Pharmacovigilance Tamil

kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G fs;sg;gpzp
kUj;Jtf; fz;fhzpg;G KiwikAk;

rpj;j kUj;JtKk;
Kjy;epiy kUj;Jtf; fz;fhzpg;G ikak;

rpj;j kUj;Jt ika Muha;r;rp epiyak;>
(kj;jpa rpj;j kUj;Jt Muha;r;rpf; FOkk;
MA~; mikr;rfk;> ,e;jpa muR)>
mwpQu; mz;zh muR kUj;Jtkid tshfk;> nrd;id – 600 106.
~ 2021 ~
kj;jpa rpj;j kUj;Jt Muha;r;rpf; FOkk; rpj;j kUj;Jt ika Muha;r;rp epiyak;
kUj;Jtf;fz;fhzpg;G
E}y; Fwpg;G
E}ypd; ngau; kUj;Jtf; fz;fhzpg;G KiwikAk; rpj;j

kUj;JtKk;
gjpg;G Kjy; gjpg;G
gjpg;Ghpik kj;jpa rpj;j kUj;Jt Muha;r;rpf; FOkk;
MA~; mikr;rfk;> ,e;jpa muR
nrd;id 600106.
nkhop jkpo;
nghUs; rpj;j kUj;Jtk; - Pharmacovigilance
tif kpd;D}y;
gf;fk; 111
msT A4
ntspaPL Kjy;epiy kUj;Jtf; fz;fhzpg;G ikak;
mwpQu; mz;zh muR kUj;Jtkid tshfk;>
nrd;id – 600 106.
nghWg;Gj;Jwg;G
“kUj;Jtf; fz;fhzpg;G KiwikAk; rpj;j kUj;JtKk;” vd;Dk; ,e;E}y; cUthf;fj;jpd; Nehf;fkhdJ kUj;Jtf;
fz;fhzpg;G gw;wpa tpopg;Gzh;T Vw;gLj;Jtjw;fhf kl;LNk. kUe;J / kUj;Jtf; fz;fhzpg;G gapd;wtu;fSf;Fk;
Vw;fdNt ,jpy; gapw;rp ngw;wtu;fSf;Fk;> Muha;r;rpahsu;fSf;Fk;> ,J gw;wpa Gupjy; ed;whfNt ,Uf;fyhk;. ,Ue;j
NghjpYk; ,sq;fiy (Under Graduates) & KJfiy (Post Graduates) kUj;Jt khztu;fSf;Fk;> muRj;Jiw rhuhj
rpj;j kUj;Jtu;fSf;Fk;> ghuk;gupa rpj;j kUj;Jtu;fSf;Fk; xU tpopg;Gzu;T Vw;gLj;Jtjw;fhfTk;> mbg;gilg;
GupjYf;fhfTk; cUthf;fg;gl;ljhFk;.
kUj;Jtf; fz;fhzpg;G gw;wpa Mq;fpy E}y;fs;, kw;Wk; tiyj;jsq;fs; mjpfstpy; cs;sd> ,Ue;jhYk; rpj;j
kUj;Jtk; kw;Wk; kUj;Jtf; fz;fhzpg;G gw;wp, jha;nkhopahk; jkpopy; gbg;gJ vspjpy; Gupe;J nfhs;tjw;fhfTk;> Fiwe;j
fhyj;jpy; vspjhf gbf;f KbAk; vd;gjw;fhfTk; Kbe;jtiu nkhopg; ngau;j;Js;Nshk;> rpy ,lq;fspy; mUfpNyNa
Mq;fpy thu;j;ijiaAk;; ,idj;Js;Nshk;. nkhopg;ngau;g;G kw;Wk; VNjDk; jtW ,Ue;jhy; Mq;fpyj;jpYs;s etPd
kUj;Jt fz;fhzpg;G E}y;;fisNah> tiyj;jsq;fisNah ghu;j;J mwpe;Jf; nfhs;sTk;. Jiw rhu;e;j fUj;Jfspy;
jtW ,Ue;jhy; Rl;bf;fhl;l Nfl;Lf;nfhs;sg; gLfpwPu;fs;. kw;witf;F Mrpupau;fs; nghWg;gy;y.
kUj;Jtf;fz;fhzpg;G
Translation & Compilation
kU. gh. fkyhnrse;juk;

jpl;l cjtpahsu;
kU. g. Njd;nkhop kU. Nt. Mu;j;jp kU. r. eluh[d;

Muha;r;rp mYtyu; (rpj;jh) Muha;r;rp mYtyu; (rpj;jh) Muha;r;rp mYtyu; (rpj;jh)
kU. K. fz;zd;
jpl;l xUq;fpizg;ghsu;
tpQ;Qhdp - III, Muha;r;rp mYtyu; (rpj;jh),
kU. g. rj;jpauhN[];tud; Nguhrpupau;. kU. f. fdfts;sp

tpQ;Qhdp - III, ,af;Feu; (nghWg;G) jiyik ,af;Feu;
rpj;j kUj;Jt ika Muha;r;rp epiyak; kj;jpa rpj;j kUj;Jt Muha;r;rp FOkk;
jl;lr ;R kw ;Wk ; njhopy ; El;g cjt p

1. uh. fdfuhR
2. uh. ee ;jpd p
3. nt. gh] ;fh ;
4. g. fhaj ;h p

mwpQu; mz;zh muR kUj;Jtkid tshfk;> nrd;id – 600 106.
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
Kd;Diu
Nehahsu; ghJfhg;Ng Kjd;ikahdJ vd;w Nehf;fj;Jld; ,e;jpa murhy; Pharmacovigilance

Programme of India vd;w mikg;G gy tUlq;fshf nray;gl;L tUfpd;wJ. 2008 Mk; Mz;by; ,Ue;J
ek; ,e;jpa kUj;Jtj;Jiwapy; Pharmacovigilance Programme nray;glj; njhlq;fpaJ.
2018-k; Mz;bw;F gpd; Central Sector Scheme for Pharmacovigilance for ASU & H Drugs vd;w
jpl;lj;jpd; fPo; jPtpukhf nray;glj; njhlq;fpaJ. ,jd; %yk; kj;jpa rpj;j kUj;Jt Muha;r;rp FOkj;jpd;
fPo; ehd;F Peripheral Pharmacovigilance Center fs; ,aq;fp tUfpd;wd. Nehahspfspd; ghJfhg;gpw;fhf
,e;j ehd;F epiyaq;fSk; rpwg;ghf gq;fhw;wp tUfpd;wd.
rpj;j kUj;Jt ika Muha;r;rp epiyak; ntspapl;Ls;s ,e;j E}ypy; etPd kUj;Jtf; fz;fhzpg;G
gw;wpAk;> rpj;j kUj;Jtj;jpy; mf;fhyk; njhl;Nl kUj;Jtf; fz;fhzpg;G vd;gJ rpwg;ghf tof;fpy;
filgpbj;jik gw;wpAk; tpupthff; $wg;gl;Ls;sJ. Pharmacovigilance vd;w thu;j;ij etPd kUj;Jtj;jpd;
20Mk; E}w;whz;by; jhd; cUthf;fg;gl;lJ. ,JNghd;w gy thu;j;ijfSf;F ,izahd jkpo;thu;j;ijfs;
,e;E}ypy; ,lk; ngw;wpUg;gJ rpwg;G tha;e;jjhf cs;sJ.
Pharmacovigilance center fs; gw;wpa Fwpg;GfisAk;> rpj;j kUj;Jtu;fs;> khztu;fs;> kUe;J

nra; epiyaq;fs;> kUe;jhSeu;fs;> Nehahsu;fs;> mtu;fSf;F vt;thW kUj;Jtf; fz;fhzpg;ig nray;
Kiw gLj;JtJ vd;gJ gw;wpAk;> NkYk; mjid gw;wpa tpopg;Gzu;T gw;wpAk; ,e;E}y; njspthf
vLj;Jiuf;fpwJ.
,e;E}y; jkpopy; cs;sjhy;> midj;J jug;gpdUk; vspjhfg; gbj;J Gupe;J nfhs;Sk; tifapy;
mike;Js;sJ. NkYk; ,e;E}ypid kpd; E}yhf (Electronic version) ntspaplg;gl cs;sjhy; midtUk;
vspjhf gad;gLj;j ,aYk;.
,e;E}ypid nkhop ngau;j;Jk;> njhFj;Jk; toq;fpa Mrpupau;fSf;Fk; kw;Wk; jl;lr;R

nra;jtu;fSf;Fk; vdJ tho;j;Jfis njuptpj;Jf;nfhs;fpNwd;.
Nguhrpupau;. kU. K. fdfts;sp

jiyik ,af;Feu;>
kj;jpa rpj;j kUj;Jt Muha;r;rp FOkk;>
mUk;ghf;fk;> nrd;id - 600 106.
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
KfTiu
rpj;j kUj;Jt ika Muha;r;rp epiyakhdJ 2017 Mk; Mz;L Kjy; Central Sector Scheme for
Pharmacovigilance of ASU Drugs vd;w jpl;lj;jpd; fPo; – Peripheral Pharmacovigilance Centre Mf nray;gl;Lf;
nfhz;L tUfpwJ. 20Mk; E}w;whz;Lf;Fg; gpd;dh; “Nehahsh; eyd;” vd;w xw;iw Fwpf;NfhSf;fhf
cUthf;fg;gl;lj; JiwNa kUj;Jtf; fz;fhzpg;Gj; JiwahFk;.
etPd kUj;Jtf; fz;fhzpg;G kw;Wk; kUe;Jfspd; gf;ftpisTfisf; fz;fhzpf;Fk; Kiwfs;

gy tUlq;fshfNt ey;y Kiwapy; nray;gl;Lf; nfhz;L ,Uf;fpwJ. mjd; ntw;wpahf> gy kUe;Jfshy;
Vw;gLk; jtwhd tpisTfspy; ,Ue;J kf;fisf; fhj;J tUfpd;wJ. Mdhy; MA~; kUj;Jtj;Jiwf;F
kUj;Jtf; fz;fhzpg;G vd;gJ KOtJkhf eilKiwg; gLj;jg;gl Ntz;Lk;.
etPd kUj;Jtf; fz;fhzpg;G kw;Wk; kUe;Jfspd; gf;ftpisTfisf; fz;fhzpf;Fk; Kiwfs;

gw;wpa gy Gj;jfq;fs;> gy nkhopfspy; cyfk; KOtJk; cs;sJ. Mdhy; MA~; kUj;Jtj;Jiw
rhh;e;j Gj;jfq;fs; rpyNt cs;sJ> mjpYk; Mq;fpyj;jpy; kl;Lk; jhd; cs;sJ. mjid vLj;Jiuf;fNt
kUj;Jtf; fz;fhzpg;G gw;wp jkpopy; ,e;E}iy ,aw;wpAs;Nshk;;.
kUj;Jtf; fz;fhzpg;G gw;wpAk;> mjd; tsh;r;rp tuyhW gw;wpAk;> nray;ghL gw;wpAk; gy;NtW
ehLfspy; eilKiwapy; cs;s kUj;Jtf; fz;fhzpg;G Kiwik gw;wpAk;> nkhopngah;j;Jk; kw;Wk;
jfty;fis; Nrfhpj;Jk;> ,e;E}ypy; gfph;e;J cs;Nshk;. ,J kl;Lk; ,d;wp> rpj;j kUj;Jtj;jpy; cs;s
kUj;Jtf; fz;fhzpg;G gw;wpa jfty;fisAk; vLj;Jiuj;Js;Nshk;. ,J rpj;j kUj;Jtj;Jf;F
GJikahdJ ,y;iyNa jtpu> GJg;gpf;fg; glNtz;ba xd;W jhd;.
,jw;F gy rhd;WfisAk;;> gy fUj;Jf;fisAk;> ,e;E}ypy; njhFj;J $wpAs;Nshk;;. ,jid ek;

jha; nkhopahd jkpo; nkhopapy; nfhLg;gjhy;> kUj;Jt khzth;fSk;> Nehahsh;fSk;> kUe;jhSeh;fSk;
vspjpy; Ghpe;J nfhs;s KbAk;. NkYk; Fiwe;j fhyj;jpy; kUj;Jtj;jpy; Ntfkhf tsh;e;J tUk; kpf
Kf;fpakhdj; Jiwiag; gw;wp KOtJkhf ,e;E}y; %yk; njhpe;J nfhs;s KbAk;.
,e;E}y; ntspapl fhuzkhf ,Ue;j rpj;j kUj;Jt ika Muha;r;rp epiyaj;jpy; cs;s
midtUf;Fk; vdJ tho;j;Jf;fis njhptpj;Jf;nfhs;fpNwd;.
kU. g. rj;jpauhN[];tud;
tpQ;Qhdp - III> ,af;Feu; (nghWg;G)
mUk;ghf;fk;> nrd;id - 600 106.
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
nghUslf;fk;
t.vz; jiyg;G gf;f
vz;
1. kUj;Jtf; fz;fhzpg;G 1
1.1. Kd;Diu 1
1.2. kUe;J 2
2. kUj;Jtf; fz;fhzpg;gpd; tuyhWk; tsu;r;rpAk; 6
2.1. Ke;ija tuyhW 6
2.2. Kf;fpa tuyhW 6
2.3. jhypNlhikl; tuyhW 8
2.4. ,e;jpahtpy;-kUj;Jtf; fz;fhzpg;gpd; tsu;r;rpAk; tuyhWk; 9
2.5. cyf Nehahsu; ghJfhg;G jpdk; 10
3. etPd kUj;Jtf; fz;fhzpg;G (PHARMACOVIGILANCE) 11
3.1. ghjfkhd tpisT (Adverse Drug Reaction) 12
3.2. ghjfkhd epfo;T (Adverse Event) 12
3.3. jPtpu ghjfkhd epfo;T (Serious Adverse Event) 13
3.4. ghjfkhd tpisTfspd; tifg;ghLfs; 14
3.5. ghjfkhd tpisTfis Muha;tjw;fhd msTNfhy;fs; 16
3.6. Signal 21
3.7. kUj;Jtf; fz;fhzpg;G Kiwfs; 21
3.8. kUe;Jfisf; fz;fhzpf;Fk; Kiwapd; Kf;fpaj;Jtk; 22
kUj;Jtj;jpy; kf;fSf;F cs;s ek;gpf;if (Ensuring Public
3.9. 24
confidence)
4. rpj;j kUj;Jtj;jpy; kUj;Jtf; fz;fhzpg;G 27
4.1. fs;sg;gpzp / kUe;jpdhy; tpisAk; NfLfs; 29
rpj;j kUj;Jt Neha;tifg;ghLfSk; kUj;Jtf;
4.2. 30
fz;fhzpg;Gk;
ghjfkhd tpisT tuhky; jLf;f rpj;j kUj;Jtk;
4.3. 31
typAWj;Jk; Kiwikfs;
4.4. %ypiffSk; - kUe;JfSld; mjd; nray;ghLfSk; 35
4.5. eQ;R KwpT kUj;Jtk; 36
4.6. ngUke;Jfspd; eQ;R FwpFzq;fSk; mtw;wpd; kUj;JtKk;; 39
rpj;j kUj;Jt E}y;fspy; ,lk; ngw;Ws;s ghjfkhd
4.7 42
tpisT
4.8 czT - czT ,iltpid tpisTk; kUj;JtKk; 48
kUj;Jtf;fz;fhzpg;G
etPd kUe;Jk; %ypif kUe;Jk; Nrh;e;J vLg;gjhy;

4.9 50
tUk; Neha; FwpFzq;fs;
5 kUj;Jtf; fz;fhzpg;G ikaq;fs; 52
5.1 cg;ryh fz;fhzpj;jy; ikak; 52
,ilepiy kUj;Jtf; fz;fhzpg;G ikak;
5.2 56
Intermediary Pharmacovigilance Centre
5.3 56
Peripheral Pharmacovigilance Centres with Code
5.4 kUj;Jtf; fz;fhzpg;G ikaq;fspd; mbg;gilj; Njitfs; 63
5.5 kUj;Jtf; fz;fhzpg;G ikaq;fspd; nghWg;Gk; nray;ghLk; 64
6 gy;NtW fz;fhzpg;G Kiwfs; 65

6.1 Hemovigilance 65
6.2 Vaccine Vigilance 69
6.3 Materio Vigilance 72
6.4 Cosmeto Vigilance 77
6.5 Therapovigilance 77
Kiwaw;w tpsk;guq;fspd; fz;fhzpg;G
7 79
(Misleading Advertisement Reporting)
8 kUj;Jtf; fz;fhzpg;G topKiwfs; 85
kUj;Jtf; fz;fhzpg;G newpKiwfspd; mtrpak;

8.1 85
(Regulatory Guidelines)
8.2 rpj;j kUj;Jtu;fSf;fhd newpKiwfs; 85
8.3 kUe;J nra; epiyaq;fSf;fhd newpKiwfs; 87
8.4 kUe;jhSeu;fSf;fhd newpKiwfs; 88
8.5 Nehahsu;fSf;fhd newpKiwfs; 88
9 Gfhu; gjpT nra;Ak; topKiw 90
9.1 Mtzg;gLj;Jjypd; Kiwfs; 90
9.2 vjidg; gjpT nra;jy; Ntz;Lk; 90
9.3 Kf;fpakhf Gfhu; mspf;fg;gl Ntz;bait 91
9.4 vq;Nf ahuplk; Gfhu; mspf;f Ntz;Lk; 91
9.5 ADR/ Form 93
10 MA~; kUj;Jtf;fz;fhzpg;gpd; vjpu;fhy gupzhkk; 108
11 KbTiu 111
kUj;Jtf;fz;fhzpg;G
1. kUj;Jtf;fz;fhzpg;G
1.1. Kd;Diu
ve;jnthU kUj;Jtj; JiwAk; jdf;fhd Ra gupNrhjidapid me;je;j
fhyj;jpw;Nfw;g nra;J nfhz;Nl tuNtz;Lk;. mg;NghJ jhd; mjd; tPr;R ehL efuq;fs;
kl;Lkpd;wp fly;jhz;b thdsT gut KbAk;. guTtJ> tpahgpg;gJ kl;Lkpy;yhky;
G+kpg;ge;jpd; kWgf;fj;jpy; trpf;Fk; khDlu;fspd; Jau; Jilf;Fk; tha;g;Gk; ngw KbAk;.
rpj;j kUj;Jtk; jq;F jilapd;wp gy;fpg; ngUfTk;> Gjpa Nkk;gl;l mLf;Ffspy;
gazpj;J ntw;wp ngwTk;> gy;NtW tifahd Mtzg;gLj;Jjy; ,d;wpaikahjJ.
mjpYk; vy;yh jug;G kf;fspilNaAk; Iakw;w Kiwapy; KO ek;gfj;jd;ikiag;
ngw;why; jhd; ek; jkpo; kUj;Jtkhfpa rpj;j kUj;JtKk; cyf kUj;Jtkhf xsp
tPrpg;gpufhrpf;f KbAk;.
etPd kUj;Jtj;jpy; kUe;Jfis fz;fhzpj;jy; vd;w Kiwapy; kUe;jpid

fz;fhzpj;J mjd; nray;ghLfis Mtzk; nra;jdu;. Mdhy; ek; kUj;Jtj;jpy; mf
kUe;;Jfs;; Gw kUe;;Jfs; kw;Wk; Gw kUj;Jt KiwfSk; gpd;gw;w gLtjhy; kUe;Jfs;
fz;fhzpg;G vd;W $Wtijf; fhl;bYk; "kUj;Jtf; fz;fhzpg;G" vd;W $WtJ kpfTk;
nghUj;jkhdjhFk;. mt;thW mf kUj;Jtj;jpdhNyh Gw kUtj;jpdhNyh Vw;gLk;
gf;f tpisTfis Mtzg;gLj;Jtjd; %yNk ek; kUj;Jtj;jpd; flysT Mokhd
mwptpay; El;gj;ij cyNfhu;f;F giwrhw;w KbAk;. ,jpy; ntw;wp ngw;why; kl;LNk ek;
kUj;Jtj;jpd;ghy; ekf;Nf fhjy; tUk;. nghJthf kUe;Jfs; kw;Wk; gf;ftpisTfis
fz;fhzpf;Fk; Kiwik vd;gjpy; midj;J kUj;Jtj; JiwfspYk; vjpupiag; ghu;f;Fk;
kdg;ghd;ik jhd; cs;sJ. mjpYk; rpj;j kUj;Jtj;ijg; nghWj;jkl;by; kUe;JfSf;F
gf;f tpisT cs;sJ vd;w $w;Nw Kw;wpYkhf kWf;fg;gLfpwJ. kUe;Jfs; kw;Wk;
gf;ftpisTfis fz;fhzpf;Fk; Kiwik vd;gJ vd;d?> mjd; topKiw vd;d?> vjw;F
mjidg; gad;gLj;j Ntz;Lk;?> vg;NghJ gjpT nra;a Ntz;Lk;?> Vd; Mtzg;gLj;j
Ntz;Lk;?> vg;gb?> vq;F? vd ,d;dgpw Nfs;tpfSf;F tpil fhz Kw;glhkNy mjid
fz;%bj;jdkhf VNjh rpj;j kUj;Jtj;jpw;;Nf vjpuhdJ vd;w kdg;ghq;F cau;
kUj;Jtk; gapd;w kUj;Jt mwptpayhsu;fSf;Fk; ,Of;ifj;jhd; jUk;. vdNt ,e;j
kdg;ghq;if tpl;L tpl;L vy;NyhUk; njspthd mwpTld; Muha;e;J mwpe;J Vw;Wf;
nfhs;sNtz;Lk;. ,e;j E}ypy; tUk; gyfUj;Jf;fs; Muha;r;rpj;Jiwapy; cs;sth;fSf;Fk;
kUj;Jtf;fz;fhzpg;G gapd;wth;fSf;Fk; ed;F mwpag;gl;l fUj;Jfshf ,Ug;gpDk;
rpj;j kUj;Jt khzth;fSf;Fk; ,jidg; gw;wp mwpahjth;fspd;; mwpTg;grpf;F
,e;E}y; xU vupnghUs; Nghd;W tpsq;Fk;.
kj;jpa rpj;j kUj;Jt Muha;r;rpf; FOkk; 1 rpj;j kUj;Jt ika Muha;r;rp epiyak;
kUj;Jtf;fz;fhzpg;G
1.2 kUe;J
cyf Rfhjhu ikak; 1946 ,y; MNuhf;fpak; vd;gjw;F xU rpwg;ghd
tpsf;fj;ij nfhLj;jJ mJ vd;dntd;why; ve;j xU NehAk; ,y;yhky; ,Ug;gJ
kl;Lky;yhJ cly;> kdk;> kw;Wk; rKf eltbf;if rpwg;ghf ,Ug;gJNt MNuhf;fpak;
vd;gJ jhd; MFk;.
,J Nghd;Nw ekJ jkpo; kUj;Jtj;jpYk; kUe;J vd;gjw;F Mokhd>
fUj;Jr;nrwpT kpf;f kw;Wk; NtW ve;j kUj;Jtj;jpYk; ,y;yhj ekf;Nf cupa
jdpj;jd;ik tha;e;j ghly; jpU%yh; jpUke;jpuk; vd;Dk; E}ypy; kUe;J vDk;
jiyg;gpl;L nfhLf;fg;gl;Ls;sJ.
kWg;gJly; Neha; kUe;njd yhFk;
kWg;g JsNeha; kUe;njdr; rhYk;
kWg;g jpdpNeha; thuh jpUf;f
kWg;gJ rhit kUe;njd yhNk
(-- jpU%yu; jpUke;jpuk; --)
jpU%yu; rpj;jupd; $w;Wg;gb kUe;J vd;gJ cly;> kw;Wk; cs;sj;jpd; Neha;fis
Nghf;FtJ> kl;Lky;yhky; Neha;fis tuhky; jLf;f Ntz;Lk;. mJkl;Lkpd;wp rhitf;$l
tu xl;lhky; jLg;gjhf ,Uf;fNtz;Lk;. my;yJ rhit ntw;wpfukhf js;spg;Nghlf;
$ba Kiwapy; ,Uf;fNtz;Lk;> vd;W $wpAs;shh;. ,e;jg;ghly;> fp.K. 3000 - j;jpw;F
Kd;dhy; jpUke;jpuk; ciuf;Fk; rhd;W.
fp.K. 3000 - j;jpw;F Kd; rpj;j kUj;Jtj;jpy; $wpa kUe;jpd; tpsf;fKk;>

1946 ,y; cyf Rfhjhu ikak; ntspapl;l MNuhf;fpaj;jpd; tpsf;fKk; mNdfkhd
xw;Wikiag; ngw;Ws;sJ. mJ vd;dntd;why; clypy; Neha; Vw;glhky; ,Ug;gJ
kl;Lk; my;yhJ MNuhf;fpa tho;tpw;F top tFf;f $baijNa rpj;ju;fs; kUe;J vd;W
Fwpg;gpl;Ls;sdu;. ,jd; %yk; rpj;j kUj;Jtj;jpd; mlu;e;j mwptpay; mwpit ehk;
czuKbAk;.
mLj;jg;gbahf ts;Stupd; thf;Fg;gb kUe;J vd;gJ vd;d vd;gij fhzyhk;.
cw;wtd; jPu;g;ghd; kUe;Jior; nry;thndd;W
mg;ghy; ehw;$w;Nw kUe;J
Fws;: 950 - mjpfhuk;: kUe;J.
,jpy;
cw;wtd; - NehAw;wtd; (Patient)
jPu;g;ghd; - kUj;Jtu; (Doctor)
kUe;J - jdpkUe;J (m) $l;L kUe;J kw;Wk; mjd;
njhlu;Gilait (Medicine and it Process, Manufacturer)
kUj;Jtf;fz;fhzpg;G
cior;nry;thd; - kUe;jpid nfhLg;gtu; (Pharmacist and Nurses)
cliy fhg;gNj kUe;J. xU KOikahd kUj;Jtk; vd;gJ xU fhuzp kl;Lky;yhJ
Nkw;$wpa ehy;tupd; $l;L Kaw;rpNa MFk;. ,e;ehy;tUk; ve;j gpioAk; nra;ahky;
,Ug;gNj xU ey;y kUe;J vd;W ts;Stu; $wpAs;shu;. ,e;j epiyia fhg;gJ jhd;
xU kUj;Jtupd; jiyahaf; flik MFk;.
gf;f tpisT vd;gJ xU KOik ngw;w G+uzj;Jtk; tha;e;j kUe;J my;yJ
rpfpr;ir Kiw vd;gJ rPtuhrpfspd; Neha;fis Fzkhf;Fk; NghJ kw;w ve;j Njitaw;w
Nkhrkhd tpisTfisAk; Vw;gLj;jhkypUg;gJ vdf;nfhs;syhk;.
"Most people die from the remedy rather than from the illness." ~ Moliere
Nkdhl;L mwpQu; Nkhypau; nrhd;dJ Nghy> ekJ Nehiaj; jPu;g;gjw;F VjhtJ

xU kUj;Jt Kiwf;F Eiotjw;F Kd;G> me;j kUe;ij vjpu; nfhs;Sk; mstpw;;F
Njwpa> jplkhd clYld; ,Ue;jhf Ntz;ba fl;lhaj;jpy; ehk; cs;Nshk;.
Nehahy; ,wf;ff;$ba kf;fis tpl kUj;Jtj;jhy; ,wf;f $ba kf;fNs mjpfk;
vd;W Fwpg;gpLfpwhu;. kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikiag;
nghWj;jtiu “ve;jnthU kUe;Jk; KOf;f KOf;f ghJfhg;gpid midj;J kf;fSf;Fk;>
vy;yh ,lq;fspYk;> vy;yh Neuj;jpYk; toq;Ftjpy;iy. mJNt mjd; ,ay;G. ,d;Dk;
RUq;fr; nrhd;dhy; 100% KOikahd ghJfhg;ig juty;yJ vd;W ve;j xU kUe;Jk;
ve;j xU kUj;Jt KiwapYk; ,y;iy> ,Uf;fTk; KbahJ.
xUtUf;F KOikahd ghJfhg;Gk;> gaDk; juty;y kUe;J> kw;nwhUtUf;F
gyNdh ghJfhg;Ngh ju ,ayhky; Nghfyhk;. xU kUe;J xNu kdpju;f;F xU jlit
KOg;ghJfhg;G je;jJ vd;whYk; $l> mNj kdpju;f;F gpupnjhU Neuj;jpy; mJ
KOg;ghJfhg;gpid juKbahky; ngupa gf;ftpisTfisNah my;yJ rpwpa mstpyhd
cly; cghijfisNah Vw;gLj;jyhk;. Nkw;nrhd;d fhuzq;fshy; jhd; 100% KOg;gyd;
kw;Wk; KOg;ghJfhg;G vd;gJ midj;J kf;fSf;Fk;> midj;J ,lq;fspYk;> vy;yh
Neuq;fspYk; fpilf;Fk; vd;gjpy; cWjpahd cj;juthjk; ,y;iy. mJNt kUe;jpd;
,ay;G.
ek; rpj;j kUj;Jtf; Nfhl;ghl;bd;gb vtndhUtd; vq;F gpwe;J tho;fpwhNdh
mtDf;F me;j ehl;by;> me;j ,lj;jpy; cs;s %ypiffisf; nfhz;Nl kUj;Jtk;
nra;a mJ kpFe;j gyidj;jUk; vd;fpwJ. vdNt xU ,lj;jpy; trpf;Fk; xU Fwpg;gpl;l
kf;fSf;F KOg;gyidAk; ghJfhg;igAk; juty;y xU kUe;J mjw;F Neu; vjpuhd
thoplj;jpy; cs;s my;yJ kw;nwhU ehl;by; trpg;gtu;fSf;F KOghJfhg;igj; ju
,ayhky; Nghfyhk;. Mjyhy; jhd; kUj;Jt Muha;r;rp (Clinical Research) apy; $l
gd;ika kUj;Jt Muha;r;rpapd; %d;whk; epiy (Multicentric Trial Phase III)k; Nru;e;J
kUj;Jtf;fz;fhzpg;G
Nrhjpj;J mwpag;gLfpwJ. mjd;gpd;G $l> re;ijg;gLj;jYf;F gpe;ija fz;fhzpg;G
ehd;fhk; epiy (Post Marketing Surveillance - Phase IV) Yk; ehk; ftdk; nrYj;JfpNwhk;.
Vnddpy; filtPjpf;F te;j gpwFk; $l kf;fspd; ghJfhg;Gf;F jPq;F tpistpg;gjhy;
jpUk;g miof;fg;gLk; gbahd (Call back) kUe;JfSk; xLf;fp jilnra;ag;gl;l (Ban)
gy kUe;JfisAk; ehk; mwpNthk;.

,e;jpah jhd; cyfpd; %d;whtJ tJ ngupa kUj;Jt re;ijahf cs;sJ.
fPNo nfhLf;fg;gl;Ls;s Gs;sptptuq;fs; ,e;jpahtpy; mz;ikapy; elj;jgl;l Ma;T
KbT:
2016 Mk; Mz;L ,e;jpahtpYs;s kUj;Jtkidfspy; nra;j Muha;r;rpapd; gb>
1. 2.85 tpOf;fhL Nehahsu;fs; kUe;jpdhy; Vw;gl;l gf;f tpistpd; fhuzkhfj;jhd;
kUj;Jtkidapy; mDkjpf;fg;gLfpd;wdu;
2. 6.34 tpOf;fhL gf;ftpisT> Nehahsu; kUj;Jt kidapy; mDkjpj;Js;s
NghNj Vw;gLfpwJ.
3. ,e;j Ma;tpd; gb kUe;Jfspd; gf;f tpisthy; Vw;gLk; capupog;G 0.08
tpOf;fhL MFk;.
Ref: Incidence of Adverse Drug Reactions in Indian Hospitals: A Systematic Review of Prospective
Studies (Tejas K Patel: 2016)
2019 Mk; Mz;L ,e;jpahtpYs;s Kjy; epiy kUj;Jtkidfspy; elj;jg;gl;l Ma;tpd;
Kbtpy; Nehahsu;fSf;F Vw;gLk; gpur;ridfspy; 8.36 tpOf;fhL gpur;ridfs; kUe;jpd;
njhlu;ghy; Vw;gl;l rpf;fy;fs; MFk;. ,k;kUe;jhy; Vw;gLk; rpf;fy;fspy; 50 tpOf;fhL
jtpu;f;ff;$baNj MFk;.
NkYk; ,e;j Ma;tpd; gb kUe;jhy; Vw;gLk; gpur;ridfs; tUtjw;fhd Kf;fpa
fhuzq;fshf $WtJ.
1. Nehahsu;fs; jhkhfNt kUe;Jfis cl;nfhs;sy;. (Self Medication)
2. kUj;Jtu;fSf;F Neha;fis gw;wpa njsptpy;yhky; ,Uj;jy;.
(Lack of Knowledge)
3. rpWth;fs; kw;Wk; Kjpath;fis fhl;bYk; eLj;ju taJ Nehahsu;fs;
kUj;Jtupd; mwpTiuia gpd;gw;whky; ,Uj;jy;.
Ref: A Prospective Study on Hospitalization due to Drug-related Problems in a Tertiary Care Hospital
(Venkateswarlu Konuru: 2019).
kUj;Jtf;fz;fhzpg;G
2014 cyf Rfhjhu ikaj;jpd; jfty; gb Mgj;ij Vw;gLj;jf; $ba> gh-
jfkhd tpisT 6.7 tpOf;fhlhfTk;> ghjfkhd tpistpdhy; kUj;Jtkidapy; mD-
kjpf;fg;gLk; Nehahsu;fs; 3.4 tpOf;fhlhfTk; cs;sdu;. ,jpy; 1.8 tpOf;fhL ,wg;G
Vw;gLtjhfTk; vLj;Jiuf;fpwJ.
Nkw;fz;l Gs;sp tpguq;fspy; cs;s gf;ftpisTfs; gjpT nra;ag;gl;lit.
Mdhy; ,e;jpahtpy; gjpT nra;ag;glhkNyNa ,Uf;ff;$ba gf;ftpisTfNs mjpfk;
vd;Wk; gy ty;Ydu;fs; $Wfpd;wdu;. ,itj; jtpu xU $W ,uj;jk; khw;Wtjpdhy;
cz;lhFk; jtwhd tpistpd; rhj;jpaf;$Wfs; 0.7 tpOf;fhL MFk;. rhjhuz tpkhd
gazj;jpy; Vw;gLk; jtwhd tpistpd; rhj;jpaf;$Wfs; 2.4 tpOf;fhL MFk;. mWit
rpfpr;irapd; NghJ jug;gLk; kaf;f kUe;J NfhshWfspdhy; cz;lhFk; jtwhd tpistpd;
rhj;jpaf;$Wfs; 7.5 tpOf;fhL MFk;. ,jid rhjhuzkhf ek;khy; Vw;Wf;nfhs;s
KbAkh? ,e;j Gs;sp tptuq;fs; 1 kpy;ypad; kf;fs; njhifapy; epfof;$ba rhj;jpa
$Wfs; MFk;.
ehk; vjw;fhf kUe;Jfspd; ghJfhg;Gj;jd;ik kw;Wk; gf;ftpisTfs; Fwpj;j

epiyapid Mo;e;J ftdpf;f Ntz;Lk;? Vd; Mtzg;gLj;j Ntz;Lk;? ve;jnthU
mwptpay; mZFKiwAk;> Gjpa fz;Lgpbg;GfSk;> Gjpa jj;Jtq;fSk; kdpjDf;F
Nky; ,y;iy. mjhtJ kdpjdpd; ghJfhg;G my;yJ gpur;rpidaw;w epiy jhd;
Kf;fpakhd xd;whFk;> kdpjdpd; ghJfhg;G vd;w xd;wpd; Nky; ve;j fhuzpAk;> ve;j
tp~aKk; ,y;iy. kUj;Jt Nritahfl;Lk;> kUj;Jt gbg;G vd;gjhfl;Lk;> kUj;Jt
Muha;r;rp vd;gjhfl;Lk; Nehapdhy; ghjpf;fg;gLk; kdpjdpd; ghJfhg;Gk;> epiyj;jd;ikAk;
kl;LNk kpfg; ngupajhFk;. mJNt ePjpAk;> KiwAk; MFk;. ,jidNa `pg;NghfpNul;];
jdJ $w;why; "Primumum non nocere" tpsf;fpAs;shu;. ,jd; tpsf;fk; vd;dntd;why;
Nehahspfspd; Nehia Fzg;gLj;Jtijf; fhl;bYk; mtu;fSf;F ve;j xU jPq;Fk;
Neuhky; ,Ug;gJNt ePjp MFk;.
** Promoting Public Health by promoting safer Drug therapy **
kUj;Jtf;fz;fhzpg;G
2. kUj;Jtf; fz;fhzpg;gpd; tuyhWk; tsu;r;rpAk;:
kUe;jpidf; fz;fhzpf;f Ntz;Lk; vd;W rpy Mz;Lfshf mjpf Kidg;Gf;fhl;b

NgrptUk; ehk; ,J vt;thW Njhd;wpaJ? vt;thW tsu;e;jJ? vd;gij tpupthf fhzyhk;.
2.1 Ke;ija tuyhW
18k; E}w;whz;bw;F Kd;du; Nehahsupd; ghJfhg;G gw;wp gy;NtW fUj;Jfs;

epytpAs;sd mit> ghgpNyhd; ehl;L rl;lj;jpd;gb xU kUj;Jtuhy; capupog;G Vw;gLkhapd;
mtu;fsJ ifJz;bf;fg;gLk; vd mg;Nghija kd;du; `Kuhgp cj;jputpl;Ls;shu;.
(fp.K. 2000 y; – `KuhgpNfhL (Hammurabi code): ‘The Doctor who causes death should
loose his hands’ ,e;j cj;jputpd; %yk; mf;fhyj;jpy; kUj;Jtj;jhy; capupog;Gfs;
epfo;e;jijAk;> mijj; jtpu;f;f muru;fs; Kidg;Gf; fhl;baJk; njupfpwJ.
fp.K. 500 – `pg;NghfpNul;]; (Hippocrates): ‘Primumum non nocere’ `pg;NghfpNul;rpd;
Nkw;$wpa $w;Wg;gb ‘Kjypy; kUe;jpdhy; ve;j jPq;F Ntz;lhk;’ vd;w nrhw;nwhlu;
Nehahspapd; ghJfhg;gpw;fhf gad;gLj;jg;gl;lJ.
10k; E}w;whz;L fhyj;jpy;> ];fhl;yhz;il Mz;l N[k;]; 6k; kd;du; rhyupNdh
kUj;Jt gs;spapy; kUe;Jfshy; Vw;gLk; ghjfkhd tpisTfSf;F fLikahd
jz;lidfis tpjpj;jhu;.
1540k; Mz;by; ,q;fpyhe;J ehl;by; Drugs and Stuffs Act vd;w rl;lk; kUe;Jfisf;
fz;fhzpf;f Vw;gLj;jg;gl;lJ.
2.2 Kf;fpatuyhW
1785-k; Mz;by; Dr. William withering vd;w Mq;fpy kUj;Jtu; b[pl;lhyp]; vd;w
kUe;jhy; Vw;gl;l ghjfkhd tpisTfis Ma;T nra;J fl;Liuahf ntspapl;lhu;.
[dtup 29> 1848-k; Mz;by; Hannah Greener `d;dh fPupdu; vd;w tlfpof;F
,q;fpyhe;ij Nru;e;j 15 taJ kjpf;fj;jf;f xU ngz;zpw;F FNshNuhghu;k; (Chloroform)
kUe;ij fhy; fl;il tpuy; efj;jpy; typ epthuzpahf gad;gLj;jpaNghJ jpbnud;W
me;j ngz; ,we;Jtpl;lhs;. mjw;F fhuzk;> kUe;jhy; Vw;gl;l ,ja glglg;G. ,e;j
epfo;T kUj;Jtf; fz;fhzpg;Gf;F xU iky; fy;yhf mike;j epfo;thFk;. 1893-k;
Mz;L FNshNuhghu;khy; epfo;e;j gy;NtW ,wg;Gfs; ,q;fpyhe;jpd; yhd;nrl; (Lancet)
vd;w gj;jpupf;ifapy; ntspaplg;gl;lJ.
kUj;Jtf;fz;fhzpg;G
1941-y;” Sulfathiazole vd;w kUe;ij Phenobarbital vd;w kUe;Jld; cl;nfhz;ltu;fs;

300 Ngu; ,we;jdu;. ,J rpy kUe;Jfis xNu Neuj;jpy; cl;nfhs;Sk; NghJ Vw;gl;l
epfo;T. ,J ,uz;L ntt;NtW kUe;Jfshy; Vw;glf;$ba tpisT. mjhtJ kUe;Jfs;
,iltpid tpisTfs; (Drug Interaction) “sulfathiazole Nrhfk;" vd;wiof;fg; gLfpwJ.
1950-k; Mz;L Chloaramphenicol vd;w kUe;ij cl;nfhz;L syndrome of grey baby
Vw;gl;L– 180 ,wg;Gfs; Vw;gl;lJ.
kUj;Jtf;fz;fhzpg;G
2.3 jhypNlhikl; tuyhW
1960 fspy; Thalidomide vd;w xU kUe;J jhd; kUe;Jfs; kw;Wk; gf;ftpisTfis

fz;fhzpf;Fk; Kiwikf;fhd kpf Kf;fpa fhuzpahf tpsq;fpw;W. INuhg;gpa ehl;by;
me;j kUe;J cl;nfhz;l midj;J fu;g;gpzpg; ngz;fSf;Fk; gpwtpf; FiwghLila>
,U iffSk; fhy;fSk; rpWj;J> clNyhL xl;ba epiyapy; Foe;ijfs; gpwe;jd.
,e;j tpisTf;F Teratogenicity vd;Wg; ngau;. mjhtJ efk;> rij> vYk;G> euk;G>
,uj;jf;Foha;fs;> Kb> Njhy;> Nghd;w cWg;Gfs; ghjpg;Gw;W mit tsh;r;rp milahky;
if> fhy;fs; Kbr;Rfs; Nghyj; Njhd;Wk;. ,e;j kdij cYf;Fk; epfo;Nt kUe;Jfs;
kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapd; Kf;fpa fhuzk; MFk;.
fPo;f;fz;l glj;jpy; cs;s epiyNa Phocomelia MFk;.
Phocomelia - jhypNlhikl; NguopT

,jid yhd;irl; gj;jpupf;ifapy; M];jpNuypahit Nru;e;j kUj;Jtu; W. Mcbride
fbjkhf ntspapl;lhu;. ,e;j epfo;Tf;Fg; gpwF jhd; gy;NtW ehLfspy; kUe;Jfis
fz;fhzpf;f gy;NtW mikg;Gfs; cUthf;fg;gl;L Jupjkhf nray;glj; njhlq;fpaJ.
1961k; Mz;L brk;gu; khjk; Pharmacovigilance vd;w thu;j;ij mjpfhu G+u;tkhf

ntspaplg;gl;lJ.
1960-64k; Mz;L ,q;fpyhe;J murhy; “Yellow Card System by the committee on the
safety of drugs of UK” vd;w kUj;Jt fz;fhzpg;G Kiwia mwpKfg;gLj;jpaJ.
kUj;Jtf;fz;fhzpg;G
,e;j Kiw kUj;Jtf;fz;fhzpg;G kpfTk; ntw;wpfukhf nray;gl;lJ> ,e;j
Kiwapy;jhd; Kjd;Kjypy; 1980-k; Mz;L gpuhe;jpaq;fSf;fhd fz;fhzpg;G ikaq;fis
cUthf;fp nray;gLj;jpdu;> ,jidNa ,g;NghJ gyehLfs; gpd;gw;Wfpd;wd.
1968y; cyfshtpa kUe;J fz;fhzpf;Fk; Kiwia 10 cWg;G ehLfisf;
nfhz;Lj; njhlq;fpaJ [WHO’s programme for International Drug Monitoring was started
initially as a pilot project in 10 countries with established national reporting systems for ADRs.]
1978 – Nkw;$wpa ikak; n[dpthtpypUe;J RtPldpYs;s cg;ryhtpw;F
khw;wg;gl;lJ> ,JNt jw;NghJ kUe;Jfisf; fz;fhzpf;Fk; ikaj;jpd; jiyik
,lkhf cs;sJ (Uppsala Monitoring Centre).
2.4 He;jpahtpy;-kUj;Jtf; fz;fhzpg;gpd; tsu;r;rpAk; tuyhWk;
,e;jpahtpy; 1986y; jhd; Kjy; Kjyhf kUe;Jfis fz;fhzpf;Fk; ikaq;fs;

njhlq;fg;gl;lJ.
1997-Mk; Mz;L ,e;jpah, cyf Rfhjhu ikaj;Jld; ifNfhu;j;jJ. 2004
Mk; Mz;L (National Pharmacovigilance Program) Njrpa kUj;Jt fz;fhzpg;G jpl;lk;
njhlq;fg;gl;lJ. 2005 Mk; Mz;L National Pharmacovigilance Program Tld; kj;jpa
kUe;Jfs; fl;Lg;ghl;L epWtdk; [Central Drug Standard Controller Organisation - CDSCO]
ika fl;Lg;ghl;L epWtdk; ,ize;J nray;glj; njhlq;fpaJ.
2008 Mk; Mz;L National Pharmacovigilance Program for ASU drugs IPGTRA
[Institute for Post Graduate Teaching and Research in Ayurveda]> Jamnagar [National
Pharmacovigilance Centre for ASU drugs] y; njhlq;fg;gl;lJ. ,J Njrpa rpj;j kUj;Jt
epWtdj;ijAk; cs;slf;fpa 8 Regional Pharmacovigilance Centre fisAk; kj;jpa rpj;j
kUj;Jt epWtdj;ij cs;slf;fpa 30 Peripheral Pharmacovigilance Centre fisAk;
nfhz;lJ.
2010Mk; Mz;L Pharmacovigilance Program of India, National Coordination centre
GJnly;ypapd; AIIMS ia jiyik ,lkhff; nfhz;L nray;glj; njhlq;fpaJ
2011Mk; Mz;L Pharmacovigilance Program of India, National Coordination centre
GJnly;ypapypUe;J fhrpahghj; (Ghaziabad) vd;w ,lj;Jf;F khw;wpaikf;fg;gl;lJ.
2008 Mk; Mz;L MA~; kUj;Jtj;jpw;fhf Muk;gpf;fg;gl;l kUj;Jtf;fz;fhzpg;G
rpwpJ njha;Tw;wjhy; mij GJg;gpf;Fk; Nehf;Fld; 2017 Mk; Mz;L etk;gu; Kjy; ehspy;
MA~; mikr;rfk; MAu;Ntjh> rpj;jh> Adhdp kw;Wk; N`hkpNahgjp kUj;Jtj;jpw;fhd
kUj;Jt fz;fhzpf;Fk; Kiwia nray;gLj;j Central Sector Scheme for Pharmacovigilance
kUj;Jtf;fz;fhzpg;G
for ASU & H Drugs vd;w xU jpl;ltiuitf; nfhz;L te;jJ. mjd;gb All India Institute
of Ayurveda National Pharmacovigilance Centre Mf mwptpf;fg;gl;lJ. ,jpy; Njrpa rpj;j
kUj;Jt epWtdj;ijAk; cs;slf;fpa 5 Intermediary Pharmacovigilance Centre fSk;>
10 rpj;j kUj;Jt epWtdq;fis cs;slf;fpa 42 Peripheral Pharmacovigilance Centre
fSk; Nju;e;njLf;fg;gl;L nray;glj; njhlq;fpaJ. ,jd; Nehf;fk; 2020 Mk; Mz;Lf;Fs;
100 Peripheral Pharmacovigilance Centre fis cUthf;FtNj MFk;.
2.5 cyf Nehahsu; ghJfhg;G jpdk;
Nk khjk; 25> 2019 Mk; Mz;L 72-tJ cyf Rfhjhu $l;likg;G eilngw;wJ.
,jpy; cyf kf;fspd; MNuhf;fpaNk Nehahsu; ghJfhg;gpy; jhd; cs;sJ vd;W
vLj;Jiuf;fg;gl;lJ. mjid midtUk; epidT $wTk; gpd;gw;wTk; nrg;lk;gh;; 17 Mk;
ehs; cyfNehahsu; ghJfhg;G jpdkhf mwptpj;jJ> mjid 2019 Kjy; nfhz;lhlg;gl;L
tUfpwJ. ,jd; %yk; kUj;Jt Copau;fs; kl;Lkpd;wp Nehahsu;fSf;Fk; tpopg;Gzu;T
Vw;gLj;j ey;y Kd;ndLg;ghf cs;sJ.
** Protecting Patient from Harm **
kUj;Jtf;fz;fhzpg;G
3. etPd kUj;Jtf; fz;fhzpg;G (PHARMACOVIGILANCE)
kUe;J> kUj;Jtk; vd;whNy kf;fSf;F ed;ik nra;tJ jhNd... ,jw;F

xOq;FKiw vd;gJ Njitah? vd;why;... Mk; mtrpak; Ntz;Lk; vd;Nw $w Ntz;Lk;.
Vndd;why; ,g;NghJs;s etPd kUj;Jtj;jpd;;gb> kUe;Jfs; cUthf;Fjy; Kjy; mJ
gadhsu;fis nrd;wilAk; tiu ehd;F fl;lq;fshf gpupf;fg;gLfpwJ. ,itaidj;Jk;
kUj;Jtf; fz;fhzpg;GfNs> Kjy; 3 fl;lq;fspy; kUe;Jfspdhy; VNjDk; gpio Vw;gbd;
mit ntspr;re;ijfSf;Nf tUtjpy;iy. Mdhy;> ehd;fhk; fl;lk; vd;gJ kUe;J
re;ijf;F te;j gpwF kUe;Jfis fz;fhzpj;jy; vd;gjhFk;. mjidg;gw;wp tpupthf
fhzyhk;.
kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwik vd;gJ

1. kUe;J rhu;e;j gpur;rpidfisAk;>
2. kUe;jpdhy; Vw;gLk; gf;ftpisTfis fz;lwpaTk;>
3. mjdhy; Vw;gLk; fhuz fhupaq;fis myrp MuhaTk; kw;Wk; mtw;iw
jLf;ff;$ba KiwiaAk;> Mfpad gw;wpa mwptpaNy MFk;.
,e;j Kiwf;F PHARMACOVIGILANCE vdg;ngau; tuf;fhuzk; vd;d?

Pharmakon vd;gJ fpNuf;fr; nrhy;yhFk;. mjd; nghUs; kUe;J vd;gjhFk;. Vigilaire
vd;gJ ,yj;jPd; nkhopr;nrhy;yhFk;. mjd; nghUs; njhlu;e;J ftdpg;gJ> tpopg;Gzu;Tld;
,Ug;gJ> gpur;ridf;fhd Kd;dwptpg;G gw;wpa tpopg;Gzu;T kw;Wk; mghak;> eyd;>
Rw;Wg;Gwk; gw;wpa tpopg;Gzu;T vd;gjhFk;. RUq;ff;$wpy;> neUq;fpa kw;Wk; njhlu;e;j
fz;fhzpg;G vd;gjhFk;.
xU kUj;Jt Kiwapd; jiyaha flik> kUe;J kw;Wk; kUj;Jt Kiwfs;

Nghd;wtw;wpd; ghJfhg;G kw;Wk;> KOg;gyd; gw;wpa fUj;Jf;fspy; njhlu;e;J Ma;T
nra;tJ kw;Wk; ftdpg;gNj MFk;. mjpy; rpytw;iw fPNoFwpg;gplg;gl;Ls;sJ.
• kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapd; Nehf;fk; vd;d?

kUj;Jtk; kw;Wk; JizkUj;Jt ,ilaPLfspy; Nehahspapd; eyd;> ghJfhg;G
Nghd;wtw;iw mjpfg;gLj;JtJ kw;Wk; tsu;g;gJ.
kUj;Jtf;fz;fhzpg;G
• xl;L nkhj;j kf;fspd; ghJfhg;G kw;Wk; eyid tsu;g;gJ.
• kUe;Jfspdhy; Vw;gLk; jPik> ed;ik> ,it kl;Lkpy;yhJ, vjpu;ghu;f;fg;gLk;
ey;tpisT> Vw;gLk; mghaq;fs; ,tw;iw Ma;e;jwptJ.
• rpf;fdk; jUk; kUe;Jfis my;yJ Fiwe;j nghUs; nryT jUk; kUj;Jt
Kiwfis fz;lwptJ> gad;gLj;JtJ.
• kUe;Jfs; gw;wp nghJkf;fSf;Fj; Njitahd Gupe;Jzu;jy;> gbg;gpid> kw;Wk;
kUj;Jtg; gapw;rp Nghd;wtw;iw czu;j;Jjy;.
Nehf;fk;:
• kUe;Jfspd; ghJfhg;ghd epiyapd; Kf;fpa fhuzpahf tpsq;FtJ kUe;Jfs;
kw;Wk; kUj;Jt fz;fhzpg;G Kiwik vd;gjhFk;.
• ,e;j Kiwapd; %yk; kUe;J cUthf;fj;jpd; tsh;r;rp epiy (k) mJ njhlh;ghd
Muha;r;rp epiyapNyNa xU ghJfhg;gw;w kUe;jpid> kf;fs; gad;ghl;bw;F tUtjw;;F
Kd;ghfNt jLj;Jtpl KbAk;.
• ntspr; re;ijapy; tpw;gidf;F te;Js;s> juk; Fiwe;j> ghJfhg;gw;w kUe;Jfis
epue;jukhf mopf;f KbAk;.
,dp kUj;Jtf;fz;fhzpg;G Kiwapy; cs;s Kf;fpakhd rpy nrhw;nwhlu;fs; gw;wp
ghu;f;fyhk;.
3.1. ghjfkhd tpisT (Adverse Drug Reaction)

kdpju;fSf;F ,ay;ghf toq;ff;$ba kUe;jpd; mstpNyNa> ehk; vjpu;ghu;f;fhj
tpisT kw;Wk; jPq;F my;yJ er;Rj;jd;ik ntspg;gLkhdhy; mJNt ghjfkhd tpisT
vd;gjhFk;. me;j kUj;Jt Kiw vd;gJ rpfpr;ir Kiw> Neha;f;fzpg;G Kiw> my;yJ
,aw;ifahf kdpjdpd; clypaq;fpaiy khw;wf;$ba epfo;Tfshf ,Uf;fyhk;.
3.2. ghjfkhd epfo;T (Adverse Event)

ghjfkhd epfo;T (Adverse Event) vd;gJ kUe;J cl;nfhs;Sk; Ntisapy;
vjpu;ghu;f;fhj tpisT kw;Wk; jPq;F Vw;gLtjpy;> fhuz fhuzpahf me;j kUe;J
,Uf;fyhk; my;yJ ,y;yhkYk; ,Uf;fyhk;. ,j;jifa vjpu;kiw epfo;T> ghjfkhd
epfo;T vdg;gLk;.
kUj;Jtf;fz;fhzpg;G
gf;ftpisT (Side Effect)

xU kUe;ij ,aw;ifahd mstpy; cl;nfhs;Sk; NghJ me;j kUe;jpdhy;
kl;LNk Vw;glf;$ba> vjpu;ghu;f;fhj tpisNt gf;ftpisT MFk;. me;j tpisT
ed;ikahdjhfTk; ,Uf;fyhk; my;yJ jPikahdjhfTk; ,Uf;fyhk;.
ghjfkhd tpisT kw;Wk; ghjfkhd epfo;Tf;fhd vLj;Jf;fhl;Lld; $ba
tpsf;fk;. xUtu; kUe;J cl;nfhs;Sk; NghJ ,utpy; rhiyNahu filapy; gNuhl;lhit
thq;fp cz;fpwhu;. jw;NghJ ,q;F xU vjpu;kiwahd tpisT Vw;gl;lhy;> ek;khy;
,jw;fhd fhuzj;ij rupahf fzpf;f KbahJ.> Vnddpy; ,e;j vjpu;kiw epfo;Tf;F
fhuzk; gNuhl;lhth my;yJ kUe;jh vd;gij ek;khy; jPu;khdpf;f KbahJ. vdNt
,ij ghjfkhd epfo;T vdyhk;.
3.3. jPtpu ghjfkhd epfo;T (Serious Adverse Event)

fhuz fhupaj;ij rupahf fzpf;f Kbahj Kiwapy; cz;lhd tpNuhj epfo;thdJ
,wg;igNah> clypy; epiyahd ,og;igNah> njhlu;e;J cs;Nehahsu; rpfpr;irg;gpuptpy;
kUj;Jtk; nra;Ak; epu;ge;jk; Vw;gl;lhNyh> jPtpu ghjfkhd epfo;T (Serious Adverse
Event) vdg;gLk;.
kUj;Jtf;fz;fhzpg;G
3.4. ghjfkhd tpisTfspd; tifg;ghLfs;

ghjfkhd tpisTfis Ie;J tifahf tifg; gLj;Jfpd;wdu;. mJ vd;d
ntd;why;
1. tif A [TYPE A (Augmented) Reactions]
2. tif B [TYPE B (Bizarre) Reactions]
3. tif C [TYPE C (Chronic) Reactions]
4. tif D [TYPE D (Delayed) Reactions]
5. tif E [TYPE E (End of use) Reactions]
6. tif F [TYPE F (Failure of Treatment) Reactions]
Nkw;$wg;gl;l tiffSf;F> vLj;Jf;fhl;Lfs; midj;Jk; Mq;fpy kUj;Jtj;jpy;
tpsf;fpAs;Nshk;.
1. tif A [TYPE A (Augmented) Reactions]
tif A vd;Dk; ghjfkhd tpisT> fzpf;ff; $ba xd;W. Vndd;why; mit
kUe;Jfis nghUj;Jk; mjd; msTfis nghUj;Jk; epfof;$baJ. ,e;j tpisT
kUe;Jfis epWj;JtJ mjd; msit Fiwg;gJ Nghd;w nray;fspdhy; Fiwf;f
,aYk;. ,jd; vLj;Jf;fhl;L; ru;f;fiuf;fhd kUe;ij vLj;Jf; nfhs;Sk; nghOJ>
ru;f;fiu mstpy; kpfTk; Fiwe;J kaf;fk;> glglg;G Nghd;w ghjfkhd tpisTfis
Vw;gLfpwJ.
,J %d;W tifahFk;. KjyhtJ gf;ftpisT> ,uz;lhtJ $Ljy; tpisT>
%d;whtJ eQ;R tpisT>
I. gf;ftpisT vd;gJ kUe;Jfspd; jf;f mstpy; kUe;Jfspd; Njitaw;w
nray;ghLfshy; epfof;$baJ.
II. ,uz;lhtJ $Ljy; tpisT vd;gJ kUe;Jfspd; Neu;kiwahd nray;fshy;
epfof;$baJ
III. %d;whtJ eQ;RtpisthdJ kUe;Jfspd; mjpfg;gbahd msthy; epfof;$baJ.
2. tif B [TYPE B (Bizarre) Reactions]
,e;jtif ghjfkhd tpisT fzpf;f ,ayhj xd;W. ,J kUe;Jfspd;
nray;fspypUe;J NtWgl;bUf;Fk;. ,jid ,uz;L gpupTfshf gpupf;fg;gl;Ls;sJ.
mit ,bNahrpd;fpu]p (Idiosyncrasy) kw;Wk; xt;thj tpisTfs;.
kUj;Jtf;fz;fhzpg;G
,bNahrpd;fpu]p vd;gJ kUe;Jfshy; kugZtpy; Vw;glf;$ba tpisT.
,jd; vLj;Jf;fhl;L CHLOROMPHENICAL vd;Dk; kUe;J kugZtpd; khw;wj;jhy;
,uj;jj;jpYs;s nts;is mZf;fisr; nraypof;f nra;fpwJ. xt;thj tpisTfs;
vd;gJ kUe;Jfs; vLj;Jf; nfhs;Sk; nghOJ> ek; cly; kUe;Jfsplk; fhl;Lk;
vjpu;tpid tpisthFk;. ,jd; vLj;Jf;fhl;L ngdprpypd; Nghd;w kUe;Jfshy; xt;thik
Vw;gLfpwJ.
3. tif C [TYPE C (Chronic) Reactions]
,e;j tpisthdJ kUe;Jfis ntF ehl;fshf njhlu;r;rpahf vLj;Jf;
nfhs;tjhy; Vw;glf; $ba epfo;T. typ kUe;Jfis njhlu;r;rpahf vLj;Jf; nfhs;Sk;
nghOJ fpl;dp ghjpg;giltJ ,e;j tif tpisTfspy; NrUk;.
4. tif D [TYPE D (Delayed) Reactions]
kUe;Jfs; cl;nfhz;L gyehl;fs; fopj;J Vw;glf;$ba tpisT. fUTw;w
jha;khu;fs; vLj;Jf; nfhs;Sk; kUe;Jfshy; Foe;ijf;F Vw;glf;$ba ghjfkhd
tpisTfs; ,jpy; mlq;Fk;
5. tif E [TYPE E (End of use) Reactions]
kUe;Jfs; njhlu;r;rpahf vLj;Jf; nfhs;Sk; nghOJ jpBnud;W kUe;ij
epWj;Jtjhy; epfof;$ba epfo;T. ,jd; vLj;Jf;fhl;L Nghijia Vw;gLj;jf;$ba
OPIOID Nghd;w kUe;Jfs; vLj;Jf; nfhs;Sk;nghOJ jpBnud;W kUe;ij epWj;Jtjhy;
gytpjkhd FwpFzq;fs; Vw;gLk;. ATENALOL vd;Dk; kUe;J vLj;Jf; nfhs;Sk;
nghOJ jpBnud;W mjid epWj;Jtjhy; khu;Gtyp Vw;gLtJz;L. NkNy Fwpg;gpl;lit
midj;Jk; ghjfkhd tpistpd; tiffSk; mtw;wpd; cl;gpupTfSk; MFk;
6. tif F [TYPE F (Failure of Treatment) Reactions]
Neha;fSf;F kUe;Jfs; rhpahf Ntis nra;ahjpUj;jy;.
kUj;Jtf;fz;fhzpg;G
3.5. ghjfkhd tpisTfis Muha;tjw;fhd msT Nfhy;fs;:

cyf mstpy; ghjfkhd tpisTfis Muha;tjw;fhf gy msT Nfhy;fs;
cs;sJ. mtw;wpy; Kf;fpakhdit ,uz;L.
1. eNud;N[h msTNfhy;
2. cyf Rfhjhu ikaj;jpd; msTNfhy;
Adverse Drug Reaction Naranjo Probability Scale
Question Yes No Do Not Score

Know
1. Are there previous conclusive reports on +1 0 0
this reaction?
,e;j vjpu;tpid Fwpj;J Ke;ija Kbthd
mwpf;iffs; cs;sjh?
2. Did the adverse event appear after the sus- +2 -1 0

pected drug was administered?
re;Njfj;jpw;fplkhd kUe;J toq;fg;gl;l
gpd;du; ghjfkhd epfo;T Njhd;wpajh?
3. Did the adverse event improve when the +1 0 0

drug was discontinued, or a specific antagonist
was administered?
kUe;J epWj;jg;gl;lNghNjh my;yJ
xU Fwpg;gpl;l vjpu; kUe;J toq;fp
epu;tfpf;fg;gl;l gpwF ghjfkhd epfo;tpd;
tPupak; Fiwe;jjh?
4. Did the adverse event reappear when the +2 -1 0

drug was readministered?
re;Njfj;jpw;Fupa kUe;jpid kWKiw
nfhLf;Fk; NghJ ghjfkhd epfo;T kPz;Lk;
Njhd;wpajh?
5. Are there alternative causes that could on -1 +2 0

their own have caused the reaction?
ghjfkhd tpisTf;F NtW fhuzq;fs;
cs;sjh?
kUj;Jtf;fz;fhzpg;G
6. Did the reaction reappear when a placebo -1 +1 0

was given?
kUe;J my;yhJ kUe;J my;yhjit
nfhLf;fg;gl;lNghJ ghjfkhd tpisT
kPz;Lk; Njhd;wpajh?
7. Was the drug detected in blood or other +1 0 0

fluids in concentrations known to be toxic?
,uj;jj;jpy; my;yJ gpw jputq;fspy;
kUe;jpd; er;Rj;jd;ik fz;lwpag;gl;ljh?
8. Was the reaction more severe when the dose +1 0 0

was increased or less severe when the dose was
decreased?
kUe;jpd; msitmjpfupf;Fk; NghJ
ghjfkhd tpisT mjpfupf;fpwjh?
kUe;jpd; msit Fiwf;Fk; NghJ gh-
jfkhd tpisTFiwthf ,Ue;jjh?
9. Did the patient have a similar reaction to +1 0 0

the same or similar drugs in any previous
exposure?
,jw;F Kd;ghf NehahsUf;F
,JNghd;w FwpFzq;fs; ,NjkUe;jpw;Nfh
my;yJ ,J Nghd;w NtWkUe;JfSf;Nfh
Vw;gl;Lsj;jh?
10. Was the adverse event confirmed by any +1 0 0

objective evidence?
ghjfkhd epfo;Tf;F VNjDk; cWjpr;
nra;ag;gl;l rhd;Wfs; cs;sjh?
Total Score:
kUj;Jtf;fz;fhzpg;G
Naranjo Algorithm - ADR Probability Scale
Score Interpretation of Scores

Total Score ≥9 Definite. The reaction
(1) followed a reasonable temporal sequence
after a drug or in which a toxic drug level had
been established in body fluids or tissues,
(2) followed a recognized response to the
suspected drug, and
(3) was confirmed by improvement on
withdrawing the drug and reappeared on
reexposure.
Total Score 5 to 8 Probable. The reaction
(1) followed a reasonable temporal sequence
after a drug,
(2) followed a recognized response to the
suspected drug,
(3) was confirmed by withdrawal but not by
exposure to the drug, and
(4) could not be reasonably explained by the
known characteristics of the patient’s clinical
state.
Total Score 1 to 4 Possible. The reaction
(1) followed a temporal sequence after a drug,
(2) possibly followed a recognized pattern to
the suspected drug, and
(3) could be explained by characteristics of
the patient’s disease.
Total Score ≤0 Doubtful. The reaction was likely related to
factors other than a drug.
kUj;Jtf;fz;fhzpg;G
Causality term Assessment criteria

(All points should be reasonably complied)
Certain • Event or laboratory test abnormality, with plausible time

epr;rak; relationship to drug intake.
• Cannot be explained by disease or other drugs.
• Response to withdrawal plausible (pharmacologically,
pathologically)
• Event definitive pharmacologically or phenomenologically
(i.e.: an objective and specific medical disorder or a
recognized pharmacologic phenomenon)
• Rechallenge satisfactory, if necessary
• kUe;jhy; Vw;gLk; epfo;T my;yJ Ma;T KbTfs;
Mfpad> kUe;J vLj;Jf; nfhz;l Neuj;NjhL epr;rak;
njhlu;GilAjhf cs;sJ.
• vLj;Jf;nfhz;l kw;w kUe;J my;yJ ,Uf;fpd;w
NehAld; xg;gpl KbahJ
• kUe;ij epWj;Jtjd; %yk; epr;rakhd gyd;
,Uf;fpwJ (kUj;Jt uPjpahfNth my;yJ Nehapay;
uPjpahfNth)
• kUe;ij kPz;Lk; gad;gLj;Jtjw;fhd mtrpakpd;ik
Probable/likely • Event or laboratory test abnormality, with reasonable

tha;g;G time relationship to drug intake.
• Unlikely to be attributed to disease or other drugs.
• Response to withdrawal clinically reasonable.
• Rechallenge not required.
Mfpad> kUe;J vLj;Jf; nfhz;l Neuj;NjhL
epahakhdKiwapy; njhlu;GilAjhf cs;sJ.
• ,e;epfo;T vLj;Jf;nfhz;l kw;w kUe;J my;yJ
,Uf;fpd;w NehAld; xg;gpl ,ayhJ
• kUe;ij epWj;Jtjd; %yk; epahakhd gyd;
,Uf;fpwJ (kUj;Jt uPjpahfNth my;yJ Nehapay;
uPjpahfNth)
• kUe;ij kPz;Lk; gad;gLj;Jtjw;fhd mtrpakpd;ik
kUj;Jtf;fz;fhzpg;G
Possible • Event or laboratory test abnormality, with reasonable

rhj;jpak;
time relationship to drug intake.
• Could also be explained by disease or other drugs.
• Information on drug withdrawal may be lacking or
unclear
Mfpad> kUe;J vLj;Jf; nfhz;l Neuj;NjhL
epahakhdKiwapy; njhlu;GilAjhf cs;sJ.
,Uf;fpd;w NehAld; xg;gplTk; ,aYk;.
• kUe;ij epWj;jpajw;fhd jfty;> ,y;iy my;yJ
njspthf ,y;iy.
Unlikely • Event or laboratory test abnormality, with a time to drug

rhj;jpakpy;iy intake that makes a relationship improbable (but not
impossible).
• Disease or other drugs provide plausible explanation.
Mfpad> kUe;J vLj;Jf; nfhz;l Neuj;NjhL rhj;jpa
kw;wjhf cs;sJ.
,Uf;fpd;w NehAld; epr;rpakhf xg;gpl ,aYk;
Conditional/unclassified • Event or laboratory test abnormality.
epge;jid/tifg;gLj;jg;gl- • More data for proper assessment needed, or
hjJ • Additional data under examination
cs;sd.
• ,e;epfo;it cWj;jpg;gLj;j> NkYk; Kiwahd kjpg;gPL
my;yJ KOikahd jfty;fs; Njitg;gLk;.
Unassessable/unclassifiable • Report suggesting an adverse reaction.

tptupf;f KbahjJ/ • Cannot be judged because information is insufficient or
tifg;gLj;j KbahjJ- contradictory.
• Data cannot be supplemented or verified.
• fpilj;j jfty;fs; ghjfkhd tpisit Fwpf;fpwJ.
• fpilf;f ngw;w Mtzq;fs; Kd;Df;F gpd;
KuzhfTk;> gw;whf; FiwahfTk; ,Uj;jy;.
• fpilf;fg;ngw;w juTfs; NkYk; epug;gNth my;yJ
rupghu;f;fNth Kbahik.
kUj;Jtf;fz;fhzpg;G
,jid rpj;j kUj;Jtj;jpw;F nghUe;j nra;tJ fbdkhf cs;sJ. ,J
Mq;fpyk; kUj;Jtj;jpw;fhf Vw;gLj;jg;gl;l xd;W. ek; MA~; mikr;rfk; %yk;
rpj;j kUj;Jtj;jpw;fhd xU msTNfhy; tiuaWg;gJ mtrpakhd xd;whFk;. mjd;
nray;ghLfs; kUj;Jtf;fz;fhzpg;Gf; FOtpd; %yk; nray;gl;Lf; nfhz;bUf;fpwJ.
3.6. Signal
Signal vd;gJ vd;d? xU kUe;Jf;Fk; mjd; fhuzkhf Vw;gl;l
gf;ftpisTf;Fk; cs;s njhlu;G ruptu njupahtpl;lhYk; my;yJ mjid KOikahf
Mtzg;gLj;jg;glhkYk; ,Ue;jhy;> mjd; Nkhrkhd tpistpd; gaq;fuj;jd;ik kw;Wk;
rupahd jfty;fisg;nghWj;J me;j kUe;jpd; kPJ eltbf;if vLg;gjhFk;. Mdhy;
xd;Wf;F Nkw;gl;l rupahd jfty;fs; ,Ue;jhy; kl;LNk Signal - I cUthf;f KbAk;.
3.7. kUj;Jtf; fz;fhzpg;G Kiwfs;
kUe;jpd; ghjfkhd tpisit fzpf;fTk;> juTfis Nrfupf;fTk; gy Kiwfs;
gpd;gw;wg;gl;L tUfpd;wd mtw;iwg;gpd; tUkhW fhzyhk;.
1.Passive surveillance
2.Stimulated Reporting
3.Active Surveillance
4.Comparative Observational Studies
5.Targeted clinical Investigations.
Passive surveillance:
ve;j xU ngUk; Kaw;rp ,d;wp Vw;fdNt kUj;Jt re;ijapy; cs;s kUe;Jfshy;
Vw;gLk; ghjfkhd tpisit jhkhfNt gjpT nra;jy;. kUj;Jt fz;fhzpg;G Jiwapy;
,J Nghd;W gjpT nra;ag;gLk; ADR fNs mjpfk;.
Stimulated Reporting:
xU Gjpa kUe;J re;ijapy; tUk; NghJ xU Fwpg;gpl;l fhyf;fl;lj;Jf;F me;j
kUe;jpd; ghjfkhd tpisit Nrfupg;gJ.
Active Surveillance:
,J passive survelliance w;F Neu;kiwahdJ. xU Fwpg;gpl;l kUe;jpid
fz;fhzpj;jypy; ,J mlq;Fk;> ,J xU kUe;jpid nfhLf;Fk; NghJ kUj;Jt
Fwpg;Gfs; %ykhfTk;> Nehahsu;fsplk; tprhupj;jy; %ykhfTk;> kUj;Jtupd; $w;wpd;
%ykhfTk; njhlu;e;J me;j kUe;jpidg; gw;wpa jftiy Nrfupj;jy;.
kUj;Jtf;fz;fhzpg;G
Comparative Observational studies:

Cross sectional study> Case control study> Cohort study ,J Nghd;w kUj;Jt
Muha;r;rpfspy; AE/ADR fisAk; Mtzg;gLj;j Ntz;baJ kpfTk; Kf;fpakhdJ>
,t;thW Mtzg;gLj;Jjypd; %yk;> jtwhd my;yJ ghjfkhd tpisT Vw;gLj;jf;
$ba kUe;Jfis fz;lwpe;J> mit nghJ kf;fSf;F nrd;wilah tz;zk;> mjd;
Muha;r;rp gbepiyfspNyNa jLj;J epWj;j KbAk;.
Targeted Clinical Investigations:

kUj;Jt Muha;r;rpfspd; NghJ kUe;jpdhy; VNjDk; vjpu;kiwahd tpisT
Vw;gLtJ Nghy Njhd;wpdhy;> me;j kUe;jpid Fwpitj;J Kiwahd kUj;Jt
gupNrhjidfs; vLf;fg;gl Ntz;Lk;. mt;thW Fwpg;gpl;l kUj;Jt gupNrhjidfs; nra;Ak;
NghJ> kUe;;J ek; clypy; vd;d khw;wq;fis Vw;gLj;JfpwJ> ekJ cly; kUe;jpw;F
vd;d khjpupahd tpisTfis Vw;gLj;JfpwJ vd;gij ehk; vspjhfNt mwpa KbAk;.
kUe;jpd; vjpu; tpisit Fwpitj;J nra;ag;gLk; gupNrhjidfs; kUe;jpd; Fwpg;gpl;l
msT> ghjfkhd tpisitj; jUfpwjh? vd;gij ek;khy; mwpe;Jf; nfhs;s KbAk;.
3.8. kUe;Jfisf; fz;fhzpf;Fk; Kiwapd; Kf;fpaj;Jtk;

kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapd; Kf;fpaj;Jtk;
vd;d?
kdpjk; njhlu;ghd Kf;fpaj;Jtk; (Humanitarian concern) mjhtJ
1. kdpju;fs; gq;F ngWk; kUj;Jt Muha;r;rpfspy; Nghjpa ghJfhg;G gw;wpa
Mjhuq;fs; ,y;yhjJ.
2. NkYk; kUj;Jt Muha;r;rpfspy; tpyq;Ffis itj;J nra;j Muha;r;rpapd;
Kd;Ndhl;lk; Nghd;wtw;wpy; Nghjpa ghJfhg;G gw;wpa Mjhuq;fs; ,y;yhjJ.
3. filfspy; tpw;gidf;F tUtjw;F Kd;G cs;s Muha;r;rpfspy; kdpju;fis
<LgLj;Jk; Kiw.
kUe;Jfs; kdpjid tho itg;gjw;Nf (Medicines are supposed to save lives
Lepakhin V. Geneva 2005)
1. rpy Neuq;fspy; Nehapdhy; ,wg;G Vw;gLfpwJ vd;gijNa ek;khy; Vw;Wf;nfhs;s
Kbtjpy;iy. NtW topapd;wp miukdNjhL Vw;fpNwhk;. Mdhy; kUe;jpdhy; my;yJ
jtwhd rpfpr;irahy; Vw;gLk; kuzj;ij xj;Jf;nfhs;sNt KbahJ.
kUj;Jtf;fz;fhzpg;G
2. mnkupf;f ehl;by; kdpju;fspd; ,wg;Gf;F Kf;fpa nghJthd fhuzk; ,e;j
gf;f tpisTfs; vd;w fhuzpahFk;> ,J 1994 y; kuzj;ij jUk; fhuzpfspy; 4-5 vd;w
,lj;ij jdjhf;fp nfhs;fpwJ. (Lazarou et. al 1998)
3. ,q;fpyhe;J ehl;by; kl;Lk; 5700 ,wg;Gfis gf;f tpisTfs; kl;LNk
cUthf;fpapUf;fpwJ. (Pirmohamed et. Al 2004)

gf;ftpisTfs; cz;lhf;Fk; kUj;Jt rpfpr;ir vd;gJ kpFe;j nghUs;
nryitj;jUk; fhuzpahFk;. (ADRs are expensive!!)
1. ,e;jpahtpy; Nehahsu;fspy; gf;f tpisTfshy; Vw;gLk; ghjpg;G kl;Lk; 3
Kjy; 7 tpOf;fhlhFk;. mjpy; 1.8 tpOf;fhL kuzj;ij jUfpd;w gf;f tpisTfshFk;.
mjdhy; Vw;gLk; nghUs; nryT Njhuhakhf &. 187 Kjy; &. 2820 tiuahFk;. ,jpy;
ruhrupahf kl;Lk; &. 690 xU gf;ftpisTf;fhf nryT nra;ag;gLfpwJ.
2. rpy Neuq;fspy; gf;f tpisTf;fhd nryT> kUj;Jt nrytpidAk; kpQ;rp
tpLfpwJ. (Gholasni K> Shalvani G. Factors associated with preventability> predictability and
severity of adverse drug reactions. Ann Pharmacother 1999; 33: 236-40)
kUe;Jfis cgNahfpf;Fk; NghJ mwpTf;F Vw;GilathW (Rational Usage of
Medicine) kUj;Jt Kiwfisf; ifahs;tJ vd;gij gutyhf;fg;gl Ntz;Lk;.
jtwhd kUj;Jt mwpTiufs; kl;Lk; xU kUe;J rPl;by; 15 f;Fk; Nkw;gl;l
kUe;J tiffis vOjpf;Ftpg;gJ. Kf;fhy; tapw;Wf;F kUe;jpidNa cz;Zk;
gbahd kUj;Jt mwpTiufs; mwpTf;F Vw;Gilajy;y. mJkl;Lkpd;wp mwptpaYf;Fk;
Muha;r;rpf;Fk; Vw;Gilajy;y. ek; kUe;Jfs; kPJk; kUj;Jt Kiwfspd; kPJk;
nghJkf;fSf;F mirf;f Kbahj ek;gpf;ifia Vw;gLj;j Ntz;LNk jtpu fPNo
cs;sthW kUe;Jfis vOjpf;Ftpg;gJ my;y. xNu Neha;f;F gy kUe;Jfis vOJtJ
my;yJ xt;nthU FwpFzq;fSf;Fk; xt;nthU kUe;Jfis vOjp czT Nghy
kUe;Jfis cz;zitg;gJ my;y.
kUj;Jtf;fz;fhzpg;G
3.9 kUj;Jtj;jpy; kf;fSf;F cs;s ek;gpf;if (Ensuring public confidence)

kUj;Jtj;jpy; VNjDk; jtwhf ele;jhy; Murphy’s Law (Anything that can go
wrong will go wrong) Nghd;w jj;Jtj;ij gpd;gw;whky; mwptpay; mwpTld; mjid
vjpu;nfhs;s Ntz;Lk;. mg;NghJ jhd; kf;fSf;F ek;kPJk; ek;kUj;Jtj;jpd; kPJk; cupa
ek;gpf;if Vw;gLk;. ,JNt ek;kUj;Jtu;fSf;Fk; ek; kUj;Jtj;jpd; kPJ msg;gupa
ek;gpf;ifia Vw;gLj;Jk;.
mwk; (Ethics):
kdpju;fSf;F jPq;F tpistpf;f $baJ vd;gij mwpe;J nfhz;l gpwF>
mjid kw;wtUf;F njuptpf;fhky; ,Ug;gJ mwj;jpw;F Gwk;ghdjhFk;. kUe;Jfs;
kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapd; mwk; vd;gJ kUe;jpdhy; Vw;gLk;
kUj;Jtf;fz;fhzpg;G
Nkhrkhd jPq;if kw;wtUf;F njuptpf;fhky; ,Ug;gJk; kw;Wk; mjid kiwg;gJk;
kUj;Jtf;fz;fhzpg;G Kiwikapd; mwk; MfhJ. ,J Nehahsu;> kUj;Jtu;> kUe;J
jahupg;gtu; kw;Wk; midj;J kUj;Jt gzpahsu;fSf;Fk;> mjpfhupfSf;Fk; nghUe;Jk;.
kdpjj;ij cynfq;Fk; giurhw;w ek;kUj;Jtj;ij xt;nthUtUk; czu ,e;j mwj;ij
filgpbg;gJ kUj;Jtu;fspd; flikahFk;.
kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapd; jpl;lKiw vd;gJ

Nkw;$wpa fhuzq;fshy; fl;lhak; kdpj rKjhaj;jpw;F Njit vd;gij mwpayhk;.
mjpYk; NehAw;w kdpju;fSf;F kUe;jpdhy; Vw;gLk; gyd;fs;> mgha tpisTfs; kw;Wk;
ghJfhg;G Nghd;w Kf;fpa fhuzpfSf;fhf ,J mtrpak; MFk;.
NkNy tpthjpj;j $w;Wfs; rup. Mdhy; NkYk; gy Nfs;tpfs; ek; kdjpy;

vOtjw;F tha;g;G cz;L. mit vd;d vd;gijg; ghu;f;fyhk;.
1. kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwik vd;gJ xU Gjpa
jpl;ltiuT Kiw> ,J ekJ gf;f tpisTfsw;w ek; kUj;Jtj;jpw;F Njitah?
2. ,t;thW kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapd;
jpl;ltiuT Kiwg;gb ,jid Mtzg;gLj;JtJ ekJ rpj;j kUj;Jt Kiwfis
nfhQ;rk; nfhQ;rkhf rpijj;J tpLk; tha;g;G cs;sjh? ,y;iyah?
3. ,e;j kUj;Jt Kiwfs; cz;ikapNyNa rpj;jkUj;Jtk;> MAu;Ntjk; kw;Wk;
Adhdp Nghd;w ,e;jpa kUj;Jt KiwfSf;Fj; Njitah?
,g;gb ,d;Dk; gy vz;z Xl;lq;fs; vy;Nyhu; kdjpYk; Xbf;nfhz;L jhd; ,Uf;fpd;wd.
mtw;iw rw;W tpupthfNt ghu;f;fyhk;.
xU kUe;J vd;gij rupahd Kiwapy; gad;gLj;jhky; my;yJ mjidg;gw;wpa
KOikahd mwpT ,d;wp gad;gLj;Jk; NghJ Nkhrkhd jPq;if Vw;gLj;jyhk;. me;j
tpisT xU $u;ikahd thSf;Nfh my;yJ nfhba ehf;Fila jP Rthiyf;Nfh
my;yJ td;ikahd eQ;Rg;nghUSf;Nfh my;yJ ,b kpd;dypdhy; Vw;gLk; tpisTf;Nfh
xg;ghdjhFk;.
NkNy tpthjpj;jit thOk; kdpju;fSf;F xU kUe;ij cgNahfg;gLj;Jtjw;F
Kd;G me;j kUe;ijg;gw;wpa KOikahd mwpT kw;Wk; Gupe;J nfhs;Sjypd; mtrpaj;ij
typAWj;JfpwJ.
xt;nthU kUj;Jt Muha;r;rpfspYk;> mjhtJ kdpju;fis Muha;r;rpf;F
cl;gLj;Jk; Kiw vJthapDk; mjpy; fl;lhakhf kUe;Jfs; kw;Wk; gf;ftpisTfis
fz;fhzpf;Fk; Kiwik vd;gJ me;j jpl;l tiutpy; ,lk;ngw Ntz;Lk;..
xt;nthU kUj;Jt Muha;r;rpfspYk; (Clinical Trial) kw;Wk; gl;l Nkw;gbg;G
kUj;Jtf;fz;fhzpg;G
njhlu;ghd Ma;TfspYk; (Dissertation) kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk;
Kiwikf;fhd njspthd tiuKiw me;j Muha;r;rpf;fhd jpl;l tiutpy; (Protocol)
fl;lhak; ,lk;ngw Ntz;Lk;. Muha;r;rpapd;NghJ ghjfkhd tpisTfNsh (ADR)
my;yJ ghjfkhd epfo;TfNsh (AE) Vw;gl;lhy; mjd;gpwF vd;d nra;a Ntz;Lk;>
vd;w topKiwfs; vy;yhk; njspthf ,lk;ngw Ntz;Lk;. mjw;fhd Fwpg;G tiuglKk;
(Flow Chart) me;j Muha;r;rp jpl;ltiutpy; mtrpak; ,lk;ngw Ntz;Lk;. mJNt ePjp
MFk;. mg;NghJ jhd; ePjp epu;zaf;FO (IEC) Tk; me;j Muha;r;rpf;fhd xg;Gjiy
toq;Fk;.
,jpypUe;J ehk; mwptJ> mwpa Ntz;LtJ vy;yhk; xd;W jhd;. 100 rjtpfpjk;
vy;NyhUf;Fk;> vy;yh fhyj;jpYk;> vy;yh ,lq;fspYk; ghJfhg;ghd kw;Wk; gyd;jUk;
kUe;J vd;w xd;W ,y;iy. vdNt mjidf; ifahSk;NghJ kUj;Jtu;fSk;
Nehahsu;fSk; kpFe;j ftdj;Jld; ,Uf;f Ntz;Lk;.
,d;Dk; xU gb NkNy Ngha; fOfpd; ghu;itaha; ghu;j;Njhkhdhy; gf;f tpisTfs;

kw;Wk; Nkhrkhd tpisTfs; vd;gJ vy;yhNk kUe;jpay; Jiwapd; (Pharmacology) xU
gFjpNaad;wp Ntwpy;iy vd;gJ nts;spil kiynad njs;sj;Jyq;Fk;.
In India -
** Where all citizens have right to access medical facility**
** where medicines are affordable for entire population**
** Where all health care professional and
Patients can Report ADRs as a concern safety **
kUj;Jtf;fz;fhzpg;G
4. rpj;j kUj;Jtj;jpd; kUj;Jtf; fz;fhzpg;G
ekJ Kd;Ndhu;fshfpa ngUikf;Fupa rpj;ju; ngUkf;fs; gy JiwfspYk;

rpwe;J tpsq;fpaJ Nghy kUj;Jtj;JiwapYk; rpwg;Gw;W tpsq;fpAs;shu;fs;. mtu;fs;
kUe;jpd; kPJ cs;s tpupthd Gupe;Jzu;jy;> mtw;why; Vw;gLk; gyd;fs;> cz;lhFk;
gf;ftpisTfs; kw;Wk; gad;gLj;Jk; rupahd Kiwfisg;gw;wpAk; ed;F mwpe;J
tpsq;fpaijNa vLj;jpak;GfpwJ.
ghuk;gupa kUj;Jtj;jpd; kPJ nghJthf kf;fSf;F cs;s kpfTk; Kf;fpakhd>
jPuhj> jtwhd ek;gpf;if ahnjdpy;
1. ,aw;ifahd kUe;Jfs; my;yJ ,aw;ifahd kUj;Jt Kiwfs; vd;gJ 100
tpOf;fhL ghJfhg;ghdJ.
2. vt;tsT ehl;fs; Ntz;LkhdhYk; njhlu;r;rpahf ,aw;if kUe;jpid
cl;nfhs;syhk;> mJTk; ghJfhg;ghdJ.
3. ghuk;gupa kUj;Jt Kiw vd;whNy ghJfhg;ghdJ vd;git jhd;. ,aw;if
vd;whNy ghJfhg;ghdJ vd;w czu;T> eyk; jUk; ek;gpf;if vd KOikahf
vLj;Jf;nfhs;s KbahJ. mJ xU FUl;L ek;gpf;ifNa MFk;. mij Gs;sp tpguq;fNshL
cq;fSf;F tpsf;FfpNwd;.
WHO – d; UMC (Uppsala Monitoring Centre) Sweden y; cs;sJ. ,jpy; cs;s
gf;f tpisTfspd; njhFg;G (ADR Data Base) 2010 d; gb ,aw;ifg; nghUs;fshy;
Vw;gLk; tpisTfspd; Gs;sptpgug;gl;bay; jug;gl;Ls;sJ. ,jpy; re;Njfg;gLk; gbahd
kw;Wk; cWjpahd Ma;twpf;iffSk; (Suspected and Interacting Case Reports) mlq;Fk;.
• Nk khjk; 2004 d; fzf;nfLg;G gb> mjhtJ 3.6 millions mwpf;iffspy;
%ypifj;njhlu;ghd gf;f tpisTfs; kl;Lk; 41> 439 MFk;.
• brk;gu; khjk; 2010 tiu> %ypiffshy; kl;Lk; Vw;glf;$ba gf;f tpisTfs;
vd fz;lwpag;gl;lit 12> 679 MFk;.
• NkYk; %ypif kw;Wk; kw;w nghUl;fs; Nru;e;j kUe;Jfshy; Vw;gl;l gf;f
tpisTfspd; vz;zpf;if 21> 951 MFk;.
kUj;Jtf;fz;fhzpg;G
Status of Natural Products

Suspected/Interacting Case Report
As of May 2004,
- Herbal related – 41439 (Total 3.6 millions)
As of December 2010,
- Only Herbal - 12679
- both Herbal and Non-Herbal - 21951
,g;NghJ NkNy nrhd;d $w;wpd; fhuzk; xusTf;fhtJ cz;ik vd xj;Jf;

nfhs;s Kbfpwjh? ,dp ehk; rpj;ju;fs; $wpAs;s kUj;Jt fz;fhzpg;G rhu;e;j gy
mwpa Fwpg;Gfis fPo;tUkhW fhzyhk;.
ek; jkpo; kUj;Jtj;jpYk; “tq;fk; nfl;lhy; gq;fk;” vd;gd Nghd;w nrhw;nwhlu;fis
ghu;j;jpUf;fpNwhk;. kw;Wk; rupahf kUe;jpid mjw;Fupa Kiwg;gb nra;J Kbf;fhky;
cgNahfg;gLj;Jk; my;yJ jtwhd Kiwapy; mjid gad;gLj;Jk; kUj;Jtd; “nfhba
,kthd; Mthd;” vd;gd Nghd;w vLj;Jf;fhl;LfisAk; ekJ E}y;fspy; fhzyhk;.
vdNt ekJ Kd;Ndhu;fshfpa ngUikf;Fupa rpj;ju; ngUkf;fs; gy JiwfspYk;
rpwe;J tpsq;fpaJ Nghy kUj;Jtj;JiwapYk; rpwg;Gw;W tpsq;fpAs;shu;fs;. mtu;fs;
kUe;jpd; kPJ cs;s tpupthd Gupe;Jzu;jy;> mtw;why; Vw;gLk; gyd;fs;> cz;lhFk;
gf;ftpisTfs; kw;Wk; gad;gLj;Jk; rupahd Kiwfisg;gw;wp ed;F mwpe;J
tpsq;fpaijNa vLj;jpak;GfpwJ.
ekJ E}w;fspYk; Xiyr;RtbfspYk; kUe;jpidg; gw;wp $Wk;NghJ mtw;wpdhy;
Fzg;gLj;Jk; Neha;fisAk; ,d;dpd;d Neha;fSf;F ,e;j kUe;J toq;fg;glyhfhJ
vd;gijAk;> kPwpg;gad;gLj;jpdhy; mtw;why; Vw;gLk; gf;f tpisTfisAk;> Kiw jtwp
gad;gLj;Jk; NghJ cz;lhFk; eQ;Rf;FwpFzq;fisg; gw;wpAk;> mjd; eQ;Rj;jd;ik
gw;wpAk;> NkYk; eQ;ir Kwpg;gjw;F cupa khw;W kUj;Jt KiwfisAk; cs;sq;if
ney;ypf;fdpnad vLj;J ek; Kd; itj;jpUf;fpwhu;fs;.
NkYk; mk;kUe;jpidg; gad;gLj;Jtjw;F Kd;G mjd; kypdq;fis ePf;fTk;>
mjd; tPupaj;jd;ikia mjpfupf;fTk;> gf;f tpisTfis Vw;gLj;Jk; mikg;Gfis
khw;wTk; Rj;jp nra;jy; vDk; mUikahd KiwapidAk; mLj;Js;s re;jjpapdu;f;F
tpl;Lg;NghapUf;fpwhu;fs;. NkNy tpthjpj;j fhuzq;fisf; nfhz;L rpj;ju; ngUkf;fs;
gf;ftpisTfs;> eQ;Rfs;> eQ;rpid ePf;Fk; Kiwfs;> eQ;Rf;FwpFzq;fs; Nghd;wtw;iw
njspthf Mtzg;gLj;jpapUf;fpwhu;fs; (Documented Adverse Drug Reaction) vd
mwpaKbfpwJ.
,jpypUe;J Kd;fhyj;jpNyNa kUe;Jfisg;gw;wpa KOikahd mwpT kw;Wk;

Gupjy; ,Ue;jpUg;gij fhzyhk;. kUe;jpd; Rit> tPupak;> tpghfk; kw;Wk; nra;if>
kUj;Jtf;fz;fhzpg;G
gad;gLj;Jk; msT> Fzg;gLj;Jk; Neha;fs;> kUe;jpdhy; Vw;gLk; gf;f tpisTfs;
(ADRs), kUe;J – czT ,iltpid tpisT (Food & Drug Interaction), kUe;J – kUe;J
(Drug & Drug Interaction) ,iltpid tpisT> xU Fwpg;gpl;l kUe;Jld; Nruf;$ba
kUe;Jfisg;gw;wpAk; (Compatibility), Nruf;$lhj kUe;Jfisg; gw;wpAk; (Incompatibility)
cs;s gue;Jgl;l mwptpid czuKbAk;.,JNghy czT-czT ,iltpid tpisT
(Food - Food Interaction) gw;wpAk; vLj;Jiuj;jpUf;fpwhu;fs;.
4.1 fs;sg;gpzp / kUe;jpdhy; tpisAq; NfLfs;

kUj;Jtf; fz;fhzpg;G vd;whNy kUe;Jfspd; ghjfkhd tpisTfs; kw;Wk;
gf;f tpisTfs; vd;gJ jhd; Kjd;ikahf fUjg;gLtJ. mjidg; gw;wp ek; rpj;j
kUj;Jtk; rhu;e;j E}y;fspy; Muha;e;j NghJ rpfpr;rh uj;jpd jPgk; itj;jpa rpe;jhkzp
vd;Dk; E}ypy; kUe;Jfshy; Vw;glf;$ba gf;ftpisTfspd; FwpFzq;fis kUe;jpdhy;
tpisAq; NfLfs; vd;Dk; ghlypy; tpspf;fpAs;sdu;. mJkl;Lkpd;wp ,t;tpisit
“fs;sg;gpzp” vd;W xU jdp NehahfNt “fz;Zrhkpak; vd;Dk; itj;jpa Nrfuk;"
vd;w E}ypy; $wg;gl;Ls;sJ. ,J ek; rpj;j kUj;Jtj;jpd; Nkd;ikia giurhw;Wk;
tpjkhf mike;Js;sJ. etPd fhyj;jpy; fz;lwpag;gl;l xU nrhw;njhlUf;F ek;ktu;fs;
gy Mz;LfSf;F Kd;du; $wpa tpsf;fk; mjw;F mtu;fs; nfhLj;Js;s fs;sg;gpzp
vd;Dk; jiyg;G tpag;igaspf;fpwJ.
kUe;jpdhy; tpisAq; NfLfs;
Ntu;j;jpLQ; rpypu;j;jpL nka;fL fLj;jpL
khu;j;jpL ke;jpf;F krjpNk ypl;bL
Kd;kj;j khapL KiujL khwpL
kpd;kj;j khnkd Ntq;fpl nra;jpLk;
- rpfpr;rh uj;jpd jPgk; itj;jpa rpe;jhkzp
cly; tpau;j;jpLk;> cly; rpypu;j;jpLk;> cly; fLfLj;jpLk;> mrjp NkypLk;>
cd;kj;jk; cz;lhFk;> ciu jLkhWk;> cd;kj;jk; Nghy Vq;fpl nra;jpLk;.
fs;sg;gpzp
nfhs;Sk; kUe;njhd;wpy; $Wk; eypjPu;j;J
fs;sgpzpNtW fz;bbd; Nfs; cs;s
kUe;jhfnjd;Nw kUj;Jtj;jp yhd;wu;
fUj;jikj;Jf; $wpdhu; fz;L
- (fz;Zrhkpak; vd;Dk; itj;jpa Nrfuk;)
kUj;Jtf;fz;fhzpg;G
ehk; rhg;gplf;$ba kUe;J xd;wpy;> me;j kUe;jhdJ Nehia> Fzkhf;fpa
gpd;G $l mJ NtW VNjDk; Nehia Vw;gLj;jpdhy;> me;j Nehia 'fs;sg;gpzp" vd;W
$Wtu;. mt;thW fs;sg;gpzp xU kUe;jpdhy; Njhd;Wkhdhy; mJ kUe;jhfhJ vd;W
fz;Zrhkpak; vd;Dk; itj;jpa Nrfuk; $WfpwJ.

etPd fhyj;jpy; cUthf;fg;gl;l ghjfkhd tpistpw;fhd nrhy;Yf;F rpj;j
kUj;Jtj;jpy; gy Mz;Lf;F Kd;dNu fs;sg;gpzp vd;w ,izahd nrhy; $wg;gl;Ls;sJ
rpwg;ghdjhFk;.
4.2 rpj;j kUj;Jt Neha;tifg;ghLfSk; kUj;Jtf; fz;fhzpg;Gk;:

rpj;j kUj;Jtj;jpy; kUe;Jfshy; vw;glf;$ba tpisTfis jdp Nehahf
tpsf;Ffpd;wdu;> vt;thW vd;why; Ruk; vd;w Neha;g; gw;wp $Wk; NghJ mjd; tiffspy;
kUe;J NtfRuk; vd;w tifia $wpAs;sdu;. kUe;J cl;f;nfhs;Sk; NghJ Vw;glf;
$ba ghjfkhd tpisthdJ Rukhf ntspg;gl;lhy; mJ kUe;J NtfRuk;. mjid
xUtifahd RuNehahf tifg;gLj;jpAs;sdu;. mJ NghyNt kUe;jPl;L ,Ukypy; kUe;jhy;
Vw;glf;$ba ,UkYk; mlq;fpAs;sJ. ,it kl;Lk; my;yhJ gy;NtW Neha;fspy;
mjd; tUk; topapy; ,urghlhz kUe;JfshYk;> vl;b> thsk;> Nghd;w %ypif Nru;e;j
kUe;JfshYk; cz;lhFk; Neha; vd;W $wpAs;sdu;. ,tw;wpd; vLj;Jf;fhl;Lfs; rd;dp>
the;jp> ngUtapW MFk;
rpj;j kUj;Jtj;jpd; ml;lhq;f Nahfj;jpy; ,akk;> epakj;jpw;F mLj;jgbaf
,Ug;gJ Mrdk; ,e;j Mrdj;jpid gapw;rp nra;tjd; %yk; Neha;tuhky; jLf;f
,aYk;> te;jNehiag; Nghf;f KbAk;> ,itfisf; fle;J tho;tpd; cr;rkhd tPLNgW
mila ,aYk;. ,g;gb ngUik tha;e;j Nahfj;jpdhy; $l Neha; Vw;gLk; vd;why; Vw;f
KbAkh? mjid ,g;nghOJs;s Ma;thsu;fs; fz;lwpe;J $wtpy;iyah> ek;rpj;ju;fs;
Nahfj;ij kl;Lk; gw;wp tpsf;fhky; Nahfj;ij KiwjtwpNah> Neuk; jtwpNah nra;Ak;
NghJ mjdhy; Vw;gLk; ghjfkhd tpisTfisAk; Neha;fisg; gw;wpf; $Wkplj;jpy;
tpsf;fpAs;sdu;. ,tw;wpd; vLj;Jf;fhl;lhf Fd;kk;> vUtha; KisNeha;> ePu;r;RUf;F>
nts;isNeha;> ntwpNeha; Nghd;w Neha;fspd; tUk; topahf NahfKk; cs;sJ.
Nkw;$wpa Neha;fspy; ngUk;ghyhdit ntt;NtW fhuzq;fshy; tuf;$bait.
Mdhy; Nahfj;jpYk; ,it tUk; vd;w fz;Nzhl;lj;jpy; ,dp Neha;f;fzpj;jiy ehk;
Nkw; nfhs;s Ntz;Lk;> Neha; fz;fhzpg;Gj;Jiwapy; cs;stu;fs; Nahfj;jhy; tUk;
Neha;g;gw;wpa tpopg;Gld; ,Ug;gNjhL tpopg;Gzu;T Vw;gLj;j Ntz;Lk;.
kUj;Jtf;fz;fhzpg;G
4.3 ghjfkhd tpisT tuhky; jLf;f rpj;j kUj;Jtk; typAWj;Jk; Kiwikfs;
rpj;j kUj;Jtj;jpy; rpj;ju;fs; kUe;J nra;tJ Kjy; kUe;jpid Nehahsdplk;
nfhLf;Fk; tiu gy tpjkhd tpjpKiwfis filg;gpbj;Js;shu;fs;. me;j
tpjpKiwfis fLikahfg; gpd; gw;wpajhy; kUe;Jfshy; Vw;gLk; ghjfkhd tpisTfs;
Vw;glhtz;zk; fhj;Js;shu;fs;. mitfs; ahnjdpd; kUe;J nghUl;fs; tpisAk; (m)
fpilf;Fk; epyk;> fhyk;> mtw;iw Nrfupf;Fk; gUtk;> Nrfupf;Fk; Kiw> ghJfhf;Fk;
Kiw> gjg;gLj;Jk; Kiw> mjid Rj;jp nra;Ak; Kiwfs;> gy tpjkhd kUe;J nra;
Kiwfs;> kUe;Jfis ghJfhf;Fk; Kiwfs; mjd; msT Kiwfs;> kUe;Jfspd;
mDghdq;fs;> kw;Wk; kUe;Jfspd; msT> ghjfkhd tpisTfs; Fwpj;j tpsf;fq;fs;>
eQ;Rfs;> eQ;Rf;FwpFzq;fs;> mjd; KwpTfs;> Fzg;gLj;Jk; topKiwfs; Nghd;wtw;iw
Muha;e;J mtw;wpd; newpfis Kiwahf tFj;Js;sdu;. mtw;wpd; tpsf;fj;ijAk;
vLj;Jf; fhl;LfisAk; fhzyhk;.
Nrfupf;Fk; Kiw:
fhl;L ntq;fhak; Nrfupf;Fk; NghJ Kw;whjjw;F Kd;dNu vLj;J mupe;J>
eLg;ghfj;ij ePf;fptply; Ntz;Lk; vd;W $wg;gl;Ls;sjhy; nrbapd; tsu; jd;ik
kUe;Jfspd; tPupaj;ij khw;wf;$Lk; vd;gjid mwpe;J mJf;Nfw;whu; Nghy; kUe;Jg;
nghUl;fis Nrfupj;Js;sdu;.
G+ePiu rpj;uh ngsu;zkp jpdj;jpy; jhd; Nrfupf;f Ntz;Lk;. kw;w jpdj;jpy; G+f;Fk; cg;G
G+ePu; MfhJ vd;W $wg;gl;Ls;sjhy; fhyj;ijg; nghUj;J kUe;Jfspd; tPupak; khWk;
vd;gJk; ntspg;gil.
kUj;Jtf;fz;fhzpg;G
mag;gw;gk; nra;tjw;F “kUj epyj;jpy; cz;lhFk; rpj;jpu %y ,iy”r; rhw;iw
nfhz;L Glk; ,l Ntz;Lk; vd;W $wg;gl;Ls;sjhy; epyk; rhu;e;J gy %ypiffspy;
gy;NtW khWjy;fs; tuf;$Lk; vd;gjid mwpe;J nray;gl;L Nrfupj;Js;sdu;.
kUe;Jfspd; Kjw;gbahd kUe;J Nrfupj;jypy; ,Ue;Nj rpj;ju;fs; ghjfkhd tpisT
tuhjthW vr;rpupf;ifNahL ,Ue;Js;sdu;> %ypifg; nghUl;fisNah my;yJ jhJrPtg;
nghUl;fisNah xU Fwpg;gpl;lf; fhyf;fl;lj;jpy; Nrfupf;Fk; nghOJ me;j nghUspd;
tPupak; ed;whf ,Uf;Fk; vd;gij gl;baypl;L nfhLj;Js;shu;fs;.
kUe;Jg; nghUl;fis Nju;e;njLf;Fk; Kiw:
%ypif-fLf;fhapy; gytif cz;L. mjpy; xt;nthU tifAk; rpwg;ghf xU
rpy Neha;fis Nghf;Fk; vd;W Fwpg;gplg;gl;Ls;sJ. mjpy; ehk; nra;Ak; kUe;JfSf;F
Vw;wthW rpwg;ghd ruf;Ffis Nju;e;njLj;J kUe;J nra;Ak; NghJ ghjfkhd
tpisTfis jtpu;f;fTk; KbAk;> tPupaj;jpid mjpfupf;fTk; KbAk;.

jhJ – ,urk;> etkzpfs; Nghd;wtw;wpy; Fw;wk; vd;W Fwpg;gplg;gl;Ls;stw;iw
rpwg;gw;wjhf fUj;jpy; nfhz;L mtw;iw ePf;fp rpwe;jtw;iw kUe;J nra;tjw;Fk;>
mzpfydhf mzptjw;Fk; Nju;e;njLj;Js;sdu;.
kUe;Jg; nghUl;fis Nrfupj;jg; gpd;> mjd; tiffis fz;lwptjd; %yk;>
rupahd nghUl;fis rupahd Neha;fSf;F gad;gLj;jp ngUk;gad; mile;jdu;. ,jdhy;
kUe;Jfspd; KOikahd gad;fs; ngwg;gl;L ghjfkhd tpisT jtph;f;fg;gLfpd;wd.
Rj;jpKiw:
%ypifapy;:
Rf;Ff;F Gw eQ;R/fLf;fha;f;F mf eQ;R vd;W Fwpg;gpl;Ls;sjhy;> Rj;jp nra;jy;
vd;gJ nghUl;fis fOTjy; Nghd;w Gw Rj;jk; kl;Lky;yhJ mjpYs;s gaDs;s
ghfq;fis vLj;Jf;nfhz;L gadw;wtw;iw my;yJ eQ;R jd;ik tha;e;jtw;iw
ePf;fpAs;sdu;.
jhJ nghUl;fspy;:
,urj;ij Rj;jp nra;ahky; nfhLj;jtUf;F ‘gQ;rkh ghjfk; tpisAk;’. vd;W
rpj;ju;fs; Fwpg;gpl;Ls;sdu;. mjhtJ xU kUe;J nra;a Njitahd nghUl;fspy;
cs;s kypdj;jhy; capUf;Nf Mgj;J vd;gij czu;j;Jk; tpjkhf ,e;j thf;fpaj;ij
$wpAs;sdu;. ,jd; %yk; Rj;jpapd; Kf;fpaj;Jtj;ij $wpAs;sdu;. ghjfkhd tpisT
tuhky; jLg;gjpy; Kf;fpakhd gq;F tfpg;git Rj;jp KiwahFk;. ,J kUe;J ruf;Ffspd;
my;yJ kUe;Jfspd; eQ;Rfis ePf;FtJ kl;Lky;yhky; kUe;jpd; tPupaj;ijAk;
mjpfupf;fpwJ.
kUj;Jtf;fz;fhzpg;G
kUe;J nra;Kiwfs;:
ghj;jpuk;-Nju;e;njLf;Fk; Kiw
kUe;J nra;Ak; ghj;jpuj;ij nghWj;J kUe;Jfspd; tPupak;> jd;ik Nghd;wit
khwf;$Lk;. ,jdhy; kUe;Jfspd; tPupak; mjpfupf;fyhk;> Fiwayhk; (m) eQ;Rj;jd;ik
Vw;glyhk;> Mifahy; jhd; rpy kUe;Jfspd; nra;Kiwfspy; Fwpg;gpl;l rpyghj;jpuq;fspy;
nra;a rpj;ju;fs; Fwpg;gpl;Ls;shu;fs;. kz;zhy; nra;j fyd; vg;nghOJNk rpwg;G. nrk;G>
gpj;jis ghj;jpuq;fspy; Gspg;Gr;Rit cs;sitfisg; ghfQ; nra;jhy; mitf;fWf;Fk;.
nts;sPa ghj;jpuj;jpy; rikj;jhy; khWjy;fs; miltjpy;iy Mifahy; jhd; nrk;G>
gpj;jis ghj;jpuq;fSf;F nts;sPak; G+rg;gLfpwJ.
v-fh
mankOF-,Uk;G rl;bapypl;L nra;jpLjy; Ntz;Lk;.
matPur;nre;J}uk;-njd;id <u;f;F fw;iwia cgNahfpj;J tWf;fTk;.
mf;fpdp:
mf;fpdpia kpfTk; El;gkhf rpj;ju;fs; gad;gLj;jpAs;sdu;. jPapd; msT vupnghUs;>
vupf;ff;$baf; fhyk; Nghd;wtw;iw kpf njspthf gy ,lq;fspy; tpsf;fpAs;sdu;.
,jd; %yk; kUe;Jfis rupahd Kiwapy; Kbf;fTk;> gf;ftpisT tUk; tha;g;Gfis
Fiwf;fTk; KbAk;.
vupg;G Kiwfs;> gy;NtW tifahdg; Glq;fs;> tpwF tiffs;> 4 tifahd
jPapd; msTfs; [G+uf;fl;L-mupjhu gw;gk;- jPghf;fpdp> fkyhf;fpdp. fhlhf;fpdp 3 jPAk;
gad;gLj;jg; gLfpwJ]> vupg;gpd; fhy msT [jq;f cuk;-25 kzp Neuk; vupf;f Ntz;Lk;].
fhyk; (k) Neuk;:
kUj;Jtk; vd;whNy NehAs;sf; fhyq;fspy; vLg;gJjhd;. mjpnyd;d fhyk; Neuk;
vd;w re;Njfk; Vw;glyhk;. Mk;! cs;sJ> rpj;ju;fs; ve;jfhyq;fspy; ve;j kUe;J rpwg;ghf
nray; GupAk; vd;W Muha;e;J mjw;F Vw;g kUj;Jtk; nra;J gf;f tpisTfisf;
Fiwj;J> kUe;Jfspd; KOg;gyidAk; ngw;Ws;sdu;.

,ypq;f gw;gk;-Grpf;f Vw;w jpq;fs;: fhu;j;jpif> gq;Fdp> rpj;jpiu> Mtzp> Ig;grp.
kw;wit MfhJ.
kUj;Jtf;fz;fhzpg;G
kUe;Jz;Zk; fhy msT:
kUe;Jz;Zk; fhy msT nghUj;jtiu> Fiwe;jsT vLj;Jf; nfhz;lhy;
KOg;gyd; fpilg;gJ re;Njfk;. mNjNghy; mjpf ehl;fs; vLj;Jf; nfhz;lhy;
eQ;rhff;$Lk;> Mifahy; kUe;Jz;Zk; fhyj;ijAk; mjd; gyidAk; tptupj;Js;sdu;.
mag; gw;gj;ij 32 ehl;fs;- cj;jkk;: 18 ehl;fs; -kj;jpkk;: 12 ehl;fs; - mjkk;: 12
Fiwe;j ehl;fs;- mjkhjkk; vd;W $wpAs;sjhy; kUe;jpd; fhy msthy; ve;j xU
jfhj tpisTk; Vw;glh tz;zk; rpj;ju;fs; toptFj;Js;sdu;.
kUe;jpd; msT:
kUe;jpd; msTfspy; Vw;gLk; gpioahNyNa ngUk;ghd;ikahd ghjfkhd
tpisT epfo;fpwJ. rpj;ju;fs; ngUk;ghd;ikahd kUe;jpd; msit kpfTk; tpupthfTk;
njspthfTk; tptupj;Js;sdu;. vs;ssT> fLfsT> cSe;jsT> Jtiu msT>
nkhr;irasT> tuhfndil> gzntil> cof;F> Mohf;F> J}f;F> Njhyh Nghd;w
vz;zw;w msTKiwfis gpd;gw;wpAs;sdu;.
v.fh: Vy tlfk;:fow;rpf;fha; msT
nrk;G gw;gj;jpd; msT: ¼ fLF-cj;jkk;: ¼ -jpid-kj;jpkk;: ¼ rhik-mjkk;: ¼
nfhs;- mjkhjkk;. jw;NghJs;s fhyfl;lj;jpy;> nkl;upf; msTfis kpfj;Jy;ypakhf
gad;gLj;JfpNwhk;. Mdhy; ve;jnthU mwptpay; rhjdq;fSk; ,y;yhj fhyj;jpNyNa
kpf Ez;zpa msTfspy; kUe;ijg;gad; gLj;j mwpTWj;jpapUf;fpwhu;fs;.
,f;fhyj;jpy; ,Nj msTfisg; gpd; gw;Wtjpy; gy rpf;fy; cs;sJ mjdhNyNa
ghjfkhd tpisT Vw;gLfpd;wJ. vg;gbnad;why; ek; rpj;ju;fs; jq;fspd; kUe;jpd;
msit Fwpg;gpLifapy; ngUk;ghd;ik jhdpaq;fs;> tpijfs; ,tw;wpd; msitNa
Fwpg;gpLfpd;wdu;. ,g;NghJs;s fhyj;jpy; ,J NtWg;gl;Ls;sJ. mJkl;Lk; my;yhky;
kdpju;fspd; cly; thFk;> gof;ftof;fq;fSk;> fyhr;rhu KiwfSk;> czTKiwfSk;>
cly; ciog;Gk; fhyj;jpdhy; NtWgl;Ls;sJ. mjdhy; kUe;Jfspd; msTfis
jw;NghJs;s Kiwf;Fj;jf;fthW tiuaWf;f Ntz;Lk;.
kUe;J itf;Fk; ghj;jpuq;fs;:
Njq;fha; FLf;if> %q;fpy;> ahid je;j rpkpo;> kuk;> kpUfq;fspd; nfhk;G>
,Uk;G> ntz;fyk; Nghd;w fyd;fspy; milg;gjpy; kUe;jpd; jd;ik khwhkYk; > kUe;J
ghohfkYk; ,Uf;Fk;. rpy kUe;Jfis fyd; khw;wp itf;Fk; NghJ mjd; jd;ik khwp>
kUj;Jtf;fz;fhzpg;G
mjdhy; ghjfkhd tpisT Neuf;$Lk; vd;gjhy; me;je;j kUe;Jf;Nfw;w fyd;fspy;
kUe;Jfis itj;Js;sdu;.
kUe;Jz;z Vw;w epyk;:
kUe;Jz;Zk; NghJ rpy epyq;fspy; cz;z Fwpg;gplf; fhuzk; cs;sJ> rpy
kUe;jpd; tPupaj;ij Kwpf;Fk;. rpy kUe;jpd; tPupaj;ij mjpfupf;Fk;> rpy xt;thJ.
Mifahy; rpj;ju;fs; epyq;fis tFj;Js;sdu;. fe;jf gw;gk;-kUjk;-MFk;:nea;jy;-
Mfh:FwpQ;rp> Ky;iy-kj;jpkk;.
Nky; Fwpg;gpl;litj; jtpu NkYk; gy E}y;fspy; rpj;ju;fs; gy;NtW topKiwfis
tFj;J kUe;Jfshy; jtW Neuh tz;zk; kUj;Jtk; nra;J te;jdu;. ,Ug;gpDk;
,ur nkOF> ru;tRuf; Fspif> nfsup khj;jpiu> jhsfg; gw;gk;> f];J}upf; fUg;G
Nghd;w ngUk; kUe;Jfshy; ghjfkhd tpisT Vw;glf;$Lk; vd;W fUjp> mtw;iw
tuhky; jLg;gjw;;fhd topKiwfisAk; mtw;wpd; kUj;Jtj;ijAk; rpj;j kUj;Jtk;
tpsf;fpAs;sJ.
4.4 %ypiffSk; - kUe;JfSld; mjd; nray;ghLfSk;
kUe;Jfs; vLj;Jf; nfhs;Sk; NghJ rpy czTg; nghUl;fNsh my;yJ
kUj;Jt FzKs;s nghUl;fNsh Nru;j;J vLf;Fk; NghJ> mg;nghUs; me;j kUe;jpd;
kPJ jhf;fj;ij Vw;gLj;Jk; mjpy; rpy kUe;jpd; Fzj;ij nfLjyhf khw;Wk;. rpy ngU
kUe;Jfspd; jd;ikiaf; Fiwf;Fk;. mtw;iw ,q;Nf tpsf;fpAs;Nshk;.
kUe ;jpd ; t Ph p aj ;ijf ; Fiwf ;ff ; $ba> md ;whl gad ;gLj ;j $ba
%y piffs ;
1. nfhk;G ghfy; kUe;Jfspd; ew;Fzj;ij khw;Wk;
2. Nrk;G kUe;Jfspd; ew;Fzj;ij khw;Wk;
3. Nrhsk; kUe;J ghohFk;
4. nfhj;jhtiu kUe;ij ghohf;Fk;
5. nfhs;S nfhs;kUe;Njh ehrk;
6. Mfhaff;fupf;fha; nra;kUe;jpd; fhe;jpAk; Nghk;
7. fliy jplkUe;ij nrjKwnra;Ak;
8. fwpg;ghiy>ewpg;ghiy nka;kUe;Jk; ngha;kUe;jhk;
9. nts;supf;fha; kUe;ij Kwpf;Fk;.
10. vs; kUe;ij nfLf;Fk;.
kUj;Jtf;fz;fhzpg;G
kUe ;jpd ; t Ph p aj ;ijf ; khw ;w $ba %y piffs ;

1. ntz;jhkiug;G+ NfhukUe;jpd; nfhLifaWk;
2. mTupNtu; vy;yhtplq;fSf;Fk; Vw;wKwpg;ghFk;
3. mWfk;Gy; kUe;Jfspd; ntg;gk; Nghk;
4. eQ;RKwpj;jhd;ghiy kUe;jpd; nfLjpfis Nghf;Fk;
5. ney;ypkuNtu; gj;jpa Nflhy; cz;lhd NfLfs;
ahTk; ePq;Fk;
4.5 eQ;R KwpT kUj;Jtk;

xU nghUis gad;gLj;Jk; NghJ mJ khWgl;l FwpFzq;fisf; fhl;bdhNyh
Neha;tha;g;gl;l epiyia cUthf;fpdhNyh capu; gpupit Vw;gLj;jpdhNyh mjid
eQ;R vd;W Fwpg;gpl;Ls;sdu; ,jdhy; Vw;gLk; FwpFzq;fis eQ;R FwpFzq;;fs; vd;gu;.
rpj;j kUj;jtj;jpy; eQ;R KwpT kUj;Jtk; vd;w gpuptpy; gy;NtW eQ;Rfisg;
gw;wpAk;> mtw;wpd; msT> FwpFzq;fs;> kUj;Jtk; Nghd;wtw;iwg; gw;wpAk;> rpj;ju;fs;
tpupthf tptupj;Js;sdu;. mjpy; tpyq;Ffshy; Vw;gLk; eQ;Rfisj; jtpu kw;iwa
eQ;Rfshd jhtueQ;R> cNyhf eQ;R> fhurhu ghlhz eQ;R ,tw;why; tUk; eQ;RfSk;
cs;sJ. kUe;Jfshy; kl;Lk; gf;f tpisT / ghjfkhd tpisT Vw;gLk; vd;w
fz;Nzhl;lj;Jld; ghuhky; czT tiffshYk; Vw;glf; $Lk; vd;W kdjpy; itj;J
gjpT nra;jy; Ntz;Lk;. ,e;eQ;R E}ypy; jhtu eQ;Rg; gpuptpy; tp~j;jd;ikAila
jhtu eQ;Rfis kl;Lk; tptupf;fhky; ehk; md;whlk; gad;gLj;Jk; %ypiffspd;
msT kpFtjhYk; cupa fhyq;fspy; mtw;iw Kiwahf vLf;fhjjhYk; rpy jhtug;
nghUl;fis fye;Jz;gjhYk; er;Rj; jd;ik Vw;gLk; vd;W tpsf;fpAs;sdu;. mjpy;
rpytw;iw gpd;tWkhW fhzyhk;.
muprp (ney;)
njd; ,e;jpahtpy; mjpfstpy; gad;gLk; muprp rhjj;ij kpFjpahf cz;gjhYk;>
nehe;J rpy;ypl;lJkhd rhjj;ij cz;gjhYk;> eQ;Rj; jd;ik cz;lhfpwJ. ,jdhy;
nrupahik> tapw;Wg; nghUky;> Ngjp> GspNag;gk;> vjpnuLj;jy;> Ruk; Nghd;wit cz;lhFk;.
kUj;Jtk;:,jw;fhd KwpT gj;J fpuhk; rPufj;ij ed;wha; Ma;e;J nte;ePu; tpl;L
miuj;jhtJ my;yJ nghupa tpl;L nghupe;jTld; 325 kpyp ePu; tpl;L 80 kpy;ypahf FbePu;
fha;r;rpahtJ 3 my;yJ 5 Ntis nfhLf;f Ntz;Lk;.
cSe;J
mLj;jg;gbahf ngUk;ghd;ikahd czTfspy; Nru;f;fg;gLk; cSe;J mjpfkhf
cz;Ztjhy; grpj;jPiaf; nfLj;J mrPuzj;ij cz;lhf;Fk;> tapw;Wf; fLg;Gk;> tapW
gSTk; cz;lhFk;. kyr;rpf;fy; (m) fopr;ry; fhZk; neQ;Rf;fupg;G Vw;gLk;.
kUj;Jtf;fz;fhzpg;G
kUj;Jtk;:
,jw;fhd KwpT kUe;J
1. nfhs;Sf;fha; Ntis
2. kpsF
3. rPufk;
4. Njd;
tiff;F 4 fpuhk; vLj;Jf; nfhz;L Njd; jtpu kw;iwa ruf;Ffis kz;rl;bapy;
tWj;J 165 kpyp ePu;tpl;L fhy; Mohf;fha; fha;r;rp mj;Jld; 4 fpuhk; Njd; Nru;j;J Neha;
td;ikf;Fj; jf;f ehssT nfhLf;f cSe;jpd; eQ;R jPUk;.
Njq;fha;
Njq;fhahy; Vw;gLk; eQ;R vd;dntd;why; mjpfstpy; thapy; ePu;Rug;G> eh
Ritapd;ik> the;jp> fopr;ry;> jiy kaf;fk;> ePu;Ntl;if cz;lhFk;.
kUj;Jtk;: ,jw;fhd KwpT fUk;G> nty;yk; my;yJ gr;ruprp ,itfspy; xd;iw
cl;nfhz;lhy; Njq;fha; eQ;R KwpAk;.
thiog;gok;
thiog;goj;ij mjpfkhf cl;nfhz;lhy; tapW ke;jg;gl;L nghUKk; gyKiw
tapw;iw typf;Fk;.
kUj;Jtk;: ,jw;fhd KwpT Gifapiyf; FbePu;.
NfhJik
tl ,e;jpahtpy; mjpfkhf gad;gLj;Jk; NfhJikapd; msT kpFtjhy; clk;gpy;
mjpf R+L cz;lhFk;. rpyUf;F kyr;rpf;fYk;> rpyUf;F fopr;rYk; Vw;gLk;. tapw;Wg;
nghUky;> grp ke;jk; Vw;gLk;.
kUj;Jtk;:,tw;wpd; eQ;R Kwpf;f> kpsfha;> gRtpd; ghy;> nea; Kjypy; ,itfis
rkaj;jpw;F jf;fthW gad;gLj;jpf;nfhs;s Ntz;Lk;.
ghyhil
clk;gpw;F td;ikiaf; nfhLf;Fk; ghyhilia mstpw;F mjpfkhf Grpg;gjhy;
grp ke;jk; Vw;gl;L tapw;Wg;nghUky;> fopr;ry;> the;jp> tapw;W typ Mfpaitfs;
cz;lhFk;.
kUj;Jtk;: ,tw;Wf;F Gspj;jNkhu; my;yJ Njd; Fbj;jhy; eQ;R jPUk;.
NfhopKl;il
mirtj;jpy; NfhopKl;ilia msT fle;J Ntfitj;Njh my;yJ mstpw;F
mjpfkhfNth cl;nfhs;tjhy; grp ke;jKk;> GspNag;gKk;> nrupahikAk; cz;lhFk;.
kUj;Jtk;:
,jw;F Ks;sq;fp fpoq;if cl;nfhz;lhy; mjd; eQ;R Ntfk; jzpAk;.
kUj;Jtf;fz;fhzpg;G
%ypifahy; Vw;gLk; eQ;Rj;jd;ikAk; mtw;wpd; KwpTfSk;

1. rjFg;ig ,jd; eQ;Rjid Kwpf;f vYkpr;ir
(m) Gspg;G khJis gor;rhW
nfhLf;fyhk;
2. fLFNuhfpzp ehf;if jpkpu;f;f$baJ.
eQ;Rj;jd;ik cz;lhf;Fk;gb
,ij rhg;gpl;lhy; Kjypy;
nte;ePiuf; nfhLj;J the;jp
MFk;gb nra;J> gpwF mgpdp
Kjypa ntg;Gg; nghUl;fis
nfhLf;f Ntz;Lk;.
3. fLf;fha; fLf;fhapd; tpijeQ;R
4. Mw;Wj;Jkl;b ,jd; kUe;Jfis mjpf mstpy;
nfhz;lhy; the;jp cz;lhFk;
5. ehtw;nfhl;il kpFe;jstpy; cz;z eQ;R.
6. ehtw;gok; ,jd; jPq;if Kwpf;f ney;ypf;fhia
nkd;W jpd;W Fsu;e;j ePu; Fbf;f
Ntz;Lk;.
7. vl;b vjpu;g;nghUl;fs;> ,urk;> G+uk;> tPuk;
Jtu;g;GnghUl;fs;.
ehtw;;gl;il - ,jd; eQ;rpf;F
khw;whFk;
8. Msptpiu ghiy Rug;gpf;Fk;> Mdhy;
,sq;fUit mopf;Fk;
9. Mw;WJk;kl;b ,e;j kUe;ij mjpf mstpy;
cz;lhy; the;jp> Fly;Gul;ly;>
FUjpf;fopr;ry; cz;lhfyhk;.
Flw; Gz; gl;ltu;fSf;Fk;>
gps;isj;jha;r;rpf;Fk; ,jdhy;
nra;ag;gl;l kUe;ij
nfhLf;fyhfhJ.
10. rptdhh; fpoq;F ehtw;nfhOe;J - ,jd; eQ;ir
Kwpf;Fk;.
11. Ckj;ij eQ;R Kwpf;f gUj;jpg;G+>
gpQ;Rf;FbePu; nfhs;syhk;.
kUj;Jtf;fz;fhzpg;G
rpj;j kUj;Jtj;jpy; gad;gLj;jg;gLk; ngUk; kUe;Jfshfpa ,ur ghlhz

kUe;Jfspd; jd;ikia khw;wf;$ba %ypiffs;
1. kpjp ghfy; ,ur ghlhzj;ij Kwpf;Fk;
2. Riuf;fha; Riuf;fha; FLf;ifr; Rl;lf;fup
,urNtf;fhl;il Nghf;Fk;
3. nrg;GneUQ;rpy; ,urNtf;fl;il mlf;Fk;
4 eQ;rWg;gd; nts;isg;ghlhzk;> vl;b> ,LkUe;J>
ghk;Gf;fb> ,tw;wpd; eQ;ir
Kwpf;Fk;.
5 ehfjhsp nre;Jtplq;fs;> nrbtplq;fs;
Nghf;Fk;.
6 nea;r;rpl;b R+jfe;jj;jhy; tUk; thaOfp ehWk;
Gd;id khw;wptpLk;
7 rpWfPiu ,urj;jhy; cz;lhd eQ;Rk; jhtpu
tplKk; Nghk;
8 mfj;jp ,LkUe;J NghFk;
9 nrk;G> nts;isghlhzk;> tPuk;
,tw;why; cz;lhd Nfl;bw;F
fUk;G
fUk;Gr;rUf;fiu kpf rpwe;j eQ;R
KwpT
10 ,LkUe;J> ,urNtf;fhL> eQ;Rfs;
fypahzg; G+rzpf;fha; ,itfSf;F ,iyia rikj;jhtJ>
rhw;iwahtJ nfhLf;fyhk;
11 fUg;gq;fhb <ak; cz;l eQ;Rg;Nghk;
4.6 ngUkUe;Jfspd; eQ;rpd; FwpFzq;fSk; mtw;wpd; kUj;JtKk;:
rpj;ju;fs; eQ;Rg; nghUl;fisf; $l kpfTk; rhJupakhf gad;gLj;jp kUe;Jfs;
nra;Js;sdu;. mtu;fs; jhJ nghUl;fs;> %ypifg; nghUl;fisf; fhl;bYk; NkyhdJ
vd;W $Wk; tifapy;
'Ntu;ghU jiog;ghU kpQ;rpdf;fhy;
nky;y nky;y gw;gk; nre;J}uk; ghNu"
vd;W $wpAs;sdu;. ,e;j thf;fpaj;jpd; %yk; clypy; Vw;gLk; Neha;fis ePf;f
Kjypy; %ypiffshy; nra;j kUe;jpidf; ifahs Ntz;Lk;. mJ rupahfhtpby;
jhJg; nghUl;fshy; nra;j gw;gr; nre;J}uq;fis gad;gLj;jp Fzg;gLj;jyhk; vd;W
$wpAs;sdu;. ,jd;%yk; ,urg; ghlhz jhJg; nghUl;fspd; rpwg;G mijf; ifahs;tjpy;
rpj;ju;fs; rpwe;jtu;fshf tpsq;fpAs;sdu;. MapDk; ,urg; ghlhzg;nghUl;fs; kpf
rpwpa mstpNyNa gy;NtW eQ;Rfis Vw;gLj;j ty;yJ. Mifahy; mjid kpf
Neu;j;jpAld; rpj;ju;fs; ifahz;L> mjpy; gy;NtW cau;e;j kUe;Jfis rpwg;ghf nra;J
kUj;Jtf;fz;fhzpg;G
Kbj;J> jPuh Neha;fisAk; Fzg;gLj;jpdu;. ,JNghd;w kUe;Jfshy; eQ;Rj;jd;ik
Vw;gl tha;g;Gs;sJ. rpj;ju;fs; ,k;kUe;Jfspd; eQ;R FwpFzq;fisAk;> mjw;fhd
kUj;Jtj;ijAk; tpupthf tpsf;fpAs;sdu;. mtw;wpy; rpytw;iw fhzyhk;.
jw;fhyj;jpy; kpftk; eQ;nrd fUJk; ghjurj;jpid rpj;ju;fs; caupa kUe;jhf
$wpAs;sdu;. mtw;wpd; rpwg;ig tpsf;Fk; nghUl;L
“ruf;fpw; fye;jpL rPtd;”
vd;W Fwpg;gpl;Ls;sdu;. ,urkhdJ vy;yh rPtdpYk; cs;sjhfTk; mJ vy;yh Neha;fisAk;
Nghf;fty;yJ vd;Wk; Fwpg;gpl;Ls;sdu;. ,jdhy; Vw;gLk; eQ;R FwpFzq;fisg; gw;wpAk;>
kUj;Jtj;ijg; gw;wpAk; tpsf;fpAs;sdu;. mJkl;Lky;yhky; xt;nthU kUe;jpw;Fk;>
gj;jpak; gy;NtW topKiwfs; Nghd;wtw;iw tpsf;fpAs;sdu;. mit jtWjyhy; Vw;gLk;
eQ;Rf; FwpFzq;fisAk; mtw;wpw;fhd kUe;ijAk; $wpAs;sdu;. ,urk;> ,ypq;fk;>
,urnre;J}uk;> tPuk;> G+uk; Mfpa ,it Ie;Jk; gQ;r #jk; vdg;gLk;. ,tw;wpd; cah;e;j
kUj;Jt Fzj;jpdhy; gy;NtW jPuhj Neha;fisAk; Nghf;f gQ;r#jj;jhy; nra;ag;gl;l
kUe;jpid gad;gLj;jpdh;. ,e;j kUe;J vLj;Jf;nfhs;Sk; NghJ gpio Vw;gl;lhy;
vd;ndd;d FwpFzq;fs; Vw;gLk; mtw;wpw;fhd %ypif kUj;Jtk; vd;d vd;gJ gw;wpAk;
rpj;j kUj;Jtk; tpthpj;Js;sJ. ,jidg;gw;wp gpd;tUkhW fhz;Nghk;. ,J kl;Ly;yhky;
rpy cNyhfk;> ghlhzk; Nghd;w kUe;Jfspd; eQ;R kUj;Jtj;ijg; gw;wpAk; ,q;F
tpsf;fpAs;Nshk;.
Hypq;f eQ;Rf; FwpFzk;
tha;> cz;zhf;F Kjy; Fuy;tis> khh;G> ngUq;Fly; Mfpa ,itfs; nte;J
Gz;zhfp ntapypy; frf;fpa gUj;jpg;G+g; NghypUf;Fk;. fhuk; glKbahJ. jhfQ;
nra;anthl;lhJ. Ngr KbahJ. thapy; nfl;lthrid cz;lhFk;. tapw;wpy; vhpr;ry;
cz;lhFk;. tha;ePh; nfl;Lg;Nghd gdq; fs;isg; Nghd;whtJ> fhbj;jz;zPh; Nghd;whtJ
,Uf;fk;.
rhjpf;fha;> thy;kpsF> nrk;gUj;jp Nth;g;gl;il Mfpa %d;iwAk; tiff;F 4 fpuhk;
tPjk; vLj;J ed;whf ,bj;J 850 kp.ypl;. ePh;tpl;L mij vl;by; xd;whff; fha;r;rp mjpy;
35 fpuhk; fw;fz;ilg; nghbj;Jg; Nghl;Lf; fhiyapYk; khiyapYkhf xU kz;lyk;
tiu cl;nfhs;s ,ypq;f eQ;R KwpAk;.
kUj;Jtf;fz;fhzpg;G
tPueQ;Rf; FwpFzk;
FwpFzk;: ,ij cl;nfhz;lhy; thapy; xUtiff; fspk;Gr; Rit cz;lhFk;.
thapy; eP&Wk;. tha; Gz;zhfp tPq;Fk;. njhz;ilAk;> Mkhrak; ahTk; tPq;fpg; Gz;zhFk;>
the;jpAk;> kyNgjpAk;> FUjpf; for;rYk; cz;lhFk;> vr;rpiyf;$l tpOq;f Kbahjgb
njhz;ilapy; typ Vw;gLk;> Kfk; tPq;fptpLk;> clk;gpYs;s Njhy; KOtJk; gl;il
gl;ilahf ntbj;Jr; rpiy ePh; tbAk;> gf;fk;> tpyh Kjypa ,lq;fspy; mjpf NehTk;
Filr;rYKz;lhFk;> mjpf ePh; Ntl;if> tpf;fy;> %h;r;ir> kaf;fk;> typ Kjypad
cz;lhFk;. ,NjhL rhTk; cz;lhFk;.
,jw;F KwpT
(1) 20 kp.ypl;. rpW neUQ;rpr; rhw;iwf; fhiyapYk; khiyapYk; Fbj;Jtu Ntz;Lk;.
(2) ePyp Nth;g;gl;ilia nte;ePh;tpl;L miuj;J xU Rz;ilf;fha; tPjk; vLj;J 80 kp.ypl;
,s nte;ePhpy; fiuj;Jf; fhiyapYk; khiyapYk; Fbj;JtuNtz;Lk;. mj;Jld; ,ijf;
FbePh;nra;J Fbj;J tuyhk;.
(3) 20 kp.ypl; nea;r;rl;bf;fPiur;rhw;iw fhiyapYk;> khiyapYk; Fbj;JtuNtz;Lk;.
(4) njd;dq;fs; mUe;jp tuyhk;. ,itfspdhy; tPu eQ;R KwpAk;. ,jpy; ehs; tpguk;
$wtpy;iyahjyhy; eQ;r KwpAk; tiuf; nfhLf;f Ntz;Lk;.
(5) Nfhop Kl;ilapd; ntz;fUitj; jz;zPh; my;yJ ghYld; fye;J mbf;fb
nfhLj;JtuNtz;Lk;.
(6) ,sePh; mUe;jpdhYk; tPuj;jpd; tpuk; jPUk;. (nra;As; - 7 )
G+ueQ;Rf; FwpFzk;
,J tpiuthf ePhpy; fiuahJ. ,J mjpf mstpy; clk;gpw;Fs; nrd;why;
eQ;Rj; jd;ikiaf; fhl;Lk;. mit - gy;yPWfSk;> ehTk;> thAk;> ce;jpAk;> jhilapd;
cl;gf;fKk; Gz;zhFk;. tha; jpwf;f KbahJ. Ehtpy; ePh; Ruf;Fk;. me;ePhpy; xUtifahd
ehw;wj;Jld; ePh;frpAk;. mijAk; tpOq;fKbahJ. NkYk; Kfj;jpy; Nth;f;FUTk;>
gUTKz;lhFk; khh;gpy; gUf;fl;b cz;lhfpg; Gz;zhFk;. ,Lg;gpy; typ cz;lhFk;>
tpiu tPq;Fk;> cz;zhf;F Gz;gLk;. Ngjpapy; ,uj;jk; tUk; Mfpa FwpFzq;fs; G+u
eQ;Rf; FwpFzkhFk;.
kUj;Jtf;fz;fhzpg;G
KwpT:
(1) Jsrpr;rhW my;yJ rpw;whkzf;F nea; my;yJ ghfy; ,iyr;rhW Mfpaitfspy;
xd;iwf; nfhLf;f Ntz;ba Kiwg;gb 3 my;yJ 5 ehs; my;yJ eQ;R jPUk;tiu
nfhLf;fNtz;Lk;.
(2) mThp Nth;g;gl;ilia nte;ePh; tpl;liuj;J xU Ntisf;Fr; Rz;ilf;fha; msT
tPjk; fhiyapYk; khiyapYkhf eQ;R jPUk; tiuf; nfhLj;J tu Ntz;Lk;.
(3) epyg;gdq;fpoq;F> ty;yhiu Nth;> nghd;dhq;fhzp Nth;> fz;Lguq;fp.
,e;ehd;F ruf;FfisAk; tiff;F 10 fpuhk; vLj;Jr; rpijj;J mjpy; 650 kp.ypl;. ePh;
tpl;L vl;Lf;nfhd;whff; FbePh; nra;J fhiyapYk; khiyapYkhf ,uz;L my;yJ
%d;W thuk; nfhLj;Jtu G+uj;jpd; tPW jzpAk;.
Hur eQ;rpd; FwpFzq;fSk; mtw;wpd; kUj;JtKk;
thapy; mr;ruj;ijg;Nghy; Gz; cz;lhFk;> gw;re;Jfspy; <Wfl;Lk;> thapy;
ePu;g;ngUFk;> gdq;fy;iyg; Nghy; tha; Fok;Gk;> tha;> njhz;il ,it nte;JtPq;Fk;>
tha; ehWk;> grp ke;jg;gLk;> Fly;> tapW ,itfs; Gz;zhFk;. gf;fj;jpy; mbf;fb
typj;Jf; nfhz;Nl ,Uf;Fk;. tapw;wpd; kPJ gl;ilg; gl;ilahf Njky; glUk;>
fhybfspy; ntbg;Gf;fz;L ePu; frpAk;> tpf;fy;> ePuilg;G> ,uj;jg;Ngjp> Nghfk; nfly;>
cly; ntSj;jy;> fhJ nrtpLgly;> fz; ghu;it ,oj;jy;> rpuq;F> Gz;> nrk;gilg;Nghy;
clk;gpy; gil cz;lhjy;> eLq;fy; Mfpa FwpFzq;fs; cz;lhFk;. NkYk; gpj;jd;
Nghd;W tha;g; gpjw;Wk; Vw;gLk;.

kUj;Jtk;: ,tw;wpw;fhd kUj;Jtk; nts;is Kw;rq;F ,iyr;rhW my;yJ kpjpg;ghfy;
,iyr;rhW ,jpy; VjhtJ xd;wpd; rhw;iw 80 kpyp fhiyapYk; khiyapYkhf %d;W
ehs; nfhLf;f Ntz;Lk;. mTupNtu;g;gl;ilia nte;ePu; tpl;L miuj;J Rz;ilf;fhasT
fhiyapYk; khiyapYkhf %d;W ehs; nfhLf;f Ntz;Lk;.
Jsrp Ntu;g;gl;ilf; FbePu;>
fUNty; nfhg;gspf;FbePu;>
Riuf;fUg;G Nghd;wtw;iw eQ;R ePq;Fk; tiu nfhLf;f Ntz;Lk;.
,ur eQ;rhy; tapw;WtypAld; rPjKk; FUjpAkhf NghFk; fLg;Gf;F japu; nty;yk;
eQ;ir ePf;fp ed;ik jUk;. ,ur eQ;rhy; tha; R+iy ePq;f vUf;Ff; nfhg;gspf; FbePu;
gad; jUk;.
kUj;Jtf;fz;fhzpg;G
fw;G+uk; - eQ;rpd; FwpFzq;fSk; mtw;wpd; kUj;JtKk;:
fw;G+uk; vd;Dk; nghUs; ,dpg;G gz;lq;fs; kw;Wk; rpj;j kUe;Jfspy;
Nru;f;fg;gLfpwJ. ,J msTf;F kpQ;Rtjhy; Vw;gLk; FwpFzq;fs; ahnjdpd;
tapnuuptNjhL cs;SWg;GfSk; Ntf;fhlilAk;. ,uj;j NgjpAk; khe;jj;ijAk;;
cz;lhFk;. jiy fzf;Fk;> cly; jsu;r;rpailAk;> njhz;il Kjy; vUthA tiu xU
tpjkhd fLg;Gld; $ba vupr;ry; cz;lhFk;. fw;G+u thridAld; Vg;gk; mjpfkhFk;.
muw;wy;> Gul;lYld; ehb eil fzj;Jk;> JbJbj;Jk;> glglj;Jk; elf;Fk;> tpau;it
mjpfupf;Fk;. ,rpTz;lhFk;> mwpT jtwp> kaf;fk;> %u;r;ir vd cz;lhFk;.
kUj;Jtk;:
vYkpr;rg;gor;rhw;wpy; 35 fp fha;r;Rf;fl;bia miuj;J gRNkhupy; fiuj;Jf;
nfhLf;f Ntz;Lk;. ,t;tpjk; nra;a eQ;rpd; NtfKk; jzpAk;.
nrk;G eQ;rpd; FwpFzq;fSk; mtw;wpd; kUj;JtKk;:
ek; ehl;by; nrk;gpdhy; nra;j ghj;jpuq;fis gy;NtW cgNahfj;jpw;fhfTk;>
nrk;gpdhy; nra;j kUe;jpidAk; gad;gLj;JfpNwhk; ,jdhy; Vw;gLk; eQ;rhdJ kpff;
nfhbaJ. mtw;wpd; FwpFzq;fs; kdk; jpfpyiljy;> mjpf ,Uky; cz;lhFjy;>
tpf;fy;> mwpT kaf;fk;> tha; ePUwy;> njhz;il cswy;> khu;G vupjy;> gpjw;wy;>
mjpfg;grp ,it cz;lhfp rpy Ntisfspy; capu; ePq;Fk;.
kUj;Jtk;: ,tw;wpw;fhd KwpT vYkpr;irg;go ,urj;ijAk; Rf;ifAk; Nru;j;J cl;nfhs;s
Ntz;Lk;. ,jd; jPf;Fzq;fis ePf;f> mjpfg;grpiag; Nghf;f nea;> ntz;nza;> mg;gk;>
mil ru;f;fiu> G+up> mty;> nghup> gaW> gotiffs; Nghd;w czTfis nfhLf;f
Ntz;Lk;.
40 kpyp ney;ypr;rhW my;yJ Gspj;j Nkhu; my;yJ vYkpr;irg; gor;rhW ,tw;iw
Fbf;f Ntz;Lk;.
mg;gpufk; eQ;rpd; FwpFzq;fSk; mtw;wpd; kUj;JtKk;

ikf;fh vd;Dk; mg;gpufk; ,jd; kpDkpDg;gpw;fhf ngUk;ghyhd moFr;rhjdg;
nghUl;fspy; Nru;f;fg;gLfpwJ. ,jd; cau;e;j kUj;Jt Fzj;jhy; gy;NtW gw;g nre;J}uk;
nra;ag; gad;gLfpwJ. ,ijg; gy KiwfshfTk; nra;tu;. nra;Kiw jtwhJ ,Ug;gpd;>
kUj;Jtf;fz;fhzpg;G
kpf;f ed;ik gaf;Fk;. NkYk; gw;gj;ijAk;> nre;J}uq;fisAk;> NtWruf;FfSld; Nru;j;J
khj;jpiufshfr; nra;J cgNahfpg;gJ tof;fk;. mt;tpjk; cgNahfpg;gjpy; nra;ghfk;
ifghfk; nrt;tNd kbe;jjhf ,Uf;f Ntz;Lk;. rpwpJ jg;gpDk; nfLjy; cz;lhFk;.
mf;nfLjy;fis kUe;jPl;lhy; cz;lhfpd;w Fw;wq;fSf;F xg;ghFk; vd;W $Wtu;.
mg;gpufj;ij Rj;jp nra;ahky; gad; gLj;jpdhNyh> KOikahf Rj;jp nra;ag;
glhj mg;gpufNkh cl;nfhz;lhy; mJ ,L kUe;jhy; Vw;gLk; FwpFzq;fis tpistpf;Fk;.
tapw;Wg; nghUkYk;> ,iur;rYKz;lhFk;. neQ;rpy; Nfhopf;FQ;rpd; rg;jj;ijg;
NghYk;> fpd;du thj;jpaj;jpd; rg;jj;ijg; NghYk;> xypf;Fk;. ,isg;G Nehahspiag;
Nghy; ,Uky; cz;lhFk;. <isiaj; Jg;gy;> Rthrk;> jilg;gl;L khu;gpy; xUtpj
rq;flj;ij mDgtpf;fr; nra;Ak;. NkYk; cg;gpr Nuhfj;ij cz;lhf;fpr; rhit
cz;lhf;Fk;.
kUj;Jtk;:
“me;j Nehafw;W khNw jbe;jpbw;Nwhd;wp Rf;Nf” vd;wjhy; mg;gpuf eQ;Rw;F
Rf;ifg; gad;gLj;j Ntz;Lk; vd;W Fwpg;gplg;gLfpwJ.
fhe;jl; fpoq;F> Rf;F ,uz;ilAk; 35 fp vLj;J ,bj;J vilf;F 20 gq;F ePu;
tpl;L FbePuhf;fp fhiy> khiy mg;gpuf eQ;R ePq;Fkl;Lk; nfhLf;f Ntz;Lk;.
ntw;wpiyr; rhW> ,Q;rpr;rhW ,uz;ilAk; Nru;j;J 40 Kjy; 80 kp.yp. tiu
fhiy> khiyahf nfhLf;f Ntz;Lk;.
tq;fk; eQ;rpd; FwpFzq;fSk; mtw;wpd; kUj;JtKk;
tq;fk; nfl;lhy; gq;fk; vd;w gonkhop tq;fj;ij ed;Kiwapy; Rj;jp nra;J jhd;
kUe;jhf;fp gad;gLj;j Ntz;Lk; ,y;iyNay; mJ jPq;if tpistpf;Fk; vd;gJthk;.
tq;fj;jhy; Vw;gl;l eQ;R FwpFzq;fs;: gy; <W fWj;jy; (m) ePy tu;z khjy;> tapw;W
Neha;>nfhg;G+o; typ> kyge;jk;> cg;grk;>iffhy; jsu;r;rp> ghupr thA> fhkhiy> ,isg;G>
<is cz;lhjYk;. Njfj;jpd; Nky; xU tpj nrhwp cz;lhjYkhk;.
kUj;Jtf;fz;fhzpg;G
kUj;Jtk;
1. fWg;G Gy;yhQ;rp ,iyia ,bj;Jg; gpope;j rhw;iw>Ntisf;Ff; fhyhohf;fhf>
fhiy khiy ,uz;L Ntis eQ;R khWk; tiuf;Fk; Fbf;f Ntz;Lk;.
2. fUq;Nfhop khkprj;ijr; rikj;J rhg;gpl Ntz;Lk;.
3. fhl;L Gspauiz Ntu; fy;fk; Rz;ilasT eQ;R ePq;Fk; tiu nfhs;s
Ntz;Lk;.
,Jtiu ,q;F eQ;R kUj;Jt Jiwapy; cs;s rpy Kf;fpakhd kUe;Jfis kl;LNk
tpsf;fp $wpAs;Nshk;. ,jid gw;wp KOikahf njhpe;Jnfhs;s eQ;R KwpT kUj;Jtk;
vd;Dk; E}ypy; ghh;f;fTk;;.
4.7 rpj;j kUj;Jt E}y;fspy;, Hlk; ngw;Ws;s ghjfkhd tpisTk; mjd;

kUj;JtKk;
mfj;jpau; itj;jpa ty;yhjp
mfj;jpau; itj;jpa ty;yhjp E}ypy; %d;W kUe;Jfisf; $Wk; NghJ kUe;Jfspd;
ghjfkhd tpistpid tpsf;fp mtw;wpd; kUe;JfisAk; tpsf;fpAs;sdu;. mjid fPNo
fhz;Nghk;.
1. G+uz ty;yhjp R+uzk;:
fhiy khiy kUe;J cz;Zk; NghJ Nghij mjpfkhfp kaf;fk; te;jhy;
ntq;fhak;>vYkpr;rg;gok; ,tw;wpd; rhiu fye;J jf;f msT nfhLf;f kaf;fk; jPUk;.
mbf;fb kaf;fk; tUkhapy; khiyapy; kl;Lk; fhw;foQ;rp nfhLf;fTk;
2. nfb R+uzf; Fspif:
,f;Fspifia cz;Zk; fhyj;J tpau;it kpf mjpfkhf cz;lhFk;. mijf;
fz;L mQ;rNtz;baJ ,y;iy. tapWisTf; fz;lhy; mgpdpAk; ntq;fhaj;ijAk;
mdypy; ntJg;gp cs;Sf;Ff; nfhLf;fyhk;.
3. fUq;FWitr; R+uzk;
,k;kUe;Jz;Zq;fhy; fLg;Gld; $ba ,uj;jNgjp fz;lhy; japUld; Nru;j;J
nfhs;sj; jPUk;
Fzg;ghlk; 2 & 3 ghfk; jhJrPt tFg;G

jhJrPt tFg;G vd;Dk; Fzg;ghlk; Gj;jfj;jpy; ,lk;ngw;Ws;s kUe;Jfs;
kUj;Jtf;fz;fhzpg;G
mtw;wpd; Nflhy; tpisAk; FwpFzq;fisAk; KwpTfisAk; fPNo fhz;Nghk;.
1. nfsup ghlhz khj;jpiu (my;yJ) ru;t Ruf; Fspif:
Nfsg;gh the;jpAld; gpj;j kPwy; fpUikAld; kpsF ePu; Fbf;f jPUk;.
- mfj;jpau; gupG+uzk; - 400
,e;j kUe;ij mUe;Jk;NghJ mNuhrfk; vd;Dk; Ritapd;ik Vw;gl;lhy; kpsFf;
FbePiu kUe;jhf mUe;j Ntz;Lk;.
ru;tRuf; Fspifia MW khj;jpiuf;F Nky; nfhLf;f $lhJ.
kUe;J mUe;Jk; fhyj;jpy; tplkpf;fhjpUj;jw;F ePypNtu;g;gl;il kpsF rpWfPiu
,tw;why; nra;j FbePiu mUe;jp tu Ntz;Lk;.
Mzhd mNuhrpaq;fs; te;jpl;lhYk;
mg;gNd gj;jpaq;fs; jtwpl;lhYk;
tPzhd kpsfjidf; fpahok; gz;zp
tPupakha;j; jhd; nfhLf;f kPSk;ghNu
- mfj;jpau; gupG+uzk; – 400
2. jhsf gw;gk;
Nghfu; Mapuk; jpul;L gb jhsf gw;gj;jpd; mgj;jpaj;jhy; if> fhy; gpbg;G> gy;
mirT> Nghd;wit Vw;gLk;. ,jw;F nfhk;G ghfy; r%yk; kUe;jhf nfhLf;fg;gLfpwJ.
jhsf gw;gk; mUe;Jk; fhyj;jpy; gj;jpag; gpio Vw;glf;$lhJ. mg;gb Neupl;lhy;
kUj;JtuhYk; Nehia mlf;f KbahJ.
Mj;k uf;~hhkpu;jk; vd;Dk; itj;jpa rhu rq;fpufk;
Mj;k uf;~hkpu;jk; vd;Dk; itj;jpa rhu rq;fpufk; vd;Dk; E}ypy; kUe;J
Kwptpw;F vd;Nw xU gFjp nfhLf;fg;gl;Ls;sJ. ,jpy; kUe;Jfshy; Vw;gl;l ghjfkhd
tpisTfisg; Nghf;f kUe;Jfisf; nfhLj;Js;sdu;. ,J gy E}y;fspy; ,y;yhj
rpwg;ghFk;.
kUe;J KwpT glyk;:
1. mTup Ntu;> gpuk;kp ,iy> kpsF ,tw;iw rpijj;J fpahok; nra;J MW Ntisf;
nfhLf;f kUe;jpd; tPW jzpAk;.
2. mUfk; Ntu; gyk; 5 kpsF ,uz;ilAk; Nru;j;J ,uz;L gb ePu; tpl;L fhy; gbahf
fha;r;rp tw;w itj;J tbfl;bajpy; khJsk; G+> mjpkJuk;> $if ePu; Mfpad xU
tuhfndil miuj;J> nfhl;ilg;ghf;fsT Mtpd; ntz;nza; fye;J %d;W ehs;
nfhLf;fr; nre;J}uk;> gw;gk;> ,Uky;> c~;zk; jPUk;.
3. urtPW jzpa Riuf; FLf;if Rl;lf;fupia Gspj;j Nkhupy; fiuj;J 3 ehs;
nfhLf;f Ntz;Lk;.
4. gUj;jpf;fha; rhW> vYkpr;rk;gor;rhW> Mtpd; ghy; ,tw;iw Xustha; fye;J
kUj;Jtf;fz;fhzpg;G
mjpy; rPdp fye;J %d;W ehs; nfhLf;f> gy nre;J}uq;fspd; tPW jzpAk;.
5. kUe;jpfspdhy; fhZk; Ngjp tapw;Wf;fLg;G> uj;jf;fLg;G ePq;f KUq;ifaPu;f;F 2
gyk;> Mthiu Ntu;g;gl;il 1 gyk;> <Us;sp 1 gyk;> ,tw;iw rpijj;J fpahok;
nra;J me;jp re;jp 5 ehs; cz;z Ntz;Lk;.
6. gh~hzj;jpw;F KwpT kUe;J kpsF miuj;J vUik ntz;nzapy; kj;jpj;J
cs;Sf;F nfhLf;f Ntz;Lk;> vUikj; japupy; re;jdj;ijf; fiuj;J clk;gpy;
G+r tPW jzpAk;.
7. Nrq;nfhl;il kUe;J KwpTf;F G+turk;gl;il urk; my;yJ Gspapiy urk;
my;yJ ey;nyz;nza; gok;Gspiaf; fiuj;J cs;Sf;F nfhLf;f Ntz;Lk;.
ntspg;gpuNahfkhf jhd;wpf;fhiaAk;> GspapiyiaAk; Xu;epiuaha; miuj;J
clk;gpy; G+R mjd; tPW jzpAk;.
8. tPuj;jpw;Fk; urg;gw;gj;jpw;Fk; KwpT kUe;J 12 Nfhop Kl;il nts;isf; fUit
jz;zPupy; fye;J mbf;fb nfhLj;Jf;nfhz;bUf;f kUe;jpd; tPW jzpAk;.
9. mTupf;Fk; Kw;wpd rhuil r%yj;jpw;Fk; rfy eQ;Rt];Jf;fspd; tPW mlq;Fk;.
10. ,e;E}ypy; eQ;ir cz;lhf;f $ba %ypiffis gl;baypl;L mjw;fhd
KwpT nghUl;fisAk; tpyf;fpAs;shh;. mij fPNo cs;s ml;ltizapy;
nfhLf;fg;gl;Ls;sJ.
eQ;ir cz;lhf;Fk; %ypif eQ;ir Kwpf;Fk; %ypif
ehtp rpWfPiu
rptij nts;Ntyk; gl;il
fs;sp Mthiu Ntu;
kUNjhd;wp jhd;wpf;fha;
Ckj;jk; jhkiuf;fpoq;F
myup fLf;fha;
vl;b ehtw;nfhOe;J
mgpd; Mtpd;nea;
vUf;fpiy vs;Sk; ru;f;fiuAk;
Fz;Lkzp nghupj;j ntq;fhuk;
ntw;wpiy> ey;nyz;nza; Njq;fha;g;ghy;
fQ;rh <Us;sp urk; / vYkpr;rk; gourk;
vUf;fk; ghy; Mtpd; Nkhu;> fUNtu;g;gl;il fpahok;
Rz;zhk;;G kQ;rs;
Nga;g;gPu;f;F Kj;jf;fhR
nea;/Njd; nte;jf;fup
jpy;yk; ghy; nfhl;ilf;fue;ij urk;
fs;spg;ghy; thiog;gl;il urk;
kUj;Jtf;fz;fhzpg;G
gjhu;j;j Fztpsf;fk;
ghjh;j;j Fzk;tpsf;fk; vd;Dk; E}ypy; nfhLf;fg;gl;l eQ;R KwpT kUj;Jtk;
rhh;e;j gjpTfs; fPNo cs;s ml;ltizapy; nfhLf;fg;gl;Ls;sJ.
gjhu;j;j Fztpsf;fk;
eQ;Rj;jd;ik Vw;gLj;Jk; %ypif eQ;R KwpT kUj;Jtk;
1. fs;sp thiog;gl;ilr;rhW> MthiurhW
Rf;Ffpahok;> gourk;> thiog;gl;ilr;rhW
2. fQ;rh
ntq;fhar;rhW
khrpf;fha;> kpsF> rPufk;> jdpah> Nrhk;G-

fpahok;, fj;jpupf;fhAld; ePuN
; ru;jJ
; nfhLf;f
3. Ckj;ij Ntz;Lk; jhkiuf; fpoq;if fhbapy; miuj;J
nfhLf;f Ntz;Lk;. gUj;jpg;ghYld; cg;G
Nru;jJ
; nfhLf;f Ntz;Lk;
Ks;sq;fp rhWld; gbfhuk;. thiog; gl;ilrhW>

4. rhuhak;
rPufk;> jdpah> nfha;ah ,iy-fpahok;
5. fs;S fLf;fha; fpahok;

6. rptij nty;Ntyk; gl;ilf; fpahok;
7. jpy;iy Nfhitr;rhW
8. kfpok;gpQ;R jhkiuNtu;
9. kUNjhd;wp jhd;wpf;fpahok;
10. ,uj;jNghsk; Nguuj;ijf;fpahok;
11. fUiz ntw;wpiy> Gsp
12. kpsF gRk;ghy;> Njq;fha;
13. khq;fha; GOq;fyuprp> Njq;fha;
14. nty;yk; vUikNkhu;
4.8 czT - czT H,iltpid tpisTk; kUj;JtKk; (Food - Food
Interaction)
,Jtiu ehk; czTfis jdpj;J cz;Ztjhy; Vw;gLk; eQ;RfisAk;
mtw;wpd; KwpT kUe;JfisAk; tpsf;fpAs;Nshk;.,dp xd;wpw;F Nkw;gl;l rpy czTg;
nghUl;fis Nru;j;J cz;Zk;NghJ rpy ghjfkhd tpisTfs; Vw;gl tha;g;G
cz;L. ,jid czT-czT ,iltpid tpisT (Food - Food Interaction) vd;W $l
miof;fyhk;. mjpy; rpy vLj;Jf; fhl;Lfis fPo;tUkhW fhzyhk;.
nea;-Njd;
nea;> Njd; ,it ,uz;ilAk; xU msthf Nru;j;Jf; Fbj;jhy; tapw;WtypAk;>
kUj;Jtf;fz;fhzpg;G
the;jpAk; cz;lhtNjhL clw;nfhjpg;Gk; ePu;vupr;rYk;> thapy; ePu; Ruj;jYk; cz;lhFk;.

kUj;Jtk;: ,tw;wpw;fhd KwpT fupia ePu;tpl;liuj;J cz;z Ntz;Lk;.
ey;nyz;nza; - NrhW
ey;nyz;nzAk; Nrhw;iwAk; fye;J cz;gjhy; ke;jk;> kaf;fk;> the;jp> fopr;ry;>
vUtha; milg;G> tapw;Wg;nghUky;> nrupah Vg;gk;> neQ;Rf;fupj;jy; vd;gd cz;lhFk;.
kUj;Jtk;:
,jw;F fhbePiuf; Fbf;f eQ;R ePq;Fk;.
rpw;rpy nghUs;fs;> xd;Nwhnlhd;W NrUk; NghJ> tPupahjp jd;ikfshy;> mitfspd;

Fzk; khWgl;L> ehsiltpy; er;Rj;jd;ik cz;lhf;Fk;. mitfSs; Kf;fpakhdtw;iw
,q;Ff; $WNthk;.
1. ghYld;> kPd;> Gspg;Gf;fdpfs;> nfhs;S> fk;G> fhl;Lg;gapW> fPiufs; ,itfSs;
xd;iwr;Nru;j;jy;.
2. japUld; Nfhopf;fwp my;yJ khkprj;ijf; fyj;jy;.
3. japUld; thiog;goj;ijr; Nru;j;jy;.
4. gd;wp khkprj;ijAk; Ks;sk; gd;wpkhkprj;ijAk; fye;J Grpj;jy;.
5. Ks;sq;fpiaAk; cSj;jk; gUg;igAk; Nru;j;jy;.
6. kzj;jf;fhspAld;> jpg;gpyp> kpsF> Njd;> nty;yk; ,itfSs; xd;iwNah> my;yJ
gytw;iwNah Nru;j;jy;.
7. NjDk; jhkiutpj;Jk; fye;j gz;lj;ij cz;zy;.
8. ntw;wpiyiaAk; vz;nziaAk; Nru;j;jy;.
9. nfhj;Jg; griyAld; vs;isr; Nru;j;Jg; ghfQ;nra;jy;.
10. Njd;> nea;> nfhOg;G> vz;nza;> ePu; ,itfspy; ,uz;Nlh> %d;Nwh> my;yJ
midj;JNkh rk mstpy; Nru;j;jy;.
11. ehiuiag; gd;wp nea;apy; nghupj;jy;.
12. kPd; nghupj;j vz;nza; my;yJ nea;ia cz;Zjy;.
13. kPd;> Ks;sq;fp> fPiufs; Grpj;jTld; ghy; mUe;jy;.
14. fUk;G jpd;wTld; ePu; mUe;jy;.
15. rhuhaKk; ru;f;fiuAk; Nru;j;jy;.
NkNy> er;Rj;jd;ik vd;W $wpg;gpl;Ls;sJ rpwpa FwpFzq;fs; Mfpa tapW nghUky;>
nrupahik> the;jp Nghd;wtw;wpy; ,Ue;J ,wg;G epiy tiuAk; Vw;glyhk;
kUj;Jtf;fz;fhzpg;G
4.9 etPd kUe;Jk; %ypif kUe;Jk; Nru;e;J vLg;gjhy; tUk;

Neha;FwpFzq;fs;
mKf;Fuhfpoq;F - Barbiturates
rpj;j kUj;Jtu;fshy; mjpfstpy; gad;gLj;jg;gLk; kUe;Jfspy; xd;W
mKf;Fuhfpoq;F ,jid barbiturates vd;Dk; etPdkUe;Jld; cl;nfhz;lhy; mJ> me;j
kUe;jpd; tPupaj;ij mjpfg;gLj;jp kaf;fj;jd;ikia cz;lhf;Fk;.
mKf;Fuhfpoq;F - Diazepam
Diazepam vd;w kUe;J cwf;fKz;lhf;fpahf nray;gLk; kUe;J. ,jid
mKf;Fuh fpoq;Fld; vLf;Fk; NghJ mJ Nghijj; jd;ikia mjpfupf;Fk;.
Ff;fpy; - Anti Lipidemic Drug
cly; ,isj;jy; fhuzkhfTk; typ epthuzpahfTk; Ff;fpy; Nru;e;j kUe;Jfis
kUj;Jtu;fs; gad;gLj;jpfpd;wdu;. ,e;j kUe;J nfhOg;Gfis Fiwf;Fk; jd;ikAilaJ.
,jid etPd kUe;jhfpa Anti – Lipidemic Drug fSld; Nru;j;J nfhLf;Fk; NghJ clypy;
,Ue;J mjpf msthd nfhOg;G ntspNaw;wg;gl;L gy FwpFzq;fis fhl;LfpwJ.
Ff;fpy; - Warfarin
Ff;fpy; kUe;ij Warfarin vd;w kUe;Jld; vLj;Jf;nfhz;lhy; ,uj;jk; ciwaf;$ba
Neuj;ij mjpfupj;J Mgj;jhd tpisTfis Vw;gLj;Jk;.
Ff;fpy; - Propanalal
Propanalal Nghd;w kUe;jpd; Bio – Availability ia Fiwf;ff; $banraiy Ff;fpy;
nra;fpwJ.
mjpkJuk; - Prednisolone
mjpkJuj;ij jdpj;Njh my;yJ mjpkJuk; Nru;e;j kUe;Jfis mjpf mstpNyh
my;yJ ePz;l ehl;fSf;Nfh gad;gLj;Jk; NghJ gy Neha; FwpFzq;fis cz;lhf;Fk;.
,jid Prednisolone cld; vLj;J nfhs;Sk; NghJ Prednisolone gpsh];kh msit
kpfTk; mjpfupj;J> ghjfkhd tpisit Vw;gLj;JfpwJ.
mjpkJuk; - Contraceptives
fUj;jil kUe;Jld; mjpkJuj;ij cl;nfhs;Sk; NghJ ,uj;jf;nfhjpg;G>
fhy;tPf;fk; Nghd;wit Vw;gLfpwJ.
mjpkJuk; - Thiazide/Loop Diuretic
Thiazide kw;Wk; Loop Diuretic cld; mjpkJuj;ij cl;nfhz;lhy; ,uj;jj;jpy;
nghl;lhrpaj;jpd; msT Fiwe;J tpLfpwJ.
,Jtiu etPd kUe;JfSf;Fk;> %ypif kUe;JfSf;Fk; ,ilNaahd Drug
interaction id ghu;j;Njhk;. ,dp tPl;by; gad;gLj;Jk; rpy kUj;Jt FzKila
nghUl;fSld; etPd kUj;Jtk; NrUtjhy; Vw;gLk; FwpFzq;fisf; fhz;Nghk;.

kUj;Jtf;fz;fhzpg;G
G+z;L - Warfarin / NSAID
ek; cztpy; md;whlk; gad;gLj;Jk; nghUspy; G+z;L Kf;fpakhdJ ,jd;
kUj;Jt Fzj;jpw;fhf> kf;fs; ,jid njhlu;e;J gad;gLj;Jfpd;wdu;. ,g;G+z;il
Warfarin kw;Wk; NSAID Nghd;w kUe;JfSld; cl;nfhs;Sk;NghJ ,uj;jk; ciwAk;
jd;ik ghjpf;fg;gl;L ,uj;jf; frpT Vw;gl tha;g;Gs;sJ. Mifahy;> ve;j kUe;J
cl;nfhz;lhYk; tPl;by; nra;af;$ba rpWrpW itj;jpaq;fisAk; kUj;Jtupd;
MNyhrid ngw;w gpwF> Kaw;rp nra;jy; Ntz;Lk;. Ra kUj;Jtk; kpfTk; Mgj;jhdJ.
Rf;F - Analgesic
Rf;Fld; etPd typ epthuzp (Analgesic) kUe;Jfis vLj;Jf; nfhz;lhy; mjd;
nraiy Rf;F Fiwf;fpwJ.
Rf;F - Warfarin, Heparin
Rf;Fld; Warfarin, Heparin Nghd;w kUe;Jfis vLj;Jf;nfhz;lhy; ,uj;jf;frpT
Vw;gLj;Jk; tha;g;ig mjpfupf;fpwJ.
kpsF -– Phenytoin, Propananlol & Theophylline
kpsFld; Phenytoin, Propananlol & Theophylline Nghd;w kUe;Jfis cl;nfhz;lhy;
,uj;jj;jpy; kUe;jpdsT Ntfkhf mjpfupj;J ghjfkhd tpisT Vw;gLfpwJ.
%ypif kUe;Jfis etPd kUe;JfSld; Nrh;j;J cl;nfhs;Stjhy; gy;NtW
tpjkhd ghjfkhd tpisTfs; epfo;fpwJ. Mifahy; kUj;Jthpd; MNyhrid ngw;w
gpwNf kUe;Jfis vLj;Jnfhs;s Ntz;Lk;;.
** Let us join hands with Pharmacovigilance to ensure Patient safety**
kUj;Jtf;fz;fhzpg;G
5. kUj;Jtf; fz;fhzpg;G ikaq;fs;

5.1 cg;ryh fz;fhzpj;jy; ikak;:
cyf Rfhjhu ikakhdJ 50 tUlq;fSf;F Nkyhf kUe;Jfis fz;fhzpj;J>
kf;fis kUe;Jfshy; Vw;gLk; ghjfkhd tpistpy; ,Ue;J ghJfhj;J tUfpwJ.
Kf;fpakhf kUe;Jfs; fz;fhzpj;jy; gpupT kpfj;Jupjkhf nray;gl;L tUfpwJ.
kUe;Jfs; fz;fhzpg;G vd;gJ etPd kUe;Jfs;> kuG rhu;kUe;Jfs;> jLg;G kUe;Jfs;
kw;Wk; Nghyp kUe;Jfs; cs;slq;Fk; kw;Wk; kUj;Jt cgfuzq;fs; ,tw;iwAk;
ed;F fz;fhzpj;J mjdhy; Vw;gLk; ghjfkhd tpisit cyfpw;F vLj;Jiuf;fNt
cUthf;fg;gl;l xU ikak; cg;ryh fz;fhzpg;G ikak; MFk;. ,e;j cyfshtpa
ikaj;jpd; Kf;fpa gq;fspg;ghsu;fshf jpfo;gtu;fs; kUe;J jahupf;Fk; epWtdq;fs;>
Muha;r;rp epWtdq;fs;> Rfhjhu mikg;Gfs;> kUj;Jtkidfs;> kUe;jfq;fs; kw;Wk;
midj;J Rfhjhu Copau;fSk; Mthu;fs;. ,J jdpj;Jtkhf ,aq;ff;$ba cyfshtpa
mwptpay; Muha;r;rp kw;Wk; Nrit ikak; MFk;. kUe;Jfs; cl;nfhs;tjhy; Vw;gLk;
gad;fisAk;> vjpu;tpisTfisAk; Muha;jy; kw;Wk; kf;fs; midtUf;Fk; ghJfg;ghd
kUe;Jfis nfhz;L nry;tJ Mfpad ,jd; Fwpf;NfhshFk;. 1960 Kjy; Nk khjk; 2019
tiu Rkhu; 20 kpy;ypad; Gfhu;fis gjpT nra;Js;sJ. ,e;j jfty;fs; midj;Jk;
juTfshf Nrkpf;fg;gLfpwJ. 1963 ,y; ele;j 16MtJ cyf Rfhjhu Nguitapd; fPo;
ghjfkhd tpisTfshf> nghJ kf;fSf;F ntspaplg;gl;lJ. 1978 Kjy; juTfs;
midj;Jk; cg;ryh ikaj;jpd; fPo; nfhz;Ltug;gl;lJ. ,J 150 cWg;G ehLfisf;
nfhz;ljhFk;. 1978 ,y; epWtg; gl;ljhFk;.

cg;ryh fz;fhzpg;G ikaj;jpy; Muk;gf;fhyf; fl;lk; Kjy; mz;ikf; fhyk;
tiu gjpthd ghjfkhd tpisTfs;:
1978 - 1.15.000.
1995 - 1.5 million.
2004 - 3 million.
2010 - 5 million.
2014 - 10 million.
2018 - 16.8 million.
cg;ryh fz;fhzpg;G ikaj;jpy; 1968 y; 10 cWg;G ehLfs; kl;LNk ,Ue;jJ. Mdhy;
jw;NghJ 2018 y; 130 cWg;G ehLfisj; jd;dplj;Nj nfhz;Ls;sJ.
kUj;Jtf;fz;fhzpg;G
,f;fz;fhzpf;Fk; ikak; kf;fspd; ghJfhg;gpy; ngUk;gq;fspf;fpwJ> gy;NtW
ehLfspypUe;J jfty;fs; ngwg;gl;L> mit Ma;T nra;ag;gl;L> kUe;Jfspd; cz;ikj;
jd;ikia ntspapLfpd;wdu;. me;j juTfis Nrfupf;fTk;> MuhaTk;> mij kf;fs;
vspjhff; fz;L gad; ngwTk; cUthf;fg;gl;lNj tp[pNg]; (Vigibase), tp[piy];
(Vigilyze), tp[pmf;r]; (Vigiaccess) MFk;. mtw;iw gpd;tUkhW fhzyhk;.

tp[pNg]; [VIGIBASE]
tp[pNg]; vd;gJ jdpj;Jtkhd jfty; juTj;jsk;. ,jpy; 1968 Mk; Mz;L Kjy;
kUe;Jfshy; vw;gLk; ghjfkhd tpisTfs; gw;wpa jdpg;gl;l Nehahspapd; kUj;Jt
mwpf;iffs; [Individual Case Safety Report] gy;NtW cWg;G ehLfspypUe;J jfty;
jpul;lg;gl;L gjpNtw;wk; nra;ag;gl;L tUfpd;wd.

tp[piy]; [VIGILYZE]
tp[piy]; vd;gJ tp[pNg]py; cs;s jfty;fis gFg;gha;T nra;af;$baJ.
,jd; %yk; tp[pNg]py; ekf;F Njitahd jfty;fis tpiuthfTk;> njspthfTk;
jpul;lyhk;> mJkl;Lkpd;wp ,jd; %yk; Njitg;gLk; jfty; juTfis ehL>
,dk;> taJ> kw;Wk; tpisTfspd; mbg;gilapy; gpupj;jwpa gad;gLfpwJ. ,e;j
tp[piy]py; ,Uf;Fk; gjptpid UMC cWg;G ehLfspd; kj;jpa kUe;Jfs; fz;fhzpj;jy;
ikaj;jpdhy; ,ytrkhf Muha ,aYk;.

tp[pmf;r]; [VIGIACCESS]
,jpy; cau;e;j mstpy;> xUq;fpizf;fg;gl;l Gs;sp tptuq;fs; nghJ kf;fspd;
gad;ghl;bw;fhfj; jug;gl;Ls;sd> Nehahspapd; Ratptuk; ,jpy; ,lk; ngwhJ. ,jd; %yk;
Vw;fdNt ghjfkhd tpisthy; gjpT nra;j kUe;J rhu;e;j Gfhu;fis> vspjpy; nghJ
kf;fshy; fhz ,aYk;. ,jd; %yk; cyfj;jpy; nghJthf gad;gLj;jf; $ba etPd
kUe;Jfspd; ghjfkhd tpisTfis fz;lwpe;J jtpu;f;f ,aYk;. mJkl;Lkpd;wp ,jpy;
jhtu tif rhu;e;j kUe;Jfspd; juTfSk; ,lk; ngw;Ws;sJ. ,jd; %yk; ghuk;gupa
kUj;Jtu;fSk; %ypiffspd; ghjfkhd tpisTfis vspjpy; fz;lwpe;J jtpu;f;f
,aYk;. ,jd; cWg;G ehLfspy; ,e;jpahTk; gq;Nfw;W cs;sjhy; ,e;jpahtpypUe;Jk;
kUe;J rhu;e;j gy;NtW Gfhu;fis cg;ryhtpy; gjpT nra;Js;shu;fs;.
http://www.vigiaccess.org/ vd;w URL y; cs;s tiyj;jsj;jpd; gf;fj;jpy; NjLf
(Search) vd;W ,Uf;Fk;> ,jpy; ehk; mwpa Ntz;ba kUe;Jfspd; ngaiu vOjpdhy;
kUj;Jtf;fz;fhzpg;G
kUe;Jfisg; gw;wpa jftiyg;ngw ,aYk;. mit
1. gjpT nra;ag;gl;l ghjfkhd tpisTfs; - ADR
,jpy; FwpFzq;fSk;> ve;j cWg;gpy; Fiwfs; Vw;gl;Ls;sJ vd;Wk; Fwpg;gplg; gl;bUf;Fk;.
2. ve;j epyg;gug;gpy; vt;tsT ghjpg;G vd;W Fwpg;gplg; gl;bUf;Fk;
3. taJ thupahf Fwpg;gplg; gl;bUf;Fk;.
4. ghypdk; thupahf Fwpg;gplg; gl;bUf;Fk;.
xt;nthU Mz;Lk; vt;tsT Gfhu;fs; te;Js;sJ vd;gijAk; Fwpg;gplg;gl;bUf;Fk;.
tp[pg;Nsh [VIGIFLOW]
,J jdp egu; Nehahsp mwpf;iffSf;fhd ,izar; nray;ghL MFk;. ,jpy;
cWg;gpdu; ehLfs; jfty;fis Nrfupf;fTk;> gjpT nra;aTk;> gfpuTk; cjTk; ,izar;
nray;ghL MFk;.
Muk;g fhyj;jpy; cyfshtpa kUe;J fz;fhzpf;Fk; ikaj;ij 10 ehLfs; Nru;e;J
epWtpaJ. mitfs; M];jpNuypah> fdlh> nrf;NfhRNyhtpah> n[u;kdp> mau;yhe;J>
nenju;yhe;J> epA+rpyhe;J> RtPld;> gpupl;ld;> kw;Wk; mnkupf;fh.
jw;NghJ cg;ryh fz;fhzpf;Fk; ikaj;jpy; 136 cWg;G ehLfs; cs;sJ. 30
ehLfs; ,iz cWg;G ehlhf cs;sJ. ,e;j mikg;gpy;> 1998 ,y; ,e;jpah cWg;G
ehlhf ,izf;fg;gl;lJ.
tp[prh;r; VIGISEARCH
etPd kUj;Jtf; fz;fhzpg;gpy; gzpahw;wf; $batu;fSf;F kUe;Jfs;> gf;f
tpisTfs; gw;wp VNjDk; re;Njfk; Vw;gbd; mtw;iw gw;wp mwpe;J mtu;fs; njspT
ngw cUthf;fg;gl;lNj mFk;> ,jpy; ,iztjw;fhd tpz;zg;gg; gbtj;jpid G+u;j;jp
nra;J mjid cg;ryh fz;fhzpg;G ikak; Vw;Wf; nfhs;Sk; gl;rj;jpy;> mtu;fs;
Vigisearch ia gad;gLj;j ,aYk;.
cg;ryhtpd; nray;ghLfs;
cyfshtpa kUj;Jtf; fz;fhzpg;gpd; jw;NghJs;s juTfs; midj;Jk;
cg;ryh ikaj;jpy; jhd; Nrfupj;J itf;fg;gLfpwJ> mJkl;Lky;yhky; me;j midj;J
Gfhu;fisAk; Muha;e;J> mjid cWjp nra;tJk; cg;ryh ikaj;jpd; nray;ghLfshFk;.
cg;ryhtpd; fPo;jhd; WHO Drug Portfolio vd;w ,yhfh cs;sJ. ,J WHO
kUj;Jtf;fz;fhzpg;G
Drug vd;w kUj;Jt mfuhjpia cs;slf;fpaJ. ,J jhd; jw;NghJ mjpf
kf;fshy; gad;gLj;jf;$ba kUj;Jt mfuhjpahf cs;sJ. ,jpy; kUe;Jfspd;
KOtptuq;fSk; ,lk; ngw;Ws;sJ> ,it Mq;fpyj;jpYk; rPdnkhopapYk; cs;sJ.
kUj;Jt fz;fhzpg;G rhu;e;j gapyuq;fk;> fUj;juq;fk;> gapw;rp tFg;G Nghd;w
epfo;Tfis cyfstpy; njhlu;r;rpahf elj;jpitf;fpwJ.
kUj;Jtf;fz;fhzpg;G
National Pharmacovigilance Centre For ASU & H Drugs.[1]
[Ayurveda, Siddha, Unani, and Homeopathy]
All India Institute of Ayurveda, New Delhi.
5.2 Intermediary Pharmacovigilance Centre [5]
1. AYURVEDA
National Institute of Ayurveda, Jaipur, Rajasthan- IPvC
2. AYURVEDA
IPGT & RA, Jamnagar, Gujarat- IPvC
3. SIDDHA
National Institute of Siddha, Chennai, Tamil Nadu- IPvC
4. HOMOEOPATHY
National Institute of Homoeopathy, Kolkata, West Bengal- IPvC
5. UNANI
National Institute of Unani Medicine, Bengaluru, Karnataka- IPvC
5.3 Peripheral Pharmacovigilance Centres with Code
AYURVEDA
Under National Institute of Ayurveda, Jaipur, Rajasthan- IPvC
1. Central Ayurveda Research Institute for Cardiovascular Diseases, Delhi

Center Code: Ay-NIA/ 001
2. Raja Ramdeo AnandilalPodar (RRAP) Central Ayurveda Research Institute for Cancer,
RA Podar College, Worli, Mumbai, Maharashtra
3. Regional Ayurveda Research Institute for Drug Development, Govt. Ayurvedic
Hospital, Gwalior, M.P.
4. Rajiv Gandhi Government Post Graduate Ayurvedic College, Paprola, Himachal
Pradesh
5. Uttarakhand Ayurved University, Dehradun, Uttarakhand
kUj;Jtf;fz;fhzpg;G
6. Shri Narayan Prasad Awasthi Govt. Ayurved College, Raipur, Chhattisgarh
7. Bharati Vidyapeeth, College of Ayurved, Pune, Maharashtra
8. Khushilal Sharma Government Ayurveda College and Institute Bhopal, M.P.
9. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan
10. Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan
11. Brahm Prakash Ayurved Charak Sansthan, New Delhi
12. Dhanwantri Ayurvedic Medical College, Ujjain, Madhya Pradesh
13. Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
14. Tilak Ayurvedha maha vidyalaya ,Pune,Maharashtra.
15. Govt Ayurveda college, Bilaspur, Chattisgarh.
16. Govt Ayurvedhiccollege, Kadhakpura, Nanded, Maharashtra.
17. Govt Ayurvedcollege, Raghujinagar, Nagpur, Maharashtra.
AYURVEDA
Under IPGT & RA, Jamnagar, Gujarat- IPvC
1. Central Ayurveda Research Institute for Drug Development, Kolkata, West Bengal
Center Code: Ay-IPGT/ 014
2. Regional Ayurveda Research Institute for Metabolic Disorders, Bengaluru, Karnataka
3. North Eastern Institute of Ayurveda and Homeopathy, Mawdiangdiang, Shillong,
Meghalaya Center Code: Ay-IPGT/ 016
kUj;Jtf;fz;fhzpg;G
4. Vaidyaratnam P. S. Varier Ayurveda College, Kottakkal, Kerala
5. Shri BM Kankanawadi Ayurved Mahavidyalya, Belagavi, Karnataka
6. Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital, Thanniruhalla,
Hassan, Karnataka
7. SDM Institute of Ayurveda & Hospital, Bengaluru, Karnataka
8. JSS Ayurvedic Medical college & Hospital, Mysuru, Karnataka.
9. Ayurveda Department, Amirta Institute of Medical science, Kochi, Kerala.
10. Govt Ayurveda College, Bangalore, Karnataka
11. JB Roy Ayurveda College, Kolkata, West Bengal.
SIDDHA
Under National Institute of Siddha, Chennai, Tamil Nadu- IPvC
1. Siddha Central Research Institute (CCRS), Arumbakkam, Chennai, Tamil Nadu
Center Code: Si-NIS/ 001
2. Siddha Regional Research Institute (CCRS), Puducherry
3. Siddha Regional Research Institute (CCRS), Thiruvananthapuram, Kerela
4. Siddha Medical College, Palayamkottai, Tamil Nadu
5. Government Siddha Medical College, Arumbakkam, Chennai, Tamil Nadu
6. AMO, Govt. Hospital (Siddha Wing), Perundurai, Erode, Tamil Nadu
7. Govt District HQ Hospital (Siddha Wing), Dindigul, Tamil Nadu
kUj;Jtf;fz;fhzpg;G
8. Kulumani, Govt District HQ Hospital (Siddha Wing), Trichy, Tamil Nadu
9. Siddha wing Government Kamaraj Hospital, Chidambaram, Tamil Nadu
10. Government Villupuram Medical College and Hospital (Siddha Wing), Villupuram,
Tamil Nadu
11. Siddha Clinical Research Unit [functioning under CCRS],Krol Bagh, New Delhi.
12. Government.Hospital, Kamuthi, Ramanathapuram district, Tamilnadu.
13. Government.Theni Medical College Hospital, Madurai district, Tamilnadu. Center
Code: Si-NIS/ 013
14. Government hospital, Kuzhithurai, Kaniyakumari, Tamilnadu.
HOMOEOPATHY
Under National Institute of Homoeopathy, Kolkata, West Bengal

1. D. P. Rastogi Central Research Institute for Homoeopathy, Noida, Uttar Pradesh
Center Code: Ho-NIH/ 001
2. National Homoeopathy Research Institute in Mental Health - NHRIMH, Kottayam,
Kerala Center Code: Ho-NIH/ 002
3. Regional Research Institute of Homoeopathy, Dr. GGH Medical College Campus,
Gudivada, Andhra Pradesh
4. Regional Research Institute for Homoeopathy, Guwahati, Assam
5. Anjali Chatterjee Regional Research Institute for Homoeopathy, Kolkata, West Bengal
6. Regional Research Institute for Homoeopathy, Navi Mumbai, Maharashtra
7. Homoeopathic Medical College and Hospital, Bhopal, Madhya Pradesh
kUj;Jtf;fz;fhzpg;G
8. Mahesh Bhattacharya Homeopathic Medical College & Hospital, Howrah, West
Bengal. Center Code: Ho-NIH/ 008
9. Sarada Krishna Homeopathic Medical College, Kanyakumari, Tamil Nadu. Center
Code: Ho-NIH/ 009
10. Father Muller Homeopathy Medical College & Hospital, Mangaluru, Karnataka.
11. Dr. Abhin Chandra Homoeopathic Medical College & Hospital, Bhubaneswar, Odisha.
UNANI
Under National Institute of Unani Medicine, Bengaluru, Karnataka

1. Central Research Institute of Unani Medicine, Hyderabad
Center Code: Un-NIUM/ 001
2. Central Research Institute of Unani Medicine, Lucknow, Uttar Pradesh
3. Regional Research Institute of Unani Medicine, Mumbai, Maharashtra
4. Regional Research Institute of Unani Medicine, Chennai, Tamil Nadu
5. Regional Research Institute of Unani Medicine, Srinagar (J&K)
6. Regional Research Institute of Unani Medicine, New Delhi
7. Ajmal Khan Tibbiya College, Aligarh muslim University, Aligarh, Uttar Pradesh.
8. Hakim Syed Ziaul Hasan Govt Unani Medical College &Hospital, Bhopal, Madhya
Pradesh.
Center code: Un-NIUM/008
9. Dr. Abdul Haq Unani Medical College, Kurnool, Andhra Pradesh.
Center Code: Un-NIUM/ 009.
10. Regional Research Institute of Unani Medicine.
kUj;Jtf;fz;fhzpg;G
Peripheral Pharmacovigilance Centres in Siddha
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
5.4 kUj;Jtf; fz;fhzpg;G ikaq;fspd; mbg;gilj; Njitfs;
Njrpa kUj;Jtf; fz;fhzpg;G ikaj;jpd; mbg;gilj; Njitfs;
• epue;jukhd Copau; ,Uf;f Ntz;Lk;.
• rPuhd epjpAjtp ,Uj;jy; Ntz;Lk;.
• ey;y cl;fl;likg;G ,Uj;jy; Ntz;Lk;.
• cyf Rfhjuikaj;Jld; njhlu;gpy; ,Uj;jy; Ntz;Lk;.
• ADR Form, ICSR Form, ghjfkhd tpisit njhlu;e;J gjpT nra;jpUj;jy;
Ntz;Lk;.
• gjpT nra;ag;gl;l ghjfkhd tpistpd; juTfs; Nrkpj;J itj;jpUj;jy; Ntz;Lk;.
kw;w kUj;Jt fz;fhzpj;jy; ikaj;jpd; mbg;gilj; NjitfSk; flikfSk;.
• kUj;Jtj;Jiw> kUe;jpay;Jiw> eQ;R kUj;Jtj;Jiw Mfpad cs;slf;fpa
kUj;Jtkid my;yJ kUj;Jt epWtdkhf ,Uj;jy; Ntz;Lk;.
• kUj;Jt fz;fhzpg;gpw;nfd;Nw epakpf;fg;gl;l Copau;fs; kw;Wk; cl;fl;likg;G
trjp ,Uj;jy; Ntz;Lk;.
• Copau;fSf;F ,e;j Jiwrhu;e;j Ntiyfs; gw;wp ed;F gapw;rpaspj;jy; Ntz;Lk;.
• cyf Rfhjhu epWtdj;Jld; njhlu;G ,Uj;jy; Ntz;Lk;.
• kUj;Jtkidapy; cs;s Copau;fSf;F> kUj;Jtf; fz;fhzpg;G njhlu;ghd
tpopg;Gzu;T Vw;gLj;jy; Ntz;Lk;.
• ADR Gfhu;fis gjpT nra;a gbtj;ij jahu; nra;J> jd; kUj;Jtkid kw;Wk;
mUfpy; cs;s kUj;JtkidfSf;F nfhLj;jy; Ntz;Lk;.
• Gfhu; nra;ag;gl;l juTfis Kiwahf Nrfupj;jy; Ntz;Lk;.
• mt;tg; NghJ kUj;Jtkid Copau;fs;> kUj;Jt fy;tpahsu;fs;> kw;Wk; ,J
rhu;e;j Jiwapy; cs;stu;fsplk; fye;jha;T elj;jg;gl Ntz;Lk;.
• ADR Reporting gw;wpa tpopg;Gzu;T Vw;gLj;jy; Ntz;Lk;.
• Reported ADR gw;wpa Muha;r;rp KbTfis kUj;Jt ehspjopy; ntspapl;L
tpopg;Gzu;T Vw;gLj;jy; Ntz;Lk;.
kUj;Jtf;fz;fhzpg;G
5.5 kUj;Jtf; fz;fhzpg;G ikaq;fspd; nghWg;Gk; nray;ghLk;
Njrpa kUj;Jtf; fz;fhzpg;G xUq;fpizg;G ikaj;jpd; nghWg;Gk;
nray;ghLk; (Responsibilities of NPvCC)
• MAu;Ntjh> rpj;jh> kw;Wk; Adhdp kUj;Jtj;jhy; Vw;glf;$ba ghjfkhd
tpisTfis fz;fhzpj;jy;> kw;Wk;Mtzg;gLj;Jjy;.
• kUj;Jt fz;fhzpg;Gg; gw;wpa tpopg;Gzu;T epfo;r;rpfis elj;JtJ.
• Kjy;epiy > ,il epiy kUj;Jtf; fz;fhzpg;G ikaq;fspd; juTfis Muha;e;J
mtw;iw xOq;FgLj;Jjy;.
• gy;NtW ikaq;fspypUe;J tUk; rpf;diy Muha;e;J eltbf;if vLj;jy;.
Hilepiy kUj;Jtf; fz;fhzpg;G ikaj;jpd; nghWg;Gk; nray;ghLk;
(Responsibilities of IPvC):
• MAu;Ntjh> rpj;jh> kw;Wk; Adhdp kUj;Jtj;jhy; Vw;glf;$ba ghjfkhd
tpisTfis fz;fhzpj;jy;> kw;Wk; Mtzg;gLj;Jjy;.
• gy;NtW ikaq;fspypUe;J tUk; ghjfkhd tpisTfs; gw;wpa Mtzq;fis
Nrfupj;jy;.
• ghjfkhd tpisTfs; gw;wpa mwpf;iffis gupe;Jiuf;fg;gl;l ,ilntspapy;
Njrpa kUj;Jtf; fz;fhzpg;G ikaj;jpw;F mDg;Gjy;.
Kjy;epiy kUj;Jtf; fz;fhzpg;G ikaj;jpd; nghWg;Gk; nray;ghLk;
(Responsibilities of PPvC):
• MAu;Ntjh> rpj;jh> kw;Wk; Adhdp kUj;Jtj;jhy; Vw;glf; $ba ghjfkhd
tpisTfis fz;fhzpj;jy;> kw;Wk; Mtzg;gLj;Jjy;.
• ghjfkhd tpisTfs; gw;wpa mwpf;iffis gupe;Jiuf;fg;gl;l ,ilntspapy;
,ilepiy kUj;Jtf; fz;fhzpg;G kw;Wk; Njrpa kUj;Jtf; fz;fhzpg;G
ikaj;jpw;F mDg;Gjy;.
** Build a Global Patient Safety culture **
kUj;Jtf;fz;fhzpg;G
6. gy;NtW fz;fhzpg;G Kiwfs;

cyfpy; gy;NtW kUj;Jt Kiwfs; gpd;gw;wg;gl;L tUfpd;wJ “xUtUf;F> vy;yh
kUe;JfSk; vy;yh Neuq;fspYk; vy;yh epiyfspSk; ghJfhg;ghdJ ,y;iy” vd;w
$w;why; kUe;Jfisf; fz;fhzpf;f Pharmacovigilance vd;w Jiw cUthf;fg;gl;lJ.
gpd; ,jd; Kf;fpaj;JtKk;> NjitAk; mjpfupj;jjhy; ,jid NkYk; gy gpupTfshf
gpupj;jdu;. ,itfspy; FUjpiaNah> FUjpapYs;s nghUl;fisNah> xUtuplkpUe;J
kw;nwhUtUf;F khw;Wk; NghJ rpy xt;thikfs; Vw;gLfpwJ. mjid fz;fhzpg;gjw;fhf>
Hemovigilance vd;w JiwAk;> jLg;G kUe;Jfis gad;gLj;Jk; NghJ Vw;gLk; cghijia
fz;fhzpg;gjw;fhf Vaccinovigilance vd;w JiwAk;> kUj;Jt cgfuzq;fisg;
gad;gLj;Jk; NghJ tUk; cghijia fz;fhzpg;gjw;fhf Materiovigilance vd;w JiwAk;>
moFrhjdg; nghUl;fisg; gad;gLj;Jk; NghJ Vw;gLk; cghijfis fz;fhzpg;gjw;fhf
cosmetovigilance vd;w JiwAk;> cUthf;fg;gl;lJ. ,it vy;yhtw;iwAk; tpupthf
fhzyhk;. kUe;JfshNyh my;yJ gpw fhuzq;fSf;fhfNth ek; Rw;Wg;Gwj;jpy; cs;s
czTrq;fpyp ghjpg;giltij fz;fhzpf;Fk; Kiwia Ecopharmacovigilance vd;gu;.
,J Nghd;w gy JiwfSk; cUthf;fg;gLfpwJ.
6.1 Hemovigilance
cyfpYs;s gy;NtW mwpQu;fSk; tpyq;Ffspy; ,Ue;J kdpju;fSf;F ,uj;jj;ij
khw;wp gupNrhjid nra;J ghh;j;jdh;. ,e;j Kaw;rp 17-k; E}w;whz;L Muk;g fhyj;jpNyNa
eilngw;wJ mg;NghJ mjpy; ntw;wp fpilf;ftpy;iy. khwhf gy capupog;Gfs; jhd;
epfo;e;jd. Mifahy; 18-k; E}w;whz;by; gpnuQ;R ehl;il Mz;l 14-Mk; Y}ap];
kd;dd; ,e;j ,uj;j khw;W Kiwiaj; jil nra;jhu;. gpd; 19-Mk; E}w;whz;by;
xU kdpjupy; ,Ue;J kw;nwhU kdpjUf;F ,uj;jj;ij khw;wp Kjd; Kjyhf ,U
mwpQu;fs; Ma;T nra;jdu;. mJTk; Njhy;tpapNyNa Kbe;jJ. 20-Mk; E}w;whz;by;
,uj;j tifg;gLj;Jjiy fz;Lg;gpbj;jjw;F gpd;du; kdpju;fSf;F ,ilNaahd ,uj;j
khw;wk; ntw;wp fukhf nray;glj; njhlq;fpaJ. ,jdhy; ,uj;j ,og;ghy;> gyp epfohky;
gy capu;fs; fhg;ghw;wg;gl;ld. kUe;Jfs; gad;gLj;Jtjpy; vt;thW tpopg;Gld; ,Uf;f
Ntz;LNkh mNj Nghd;W ,uj;j khw;wk; nra;Ak; NghJk; tpopg;NghL ,Uf;f Ntz;Lk;.
,y;iyNay; gy rpf;fy;fs; te;jilAk;> vt;thW vdpy; ,uj;jk; nfhLg;gtu; ey;y cly;

kUj;Jtf;fz;fhzpg;G
epiyapy; ,y;yhj fhuzj;jpdhYk;>Neha; njhw;W VNjDk; ,Ug;gjhYk;> Nrfupf;fg;gLk;
,uj;jj;jpy; fpUkpfs; cz;lhtjhYk;> fhyhtjpahd ,uj;jj;jhYk;> ghjfkhd tpisTfs;
Vw;glf;$Lk;. ,jidf; fz;fhzpg;gjw;fhf Vw;gLj;jg;gl;lJ jhd; Hemovigilance MFk;.
,J ,e;jpahtpy; Hemovigilance Program of India 2012 y;> National Institute of
Biologicals, Noida, Uttarpradesh y; njhlq;fg;gl;lJ. ,J Pharmocovigilance Program of
India tpd; fPo; nray;gLfpwJ. ,jd; Kf;fpa Nehf;fk; ,uj;jk; khw;Wtjhy; Vw;gLk; jPa
tpisTfis gjpT nra;tjhFk; ,jd;%yk; gpw;fhyq;fspy; ,j;jtW Neuh tz;zk;
jw;fhj;Jf; nfhs;sg;gLk;.
http://www.nib.gov.in/Haemovigilance/TRRF_Form.pdf
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
6.2 Vaccino Vigilance
jLg;G+rp kUe;J cw;gj;jpapYk; Vw;WkjpapYk; ,e;jpah ngUk; gq;F tfpf;fpwJ.
1986 -Mk; Mz;L Universal Immunisation Program njhlq;fg;gl;lJ. kUe;Jfspd;
Muha;r;rpapd; NghJ jLg;G kUe;Jfshy; Vw;gLk; ghjfkhd tpistpid fz;lwptJ
ngUk; rthyhf ,Ue;jJ. Mifahy; jLg;G kUe;J tpw;gidf;F te;j gpwF kUe;Jfis
KOikahf fz;fhzpj;jdu;. 1986 - Mk; Mz;L ,e;jpa murhy; AEFI (Adverse
Event Following Immunisation) vd;w mikg;G cUthf;fg;gl;lJ. jLg;G kUe;Jfshy;
Vw;glf;$ba ghjfkhd tpisTfspy; %d;W Kf;fpakhdit> mitfis gjpT nra;tjw;F
kUj;Jtu;> nrtpypau;> kUj;Jt cjtpahsu;> fpuhkg;Gw nrtpypau; Nghd;Nwhu;fSf;F
gapw;rp mspf;fg;gl;lJ. mjpy; KjyhtJ fha;r;ry;> jiytyp> Fkl;ly; Nghd;w rpwpa
Neha;f;FwpFzq;fs; MFk;. ,uz;lhtJ ,ayhik (m) ,wg;G Vw;glhky; cliy
thl;Lk; jPtpukhd tpisT> %d;whtJ ,ayhik> (m) ,wg;ig Vw;gLj;Jk; ngupa
tpisT. ,e;j jLg;G kUe;J fz;fhzpg;G vd;gJ cUthf Kf;fpa fhuzkhf ,Ue;jJ
Rota Virus jLg;G kUe;J jhd;. fPNo nfhLf;fg;gl;l ml;ltizapy; jLg;G kUe;jhy;
Vw;gl;l tpisTfisf; fhzyhk;.
S. No Vaccine Adverse Reaction Onset Interval

1. Rota Virus Vaccine Intussusceptions 3 - 14 days
2. Oral Polio Vaccine Vaccine Associated Paralysis 4 - 30 days
3. Tetanus Vaccine Brachial Neuritis 2 - 28 days
4. BCG Vaccine Disseminated BCG Infection 1 - 12 months
5. Hepatitis B Vaccine Anaphylaxis 0 - 1 Hours
6. Measles Vaccine Encephalopathy 6 - 12 days
7. DTP Vaccine Hypotonic Hypo responsive 0 - 48 Hours

episodes
https://www.who-umc.org/media/1075/india.pdf
(Adverse Events following Immunization - Reporting Form)
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
6.3 Materio Vigilance

Materio Vigilance kUj;Jtg; nghUl;fs; / fUtpfs; Neha; fz;lwpaTk;>
Nehapy; ,Ue;J jw;fhj;Jf;nfhs;sTk;> kUj;Jtj;jpw;fhfTk; ngupJk; gad;gLj;jg;gl;L
tUfpwJ. ,t;thW gad;gLj;jg;gLk; kUj;Jtg; nghUl;fs; / fUtpfs; ahnjdpd;
fl;Lf;fhf gad;gLj;jg;gLk; Bandage, Crp Nghd;w rpwpa nghUl;fs; Kjy; ];Nfd;
nra;a gad;gLj;jg;gLk; ngupa fUtpfs; tiu cs;slq;Fk;. ,t;thW gad;gLj;jg;gLk;
fUtpfshy; NehahspfSf;F Vw;gLk; ghjfkhd tpisNt Materio Vigilance vd;W
$wg;gLfpwJ. ,J ,e;jpahtpy; 2015 -k; Mz;L MvPI (Materio Vigilance Program of
India) vd;w jpl;lkhdJ Indian Pharmacopiea commission fPo; nray;glj; njhlq;fpaJ.
https://www.ipc.gov.in/images/MEDICAL_DEVICE_ADVERSE_EVENT_REPORTING_
FORM_editable.pdf
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
6.4 Cosmeto Vigilance
moF rhjdg; nghUl;fs; vdg;gLtJ clypid Rj;jk; nra;tjw;fhfTk;>
mofpid Nkk;gLj;Jtjw;fhfTk;> trPfuj;jd;ikia kpFjpg;gLj;Jtjw;fhfTk;>
cUkhw;wj;jpw;fhfTk; gad;gLj;jg;gLfpwJ. moF rhjdg; nghUl;fs; ehd;F tiffshf
gpupf;fg;gl;Ls;sJ. mit Njhy;> Kb> efk; kw;Wk; gw;fSf;fhf gad;gLj;JtdthFk;.
,e;jpahtpy; jhd; moF rhjdg;nghUl;fs; mjpfkhf jahupf;fg;gl;L re;ijg;gLj;jg;gLfpwJ.
mtw;why; Vw;gLk; ghjfkhd tpisTfis fz;fhzpf;Fk; Kiwik ,e;jpahtpy; ,y;iy.
Mdhy; ,e;jpa rl;lj;jpy; Drug and Cosmetic Act 1940 and 1945 rl;lj;jpd; fPo; moF
rhjdg; nghUl;fspd; ,wf;Fkjp jahupg;G gjpT nra;jy;> tpw;wy;> mjd; tpsk;guq;fis
newpg;gLj;Jjy; Nghd;w topKiwfis tFj;Js;sdu;. ,jid kPWgtu;fSf;F jz;lid
toq;fg;gl;Lk; tUfpwJ.
6.5 Therapovigilance
,e;j tif tp[pyd;]; ,Jtiu tof;fpy; ,y;iy> Mdhy; MA~; kUj;Jtj;Jiwapy;
kUj;Jtf; fz;fhzpg;Gj; Jiw ed;F tsu;e;jpUe;jhy; ,t;tifNa ngUthupahf ,lk;
ngw;wpUf;Fk;. Vndd;why; njug;gp vd;W nrhy;yf;$ba Gw kUj;Jtk; mjpfkhf ,lk;
ngw;wpUg;gJ MA~; kUj;Jtj;Jiwapy; jhd;. ,jpy; NeUk; jtWfshYk;> ghjfkhd
tpisTfs; Vw;gLfpwJ. Therapovigilance vd;w thu;j;ij rpj;j kUj;Jt Muha;r;rp
epiyak; rhu;ghf 20 gpg;utup 2020 md;W elj;jg;gl;l kUj;Jt fz;fhzpg;G rhu;e;j
tpopg;Gzu;T kw;Wk; gapw;rpapd; NghJ Kjd; Kiwahf vLj;Jiuf;fg; gl;lJ.
ek; rpj;j kUj;Jtj;jpd; %yk; kUe;Jfs; fz;fhzpj;jy; gpupT vd;gijj;jhz;b

kUj;Jtf; fz;fhzpj;jy; gpupT vd;W khw;wpaikf;fg;gl;Ls;sJ. Vnddpy; kUe;Jfs;
kl;Lky;yhJ gy tif kUj;Jt KiwfSk; (rpwg;ghf Gw kUj;Jt rpfpr;ir Kiwfs;-
tu;kk;> njhf;fzk;> vYk;G KwpT rpfpr;ir> ml;il tpLjy;> xw;wlk;> fypf;fk;> Mf;fpuhzk;>
Rl;bif ,d;dgpw...>) mtw;wpw;fhd topKiwfSk; njspthf $wg;gl;Ls;sJ. vdNt
mtw;wpy; Vw;gLk; gpioahy; GwkUj;Jtk; rhu;e;j ghjfkhd tpisTfSk; Vw;glyhk;.
mjdhy; ,jid gjpT nra;jy; %yk; ,jid Kiwahf newpg;gLj;j cjTk;. vdNt
jhd; rpj;j kUj;Jt Muha;r;rp epiyak; rhu;ghf 20 gpg;utup 2020 md;W elj;jg;gl;l
kUj;Jt fz;fhzpg;G rhu;e;j tpopg;Gzu;T kw;Wk; gapw;rpapd; Kjy; Rw;wpf;if> rhd;wpjo;>
Ngr;rhsu;fspd; jftywpf;if> miog;gpjo; Nghd;wtw;wpy; $l kUj;Jtf;fz;fhzpg;G
vd;Nw mr;rplg;gl;L toq;fg;gl;lJ.
kUj;Jtf;fz;fhzpg;G
Nkw;Fwpg;gpl;l fhuzq;fshYk;> kUe;ijj; jtpu> gytif fz;fhzpg;G
Kiwfspd; tsu;r;rpahYk;> “kUe;J fz;fhzpg;G” vd;w nrhw;nwhliuf; fhl;bYk;
“kUj;Jtf;fz;fhzpg;G” vd;gNj kpf kpf nghUj;jkhdjhFk;. mJNt rhyr;rpwe;jhFk;.
ek; jkpo; kUj;Jtkhk; rpj;j kUj;Jtj;jpd; rpwg;Ng mjd; fUj;Jr;nrwpTk; mjd;nkhop
tsKk; jhd;. ghJfhg;gw;w tpisTf;F $l rpj;j kUj;Jtk; fs;sg;gpzp vd;w mofhd>
tpsf;fk; juf;$ba nrhw;nwhliu vLj;jpak;GfpwJ. ,e;j midj;J Kaw;rpfSk;>
gapw;rpfSk;> Mtzg;gLj;JjYk; kf;fspd; my;yJ Nehahsu;fspd; ghJfhg;Gf;fhf
kl;LNk.
** The safer use of medicine depends on everyone’s constant

awareness and vigilance **
kUj;Jtf;fz;fhzpg;G
7. Kiwaw;w tpsk;guq;fspd; fz;fhzpg;G

(Misleading Advertisement Reporting)
,e;jpahtpy; 2015 Mk; Mz;L Kjy; 2018 Mk; Mz;L tiu 804 tpjkhd
Kiwaw;w tpsk;guq;fs; %ypif/MA~; kUe;Jfspd; ngaupy; gjpTnra;agl;Ls;sJ.
NkYk; 2017-2018 tiu 732 Kiwaw;w tpsk;guq;fSk;> 2018-2019 tiu 497 Kiwaw;w
tpsk;guq;fSk; gjpTnra;agl;Ls;sJ.
ehk; njhiyf;fhl;rp> kw;Wk; rKf tiyj;jsq;fspYk; fhZk; gw;gir tpsk;guk;
Kjy; Foe;ijfSf;fhd czTg; nghUl;fs; tpsk;guk; tiu gy tpsk;guq;fs;
kpifg;gLj;jg;gl;l Kiwaw;w tps;kguq;fs; ,lk;ngw;Ws;sJ ,J Nghd;w tpsk;guq;fis
gjpT nra;J rl;l eltbf;if vLf;f top tif nra;tJ ASCI (Advertising Standard
Council of India) vd;w mikg;ghFk; MA~; mikr;rfk; ASCI (Advertising Standard
Council of India) mikg;Gld; nra;J nfhz;l cld; gbf;ifapd; gadhf Nkw;$wpa
Kiwaw;w tpsk;guq;fis 2018 tiu gjpT nra;J te;jdu;. me;j tpsk;guq;fs; kPJ
eltbf;if vLg;gjw;fhf khepy cupkk; toq;Fk; mjpfhupaplk; mDg;gpitf;fg;gLfpwJ.
2018 Mk; Mz;bw;F gpd; ,e;jpahtpd; gy;NtW gFjpfspy; kUj;Jtf; fz;fhzpg;G
gpupT njhlq;fg;gl;L mjd; %ykhf Kiwaw;w tpsk;guq;fs; Nrfupf;fg;gl;L
mDg;gg;gLfpwJ. 2018-2019 tiuapyhd Kiwaw;w tpsk;guq;fspd; vz;zpf;if 1127 MFk;.
jtwhd (m) Kiwaw;w tpsk;guq;fis gjpTnra;tJk; kUj;Jtf; fz;fhzpg;G xU
gFjpahf Nru;f;fg;gl;Ls;sJ. ,jd; %yk; kUe;Jfshy; Vw;gLk; gf;ftpisTfis
Fiwf;fKbAk;.
goikahd kUj;Jtkhfpa ek; rpj;j kUj;Jtj;ij kPl;nlLf;f midtUk;
gy;NtW topfspy; Nghuhb tUfpd;wdu;. ,e;j cau;e;j Nehf;fpy; ,g;NghJ gyu;
jdf;Fj; njupe;j kUj;Jtf; Fwpg;GfisAk;> njhiyj; njhlu;G rhjdkhd nra;jpj;jhs;>
njhiyf;fhl;rp> njhiyNgrp> tiyj;jsq;fs;> %yk; kf;fSf;F rpj;j kUj;Jtj;ij
nfhz;L Nru;f;fpd;wdu;.
,J ek; kUj;Jtj;jpw;F ed;ik vd;W vz;zpdhYk; ,jpy; gy Mgj;JfSk;
epiwe;Js;sJ. Vndd;why; Neha; Fzkhf kUe;J kl;Lk; njupe;jhy; NghjhJ> Nehapd;
jd;ik Nehahspapd; jd;ik> kUe;jpd; jd;ik> Nghd;witfSk; njupe;jpUj;jy;
mtrpak;. kf;fs; me;j tpopg;Gzu;T ,y;yhky; kUj;Jt Fwpg;Gfis kUj;Jtk; Nghy;
gpd;gw;WtJ Mgj;jhdJ. Ra itj;jpak; kpfTk; Mgj;jhdJ. ,J kl;Lkpd;wp kUe;J
tpw;gidahsu;fs; tpahghu Nehf;Fld; kUe;Jfis tpsk;guk; nra;fpd;wdu;> mjpYk;
rpyu; jPuhj Nehiaf;$l jPu;j;JtpLtjhfTk;> Fiwe;j Neuj;jpy; jPu;j;J tpLtjhfTk; $wp
kf;fis Vkhw;wp tpw;gid nra;fpd;wdu;. ,jdhy; kf;fs; jhkhfNt kUe;Jfis thq;fp
kUj;Jtf;fz;fhzpg;G
ehl;fs; fzf;fpd;wp kw;Wk; Kiwahd topfhl;Ljypd;wp cl;nfhs;fpd;wdu;> ,jdhy; gy
gf;ftpisTfs; cz;lhfpwJ.
,jid fl;Lg;gLj;Jk; Nehf;Fld; PHARMACOVIGILANCE - d; xU gFjpahf
Misleading Advertisement Reporting ,izf;fg;gl;lJ.
khepy murhy; epakpf;fg;gl;l xU mjpfhup Drugs and Magical remedies
(Objectionable advertisement) Act, 1954> section 8 (1) fPo; jtwhfNth my;yJ tpjpfis
kPwpNah rpj;jh> MAu;Ntjh> kw;Wk; Adhdp kUe;Jfis tpw;gid nra;jhy; kUe;Jfis
gwpKjy; nra;aNth> eltbf;if vLf;fNth cupik cz;L. 22 khepyq;fspy; 621
mjpfhupfs; epakpf;fg;gl;bUf;fpd;wdu;. ,k;Kiwaw;w tpsk;guq;fis ,e;jpa Kiw
kUj;Jtj;jpd; khepy kUe;J cupkk; toq;Fk; mjpfhupaplk; rku;g;gpf;fg;gLfpd;wd. mtu;
rl;l Kiwahd eltbf;iffis vLg;ghu;.
Drugs and Magical remedies (Objectionable advertisement) Act, 1954
An act to control the advertisement of the drugs in certain cases to prohibit the advertisement
for certain purposes of remedies alleged to possess magic qualities and to provide for matters
connected therewith
1. ,r;rl;lj;jpd;gb kUe;Jfisf; fPo;f;$wpathW tpsk;guk; nra;jy; rl;lg;gb jtW
2. kUe;Jfspd; cz;ikj; jd;ikia Kw;wpYk; khw;wp>ngha;ahd tpsk;guk; nra;jy;
3. kUe;Jfisg;gw;wpa ngha;ahd $w;iw tpsk;guk; gLj;Jjy;.
4. ngha;ahd my;yJ jtwhd fUj;Jila tpsk;guk;.
Nkw;$wpa rl;lj;jpd; gb gy;NtW Neha; epiyfis FwpFzq;fis tpsk;guk; gLj;Jjy;
rl;lg;gbf;Fw;wk; MFk;.
mit:
fUf;fiyg;G (The Procurement of miscarriage in women or)
fUj;jil ( Prevention of conception in women;or)
R+jff;Nfhshiw rupnra;jy; (The correction of menstural disorder in women; or)
Foe;ijg; NgW
The schedule [sec 3(d) and 14]

1. ehq;$o; jhgpjk; ( Appendicitis)
2. Mu;bupnah];fpypNuhrp]; (Arteriosclerosis)
3. FUL (Blindness)
4. ,uj;j eQ;R (Blood poisoning)
5. gpiul;’]; Neha; (Bright’s disease)
kUj;Jtf;fz;fhzpg;G
6. Gw;W Neha; (Cancer)
7. fz; Giu (Cataract)
8. fhJ nrtpL (Deafness)
9. ePupopT (Diabetes)
10. %isapy; Vw;gLk;Neha; kw;Wk; FiwghL (Diseases and disorder of the brain)
11. fz;zpy; Vw;gLk;Neha; kw;Wk; FiwghL (Diseases and disorder of the optical system)
12. fUg;igapy; Vw;gLk; Neha; kw;Wk; FiwghL (Disease and disorder of the uterus)
13. R+jfj;jpy; Vw;gLk; NfhshW (Disorders of menstrual flow)
14. euk;Gfspy; Vw;gLk;Neha; kw;Wk; FiwghL (Disordersof nervous system)
15. Gu];j;jf;Nfhs Neha; (Disorder of the prostatic gland)
16. Nrhig (Dropsy)
17. typg;G (Epilepsy)
18. kfspu; Neha; (Female disease -in general)
19. Ruk; (Fever-in general)
20. khu;gsT khw;wk; (Forms and structure of the female bust)
21. gpj;jg;igf; fy;> rpWePuff;fy; (Gall stones, Kidney stones and Bladder stones)
22. mOfy; Gz; (Gangrene)
23. ghh;itiaa; ghjpf;Fk; fz; mOj;j Neha; (Glaucoma)
24. fOj;J foiy (Goitre)
25. ,Uja Neha; (Heart disease)
26. kpF my;yJ Fiw uj;jmOj;jk; (High or Low Blood pressure)
27. tpiutPf;fk; (Hydrocele)
28. kd Neha; (Hysteria)
29. Foe;ijfSf;F Vw;gLk; gf;fthjk; (Infantile paralysis)
30. igj;jpak; (Insanity)
31. njhO Neha; (Leprosy)
32. ntz;gil (Leucoderma)
33. jhilg; G+l;Lgpur;rpid (Lock jaw)
34. js;shl;lkhd eil (Locomotor ataxia)
35. Y}g;g]; (Lupus)
36. euk;Gf; NfhshW (Nervous debility)
37. mjpJ}yk; (Obesity)
38. gpNsf; (Plague)
kUj;Jtf;fz;fhzpg;G
39. EiuaPuy; rt;tpd; mow;rp (Pleurisy)
40. epNkhdpah (Pneumonia)
41. Klf;F thA (Rheumatism)
42. KwpT (Ruptures)
43. Mz;ikapd;ik (Sexual impotence)
44. rpd;dk;ik (Small pox)
45. Fs;sj;jdk; (Stature of Persons)
46. ngz; kyL (Sterility)
47. fz; Neha; (Trachoma)
48. fhr Neha; (Tuberculosis)
49. fl;b (Tumors)
50. Kiw Ruk; (Typhoid fever)
51. Fly; Gz; (Ulcers of gastrointestinal tracts)
52. ghy;tpid Neha; ( Venereal diseases, including syphilis, Gonorrhea, soft chancre,
venereal granuloma and lympho granuloma )
The schedule [see Rule 6]
1. ,iug;G Neha; M];Jkh (Bronchial Asthma)
2. VkNeha; (AIDS)
,e;j Neha;fis kUj;Jtj;jhy; Fzg;gLj;jyhk; vd;Nwh KOikahf
Fzg;gLj;jyhk; vd;Nwh tpsk;guk; nra;jy; rl;lg;gbFw;wk; MFk;.
kUj;Jtf;fz;fhzpg;G
Kiwaw;w tpsk;guq;fis gjpT nra;Ak; gbtk;

Misleading Advertisement Submission Format
Centre:
Month/Year:
Copy of Advertisement or Video link with snapshots
Serial No.:
• Name of the Ayurvedic/Siddha/Unani/ Homoeopathic drug
(Name of the Product):
• Name of Advertiser/ Advertising authority/ Manufacturer/Marketing agency
(Contact Details):
• Medium of Advertisement (print/electronic/internet/audio-visual)/ Language/
Place:
• Contents of the advertisement:
• Reference details: Source of Advt. (Page no.) (along with complete name and
address
of Print media/TV Channel):
• Date of Advt. (Publication/ Telecasted on):
• Under Section violated or contravened:
Date: Signature of the Coordinator
Place: (Name of the Coordinator)
,JNghd;w tpsk;guq;fis Nrfupj;J mjid kUj;Jtf; fz;fhzpg;G mYtyu;fs;>

mjw;nfd;W tiuaUf;fg; gl;l gbtj;jpy; gjpT nra;fpd;wdu;> mJ kl;Lky;yhky;
mjid rpj;jh> MAu;Ntjh> Adhdp kUe;Jfspd; khepy cupkk; toq;Fk; mjpfhupf;Fk;
gupe;Jiuf;fg;gl;l fhy mtfhrj;jpy; mDg;gp itf;fg;gLfpwJ.
kUj;Jtf;fz;fhzpg;G
Kiwaw;w tpsk;guq;fspd; rpy Gifg; glq;fis ,q;Nf nfhLj;Js;Nshk;.
ru;f;fiu Neha; vd;gJ ,Jtiu Fzg;gLj;j Kbahj NehahfTs;sJ> ,e;j

Neha;f;fhd kUe;jpw;F nfhLf;fg;gLk; tpsk;guq;fspy; ,e;Nehia Fzg;gLj;JNtd;
vd;Nwh> rpy jpdq;fspy; Fzg;gLj;JNtd; vd;Nwh> KOikahf Fzg;gLj;JNtd; vd;Nwh
vd;W Fwpg;gpLtJ jtwhFk;.
Kiwaw;w tpsk;guq;fis gjpT nra;tjw;fhf kj;jpa rpj;j kUj;Jt Muha;r;rp
epiyaj;jpd; rhu;ghf DOOR MAN [Documentation of Objectionable Advertisement
Reporting under Magical remedies Act Notification] vd;w Md;buhapL nrayp %yk;
nghJkf;fs; vspjhfTk;> clDf;FlDk; gjpT nra;a toptif nra;Js;sJ. ,e;j
nrayp 3tJ Njrpa rpj;j kUj;Jt jpUehs; 13 Jan. 2020 md;W ntspaplg;gl;lJ. ahu;
Ntz;LkhdhYk; vq;fpUe;J Ntz;LkhdhYk; jtwhd my;yJ Kiwaw;w tpsk;guq;fis
Gifg;glk; vLj;J clNd mjid gjpNtw;wk; nra;ayhk;.
** Strong communication practise is an important part of the process **
kUj;Jtf;fz;fhzpg;G
8. kUj;Jtf; fz;fhzpg;G topKiwfs;
8.1 kUj;Jtf; fz;fhzpg;G newpKiwfspd; mtrpak; (Regulatory Guidelines)
kUe;Jfis jahupf;fTk;> ntt;NtW ,lj;jpw;F nfhz;L nry;yTk;> tpw;gid
nra;aTk;> me;j kUe;jpd; tpw;gidia mjpfupf;fTk; kw;Wk; gupNrhjid nra;aTk;>
tpsk;guk; nra;aTk;> Fwpg;gpl;l xOq;F Kiwfs; filg;gpbf;f Ntz;Lk;.
ghJfhg;ghd> gyd; juf;$ba kUe;Jfspd; juf;fl;Lg;ghl;bw;fhfTk;> kf;fspd;
gad; ghl;bd; NghJ> VJk; gf;ftpisTfs; Vw;gLj;jhjthW ,Uf;fTk; xOq;F Kiwfs;
tFf;fg;gLfpd;wd.
Nehahsu;fspd; ghJfhg;Ng kpf Kf;fpakhdJ. kUj;Jt Muha;r;rpNah (m) kUj;Jt
NritNah> kf;fs; / Nehahsu;fspd; ghJfhg;Ng Kjd;ikahdjhf ,Uf;f Ntz;Lk;.
kf;fs; ghJfhg;ig cWjpg;gLj;Jk; NghJ> Schedule E/ Spurious drugs – Drugs &
Cosmetic Act - y; $wg;gl;l eQ;Rj;jd;ikAila kUe;Jfspd; nray;ghLfis kpfTk;
$u;e;J ftdpf;f Ntz;Lk;.
jtwhd kUj;Jt Kiwfisf; ifahSjy;> Nghyp kUe;Jtu;fspd; kUj;Jtk;> kw;Wk;
kUj;Jtu;fshy; cz;lhf;fg;gLk; gf;f tpisTfs; (Iatrogenic effects) ,itahTk;
Kiwahf xOq;Fg;gLj;jg;gLjy; Ntz;Lk;.
Vigilance vd;gJ tpopg;Gld; ,Ug;gJ vd;W nghUs; gLk; vd;gij ghu;j;Njhk;.
,dp ahnuy;yhk; vt;thW nghWg;Gld; ,Uf;f Ntz;Lk; vd;gij ghu;g;Nghk;.
8.2 rpj;j kUj;Jtu;fSf;fhd newpKiwfs;
kUj;Jtu;fs; Nehahspapd; Neha; fzpg;G Kjy; kUe;jpid Nehahsu;fSf;F
toq;fp> Nehiaf;Fzkhf;Fk; tiu jq;fs; nghWg;G vd;W fUj;jpy; nfhs;sNtz;Lk;.
• kUj;Jtu;fis ehb tUk; NehahspfSf;F kUe;Jfshy; ve;j jPq;Fk; Vw;glhtz;zk;
fhj;jy; Ntz;Lk;.
• kUj;Jtu;fs; ek;kplj;jpy; tUk; Nehahspapd; FwpFzq;fisAk; Neha; mwpFwpfisAk;
Nfl;lgpd; Nehia fzpf;Fk;NghJ kpFe;j ftdj;Jld; ,Uf;f Ntz;Lk;> Vndd;why;
Neha;f;fzpg;gpy; Vw;gLk; gpioahy; kUe;Jfis jtWjyhf nfhLf;f NeUk;. mjdhy;
Nehahspf;F ghjfkhd epiy Vw;gl tha;g;Gs;sJ.

kj;jpa rpj;j kUj;Jt Muha;r;rpf; FOkk;85 rpj;j kUj;Jt ika Muha;r;rp epiyak;
kUj;Jtf;fz;fhzpg;G
• kUj;Jtu;fs; kUe;J rPl;il vOJk;NghJ ngau;> taJ> Neha;> kUj;Jtk;> kUj;Jt
Kiwfs; Mfpatw;iw njspthfTk;> gpioapy;yhkYk; vOJjy; Ntz;Lk;.
Nehahsu;fSf;F GupAk; tz;zk; ,Uf;fNtz;Lk;
• kUe;jpd; msT> mDghdk;> gj;jpak;> ehs; msT> ,it $Wk;NghJ njspthfTk;
xUKiwf;F ,UKiwAk; $wNtz;Lk;. Nehahsu;fSf;F Gupatpy;iy vd;why;
njspthf kPz;Lk; vLj;Jf;$w Ntz;Lk;.
• kUe;Jfspd; vjpu;ghu;f;fg;gl;l gf;ftpisit Nehahsu;fsplk; vr;rupf;f Ntz;Lk;.
• kUj;Jtu;fs; GwkUj;J Kiwfs; nra;Ak;NghJk; ftdj;Jld; ,Uj;jy; Ntz;Lk;.
mt;thW ,y;yhky; Nghdhy; Rl;bif> xw;wlj;jhy; jPf;fhaKk;> njhf;fzk;> tu;kj;jhy;
vYk;G KwpTfSk; Vw;glf;$Lk;. ,JTk; Nehahspapd; ghJfhg;ig Nfs;tpf;Fwpahf;Fk;.
• kUj;Jtu;fs; Nehahsu;fis tprhupf;Fk; NghJ mtu;fs; etPd kUe;JfNsh kw;w
ghuhk;gupa kUe;JfisNah vLf;fpd;wduh vd Nfl;f Ntz;Lk;. Vndd;why; mtw;iw
vLj;Jf;nfhs;Sk; Kiwapy; rpy Ntis jtW epfo;e;jhy;> mJ kUe;JfSf;F
,ilapy; tpid Vw;gl;Ls;sjhy; epfo;e;jjh my;yJ NtW fhuzj;jhy; epfo;e;jjh
vd;W fz;lwpa KbAk;. kUj;Jtu;fs; ,J Nghd;w etPd kUj;JtKk; MA~;
kUj;JtKk; xd;whf vLf;Fk; NghJ epfOk; ghjfkhd tpisTfisg; gw;wpg; gapyTk;
Ntz;Lk;. gjpT nra;jYk; Ntz;Lk;.
• kUj;Jtu;fs; ek;gpf;ifiag; ngWtjw;fhfTk; gzk; <l;Ltjw;fhfTk; jtwhd
tpsk;guq;fs; nra;tij jtpu;j;jy; Ntz;Lk;. Vndd;why; mJ rl;lg;gb jtwhd
xd;whFk;.
• midj;ijAk; vd;dhy; Fzg;gLj;j KbAk; vd;Nwh> FWfpa fhyj;jpNyNa Fzg;gLj;j
KbAk; vd;Nwh> G+uzkhf Fzg;gLj;j KbAk; vd;Nwh> gf;f tpisTfNs ,y;yhky;
Fzg;gLj;j KbAk; vd;Nwh tpsk;guq;fs; nra;tij jtpu;j;jy; Ntz;Lk;. midj;J
Neha;fSf;Fk; ,q;F rpfpr;ir jug;gLk; Nghd;w thf;fpaq;fis gad;gLj;Jjy; ed;W.
• ,e;j Neha;f;F ,e;j kUe;J vd;W tpsk;gug; gLj;Jjy; $lhJ. Vndd;why; kf;fs;
jhdhfNt kUe;J filfis mZfp kUe;Jfis cl;nfhs;sj; njhlq;Ftu;. mtu;fs;
kUe;jpd; msT> mjd; tPupak;> mjpy; cs;s nghUl;fs;> mij cl;nfhs;Sk; ehs;
msT> mjd; gj;jpak;> mjd; eQ;Rj;jd;ik Mfpatw;iw mwpahky; khjf; fzf;fpy;>
tUlf; fzf;fpy; cl;nfhz;L clypy; ngUk; ghjpg;ig Vw;gLj;jp nfhs;fpd;wdu;.

86
kUj;Jtf;fz;fhzpg;G
Mifahy; ,J Nghd;w tpsk;guq;fisj; jtpu;j;jy; Ntz;Lk;.
• rpj;j kUj;Jtu;fSs; gyu; jhNk kUe;Jfis nra;J Nehahsu;fSf;F nfhLf;fpd;wdu;.
mt;thW nra;Ak; NghJ mjd; jahupg;G ehs;> fhyhtjpahFk; ehs;> kUe;jpd; ngau;>
msT> mjd; Rj;jpKiw> mjd; gf;f tpisT Nghd;wtw;iw Mtzk; nra;jy;
Ntz;Lk;. mJkl;Lky;yhJ NehahspfSf;F nfhLf;Fk; kUe;jpd; Kfg;G ml;ilapy;
kUe;jpd;ngau;> kUe;jpd; msT> mjd; %yg;nghUl;fs; kw;Wk; msT> mij
cl;nfhs;Sk; ehs;> jahupg;G ehs;> fhyhtjpahFk; ehs;> gf;ftpisT> kUe;J
cupkk; vz;> njhlu;G vz; kw;Wk; Kftup Nghd;wtw;iw Fwpg;gpLjy; Ntz;Lk;.
• kUj;Jtu; Nehahspf;F kUe;J nfhLj;J mjdhy; ghjfkhd tpisT Vw;gLkhapd;
mjid gjpT nra;J mUfpYs;s kUe;Jfis fz;fhzpf;Fk; ikaj;jpw;F jtwhJ
mDg;Gjy; Ntz;Lk;. ,jdhy; ek; kUj;Jtj;jpw;Nfh kUj;Jtu;fSf;Nfh ve;j gopr;
nrhy;Yk; tuhJ. khwhf ek; kUj;Jtj;ij jw;fhyj;jpw;F jFe;jhu;g; Nghy; khw;wp
mikf;f KbAk;. kf;fSf;F> Nehahsu;fSf;F ghJfhg;igg; ngw;Wj; ju KbAk;.
rpj;j kUj;Jtj;ijAk; mjd; ngUikiaAk;> fly; jhz;b cyNfhu; czur;nra;a
KbAk;.
8.3 kUe;J nra; epiyaq;fSf;fhd newpKiwfs;
ngUk;ghyhd ghjfkhd tpisT kUe;jpy; Vw;gLk; Fw;wj;jhNyNa epfo;fpwJ.
me;jf; Fw;wj;ij rupnra;tJ kUe;Jnra; epiyaq;fspd; flikahFk;.
• kUe;Jg; nghUl;fis Nrfupf;Fk; Kiw> gjg;gLj;Jk; Kiw> Rj;jp nra;Ak; Kiw>
mjd; kUe;J nra;Kiw> mjid ghJfhj;J itf;Fk; Kiw> nghjp nra;jy;> xU
,lj;jpypUe;J kw;Nwhu; ,lj;jpw;F nfhz;L nry;Yjy; ,tw;wpy; Vw;gLk; gpiofshy;
kUe;Jfspy; Fw;wk; Vw;gLfpwJ. ,jidj; jtpu;f;f kUe;J nra; epiyaq;fs; kUe;J
nra;Ak; xt;nthU gbepiyfisAk; ed;F Muha;e;J ey; kUe;ij kf;fSf;F
nfhLf;f Ntz;Lk;.
• rpy kUe;Jfs; re;ijf;F te;j gpwF ghjfkhd tpisit ntspg;gLj;JfpwJ.
mjidf; fz;fhzpg;gjw;fhf midj;J kUe;J nra; epiyaq;fspYk; kUj;Jtf;
fz;fhzpg;gpw;F jdpg;gpupT Vw;gLj;j Ntz;Lk;.
• kUe;jpd; ml;ilapy; ghjfkhd tpisT Vw;gl;lhy; njhlu;G nfhs;s njhiyNgrp
kUj;Jtf;fz;fhzpg;G
vz;Nzh my;yJ kpd;dQ;ry; KftupNah nfhLj;jpUj;jy; ey;yJ. ,jd; %yk;
kUe;jpd; gyd;fis KOikahf fz;lwpe;J jtWfis fisa ,aYk;.
8.4 kUe;jhSeu;fSf;fhd newpKiwfs;
• kUe;jhSeu; Nehahsuplk; ,Ue;J ngWk; kUe;J rPl;by; cs;s kUe;Jfis vLf;Fk;
NghJ epjhdkhfTk; ftdj;JlDk; ,Ue;J kUe;ij nfhLf;f Ntz;Lk;.
• kUe;Jfisf; nfhLf;Fk; NghJ cupa eguplk; nfhLf;f Ntz;Lk;> rpyu; gjw;wj;jpy;
kUe;Jfis nfhLf;Fk; NghJ khw;wp nfhLj;J tpLfpd;wdu;. mjdhy; gy tpguPj
tpisTfs; Vw;gLfpwJ.
• kUe;jhSeu; kUe;jpid gad;gLj;Jk; Kiwiag; gw;wp $Wk; nghOJ kUj;Jtu;
Fwpg;gl;lijNa topnkhopa Ntz;Lk;. mg;gbAk; re;Njfk; ,Ug;gpd; kUj;Jtupd;
MNyhridiag; ngw;Wg; gpd; $w Ntz;Lk;.
• kUe;Jfis khw;wpf; nfhLf;f $lhJ. kUj;Jtu; gupe;Jiuj;j kUe;JfisNaf;
nfhLf;f Ntz;Lk;.
• kUj;Jtu; gupe;Jiuj;j kUe;Jfis mjpy; Fwpg;gpl;l msTg;gbNa nfhLf;f Ntz;Lk;
8.5 Nehahsu;fSf;fhd newpKiwfs;
• Nehahsu;fs; Kjypy; kUj;Jtiu mZFk; NghJ ,tu; Nghypahdtuh ,y;iy> muR
gjpTg; ngw;w> kUj;Jtu; jhdh vd;W ed;F mwpe;j gpd;du; mtu;fspd; MNyhridiag;
ngw Ntz;Lk;.
• Nehahsu;fs; jq;fsJ FwpFzq;fis KOikahff; $wNtz;Lk;> kUj;Jtuplk;
vijAk; kiwj;jy; $lhJ.
• Nehahsu;fs; jq;fSf;F Vw;gl;Ls;s ghjpg;gpidg; gw;wpAk; Nehapidg; gw;wpAk;
xU KOikahd Gupjy; nfhz;bUf;f Ntz;Lk;. gbj;J njupe;J nfhs;s Ntz;Lk;.
my;yJ kUj;Jtuplk; Nfl;L njupe;J nfhs;s Ntz;Lk;.
• Nehahsu;fs; jhq;fs; vLj;Jf; nfhs;Sk; kw;w kUe;Jfs; (k) kUj;Jtq;fisg; gw;wp
kUj;Jtu;fsplj;jpy; $w Ntz;Lk;> ,J gy;NtW kUj;Jt Kiw rhu;e;j kUe;Jfis
(Multi pharmacy) xNu Neuj;jpy; vLf;Fk; NghJ epfOk; ghjfkhd tpistpid (Drug
-Drug Interaction) jtpu;f;f ,aYk;.
• xU Kiw kUj;Jtupd; MNyhridapd; gb kUe;J rPl;L ngw;Wf; nfhz;L> me;j
kUj;Jtf;fz;fhzpg;G
kUe;ijNa kPz;Lk; kPz;Lk; thq;fp gad;gLj;Jjy; $lhJ.
• kUj;Jtu;fshy; gupe;Jiuf;fg;gl;l my;yJ jhd; cz;zf; $ba kUe;ijg; gw;wpa
Gupjy; nfhz;bUf;f Ntz;Lk;.
• kUe;jpid kUj;Jtupd; MNyhridapd; gb msT> mDghdk;> gj;jpak;> ehs;
msT> cl;gpuNahfk; kw;Wk; ntspg;gpuNahfk;> Mfpatw;iw ed;F Nfl;L Gupe;J
gpd; kUe;jpid cl;nfhs;s/gad;gLj;j Ntz;Lk;.
kUe;jfq;fspy; ,Ue;J kUe;Jfis thq;Fk; NghJ me;j kUe;J GMP (Good
Manufacturing Practices) jur;rhd;wpjo; ngw;w epWtdj;jhy; jahupf;fg;gl;ljh? cupa
mDkjp ngwgl;Ls;sjh (License No.)> Nygpspy; [Label] kUe;jpd; ngau;> NrUk; nghUl;fs;>
cs;gpuNahfkh ntspg;gpuNahfkh> msT> ehssT> jahupg;G ehs;> fhyhtjpahFk; ehs;>
Kd;ndr;rupf;if Mfpait ,lk; ngw;Ws;sjh vd;W ftdpj;J Ntz;Lk;.
Nehahsu; nra;Ak; jtW
• FwpFzq;fis KOikahf $whky; ,Uj;jy;.
• kUj;Jtu; $wpaehs; msit tpl $l;bNah my;yJ Fiwj;Njh kUe;Jfis
cl;nfhs;sy;.
• kUj;Jtupd; MNyhridapd;wp kUe;jpd; msit $l;bNah Fiwj;Njh vLj;Jf;
nfhs;sy;.
• kUj;Jtu; $wpa mDghdj;ij khw;wp vLj;Jf; nfhs;sy;.
• gj;jpaj;ij iftply; my;yJ gj;jpaj;ij mt;tg;NghJ kPwptpLjy;.
• mwpahikahy; cs;kUe;ij ntspkUe;jhfTk; ntspkUe;ij cs;kUe;jhfTk; khw;wp
vLj;Jf; nfhs;sy;.
** ADRs are Expensive **
kUj;Jtf;fz;fhzpg;G
9. Gfhu; gjpT nra;Ak; topKiw:

,Jtiu kUj;Jtf; fz;fhzpg;G gw;wpAk;> mjpy; gad; gLj;jg;gLk; tpsf;fq;fs;
gw;wpAk; Nehf;fpNdhk;. ,dp kUj;Jtf; fz;fhzpg;gpy; vjid gjpT nra;jy; Ntz;Lk;>
Vd; gjpT nra;jy; Ntz;Lk;> vg;gb gjpT nra;jy; Ntz;Lk;> ahuplk; gjpT nra;jy;
Ntz;Lk;> vd;w tpsf;fj;ij ghu;g;Nghk;. Kjypy; Mtzg;gLj;Jjypd; top Kiwfs; gw;wp
ghh;g;Nghk;.
9.1 Mtzg;gLj;Jjypd; Kiwfs;:
• Njitahd jfty;fis Kiwahfr; Nrfupj;jy;.
• Nrfupj;j jfty;fis Kiwg;gb rupghu;j;jy;.
• ADR – ia tifg;gLj;Jjy;.
• ADR – f;F fhuzkhd kUj;Jfis rupahf FwPapL ,Ljy; (Coding)/
tifg;gLj;Jjy; (Classification).
• gf;ftpisTf;fhd fhuz fhupaq;fis myrp Muha;jy; (Causality Assessment).
• gupe;Jiuf;fg;l;l Neuj;jpw;Fs; Kiwg;gb mwpf;ifia rku;g;gpj;jy; (Submission
of reports within the appropriate timelines).
9.2 vjidg; gjpT nra;jy; Ntz;Lk;:
• kUe;Jfshy; Vw;glf;$ba ghjfkhd tpisTfs; midj;ijAk; gjpT nra;jy;
Ntz;Lk;. ,jpy; rpwpa jPq;F ngupa jPq;F vd;w ghFghL ,y;iy.
• kUj;Jtu;fshy; gupe;Jiuf;fg;gl;l kUe;Jfshf ,Ue;jhYk; gupe;Jiuf;fg;glhj
kUe;Jfshf ,Ue;jhYk; mtw;why; Vw;gLk; ghjfkhd tpisTfisg; gjpT nra;jy;
Ntz;Lk;.
• mjpf mstpyhd kUe;jpd; jd;ikahf ,Ue;jhYk;>mjpf tPupaj;jhy; epfo $ba
ghjfkhd tpisthf ,Ug;gpDk; gjpT nra;jy; Ntz;Lk;.
• kUe;Jfspd; $l;Lwthy; Vw;glf;$ba ghjfkhd tpisTfis gjpT nra;jy;
Ntz;Lk;. mit fPo;Fwpg;gpl;l ve;j $l;Lwthf Ntz;LkhdhYk; ,Uf;fyhk;.
kUj;Jtf;fz;fhzpg;G
kUe;J – kUe;J
kUe;J – czT
kUe;J – czTg; nghUl;fs;
9.3 Kf;fpakhf Gfhu; mspf;fg;gl Ntz;bait:
kUe;Jfspd; ghjfkhd tpisT fhuzkhf Vw;gLk; fPo;f;fz;l tpisTfis
Kf;fpakhf Gfhu; mspf;fg;gl Ntz;Lk;
• kuzk;
• capUf;F Mgj;jhd epiy
• kUj;Jtkidapy; mDkjpf;fg;gl Ntz;ba mtrpak;
• cly; cWg;Gfspd; FiwghL
• fUtpy; cs;s Foe;ijfSf;F Vw;gLk; FiwghL
• epue;juf; FiwghL
9.4 vq;Nf> ahuplk; Gfhu; mspf;f Ntz;Lk;
kUj;jtkid Copau;fs; ahu; Ntz;LkhdhYk; Gfhiu gjpT nra;ayhk;
v.fh -
kUj;Jtu;>
nrtpypau;>
kUe;jhSdu;>
kUj;Jt cjtpahsu;>
kUj;Jt khztu;fs; (kUj;Jtu;fs; kw;Wk; kUj;Jt Mrpupau;fs; thapyhf)
Nehahspfs;.
Nehahsp kUj;JtuplNkh my;yJ kUj;Jtkid Copau;fsplNkh Gfhu;
mspf;fyhk;. kUj;Jtkid Copau;fs; Gfhiu gjpT nra;J kUj;Jtuplk; nfhLf;f
Ntz;Lk;. kUj;Jtu; mjid mUfpy; cs;s ghu;kNfhtp[pyd;]; ikaj;jpw;F mDg;g
Ntz;Lk;.
jPtpu ghjfkhd epfo;T (Serious Adverse Event) Vw;gl;lhy; 15 ehl;fspy; Gfhu;
mspf;f Ntz;Lk;. kw;w ghjfkhd epfo;Tfs; kw;Wk; tpisTfis 1 khjj;jpw;Fs;
mDg;g Ntz;Lk;. ,it my;yhky; kUe;jhNyh kUj;Jtj;jhNyh ,wg;G Vw;gbd; clNd

kUj;Jtf;fz;fhzpg;G
mjhtJ 1 ehSf;Fs; Gfhu; mspj;jy; Ntz;Lk;.
,e;j Gfhiu Mtzg;gLj;jp njuptpf;f ,jw;nfd tiuaWf;fg;gl;L jPu;khdpf;fg;gl;l
gbtk; (ADR Reporting Form) cs;sJ. mjid Kiwahf> tpLjypd;wp G+u;j;jp nra;J>
mjid Nkw;Fwpf;fg;gl;l NPvCC, IPvC, PPvC - f;fspy; njuptpf;f Ntz;Lk;. mjd; khjpup
gbtk; ,jDld; ,izf;fg;gl;Ls;sJ> mjid vg;gb G+u;j;jp nra;a Ntz;Lk; vd;w
topKiwfSk; ,jDld; ,izf;fg;gl;Ls;sJ .
,jpy; Fwpg;ghf Nehahspg;gw;wpa jfty;fs;> kUe;J gw;wpa jfty;fs; kw;Wk;
gf;f tpisT my;yJ Nkhrkhd tpisT Mfpad gw;wpa Fwpg;Gfs; mlq;Fk;. NkYk;
Mtzg;gLj;Jgtu; my;yJ njuptpg;gtupd; Fwpg;Gfs; fl;lhak; ,lk;ngWk;. ,it
midj;Jk; kpf ek;gpf;ifahd Kiwapy; ghJfhf;fg;gLk;. Mtzg;gLj;Jgtu; kPJ ve;j
eltbf;ifAk; vLf;fg;gl khl;lhJ. mtiug;gw;wpa Fwpg;Gfs; ,ufrpakhf itf;fg;gLk;.
,Jkl;Lkpd;wp Nehahsu;fs; jhkhfNt Neubahf Gfhu; mspf;f VJthfTk;> kUj;Jtu;fSk;>
kUj;Jtkid Copau;fSk; kpf vspikahf Gfhu; mspf;f gy topKiwfis kUj;Jtf;
fz;fhzpg;gpy; cs;s epWtdq;fs; nra;JtUfpwJ. ,jpy; ADR Gfhu; gbtj;ij
jq;fsJ ,izajsj;jpy; ntspaply;> nrayp mwpKfg;gLj;Jjy;> Gfhiu ngWtjw;fhd
kpd;dQ;ry; Kftup ntspaply;> fl;lzkpy;yh njhiyNgrp vz; ntspaply; Nghd;wtw;iw
mwpKfk; nra;Js;sdu;. ,jd; %yk; gbtj;ij gjptpwf;fp> G+u;j;jp nra;J> mUfpy;
cs;s kUj;JtkidapNyh my;yJ kpd;dQ;ry; %ykfNth> nraypapd; thapyhfNth>
mDg;gyhk;.
kUj;Jtf;fz;fhzpg;G
,jd; xU ngUk; Kaw;rpahf SiddARAPP- vd;w nraypahdJ rpj;jkUj;Jtj;Jiwapy;
Kjd; Kjypy; rpj;j kUj;Jt ika Muha;r;rp epiyak; (Siddha Central Research Institute
- SCRI, Chennai) rhu;ghf ASU kUe;JfSf;fhd kUe;Jfs; rhu;e;j Gfhupid gjpT
nra;tjw;fhf cUthf;fg;gl;l nrayp MFk;. ,e;j nrayp %yk; kUj;Jtu;> kUj;Jt
cjtpahsu;> nrtpypau;> kUj;Jt gzpahsu;fs;> Nehahsu;> Nehahspapd; cjtpahsu;
vd;W ahu; Ntz;LkhdhYk; Gfhu; mspf;fyhk;.
9.5 ADR/AE Form
2008 Mk; Mz;L Kjy; MA~; kUj;Jtj;jpw;fhd kUj;Jtf; fz;fhzpg;G
nray;glj; njhlq;fpapUg;gpDk; etPdkUe;Jfspd; ADR gbtj;ij jhd; gpd;gw;wg;gl;L
te;jJ. gpd; 2019 Mk; Mz;L njhlf;fj;jpy; (Central Sector Scheme for Pharmacovigilance
for ASU & H Drugs) fPo;nfhLf;fg;gl;l ADR gbtk; MA~; kUj;Jtj;Jiwf;fhfNt
tiuaWf;fg;gl;L gpd;gw;wg; gLfpwJ. ,e;j gbtj;ij vt;thW G+u;j;jp nra;aNtz;Lk;
vd;w topfhl;bAk; ,jDld; nfhLf;fg;gl;Ls;sJ. ,e;j topfl;bia rpj;j kUj;Jt
Muha;r;rp epWtdj;jpd; kUj;Jtf; fz;fhzpg;G gpupT rhu;gpy; 8 Vg;uy; 2019 md;W Njrpa
kUj;Jtf; fz;fhzpg;G ikaj;jpw;F mZg;gl;lJ.
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
1. CODE
Code expresses the 4 classifieds
a) ADR or AE belongs to which system of medicine either Siddha, Ayurveda, Unani or
Homeopathy medicine and represent Si/NIS, Ay-IPGT or Ay-NIA, Un-NIUM, & Ho-NIH
respectively.
b) It indicates the number which is given to Peripheral Pharmacovigilance Centre [such as
SCRI, Chennai-001] where ADR reported.
c) It indicates the serial number of the ADR documented. [It is not unique]
d) It indicates in which year ADR reported.
2. Name of the person who had ADR or AE. But due to the maintenance of confidentiality,
initials can be marked here.
3. Any number or code represents the patient given by the Institution or Hospitals usually
OPD number or IPD number (It should be unique in nature)
4. Birth Place of the Patient.
5. Mention the Name of Hospital or clinic and also mention whether OPD or IPD.
6. Age of the Patient.
7. Complete Address of the patient.
(N.B: Name (2), Age (6), Gender (8), Place of Birth (4), Address (7) may be registered in the
separate register for maintaining the confidentiality and it can be traceable with unique Id – OP
id or IP ID).
8. Gender of the Patient. Mention female, male, or transgender.
9. Mention the diagnosis [either provisional or complete diagnosis] for which the patient
took medication.
10. Write the appropriate constitution & temperament of the ADR suspected Person.
According to the Siddha system of medicine Body Constitution (YakkaiyinIlakkanam) classified
into 10 types. [Ex: Vathapitham]
11. Write the exact date and time of Adverse Drug Reaction (ADR)/ Adverse Event (AE)
starts. [Ex: DD/MM/YYYY at 5.30 pm]
12. Write each & every Reaction of the ADR (signs & symptoms).
13. Mention whether the patient suffers with any long-term disorders or under medication
for any chronic diseases such as Hepatic, Renal, Cardiac, Diabetes, Hypertension (May be
included), etc. if it is other than the above select any other and it is to be mentioned separately.
14. If yes, mention whether the ADR suspected person addicted to any drugs or alcohol,
kUj;Jtf;fz;fhzpg;G
tobacco, etc. and also, specify the quantity of the items per day/week/month. Mention the
habitual period. [Ex: Alcohol addiction for more than 5 years & took 180 ml daily or Habit of
tobacco smoking for more than 2 years & smoke 5cigarette per day]
15. If yes, mention the previous history of the allergic reaction towards any substances or
any food or any medicine. [Ex: Substance -allergy to acid, Medicine – allergy to Sulpha drug,
Food- allergy to Seafoods]
16. Full name of the medicine belongs to any one of the ASU& H medicines taken by the
patient for a month before the occurrence of ADR/AE. It may be an individual medicine (Single
or multi-ingredient), or formulation (Herbal or Herbo-mineral).
[Ex: Siddha medicine formulation-Thiripalachooranam]
17. Mention the name of Pharmaceuticals where the medicine manufactured and also
manufacturing date and batch number which is mentioned in the label.
[Ex: Name of pharmaceuticals-XXX Pharmaceuticals
Manufacturing date-DD/MM/YYYY
Batch No: xxxx]
18. Mention the dose of the medicine in specific measurements such as number or grams
or mg per day. [Ex: If tablet or capsule write the number such as 1 or 2 per day, If the medicine
in Powder form mention in grams per day]
19. Mention the Pharmaceutical form of the medicine like Chooranam, Parpam, Chenduram,
or liquid form [Ex: powder, liquid and semisolid] and also the route of administration like
orally, or external application of medicine.[Ex: Tablet xxx-oral; yyy oil-External application]
20. Mention the starting date of medicine consumed [any one of the ASU& H medicines].
21. Mention the date whether the medicine stopped, or mention continued.
22. Mention the purpose of diagnosis of the patient to take the particular medicine. [Ex:
xxx medicine for cough]
23. Mention any unwanted occurrence occurs while taking the medicine. [Ex: Heart burns
occurs while took some medicine]
(N.B: from 16 to 23 mention all the information for each and every medicine taken by the
patient)
24. Mention Full name of the other medicine (Other than the specified system of medicine)
taken by the patient for a month before the occurrence of ADR [other than given in the above
table from 16 to 23].
25. Mention the name of the Pharmaceuticals where the medicine manufactured and also
manufacturing date, the batch number which is mentioned in the label.
kUj;Jtf;fz;fhzpg;G
Ex: Name of pharmaceuticals-XXX Pharmaceuticals
Manufacturing date-DD/MM/YYYY
Batch No: xxxx]
26. Mention the dose of the medicine in specific measurements such as number or grams
or mg per day. [Ex: If tablet or capsule write the number such as 1 or 2 per day, If the medicine
in Powder form mention in grams per day]
27. Mention the form of medicine like liquid, semisolid or solid form [Ex: powder, liquid
and semisolid] and also the route of administration like oral,
28. parenteral or external application of medicine. [Ex: Tablet xxx-oral; yyy oil-External
application].
29. Mention the starting date of medicine consumed.
30. Mention the date whether the medicine stopped, or mention continued.
31. Mention the purpose of diagnosis of the patient to take the particular medicine.
32. Mention any unwanted occurrence occurs while taking medicine.
33. Mention the Name of suspected drug which may be considered to be the reason for
ADR/AE.
34. Mention the Manufacturing date and Expiry date of the suspected medicine which are
available in the label of the medicine
35. Remaining pack/label (if available) of the suspected medicine.
36. Mention whether the medicine taken orally or any other route of administration
and mention the adjuvant/vehicle took along with the suspected medicine. [Ex:
ThirikaduguChooranam took orally with honey]
37. Mention the dietary precautions advised by the physician while taking the suspected
medicine. [Ex: While SerankottaiNei, Siddha medicine Physician strictly advised to avoid
tamarind & salt]
38. Mention whether the suspected drug is consumed under medical supervision or used
as self-medication.
39. Any other relevant information associated with the suspected drug use such as sleep
disturbance, changes in daily activity, took different foods, etc.
40. Mention any treatment given to the patient for managing the ADR or AE.
Indicate the outcome of the suspected adverse reaction (tick appropriate)
41. Tick whether the patient recovered from ADR.
[patient’s ADR - signs & symptoms reduced well]
42. Tick whether the patient not recovered from ADR
kUj;Jtf;fz;fhzpg;G
[patient’s ADR - signs & symptoms not reduced well]
43. Tick if the patient doesn’t know whether the ADR/AE reduced or not.
44. Tick fatal, if the patient died due to suspected medicine.
45. If fatal, Mention the date of death if the patient dead.
46. Mention whether the reaction of the ADR/AE is severe Tick Yes, if not Tick No.
47. Mention the ADR/AE reduced after the drug stopped or reduced (De-challenge)
48. Mention the status of reaction while re-administrating the medicine. (Re-challenge - This
should be done if the ADR/AE is not a serious one)
[Note: 46 & 47 Karpoorachindhamanimathirai: Nausea & vomiting are the ADR recorded for
the drug.
The symptoms reduced while the dosage of the drug reduced - De-challenge.
The symptoms while re –administrated of the drug, Re-challenge]
49. Whether the patient suffers from ADR/AE and if admitted in the hospital due to ADR/
AE, Mention the Name and Address of the hospital.
50. Mention the relevant Laboratory findings to Pre or Post-episodes of ADR
[Ex: Sr.Ferritin for the ADR due to Iron related medicine].
51. Mention the position of the Reporter such as Patient / Attendant / Nurse / Doctor /
Pharmacist / Health worker / Drug Manufacturer / Any other.
52. Mention the Name of the Reporter.
53. Mention the Address of the Reporter
54. Mention the Telephone number & mail Id of the reporter
55. Put the signature of the reporter in this field.
56. Mention the date of recording of ADR in this field.
kUj;Jtf;fz;fhzpg;G
The ADR probability scale:

Each question has three options and based on the appropriateness; the answer will be given.
1. If any previous conclusive report is available in line with current ADR reported, then
“Yes”, or else “No” has to be selected. If no known report means, then select the “Don’t Know”
option.
2. If ADR appears after the suspected drug was administered, then choose “Yes”, or else
Choose “No” option. If you are not confirmed, then choose “Don’t know” option.
3. If ADR recovered/reduced, when the drug was discontinued and a specific antagonist
was administered, then choose the option “Yes” or else “No” has to be selected. If you are not
confirmed, then choose “Don’t know” option (De-challenge Phenomena).
4. If the ADR, reappears when the drug was re-administered, then choose the option “Yes”
or else “No” has to be selected. If you are not confirmed, then choose “Don’t know” option (Re-
challenge Phenomena).
5. If any alternatives other than the suspected drug causes the ADR, then choose the
option “Yes” or else “No” has to be selected. If you are not confirmed, then choose “Don’t know”
option.
6. If you find the suspected drug concentration in the blood as in the toxic level, then
choose the option “Yes” or else “No” has to be selected. If you are not confirmed, then choose
“Don’t know” option.
7. If you increase the dose of the suspected drug, the reaction was more severe or if you
decrease the dose of the suspected drug, the reaction was less severe, then choose the option
“Yes” or else “No” has to be selected. If you are not confirmed, then choose “Don’t know” option.
This will once again confirm the causal relationship of the suspected drug and the reaction.
8. If the patient has a similar reaction to the same suspected drug or similar drugs in any
previous exposure, then choose the option “Yes” or else “No” has to be selected. If you are not
confirmed, then choose “Don’t know” option.
9. If any confirmation report with objective evidence of the suspected report and the
ADR, then choose the option “Yes” or else “No” has to be selected. If you are not confirmed,
then choose “Don’t know” option.
,Jtiu ehk; AYUSH kUj;Jtj;jpw;fhd ghjfkhd tpisTfis gjpT
nra;tjw;fhd gbtj;ijAk; mjid G+u;j;jp nra;tjd; topKiwfis ghu;j;Njhk;.,dp
Indian Pharmacopeia Commission %yk; Mq;fpy kUj;Jtj;jpw;fhf cUthf;fg;gl;l
ADR gbtq;fis fhzyhk;. ,e;jpah xU gd;Kfj;jd;ik nfhz;l ehL ,q;Nf gy;NtW
kUj;Jtf;fz;fhzpg;G
nkhopfs; Ngrg;gLfpwJ> MfNt ,e;jpahtpYs;s ngUk;ghd;ikahd kf;fs; jq;fspd;
kUe;Jfs; rhu;e;j Gfhu;fis vspjhf gjpT nra;a Ntz;Lk; vd;gjw;fhf ,e;j ADR
gbtkhdJ Mq;fpyk; kl;Lky;yhky; jkpo;> njYq;F> Nghd;w ,e;jpahtpy; Ngrg;gLfpw
gj;J nkhopapy; nkhopg; ngau;f;fg;gl;Ls;sJ. ,jpy; Mq;fpyk; kw;Wk; jkpopy; cs;s
ADR gbtk; fPNof; nfhLf;fg;gl;lJ.
kUj;Jtf;fz;fhzpg;G
cyfpy; cs;s gy;NtW ehLfspy; kUe;Jfis fz;fhzpg;gjw;fhfNt ngUk;

Kaw;rp vLf;fpd;wdu;> mt;thW tpopg;Gzu;T Vw;gLj;Jk; nghUl;Lk; gjpTfis Cf;f
gLj;Jk; nghUl;Lk; gy tpj;jpahrkhd ADR gbtq;fis mwpKfk; nra;jdu;. mjpy;
kpfTk; tpku;rpahdJ Yellow card/Blue card - ADR gbtk; fPNof;nfhLf;fg;gl;Ls;sJ.
https://yellowcard.mhra.gov.uk/resources/reporting-forms/member-of-public-yellow-card-
reporting-form/
kUj;Jtf;fz;fhzpg;G
https://www.tga.gov.au/sites/default/files/blue-card-adverse-reaction-reporting-form.pdf
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
https://www.tga.gov.au/sites/default/files/blue-card-adverse-reaction-reporting-form.pdf
kUj;Jtf;fz;fhzpg;G
** Enhance Reporting Culture prevents tomorrow ADR**
kUj;Jtf;fz;fhzpg;G
10. MA~; kUj;Jtf;fz;fhzpg;gpd; gupzhkk;;
,e;jpahtpy; ngUk;ghyhd kf;fshy; Vw;Wf; nfhs;sg;gl;l kUj;Jt Kiw> MA~;

mikr;rfj;jpw;Fl;gl;l ghuk;gupa kUj;Jt KiwfshFk; ,jid tsu;r;rpg;ghijfSf;F
vLj;Jr; nry;tjw;fhfTk; newpg;gLj;Jtjw;fhfTk; ek; eLtd; muR gy
jpl;lq;fis nray;gLj;jpAs;sJ> mjpy; kpf Kf;fpakhdJk; jw;Nghija R+oYf;F
mj;jpahtrpakhdJkhd kUj;Jtf; fz;fhzpg;G vd;Dk; Pharmacovigilance MFk;.
,jid vjpu;fhyq;fspy; cWjpahf epiyf;Fk; gb ,Uf;f rpy mbg;gilfs; mtrpak;
MfpwJ. mtw;iwg; gw;wp fhz;Nghk;> ,jpy; Kjd;ikahdJ>
1. midtUf;Fk; MA~; kUj;Jtf; fz;fhzpg;G gw;wpa tpopg;Gzu;it Vw;gLj;Jjy;.
2. ,jd; njhlu;r;rpahf ghjfkhd tpisT/epfo;tpid gjpT nra;Ak; Kiwia
fyhr;rhukhfNt cz;lhf;Fjy;.
rpwe;j kUj;Jt gapw;rpf;F Good Clinical Practices (GCP) vd;W ,Ug;gJ Nghy>
rpwe;j kUe;Jfs; jahupg;gpw;F Good Manufacturing Practices (GMP) ,Ug;gJ Nghy
MA~; Jiwapy; rpwe;j kUj;Jt fz;fhzpg;G gapw;rp Good Pharmacovigilance Practices
(AYUSH-GPvP) ,Uj;jy; Ntz;Lk;> AYUSH-GPvPI epWt Kiwg;gLj;jg; gl;l jpl;l
tiutpid cUthf;f Ntz;Lk;.
Drug Safety Update Report (DSUR) –vd;gJ kUe;Jfis re;ijg;gLj;Jtjw;F

Kd;ghfNth> my;yJ kUj;Jt Muha;r;rpfs; eilngWk; NghNjh> kUe;Jfspd; ghJfhg;G
gw;wpa (Phase-I Kjy; III) mwpf;ifahFk;. ,e;j tif mwpf;iffis MA~; Jiw
rhu;e;j kUj;Jt KiwfSf;F> Muha;r;rpfSf;F gad;gLj;j Ntz;Lk;.
Periodic Safety Update Report (PSUR) - vd;gJ kUe;Jfis re;ijg;gLj;jpa gpwF

(Phase - IV) kUe;Jfspd; ghJfhg;G gw;wpa> Fwpg;gpl;l fhy msT tiu rku;g;gpf;fg;gl
Ntz;ba mwpf;if MFk;.
Periodic Adverse Drug Experience Report (PADER): Phase – IV – y; gad;gLj;Jk;

mwpf;if> Fwpg;ghf xl;Lnkhj;j (cumulative safety) ghJfhg;G mwpf;if MFk;. nghJthf
ehl;gl;l Neha;fSf;F rpj;j kUj;Jtk; kpFe;j gyd; jUk; vd;gjpy; Iakpy;iy. vdNt
,e;j ehl;gl;l Neha;fSf;F> ehl;fzf;fpy; kUj;Jtk; Njitg;glyhk;. vdNt MA~;
kUj;Jt Kiwf;F ,k;khjpupahd xl;Lnkhj;j ghJfhg;G mwpf;if> Fwpg;gpl;l kUe;J /
kUj;JtKiwf;F ehk; gad;gLj;j Ntz;Lk;.
kUj;Jtf;fz;fhzpg;G
SUSAR (Suspected Unexpected Serious Adverse Reactions):
,J vjpu;g;ghu;f;f Kbahj> kUe;Jfis re;Njfpf;Fk; gbahd> mghafukhd gf;f
tpisTfis gw;wpa mwpf;if MFk;. ,e;j mwpf;if kUe;Jfspd; gupe;Jiuf;fg;gl;l
mstpid nghUj;Njh> my;yJ msTf;F njhlu;gpy;yhkNyh ,Uf;fyhk;. Mdhy;
vjpu;ghu;f;f Kbahj> jPtpu gf;ftpisTfshf ,Uf;f Ntz;Lk;. ,J MA~; kUj;Jt
Kiwfspy; Gjpjhf VNjDk; kUe;J fz;Lgpbf;Fk; Muha;r;rpfspy; ,e;j mwpf;ifiag;
gad;gLj;j Ntz;Lk;.
Focused Drug Case Study (FDCS):
Fwpg;gpl;l kUe;Jfis njhlu;e;J fz;fhzpj;J> mjd; mwpf;ifia rku;g;gpj;jy;.
MA~; kUj;Jt Jiwfspy;> nghJthf gpugykhf ,Uf;ff; $ba kUe;JfSf;F ehk;
,e;j mwpf;ifia gad;gLj;jyhk;. (v.fh. ,urk; Nru;e;j kUe;Jfs;> kw;Wk; jq;fgw;gk;
Nghd;w kUe;Jfs;).
Orange – Guide
ekJ kUj;Jtj; Jiwapy;> vy;yh kUe;J jahupg;ghsu;fspd; kw;Wk;
tpepNahfg;ghsu;fspd; njhlu;Gf; Fwpg;Gfs; mlq;fpa ifNaL my;yJ nkd; nghUs;
jahupf;fyhk;. ,J Njitahd NghJ gad;gLj;j kpfTk; vspjhdJ. Mq;fpy kUj;Jt
Kiwfspy; cs;s Orange – Guide vd;gJ Nghy> ekJ MA~; kUj;Jt KiwfSf;Fk;
ehk; cUthf;f Ntz;Lk;.
Line – Listing
ADR fs; nkhj;jkhf Excel - nrayp KiwapNyh> my;yJ mjw;fhd gpuj;Nafkhf
,Uf;f$ba nkd; nghUs;fspNyh> juTj;jskhfNth gjpT nra;ayhk;. ,J Njitahd
NghJ vspjhf NjLk; Kiwapy; (Searchable) vspikahf gad;gLj;j KbAk;.
EURD
xt;nthU kUe;jpYk; ,Uf;ff;$ba Kiwahd kUe;J %yf;$Wfis jdpahfNth
(m) $l;L kUe;J %yf;$WfisNah ehk; xU juTj;jskhf jahupj;J itf;fyhk; -
Njitahd NghJ gf;ftpisTf;fhd fhuz fhupaq;fis Muha;e;J mwpa ,J cjTk;.
jw;NghJ eilKiwapy; cs;s gf;f tpisTfspd; fhuz fhupaq;fis myrp MuhAk;

kUj;Jtf;fz;fhzpg;G
Kiw> Mq;fpy kUj;Jt Kiwf;F nghUe;jf; $bajhf ,Uf;fpwJ. mJ mg;gbNa
KOikahf MA~; kUj;Jt KiwfSf;F nghUe;jhJ. “ehuQ;Nrh” msTNfhy; Nghd;W
ekJ kUj;Jt KiwfSf;F> kUe;JfSf;F nghUe;Jk; gbahd msTNfhy; jahupf;f
Ntz;bAs;sJ. ,jid Kiwahf jahupj;J> rupahd Kiwapy; jug;gupNrhjid nra;J>
gpd;G gad;Lj;j Ntz;Lk; ,J kpfTk; gaDs;sjhf mikAk;. ,J xU Kf;fpakhd vjpu;fhy
tsu;r;rp tha;g;ghFk;. Mtzg;gLj;Jjiyg; gw;wp kPz;Lk; kPz;Lk; typAWj;jpf;nfhz;Nl
,Ug;gpDk;> ,e;j Mtzq;fs; midj;ijAk; Nrfupj;J mjpy; cs;s jfty;fis
xg;gpl;L ghu;g;gjw;Fk; Ntw;Wik gLj;jp ghu;g;gjw;Fk;> Nrkpj;J itg;gjw;Fk; ,g;NghJs;s
njhopy; El;gk; jhd; JizGupAk;> etPd kUj;Jt fz;fhzpg;G Kiwapy; ,jw;nfd;W
jdp nkd;nghUs; cs;sJ mjd; ngau;fs; Oracle Argus Safety, Oracle Adverse Event
Reporting System etc. ,J Nghd;W MA~; kUj;Jtf; fz;fhzpg;gpw;fhd nkd;nghUis
cUthf;f Ntz;Lk;.
etPd kakhf;fg;gl;l MA~; kUj;Jtkidfspy; AYUSH-Hospital Management
Information System-Electronic Health Records nkd;nghUspd; xU mq;fkhf kUj;Jtf;
fz;fhzpg;G ,Uf;fpd;wJ. ,itahTk; ,e;j kUj;Jtf; fz;fhzpg;ig Nkk;gLj;jTk;>
epiyehl;lTk; cjTk;.
** Take and Tell-Together for safer medicine **
kUj;Jtf;fz;fhzpg;G
11. KbTiu
,e;E}ypy; etPd kUj;Jtf; fz;fhzpg;Gg; gw;wp $wpapUg;gpDk; ek; rpj;j
kUj;Jtj;jpy; kUj;Jtf; fz;fhzpg;gpd; rhuhk;rk; ngUkstpy; njspthf tiuKiw
nra;J ,Ug;gjhy; mjid tptupj;Jf; $wpAs;Nshk;. (The Pharmacovigilance system was
well established in the ancient days). ,d;iwa R+oypy; ehk; nra;a Ntz;Ltd ahnjdpy;
kUe;Jfs; kw;Wk; gf;ftpisTfis fz;fhzpf;Fk; Kiwikapid kw;Wk; mjd; jpl;l
tiutpid kPz;Lk; kWkyu;r;rp nra;a Ntz;Lk;. ghjfkhd tpisTfis rpwpa tpisT
ngupa tpisT vd;W ghuhky; rupahd Kiwapy; cupa Neuj;jpy; Mtzg;gLj;j Ntz;Lk;.
(Re – Establish with suitable documentation for our System) ,jid rupahd Kiwapy; ehk;
nray;gLj;jpdhy; NghJk;. ,jid nray; gLj;JtJ kUj;Jtu;> kUe;jhSdu;> kUe;J
jahupg;ghsu;> nrtpypau;> mJkl;Lkpd;wp kpf Kf;fpakhf nghJ kf;fspd; flikahFk;.
,jidg; gw;wp kUj;Jtu;fSf;Fk;> nrtpypau;fSf;Fk;> kUe;jhSdu;fSf;Fk;
ghlj;jpl;lj;jpy; ,jidg;gw;wp Nru;j;jy; mtrpakhdJ. kUe;Jfis jahu; nra;Ak;> kUe;J
nra; epiyaq;fspy; kUj;Jt fz;fhzpg;gpw;F vd;Nw jdp xU gpuptpid Vw;gLj;jp
kUe;Jfis njhlu;e;J fz;fhzpj;J Mtzg;gLj;jy; mtrpak;. ,t;thW nra;tjd;
%yk; ekJ rpj;j kUj;Jtj;jpd; khz;ig cyfwpar; nra;tJld; gue;J gl;l G+kpapy;
cs;s midj;J kf;fSf;Fk; ek; jkpo; kUj;Jtj;jpd;kPJ Mzpj;jukhd ek;gpf;ifia
Vw;gLj;j KbAk;.. mjd;%yk; ahtUk; Neha;jPu;e;J gyd; ngWk; tha;g;Gk; ngwKbAk;.
rpj;jkUj;Jtj;ijNa Rthrpf;Fk; ekf;Fk;> ek; ehl;L kf;fSf;Fk;> ,jd;ghy;

cs;s mwptpay; Moj;ij czu;e;J nfhs;sTk;> kUj;Jtj;jpy; Gjpa rpe;jidfis
GFj;jp mLj;j ,yf;F Muha;r;rpfisAk; ntw;wpfukhf nra;J Kbf;Fk; ek;gpf;ifiaAk;
ekf;Fj;jUk;.
Vigilance is Essential for every Country!!
Pharmacovigilance is Very Essential for every Health Care System!!
xU ehL Coy; Nghd;w Gw;WNeha;fshy; ghjpf;fg;glhky; tsk; ngw;W tsu
Vigilance (yQ;r xopg;G) vt;thW Kf;fpakhf Njitg;gLfpwNjh> mJNghy xt;nthU
kUj;JtKiwAk; jd;id fhyj;jpw;Nfw;g GJg;gpj;Jf;nfhz;Nl> mwptpay; G+u;tkhd
KiwfisAk; msTNfhy;fisAk; Vw;Wf;nfhz;L> Nkd;NkYk; tsu Pharmacovigilance
(kUj;Jtf; fz;fhzpg;G) kpf kpf ,d;wpaikahjJ MFk;.
** Making Medicines safer for Patients everywhere**
kUj;Jtf;fz;fhzpg;G
kUj;Jtf;fz;fhzpg;G
ABBREVIATION
ADR - Adverse Drug Reaction
AE - Adverse Event
AEFI - Adverse Event Following Immunisation
A-HIMS - AYUSH Hospital Management Information System (Electronic
Health Records)
AIIA - All India Institute of Ayurveda
AIIMS - All India institute of Medical science
AMC - ADR Monitoring Centre
ASU & H- Ayurveda, Siddha, Unani & Homeopathy drugs
AYUSH – Ayurveda Yoga Unani Siddha and Homeopathy
CCRS - Central Council for Research in Siddha
CDSCO - Central Drug Standard Controller Organisation
CIOMS - Council for International Organizations of Medical Sciences
CTD - Comprehensive Technical
DCGI - Drug Controller General of India
DMR - Drugs and Magical remedies
DOOR MAN - Documentation Of Objectionable advertisements Reporting under
Magic remedies Act Notification.
DSUR - Drug Safety Update Report
FDA - Food and Drug Administration (USA regulatory body)
GCP - Good Clinical Practise

kUj;Jtf;fz;fhzpg;G
GMP - Good Manufacturing Practise
GPvP - Good Pharmacovigilance Practise
GSDC - Global Safety Data Collection
ICH - International Conference on Harmonization of Technical Require-
ments for Registration of Pharmaceuticals for Human Use
ICSR - Individual case safety report
IEC - Institutional Ethical Committee
IHMP - Intensive Hospital Monitoring Programme
IPC - Indian Pharmacopiea commission
IPGTRA - Institute for Post Graduate Teaching and Research in Ayurveda
IPvC - Intermediary Pharmacovigilance centre
MCI - Medical Council of India
MedDRA- Medical Dictionary for Drug Regulatory Affairs
MLA - Misleading Advertisement
MvPI - Materio Vigilance Program India
NCC - National Coordination centre
NIS - National Institute of Siddha
NPP - National Pharmacovigilance Program
NPvC - National Pharmacovigilance centre
NSAID - Non Steroidal Anti Inflammatory Drug
OTC - Over-the-counter
PADER - Periodic Adverse Drug Experience Report
kUj;Jtf;fz;fhzpg;G
PMS - Post Marketing Surveillance(Phase IV)
PPvC - Peripheral Pharmacovigilance centre
PSUR - Periodic safety update report
PV - Pharmacovigilance
PvPI - Pharmacovigilance Program of India
SAE - Serious Adverse Event
SCRI - Siddha Central Research Institute,Chennai (PPvC)
SCRU - Siddha Clinical Research Unit, New Delhi (PPvC)
SiddAR - Siddha Intiative for Documentation of Drug Adverse Reaction
SPC - Siddha Pharmacoepia Committee
SRRI - Siddha Regional Research Institue, Puducherry (PPvC)
SRRI - Siddha Regional Research Institue,Thiruvananthapuram (PPvC)
SUSAR - Serious Unexpected Serious Adverse Reaction
UIP - Universal Immunisation Program
UMC - Uppsala Monitoring centre
WHO - World Health Organisation
kUj;Jtf;fz;fhzpg;G
Reference books
1. Thirumoolar. Thirumanthiram Moovayiram - 1st part. Chennai: Thamarai
Noolagam; 1954.
2. Shuddhananda Bharathi. Thirukkural moolam parimalazhagar Vurai. Chennai:
A. Ranagswamy’s Mudaliar & Sons; 1931.
3. Kandaswamy Pillai C. Chikichcharathna Deepam Ennum Vaidya Nool B. Chen-
nai: Rathana Nayakar & Sons; 2014.
4. Kannuswamy Pillai C. Kannusamiyam Ennum Vaidya Saagaram. Madras: B.
Rathannayakar & Sons; 1963.
5. Murugesa Mudaliar. Gunapadam (Mooligai Vaguppu). Chennai: Department of
Indian Medicine & Homeopathy; 1951.
6. Thyagarajan R. Gunapadam (Thathu Jeeva Vaguppu). Chennai: Department of
Indian Medicine & Homeopathy; 1952.
7. Kumaraswamy Mudaliar KN. Siddha Maruthuvam (Phodu). Chennai: Depart-
ment of Indian Medicine & Homeopathy; 2007.
8. Thiyagarajan R. Siddha Maruthuvam (Sirappu). Chennai: Department of Indian
Medicine & Homeopathy; 2008.
9. Murugasa Mudaliar KS. Nanju Murivu Nool. Chennai: Department of Indian
Medicine & Homeopathy; 2006.
10. Kasim Muhaiyadeen Raouthar. Pathartha Guna Cinthamani(Moolamum - Vurai-
yum). Chennai: B. Rathna Nayakar Sons. 1932.
11. Kannuswamy Pillai S. Siddha Vaidya Pathartha Guna Vilakkam (Meteria Medi-
ca - Mineral Animal kingdom. Chennai: Rathna Nayakar & sons; 2006.
12. Agathiar. Agathiar Vaidya Vallathi-600. Madras: Munuswamy’s Mudaliyar;
1909.
13. Kandaswamy Mudaliar. Aathmaratchamirtham ennum Vaidya Sara Aangirag-
am. Chennai: B. Rathna Nayakar Sons. 1931.
14. Durai Rajan C. Noi Illa Neri. Chennai: Department of Indian Medicine & Ho-
meopathy; 1993.
kUj;Jtf;fz;fhzpg;G
15. Vijay Malik. Law relating to Drugs & Cosmetics Act. Luchnow: Eastern Book
Company 2008.
16. Gad SC. Drug Safety Evaluation. New Jersy: Wiley; 2009.
17. Mann RD. et.al. Pharmacovigilance. New Jersy: Wiley; 2007.
Reference - Website
https://www.who.int/
https://www.who-umc.org/
https://cdsco.gov.in/opencms/opencms/en/Home/
https://www.ipc.gov.in/
https://ipc.gov.in/PvPI/pv_home.html
https://aiia.gov.in/
https://www.ayushsuraksha.com/
https://nischennai.org/index.html
http://siddhacouncil.com/
https://crisiddha.tn.nic.in/
https://www.ayush.gov.in/

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kUj;Jtf;fz;fhzpg;G

kUj;Jtf; fz;fhzpg;G KiwikAk;

Kjy;epiy kUj;Jtf; fz;fhzpg;G ikak;

E}ypd; ngau; kUj;Jtf; fz;fhzpg;G KiwikAk; rpj;j

Translation & Compilation

kU. gh. fkyhnrse;juk;

kU. g. Njd;nkhop kU. Nt. Mu;j;jp kU. r. eluh[d;

kU. g. rj;jpauhN[];tud; Nguhrpupau;. kU. f. fdfts;sp

jl;lr ;R kw ;Wk ; njhopy ; El;g cjt p

Kjy;epiy kUj;Jtf; fz;fhzpg;G ikak;

Nehahsu; ghJfhg;Ng Kjd;ikahdJ vd;w Nehf;fj;Jld; ,e;jpa murhy; Pharmacovigilance

Pharmacovigilance center fs; gw;wpa Fwpg;GfisAk;> rpj;j kUj;Jtu;fs;> khztu;fs;> kUe;J

,e;E}ypid nkhop ngau;j;Jk;> njhFj;Jk; toq;fpa Mrpupau;fSf;Fk; kw;Wk; jl;lr;R

Nguhrpupau;. kU. K. fdfts;sp

etPd kUj;Jtf; fz;fhzpg;G kw;Wk; kUe;Jfspd; gf;ftpisTfisf; fz;fhzpf;Fk; Kiwfs;

etPd kUj;Jtf; fz;fhzpg;G kw;Wk; kUe;Jfspd; gf;ftpisTfisf; fz;fhzpf;Fk; Kiwfs;

,jw;F gy rhd;WfisAk;;> gy fUj;Jf;fisAk;> ,e;E}ypy; njhFj;J $wpAs;Nshk;;. ,jid ek;

etPd kUe;Jk; %ypif kUe;Jk; Nrh;e;J vLg;gjhy;

5.5 kUj;Jtf; fz;fhzpg;G ikaq;fspd; nghWg;Gk; nray;ghLk; 64

6 gy;NtW fz;fhzpg;G Kiwfs; 65

kUj;Jtf; fz;fhzpg;G newpKiwfspd; mtrpak;

etPd kUj;Jtj;jpy; kUe;Jfis fz;fhzpj;jy; vd;w Kiwapy; kUe;jpid

fp.K. 3000 - j;jpw;F Kd; rpj;j kUj;Jtj;jpy; $wpa kUe;jpd; tpsf;fKk;>

Nkdhl;L mwpQu; Nkhypau; nrhd;dJ Nghy> ekJ Nehiaj; jPu;g;gjw;F VjhtJ

ek; rpj;j kUj;Jtf; Nfhl;ghl;bd;gb vtndhUtd; vq;F gpwe;J tho;fpwhNdh

mtDf;F me;j ehl;by;> me;j ,lj;jpy; cs;s %ypiffisf; nfhz;Nl kUj;Jtk;

nra;a mJ kpFe;j gyidj;jUk; vd;fpwJ. vdNt xU ,lj;jpy; trpf;Fk; xU Fwpg;gpl;l

kf;fSf;F KOg;gyidAk; ghJfhg;igAk; juty;y xU kUe;J mjw;F Neu; vjpuhd

thoplj;jpy; cs;s my;yJ kw;nwhU ehl;by; trpg;gtu;fSf;F KOghJfhg;igj; ju

,ayhky; Nghfyhk;. Mjyhy; jhd; kUj;Jt Muha;r;rp (Clinical Research) apy; $l

Nrhjpj;J mwpag;gLfpwJ. mjd;gpd;G $l> re;ijg;gLj;jYf;F gpe;ija fz;fhzpg;G

Vnddpy; filtPjpf;F te;j gpwFk; $l kf;fspd; ghJfhg;Gf;F jPq;F tpistpg;gjhy;

jpUk;g miof;fg;gLk; gbahd (Call back) kUe;JfSk; xLf;fp jilnra;ag;gl;l (Ban)

gy kUe;JfisAk; ehk; mwpNthk;.

2014 cyf Rfhjhu ikaj;jpd; jfty; gb Mgj;ij Vw;gLj;jf; $ba> gh-

jfkhd tpisT 6.7 tpOf;fhlhfTk;> ghjfkhd tpistpdhy; kUj;Jtkidapy; mD-

kjpf;fg;gLk; Nehahsu;fs; 3.4 tpOf;fhlhfTk; cs;sdu;. ,jpy; 1.8 tpOf;fhL ,wg;G

Nkw;fz;l Gs;sp tpguq;fspy; cs;s gf;ftpisTfs; gjpT nra;ag;gl;lit.

Mdhy; ,e;jpahtpy; gjpT nra;ag;glhkNyNa ,Uf;ff;$ba gf;ftpisTfNs mjpfk;

vd;Wk; gy ty;Ydu;fs; $Wfpd;wdu;. ,itj; jtpu xU $W ,uj;jk; khw;Wtjpdhy;

cz;lhFk; jtwhd tpistpd; rhj;jpaf;$Wfs; 0.7 tpOf;fhL MFk;. rhjhuz tpkhd

gazj;jpy; Vw;gLk; jtwhd tpistpd; rhj;jpaf;$Wfs; 2.4 tpOf;fhL MFk;. mWit

rpfpr;irapd; NghJ jug;gLk; kaf;f kUe;J NfhshWfspdhy; cz;lhFk; jtwhd tpistpd;

rhj;jpaf;$Wfs; 7.5 tpOf;fhL MFk;. ,jid rhjhuzkhf ek;khy; Vw;Wf;nfhs;s

KbAkh? ,e;j Gs;sp tptuq;fs; 1 kpy;ypad; kf;fs; njhifapy; epfof;$ba rhj;jpa

ehk; vjw;fhf kUe;Jfspd; ghJfhg;Gj;jd;ik kw;Wk; gf;ftpisTfs; Fwpj;j

** Promoting Public Health by promoting safer Drug therapy **

2. kUj;Jtf; fz;fhzpg;gpd; tuyhWk; tsu;r;rpAk;:

kUe;jpidf; fz;fhzpf;f Ntz;Lk; vd;W rpy Mz;Lfshf mjpf Kidg;Gf;fhl;b

2.1 Ke;ija tuyhW

18k; E}w;whz;bw;F Kd;du; Nehahsupd; ghJfhg;G gw;wp gy;NtW fUj;Jfs;

1941-y;” Sulfathiazole vd;w kUe;ij Phenobarbital vd;w kUe;Jld; cl;nfhz;ltu;fs;

2.3 jhypNlhikl; tuyhW

1960 fspy; Thalidomide vd;w xU kUe;J jhd; kUe;Jfs; kw;Wk; gf;ftpisTfis

Phocomelia - jhypNlhikl; NguopT

1961k; Mz;L brk;gu; khjk; Pharmacovigilance vd;w thu;j;ij mjpfhu G+u;tkhf

2.4 He;jpahtpy;-kUj;Jtf; fz;fhzpg;gpd; tsu;r;rpAk; tuyhWk;

,e;jpahtpy; 1986y; jhd; Kjy; Kjyhf kUe;Jfis fz;fhzpf;Fk; ikaq;fs;

2.5 cyf Nehahsu; ghJfhg;G jpdk;

** Protecting Patient from Harm **

Promoting Public Health by promoting safer Drug therapy

Protecting Patient from Harm