the

board of medical experts and consent to donate the same for therapeutic purposes.

Please tick as applicable(Following tissues can also be donated after

['IWl II-~ 3(i)] 57

brain stem death as well as cardiac death)Heart D Comeas/Eye Balls DLungs D Skin DKidneys D Bones DLiver D Heart Valves DPancreas D Blood Vessels DAny Other Organ (PI. specify) Any other Tissue (PI. specify)All Organs D All Tissues DMy blood group is (ifknown) .

Signature of Pledger. .Address for correspondence .

Telephone No .Email: .

Dated:(Note: In case of online registration of pledge, one copy of the pledge will be retained by pledger, one by the institutionwhere pledge is made and a hard copy signed by pledger and two witnesses shall be sent to the nodal networkingorganisation.)

(Signature of Witness 1)

I.Shri/Smt.lKm S/o,D/o,W 10 .

aged resident of Telephone

No Email: .


2. Shri/Smt.lKm S/o,D/o,W/o .


No Email:............................... is a near relative to the donor as .

Dated .Place .Note: (i) Organ donation is a family decision. Therefore, it is important that you discuss your decision with familymembers and loved ones so that it will be easier for them to follow through with your wishes.(ii) One copy of the pledge form/pledge card to be with respective networking organisation, one copy to be retained byinstitution where the pledge is made and one copy to be handed over to the pledger.(iii) The person making the pledge has the option to withdraw the pledge.

FORM 8_For Declaration cum consent

(To be filled by near relative or lawful possessor of brain-stem dead person)[See rules 5(1)(b), 5(4)(b) and 5(4)(d)]

DECLARATION AND CONSENT FORM .1. S/o,D/o,W/o .

aged resident of in the presence of persons mentioned

below, hereby declare that:

I. I have been informed that my relative (specify relation) .

S/o,D/o,W/o aged has been declared brain-stem dead I

dead.

2. To the best of my knowledge (Strike off whichever is not applicable):


a. He/She. (Name of the deceased) had / had not, authorised before hislher

death, the removal of (Name of organltissuelboth) of hislher body after hislher death for

therapeutic purpose. The documentary proof of such authorisation is enclosed/not available

b. He/She. (Name of the deceased) had not revoked the authority as at No.2 (a)

above ( If applicable) .

c. There are reasons to believe that no near relative of the said deceased person has objection to any of

his/her organs/tissue being used for therapeutic purposes.

3. I have been informed that in the absence of such authorisation, I have the option to either authorise or decline

donation of organltissuelboth including eye/cornea of (Name of the deceased) for

therapeutic purposes. I also understand that if corneas/eyes are not found suitable for therapeutic purpose, then

may be used for education/research.

4. I hereby authorise / do not authorize removal of hislher body organ(s) and/or tissue(s), namely (Any organ and

tissue! Kidney /Liver IHeart ILungs /lntestine IComea ISkin !Bone !Heart Valves IAny other; please specify)

.................................................. for therapeutic purposes. Ialso give permission for drawing of a blood

sample for serology testing and am willing to share sociallbehavioural and medical history to facilitate proper

screening of the donor for safe transplantation of the organs/ tissues.

Date .correspondence* .Place .

Signature of near relative /person in lawful possession of the dead body, and address for

Telephone No Email: .

* in case of the minor the declaration shall be signed by one of the parent of the minor or any near relative authorisedby the parent. In case the near relative or person in lawful possession of the body refuses to sign this form, the sameshall be recorded in writing by the Registered Medical Practitioner on this Form.

(Signature of Witness I)

I.Shri/Smt.lKm S/o,D/o,W/0 ········

aged resident of... ····· Telephone

No Email: .

(Signature of Witness 2)2.ShrilSmt.lKm S/o,D/o,W/0 .


No Email: .

FORM 9For unclaimed body in a hospital or prison

(To be completed by person in lawful possession of the unclaimed body)(see rule 5(J)(b)l

1. , S/o,D/o,W/o .

aged resident of having lawful possession of the dead

body of Shri/Smt.lKm .

S/o,D/o,W/o . aged resident of

............................................................ and having known that no person has come forward to claim the body

of the deceased after 48 hours of death and there being no reason to believe that any person is likely to come to claim the

body hereby, authorise removal of his/her body organ(s) and/or tissue(s),

namely .for therapeutic purposes.

['IJ11 I1-l§1l'S 3( i)] 59

Signature, Name, designation and Stamp of person in lawful possession of the dead body.

Dated Place .

Address for correspondence ..

Telephone No Email ..


l.Shri/Smt.!Km S/o,D/o,W/o .

aged resident ~f Telephone

No Email .


2.Shri/Smt.!Km Slo,Dlo, W10 .

aged resident of Telephone No Email

FORM 10_For certification of brain stem death

(To be filled by the board of medical experts certifying brain-stem death)[See rules 5(4)(c) and 5(4)(d)]

We, the following members of the Board of medical experts after careful personal examination hereby certifythat Shri/Smt.!Km .aged about _sonof Iwife of I daughter of Resident of

is dead on account of permanent and irreversible cessation of all functions of the brain-stem. The tests carried out by usand the findings therein are recorded in the brain-stem death Certificate annexed hereto.Dated.................. Signature .1. R.M.P.- Incharge of the Hospital 2. R.M.P. nominated from the panel of

In which brain-stem death has occurred. Names sent by the hospitals andapproved by the Appropriate Authority.

3. Neurologist/Neuro-Surgeon 4. R.M.P. treating the aforesaid deceased person(where Neurologist/Neurosurgeon is not available, any Surgeon or Physician and Anaesthetist or lntensivist,nominated by Medical Administrator Incharge from the panel of names sent by the hospital and approved by theAppropriate Authority shall be included)

BRAIN-STEM DEATH CERTIFICATEPATIENT DETAILS ..(A)

I. Name of the patient:S.O.ID.O.IW.O.

Mr.!Ms .Mr.lMs .Sex Age .

2. Home Address:

3. Hospital Patient Registration Number (CR No.): ..4. Name and Address of next of kin or person .

responsible for the patient .(if none exists, this must be specified) .

5. Has the patient or next of kin agreedto any donation of organ andlor tissue?Is this a Medico-legal Case?PRE-CONDITIONS:Diagnosis: Did the patient suffer from any illness or accident that led to irreversible brain damage?Specify details .

yes No ..6.(B)I.


Date and time of accident/onset of illness .Date and onset of non-reversible coma .

2. Findings of Board of Medical Experts:First Medical ExaminationSecond Medical Examination

(I) The following reversible causes of coma have been excluded:Intoxication (Alcohol)Depressant DrugsRelaxants (Neuromuscular blocking agents)Primary HypothermiaHypovolaemic shockMetabolic or endocrine disordersTests for absence of brain-stem functions

(2) Coma(3) Cessation of spontaneous breathing(4) Pupillary size(5) Pupillary light reflexes(6) Doll's head eye movements(7) Corneal reflexes (Both sizes)(8) Motor response in any cranial nerve distribution, any responses to stimulation of face, limb or trunk.(9) Gag reflex(10) Cough (Tracheal)(II) Eye movements on caloric testing bilaterally.(12) Apnoea tests as specified.(13) Were any respiratory movements seen?

Date and time of first testing: .Date and time of second testing: ..

This is to certify that the patient has been carefully examined twice after an interval of about sixhours and on the basis of findings recorded above,Mr.lMs is declared brain-stem dead.Date:Signatures of members of Brain Stem Death (BSD) Certifying Board as under:1. Medical Administrator lncharge of the hospital 2. Authorised specialist.3. Neurologist/Neuro-Surgeon 4. Medical Officer treating the Patient.

Note.I. Where Neurologist/Neurosurgeon is not available, then any Surgeon or Physician and Anaesthetist or

Intensivist, nominated by Medical Administrator Incharge of the hospital shall be the member of the board ofmedical experts for brain-stem death certification.

II. The minimum time interval between the first and second testing will be six hours in adults. In case of children 6to 12 years of age, 1 to 5 years of age and infants, the time interval shall increase depending on the opinion ofthe above BSD experts.

III. No.2 and No.3 will be co-opted by the Administrator lncharge of the hospital from the Panel of experts(Nominated by the hospital and approved by the Appropriate Authority).

FORM 11APPLICATION FOR APPROVAL OF TRANSPLANTATION FROM LIVING DONOR

(To be completed by the proposed recipient and the proposed living donor)[See rules 5(3)(d), 5(3)(e) and 10]

To be self attestedacross the affixed

photographwithout disfiguring

face

To be self attestedacross the affixed

photographwithout disfiguring

face

Photograph of the Donor Photograph of the recipient

['WI II-~ 3(i)] 61

Whereas Slo, Dlo, Wlo, Shri/Smt.

aged residing at

have been advised by my

doctor that am suffering from

and may be benefited by transplantation of

................................................ into my body.

And whereas S/o, Dlo, Wlo, Shri/Smt.

aged residing at

.......................................................................... by the following reason(s):-

a) by virtue of being a near relative i.e .

b) by reason of affection/attachment/other special reason as explained below :-

I would therefore like to donate my (name of the organ) to ShrilSmt.

We ; and .(Donor) (Recipient)

hereby apply to competent authority I Authorisation Committee for permission for such transplantation to be carried out.

We solemnly affirm that the above decision has been taken without any undue pressure, inducement, influenceor allurement and that all possible consequences and options of organ transplantation have been explained to us.Instructions for the applicants:-I. Form II must be submitted along with the completed Form I or Form 2 or Form 3 as may be applicable.2. The applicable Form i.e. Form I or Form 2 or Form 3 as the case may be, should be accompanied with all

documents mentioned in the applicable form and all relevant queries set out in the applicable form must beadequately answered.

3. Completed Form 5 must be submitted along with the laboratory report.4. The doctor's advice recommending transplantation must be enclosed with the application.5. In addition to above, in case the proposed transplant is between unrelated persons, appropriate evidence of vocation

and income of the donor as well as the recipient for the last three years must be enclosed with this application. It isclarified that the evidence of income does not necessarily mean the proof of income tax returns, keeping in viewthat the applicant(s) in a given case may not be filing income tax returns.

6. The application shall be accepted for consideration by the competent authority I Authorisation Committee only if itis complete in all respects and any omission of the documents or the information required in the forms mentionedabove, shall render the application incomplete.

7. When the donor is unrelated and the donor and/or recipient belong to a StatelUnion Territory other than theStatelUnion Territory, where the transplant is intended to take place, then the Tehsildar or the officer authorised forthe purpose of the domicile state of the donor or recipient as the case may be, would provide the verificationcertificate of domicile of donorlrecipient as the case may be as per Form 20. The approval for transplantationwould be considered by the authorisation committee of the State/Districtlhospital (as the case may be) where thetransplantation is intended to be done. Such verification Certificate will not be required for near relatives includingcases involving swapping of organs (permissible between near relatives only).

We have read and understood the above instructions.Signature of the Prospective Donor Signature of Prospective RecipientAddress for correspondence: Address for.correspondence:Date: Date:~~: ~~:

FORM 12


APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN OR TISSUETRANSPLANTATION OTHER THAN CORNEA

(To be filled by head of the institution)(See rule 24(1))

ToThe Appropriate Authority for organ transplantation .

(State or Union territory)We hereby apply to be registered as an institution to carry out organ/tissue transplantation.

Name(s) of organ (s) or tissue (s) for which registration is required ..

The required data about the facilities available in the hospital are as follows:-

(A) HOSPITAL:I. Name:2. Location:3. Government/Private:4. Teaching/Non-teaching:5. Approached by:

Road:

Rail:Air:

Yes

YesYes

No

NoNo

6. Total bed strength:7. Name of the disciplines in the hospital:8. Annual budget:9. Patient turn-over/year:(B) SURGICAL FACILITIES:

I. No. of beds:2. No. of permanent staff members with their designation:

3. No. of temporary staff with their designation:

4. No. of operations done per year:5. Trained persons available for transplantation (Please specify

Organ for transplantation):(C) MEDICAL FACILITIES:I. No. of beds:2. No. of permanent staff members with their designation:3. No. of temporary staff members with their designation:

4. Patient turnover per year:5. Trained persons available for transplantation (Please specify

Organ for transplantation):6. No. of potential transplant candidates admitted per year:

(0) ANAESTHESIOLOGY:I. No. of permanent staff members with their designations:2. No. of temporary staff members with their designations:3. Name and No. of operations performed:4. Name and No. of equipments available:5. Total No. of operation theatres in the hospital:6. No. of emergency operation-theatres:7. No. of separate transplant operation theatre:(E) l.C.U'/H.O.U. FACILITIES:I. l.C.U.IH.O.U. facilities: Present Not present ..

2. No. of l.C.U. and H.D.U. beds:3. Trained:

Nurses:

['IWT II-~ 3(i)] 63

Technicians:4. Name of equipment in l.C.U.(F) OTHER SUPPORTIVE FACILITIES:Data about facilities available in the hospital:(Fl) LABORATORY FACILITIES:I. No. of permanent staff with their-designations:2. No. of temporary staff with their designations:3. Names of the investigations carried out in the Department:4. Name and number of equipments available:(F2) IMAGING FACILITIES:I. No. of permanent staff with their-designations:2. No. of temporary staff with their designations:3. Names of the investigations carried out in the Department:4. Name and number of equipments available:(F3) HAEMATOLOGY FACILITIES:l. No. of permanent staff with their-designations:2. No. of temporary staff with their designations:3. Names of the investigations carried out in the Department:4. Name and number of equipments available:(F4) BLOOD BANK FACILITIES ( Inhouse or access): Yes No .(F5) DIALYSIS FACILITIES: Yes No .F 6. Transplant coordinators (Eye Donation Counselors, in case of Cornea Transplantaion):

Yes NoNumber Posted:Number Trained

(F 7) OTHER SUPPORTIVE EXPERT PERSONNEL:l. Nephrologist YeslNo2. Neurologist YeslNo3. Neuro-Surgeon YeslNo4. Urologist YeslNo5. G.l. Surgeon YeslNo6. Paediatrician YeslNo7. Physiotherapist Yes/No8. Social Worker Yes/No9. Immunologists YeslNo10. Cardiologist YeslNoII. Respiratory physician YeslNo12. Others ............................... Yes /NoThe above said information is true to the best of my knowledge and I have no objection to any scrutiny of our facility byauthorised personnel. A Bank Draft/cheque of Rs. 10000/ (for new registration) and Rs. 5000 (for renewal) in favour of___ is enclosed.

Sd/HEAD OF THE INSTITUTION

FORM 13APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGANffISSUE RETRIEVALOTHER THAN EYE/CORNEA RETRIEVAL

(To be filled by head o(the institution)(See rule 24(1))

Note: Retrieval Hospitals may also be identified based on pre-defined criteria and registered as retrieval hospital by theappropriate authority.To

The Appropriate Authority for organ transplantation .(State or Union territory)We hereby apply to be registered as an institution to carry out organ/tissue retrieval.

The required data about the facilities available in the hospital are as follows:-(A) HOSPITAL:I. Name:2. Location:3. GovernmentlPrivate:4. TeachingINon-teaching:


5. Approached by:Road:Rail:Air:

YesYesYes

NoNoNo

6. Total bed strength:7. Name of the disciplines in the hospital:8. Annual budget:9. Patient turn-over/year:(B) SURGICAL FACILITIES:I. No. of beds:2. No. of permanent staff members with their designation:3. No. of temporary staff with their designation:4. No. of operations done per year:5. Trained persons available for retrieval (Please specify

Organ and/or tissue for retrieval):(C) MEDICAL FACILITIES:I. No. of beds:2. No. of permanent staff members with their designation:3. No. of temporary staff members with their designation:4. Patient turnover per year:5. Trained persons available for retrieval (Please specify

Organ and/or tissue for retrieval):6. No.of critical trauma cases admitted per year.7. No.of brain stem death declared per year.(D) ANAESTHESIOLOGY:I. No. of permanent staff members with their designations:2. No. of temporary staff members with their designations:3. Name and No. of operations performed:4. Name and No. of equipments available:5. Total No. of operation theatres in the hospital:6. No. of emergency operation-theatres:7. No. of separate retrieval operation theatre:(E) l.C.U.lH.D.U. FACILITIES:I. l.C.U.lH.D.U. facilities: Present. Not present. .2. No. of l.C.U. and H.D.U. beds:3. Trained:

Nurses:Technicians:

4. Name of equipment in l.C.U.(F) OTHER SUPPORTIVE FACILITIES:Data about facilities available in the hospital:(FI)I.2.3.4.(F2)I.2.3.4.(F3)1.2.3.4.(F4)(F 5 )

LABORATORY FACILITIES:No. of permanent staff with their-designations:No. of temporary staff with their designations:Names of the investigations carried out in the Deptt.:Name and number of equipments available:IMAGING FACILITIES:No. of permanent staff with their-designations:No. of temporary staff with their designations:Names of the investigations carried out in the Deptt.:Name and number of equipments available:HAEMATOLOGY FACILITIES:No. of permanent staff with their-designations:No. of temporary staff with their designations:Names of the investigations carried out in the Deptt.:Name and number of equipments available:BLOOD BANKFAClLITlES: (in house or access)Transplant coordinators:Number Posted:Number Trained

Yes No .Y~ No

['qTlJ II-~ 3m] 65

The above said information is true to the best of my knowledge and I have no objection to any scrutiny of ourfacility by authorised personnel. I hereby give an undertaking that we shall make the facilities of the hospital includingthe retrieval team of the hospital available for retrieval of the organ/tissue as and when needed.


To

FORM 14APPLICA TION FOR REGISTRATION OF TISSUE BANKS OTHER THAN EYE BANKS

(To be tilled by head of the institution)(See rule 24(1 »

The Appropriate Authority for organ transplantation .(State or Union Territory)We hereby apply to be registered as Tissue bank, Name:

Name(s) of tissue (s)(Bone, heart valves, skin, cornea etc) for which Registration is required .The required data about the facilities available in the institution are as follows:-

A. General Information:I.Name

2. Address3. GovernmentlPrivatelNGO4. Teaching /Non- teaching5. Approached by:

Rail: YesRoad: YesAir: Yes

NoNoNo

5.1nformationEducation and Communication ( IEC) for Tissue Donation6.Type of tissue bank: Auto Logons /Allograph/Both

B. DONOR SCREENINGREMOVAL OF TISSUE AND STORAGE:

I.Availability of adequate trained and qualifiedPersonnel for removal Tissue( annex detail).2. Names, qualification and address of the doctors/technician who will be doing removal of

tissue.(annex details)

3.Facilities for removal of Tissues4.Whether register of recipient waiting list available.

Yes/No

YesINo

5. Telephone arrangement available.(Telephone Number. )

6. Availability of ambulance/ vehicle or funds toPay taxi for collecting tissue from outside:

7. Sets of instruments for removal of tissue

YesINo

Yes/No

Yes/No

Yes/NoYesINo

8. Facilities for processing of tissue9. Refrigerator for preservation of tissue

Yes/NoYes/No

10. Special containers for preservation of tissue during transit. Yes/No

I I. Suitable preservation media12. Any other specific requirement as per tissue

Yes/NoYesINo

C.PRESERVATIONS OF TISSUEArrangement of preservation of Tissue Yes/No

D.RECORDS

I. Arrangement for maintaining the records YesINo


2. Arrangement for registration of cases, donorsand follow up of cases.

E.EQUIPMENT:

Yes/No

Instruments specific for the tissueF.LABORATORY FACILITIES(Ifthe information is exhaustive please annex it)

a. Names of the investigations carried outin the department.

b. Facility for testing for:i. Human Immunodeficiency Virus Type I and II

YeslNo

. Yes/No

11. Hepatitis B Virus - HBc and HBs

iii. Hepatitis C Virus - HCV

iv. Syphilis- VDRL

c. If no where do you avail it ? Please mentionname and address of institute.

d. Facility for culture and sensitivity of tissue Yes/No

G.OTHER PERSONNELI.No. of permanent staff member with their designation.2. No. of temporary staff with their designation3. No. of trained persons

ANY OTHER INFORMATION

The above said information is true to the best of my knowledge and I have no objection to any scrutiny of our facility byauthorised personnel. A Bank Daftlcheque of Rs. 10000/ (for new registration) and Rs. 5000 (for renewal) in favour of___ is enclosed.


FORM 15APPLICATION FOR REGISTRATION OF EYE BANK, CORNEAL TRANSPLANTATION CENTRE, EYERETRIEVAL CENTRE UNDER TRANSPLANTATION OF HUMAN ORGANS ACT

[See rule 24(1)]I. EYE BANKING:

A. EYE BANK and institution affiliated Ophthalmic / General HospitalI. Name2. Address3. GovernmentlPrivate!Voluntary4. Teaching /Non- teaching5. IEC for Eve Donation

B. REMOVAL OF EYE BALLS AND STORAGE:1. Availability of adequate trained and qualified personnel for removal of whole globe or YeslNo

corneal(annex detail)

2. Names, qualification and address of the designated staff who will be doing removal of YeslNowhole globe / cornea retrieval.(annex details)

3. Availability of following as per requirement: YeslNo

a. Whether register maintained for tissue request received from surgeon of cornealtransplant centre.

b. Telephone arrangement available. YeslNo(Dedicated Telephone Number................ )

c. Transport facility for collecting Eyeballs from outside: Yes/Nod. Sets of instruments for removal of whole globe / cornea as per requirement Yes/No

["WI II-~ 3(i)] 67

e. Special bottles with stands for preservation of Yes/NoEye balls! cornea during transit.

f. Suitable preservation media Yes/Nog. Biomedical Waste Management. Yes/Noh. Uninterrupted Power supply. Yes/No

C ManpowerI. Incharge / Director (Ophthalmologist) -I2. Eye Bank Technician- 23. Eye Donation Counselors (EDC)-2 per attached HCRP (Hospital Cornea Retrieval

Cornea Programme) Hospital, who will be posted at eye Bank.4. Multi task Staff(MTS) -2

D. Space requirement for eye Banks Yes/No(400sqft minimum)

E. RECORDSI. Arrangement for maintaining the records Yes/ No2. Arrangement for registration of pledges,! donors Yes/

and maintenance of utilization report No3. Computer with internet facility and Printer Yes/ No

F. EQUIPMENT:I. Slit Lamp Biomicroscope-I Yes/No2. Specular Microscope for Eye Bank-I3. Laminar tlow(Class I1)-14. Sterilization facility ( In-house or outsourced)5. Refrigerator with temperature monitoring for preservation of eye balls/Cornea-l

G LABORATORY FACILITIESI. Facility for HIV, Hepatitis Band C testing. Yes/No2. If no where do you avail it? Please mention Name and address of institute.3. Facility for culture and sensitivity of Corneoscleral ring. Yes/No

H RENEWAL OF REGISTRATION:

Period of renewal 5years after last registration.Minimum of 500 corneas to be collected in 5 years.Maintenance of eye bank standards( as per Guidelines)

II. EYE RETRIEVAL CENTRE (ERC):A. RETRIEVAL CENTRE- A Centre affiliated to an Eye Bank

I. Name2. Address3. Government/Pri vateN oluntary4. Teaching /Non- teaching5. Information, Education and Communication Activities for Eye Donation6. Name of Eye Bank to which ERC is affiliated.

B REMOVAL OF EYE BALLS AND STORAGE:I. Manpower: Adequate trained and qualified personnel for removal of eye balls/cornea

(annex detail):a. Incharge / Director) -Ib. Technician -Ic. MTS ( Multi task Staff) -I

2. Transport facility; or outsource) with storage mediumC Names, qualification and address of the personnel who will be doing enucleation/ removal of

cornea.(annex details)

D AVAILABILITY OF FOLLOWING:I. Telephone.

(Number. ............... )2. Ambulance/ vehicle or funds to pay taxi for collecting eyeballs from outside:3. Sets of instruments for removal of Eye Balls/cornea4. Special bottles with stands for preservation of5. Eye balls/ cornea during transit:6. Suitable preservation media7. Waste Disposal (Biomedical waste Management)


8. Space requirement: Designated areaE RECORDS

I. Arrangement for maintaining the recordsF EQUIPMENT:

I. Sterilization facility2. Refrigerator temperature control 24 hrs for preservation of Eye balls/Cornea.(power

back up) - I3. The retrieval centre is affiliated with an Eye bank and Eye Bank is only authorised to

distribute corneas.III. CORNEAL TRANSPLANTATION CENTREA I. Name of the Transplant Centre /hospital:

2. Address:3. Government/PrivatelY01untary:4. Teaching 1N0n- teaching:5. IEC for Eye Donation: Yes/No6. Name of the registered Eye Bank for procuring tissue:

B Staff details:I. No. of permanent staff member with their designation.(Note: Eye Surgeon's Experience: 3 month post MDIMSIDNBIDO)2. No. of temporary staff with their designation3. Trained persons for Keratoplasty and Corneal Transplantation with their names andQualifications: 2 (one Corneal Transplant surgeon should be on the pay roll of the Institute)

C Equipment: Slit lamp, Clinical Specular, Keratoplasty or intraocular instrumentsD OT facilitiesE Safe Storage facilityF Records Registration and follow upG Any other information

The above said information is true to the best of my knowledge and I have no objection to any scrutiny of our facilityby authorised personnel. A Bank draft/cheque of Rs. 10000- for new registration and Rs 5000/ for renewal ofregistration drawn in favour of is enclosed.

Head of the Institute(Name and designation)

FORM 16CERTIFICATE OF REGISTRATION FOR PERFORMING ORGANffISSUE

TRANSPLANT ATIONIRETRIEV AL AND/OR TISSUE BANKING(See rule 24(2))

This is to certify that Hospital!fissue Bank located at.. has beeninspected and certificate of registration is granted for performing the organ/tissue retrieval/transplantationlbanking of thefollowing organ(s)/tissue(s) (mention the names) under the Transplantation of Human Organs Act, 1994 (42 of 1994):-I. .2. . .3. . .4. . .

This certificate of registration is valid for a period of five years from the date of issue.This permission is being given with the current facilities and staff shown in the present application form. Any reductionin the staff and/or facility must be brought to the notice of the undersigned.Place.... Signature of Appropriate Authority .

Seal: .Date .

FORM 17Certificate of Renewal of Registration

(To be given by the appropriated authority on the letter head)[See rule 25(2)]

This is with reference to the application dated...................... from..................... (Name of thehospital/tissue bank) for renewal of certificate of registration for performing organ(s)/tissue(s)retrieval/transplantationlbanking under the Transplantation of Human Organs Act, 1994 (42 of 1994).

After having considered the facilities and standards of the above-said hospital/tissue bank, the AppropriateAuthority hereby renews the certificate of registration of the said hospital/tissue bank for a period of five years.

['lJTT II -ll!1TS 3( i)] 69

This renewal is being given with the current facilities and staff shown in the present application form. Anyreduction in the staff and/or facility must be brought to the notice of the undersigned.Place............... Signature of Appropriate Authority .

Date Seal. .

FORM 18Certificate by the Authorisation Committee of Hospital (If Hospital Authorisation committee is not available then the

Authorisation Committee of the district/State) where the transplantation has to take place(To be issued on the letter head)

{See rules 16and 231

This is to certify that as per application in form-IO for transplantation of (Name ofOrgan/tissue)from living donor, other than near relative/ swap donation cases/ all foreigner under the Transplantationof Human Organs Act, 1994 (42 of 1994) submitted on by the donor and recipient, whose details andphotographs are given below, along with their identifications and verification documents, the case was considered afterthe personal interview of donor and recipient (if medically fit to be interviewed) and their relatives as applicable by theAuthorisation Committee in the meeting held on dated .

Details of Recipient Details of DonorName...................................... Name: .Age........................................ Age .Sex Sex .Father / Husband Name . Father / Husband name .

Adddress: Address:

Hospital Reg. No '" Hospital Reg. No .Relation of donor with Recipient .

Recipient Donor(Photo of recipient and donor must be signed and stamped across the photo after affixing)Permission is granted, as to the best of knowledge of the members of the committee, donation is out of love and affectionand there is nofinancial transaction between recipient and donor and there is no pressure on / coercion of the donor.Permission is withheld pending submission of thefollowing documents .

Permission is not granted for thefollowing reasons .

(Member) (Member) (Member) (Member)Name and Designation Name and Designation Name and Designation Name and Designation(Member) (Member) (Sign of Chairmanwith stamp)Health Secretary DHS or Nominee Name and DesignationOr Nominee Name and DesignationDate and place .

* In case of SWAP transplants, details are to be annexed

FORM 19Certificate by competent authority [as defined·at rule 2(c)] For Indian near relative, other than spouse, cases (In case

of spousal donor, Form 6 will be applicable)[See rule S(3)(c»)

(Format for the decision of Competent Authority)This is to certify that as per application in Form-II for transplantation of (Name of Organ orTissue) from living donor who is a near relative of the recipient under the Transplantation of Human Organs Act,1994(42 of 1994). submitted on by the donor and recipient. whose details and photographs aregiven below, along with their identifications and verifications documents. the case was considered after the personal

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interview of donor and recipient (if medically fit to be interviewed) by the competent authority in the meeting held on

Details of RecipientName .Age .Sex .Father or Husband Name .

Details of DonorName: .Age .Sex .Father or Husband name .

Adddress: Address:

Hospital Reg. No Hospital Reg. No .Relation of donor with Recipient .

Recipient Donor(Photo of recipient and donor must be signed and stamped across the photo after affixing)Permission is granted, as to the best of knowledge of the members of the committee, donation is out of their being nearrelative and there is no financial transaction between recipient and donor and there is no pressure on / coercion of thedonor.Permission is withheld pending submission of following documents .

Permission is not granted for the following reasons .

(Signature and stamp of competent authority)Date and place .

FORM 20Verification certificate in respect of domicile status of recipient or donor

[To be issued by tehsildar or any other authorised officer for the purpose (required only for the donor - other than nearrelative or recipient if they do not belong to the state where transplant hospital identified for operation is located)]

{See rule 141Part I (To be filled by applicant donor or recipient separately in triplicate)In reference to application for verification of domicile status for donation of (Name oforganlTissue) from living donor (other than near relative) or recipient under Transplantation of Human Organ Act, 1994(42 of 1994), submitted on (date} by the applicant donor or recipient, with following details andphotograph, along with his or her identification and domicile status for verificationDetails of Applicant Recipient or DonorName .Age .Sex .Father or Husband Name .

Hospital Reg. No .

Address:

(Recent Photo of Applicant must be signed by him or her across the photo after affixing it)The detail of my donor or recipient are as under and I have enclosed his or her self-signed recent photograph:Name .

\

['lW1 II-~ 3{i)] 71

Age ..Sex .Father or Husband Name .

Address:

Hospital Reg. No .

Signature of ApplicantEnclosure: Self signed copy of the donor or recipient for the applicant (to be enclosed)

Part II (To be filled by the certificate issuing authority):The above request has been examined and it is certified that the domicile status of the applicant donor or recipientmentioned as above has been verified as under:Name Son or Daughter or Wife of .resident of village or ward Tehsil or Taluka District State orUT ..andfound correct or incorrect........................................................................................................., ................................................................................................................................Date Place Authorised SignatoryReference No Name and Designation

Office Stamp2.The authorised signatory will hand over this verification certificate to the applicant or his or her representative

for submission to the Chairperson of the Authorisation Committee of the hospital or district or state (asthe case may be), where transplantation has to take place.

3.The authorised signatory shall keep one copy of the above verification certificate for his records and send a copyto the Secretary, Health and Family Welfare of the State Government (Attention Appropriate authorityfor organ transplant) for information.

4.In case of any suspicion of organ trading, the authorised signatory mentioned above or Appropriate Authorityof the state may inform police for making enquiry and taking necessary action as per theTransplantation of Human Organs Act, 1994 (42 of 1994).

FORM 21

Certificate of relationship between donor and recipient in case of foreigners

(To be issued by the Embassy concerned)

[See rule 20(a)]

The embassy of (Name of Country) in India, is in receipt of an application receivedfrom (Name of Organ donor and recipient) on (Date) recommendedby (Name of Government Department of country of origin) for facilitation of donation of___________ (Name of Organ or Tissue) from living donor (Name ofdonor) to the recipient (Name of recipient) for therapeutic purposes under theTransplantation of Human Organ Act, 1994(42 of 1994).The details of donor and recipient and photographs are as givenbelow.

Details of RecipientName ..Age ..Sex .Father or Husband Name .

Details of DonorName: ..Age ..Sex .Father or Husband name ..

Adddress: Address:


Recipient Donor(Photo of recipient and donor must be signed and stamped across the photo after affixing)I, This is to certify that relationship between donor and Recipient is .2. The authenticity of following enclosed identification and verification documents is certified

a.. ___b. _

'No objection certificate' is granted, as to the best of my knowledge, the donor is donating out of love and affection oraffection and attachment towards the recipient, and there is no financial transaction between recipient and donor andthere is no pressure on or coercion of the donor.

Date:Place:

(Signature of Senior Embassy Official)Name: ..

Designation ..[No S.12011/28/2012-MG/MS]

ARUN K. PANDA, Jt. Secy.

Prir.red by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi- I I0064and Published by the Controller of Publications, Delhi·110054.

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