Pharmacy Law and EthicsPHARMACEUTICAL LEGISLATION15 Octo!r "#1$PHARMACEUTICAL LEGISLATIONESTA%LISHMENT O& STATUTOR' (RUG LEGISLATION IN (E)ELOPING COUNTRIES *HO r!comm!ndations o+ dr,- .!-is.ation +or d!/!.o0in- co,ntri!sBasic elements of a drug Acti. General provisions; Title; .on- tit.! or th! sco0! as w!.. as th! short tit.!1 Purpose: in th! o/!ra.. nationa. 0harmac!,tica. s,00.y syst!m2 sa+! and !3!cti/! dr,-s +or int!nd!d ,s!s and o+ 4,a.ity r!ach th! cons,m!r1 Extent: t!rritoria. ar!a to which th! Act a00.i!s Application/relation to oth!r .aws not arr!d Interpretation or Denitions o+ /ario,s t!rmsPHARMACEUTICAL LEGISLATIONii. !pecic ProvisionsSho,.d 0ro/id! a,thority thro,-h .ic!nsin- +or th! +o..owin-5a. Import and export of drugs; conditions +or im0ort6!70ort2 0!rsons 4,a.i8!d to im0ort6!70ort2 +!!s2 ty0!s o+ 0!rmit r!4,ir!d to im0ort6!70ort2 stora-! at 0.ac!s o+ im0ort o+ dr,-s 0!ndin- r!.!as!2 r!cords to ! 9!0tPHARMACEUTICAL LEGISLATION1 (r,- r!-istrationc1 Sch!d,.in- o+ dr,-sd1 Contro. o+ Man,+act,r!!1 Contro. o+ distri,tion2 s,00.y2 stora-! and sa.! o+ dr,-s+1 La!..in--1 In+ormation and Ad/!rtisin-h1 Im0osition o+ +!!s : +or .ic!nc!s2 !tc1PHARMACEUTICAL LEGISLATIONiii1 (r,- Contro. Administration a1 Or-anisation and +,nctions ; (RU1 (r,- ad/isory oard5 r!-istration2 !/a.,ation2 r!/ocation !tc1c1 Ins0!ctorat! s!r/ic!sd1 Laoratory s!r/ic!s +or 4,a.ity contro.i/1 Prohiitions2 o3!nc!s2 0!na.ti!s and .!-a. 0roc!d,r!s/1 Pow!rs to ma9! r,.!s and r!-,.ations : a00ro0riat! a,thority to !sta.ish sch!d,.!s and r!-,.ations +or th! 0,r0os! o+ th! Act/i1 R!0!a.s and transitiona. 0ro/isions/ii1E7!m0tions +rom th! 0ro/isions o+ th! .awPHARMACEUTICAL LEGISLATION (E)ELOPMENT O& NATIONAL (RUG POLIC'< St!0s In/o./!d in +orm,.atin- a Nationa. dr,- Po.icy5!tep ": #rgani$e t%e polic& process!tep ': Identif& t%e main pro(lems!tep ): *a+e a detailed situation anal&sis!tep ,: !et goals and o(-ectives for a national drug polic& !tep .: Draft t%e text of t%e polic& !tep /: 0irculate and revise t%e draft polic& !tep 1: !ecure formal endorsement of t%e polic&!tep 2: 3aunc% t%e national drug polic&(E)ELOPMENT O& NATIONAL (RUG POLIC'St!0 1= #rgani$e t%e polic& processth! ministry o+ h!a.th ta9!s th! .!ad ro.! in +orm,.atin- a nationa. dr,- 0o.icy1 d!/!.o0m!nt 0roc!ss that wi.. id!nti+y th! str,ct,r! o+ th! 0o.icy2 its ma>or o>!cti/!s and its 0riority com0on!nts1 id!nti+y sta9!ho.d!rs2 n!c!ssary r!so,rc!s2 This sta-! can ! carri!d o,t within th! ministry o+ h!a.th with s,00ort +rom a sma.. committ!! o+ s!.!ct!d !70!rts1(E)ELOPMENT O& NATIONAL (RUG POLIC'!tep ': Identif& t%e main pro(lemscarryin- o,t an initia. sit,ation ana.ysis1rin- to-!th!r a t!am o+ !70!rts +rom th! ministry o+ h!a.th and +rom oth!r disci0.in!s and ac9-ro,nds1 id!nti+y th! main 0ro.!ms2 ma9! r!comm!ndationsid!nti+y 0ossi.! a00roach!s1 +orm,.at! conso.idat!d ad/ic! to th! -o/!rnm!nt1 (E)ELOPMENT O& NATIONAL (RUG POLIC'!tep ): *a+e a detailed situation anal&sisA mor! d!tai.!d sit,ation ana.ysis o+ th! 0harmac!,tica. s!ctor and its com0on!nts may ! n!!d!d1 +,rth!r ana.ys! th! so,rc! o+ th! 0ro.!ms2id!nti+y 0ot!ntia. so.,tions2choos! th! most a00ro0riat! strat!-i!s2 s!t 0rioriti!s2 s!r/! as a as!.in! +or monitorin- and !/a.,ation1(E)ELOPMENT O& NATIONAL (RUG POLIC'!tep ,: !et goals and o(-ectives for a national drug polic& S!t -oa.s Id!nti+y 0riority o>!cti/!s2 !1-1 i+ th! 0ro.!m is .ac9 o+ acc!ss to !ss!ntia. dr,-s2 on! o+ th! 0riority o>!cti/!s sho,.d ! to im0ro/! th! s!.!ction2 a3ordai.ity and distri,tion o+ !ss!ntia. dr,-s1 A wor9sho0 in/o./in- a sma.. n,m!r o+ 9!y 0o.icyma9!rs may ! h!.0+,.1 Th! sit,ation ana.ysis sho,.d >,sti+y th! choic!s and s!r/! as th! asis +or d!cisions1 (isc,ss th! main o>!cti/!s and strat!-i!s with a.. sta9!ho.d!rs %road cons,.tation ar! n!c!ssary to s!t achi!/a.! o>!cti/!s and to +orm,.at! a00ro0riat! strat!-i!s to attain th!m1(E)ELOPMENT O& NATIONAL (RUG POLIC'!tep .: Draft t%e text of t%e polic& A dra+t t!7t o+ th! nationa. dr,- 0o.icy sho,.d +o..owIt sho,.d s!t o,t th! -!n!ra. o>!cti/!s o+ th! 0o.icy &or !7am0.!5to !ns,r! that !ss!ntia. dr,-s ar! acc!ssi.! to th! !ntir! 0o0,.ation5that th! dr,-s ar! sa+!2 !?cacio,s and o+ -ood 4,a.ity5 andthat th!y ar! ,s!d rationa..y y h!a.th 0ro+!ssiona.s and cons,m!rs1 Th! s0!ci8c o>!cti/!s sho,.d a.so ! d!scri!d2 +o..ow!d in !ach cas! y th! strat!-y to ! ado0t!d1 (E)ELOPMENT O& NATIONAL (RUG POLIC'!tep /: 0irculate and revise t%e draft polic& *id! circ,.ation o+ th!dra+t doc,m!nt +or comm!nts y a.. sta9!ho.d!rs inc.,din- th! 0ri/at! and acad!mic s!ctors1 Endors!m!nt y -o/!rnm!nt s!ctors r!s0onsi.! +or 0.annin-2 8nanc! and !d,cation is im0ortantOnc! this wid! cons,.tation is com0.!t!2 th! dra+t doc,m!nt sho,.d ! r!/is!d in th! .i-ht o+ th! comm!nts r!c!i/!d2 and 8na.is!d1(E)ELOPMENT O& NATIONAL (RUG POLIC'!tep 1: !ecure formal endorsement of t%e polic& an administrati/! doc,m!nt that s!r/!s as a asis +or im0.!m!ntation 0.ans and chan-!s in th! .aw and r!-,.ations1 In som! co,ntri!s th! !ntir! nationa. dr,- 0o.icy doc,m!nt has !com! .aw1 a d!monstration o+ 0o.itica. commitm!nt ,t it can a.so ca,s! 0ro.!ms2 as +,t,r! ad>,stm!nts to th! 0o.icy may !com! di?c,.t1c!rtain !na.in- com0on!nts o+ th! 0o.icy ar! incor0orat!d into .aw2 witho,t too many o0!rationa. d!tai.s1(E)ELOPMENT O& NATIONAL (RUG POLIC'!tep 2: 3aunc% t%e national drug polic& Introd,cin- a nationa. dr,- 0o.icy is m,ch mor! than a t!chnica. tas91 To a .ar-! !7t!nt th! 0o.icy@s s,cc!ss wi.. d!0!nd on th! .!/!. o+ ,nd!rstandin- o+ di3!r!nt s!ctors o+ soci!ty2 and on th!ir s,00ort +or its o>!cti/!s1 Th! im0.ications and !n!8ts +or a.. int!r!st!d 0arti!s sho,.d th!r!+or! ! str!ss!d1 Th! 0o.icy sho,.d ! 0romot!d thro,-h a c.!ar and w!..;d!si-n!d in+ormation cam0ai-n1 In+ormation sho,.d ! diss!minat!d thro,-h a /ari!ty o+ chann!.s to r!ach di3!r!nt tar-!t -ro,0s1 Th! m!dia can 0.ay a ma>or ro.! in !ns,rin- 0,.ic ,nd!rstandin- and s,00ort +or th! 0o.icy1 Som! co,ntri!s ha/! or-aniA!d hi-h 0ro8.! .a,nch!s1%OTS*ANA NATIONAL (RUG POLIC' B%N(PCGENERAL AIM5In accordanc! with th! 0hi.oso0hy o+ th!Nationa. H!a.th Po.icy to attain h!a.th +or a..2th! %N(P is !sta.ish!d with an aim to ma9! th!dr,-s o+ acc!0ta.! sa+!ty2 !?cacy and 4,a.ity2a/ai.a.! and a3orda.! to a.. thos! who n!!dth!m2 and to 0romot! th!ir rationa. ,s! y0r!scri!rs2 dis0!ns!rs and cons,m!rs1%OTS*ANA NATIONAL (RUG POLIC' B%N(PCO%DECTI)ES511 H!a.th o>!cti/!s"1 Economic and d!/!.o0m!nta. o>!cti/!s%OTS*ANA NATIONAL (RUG POLIC' B%N(PCH!a.th o>!cti/!s ar! to5i1 Ens,r! th! a/ai.ai.ity and acc!ssii.ity o+ !ss!ntia. dr,-s to a.. citiA!nsii1 Ens,r! th! ,s! o+ sa+!2 !?cacio,sand 4,a.ity dr,-siii1 Ens,r! -ood dis0!nsin- and 0r!scriin- 0ractic!si/1 Promot! th! rationa. ,s! o+ dr,-s y 0r!scri!rs2 dis0!ns!rs and 0ati!nts/1 Pro/id! th! n!c!ssary trainin-2 !d,cation and in+ormation/i1 Promot! 0r!/!nti/! car!2 in+orm!d d!cision ma9in- and o/!ra.. indi/id,a. r!s0onsii.ity +or h!a.th/ii1 Contri,t! to th! contro. o+ dr,- ,s! and 0r!/!ntion o+ dr,- mis,s! and a,s!1%OTS*ANA NATIONAL (RUG POLIC' B%N(PCEconomic and d!/!.o0m!nta. o>!cti/!s ar! to5i1 Promot! th! .ow!rin- o+ dr,- cost in oth th! 0ri/at! and 0,.ic s!ctorii1 Promot! th! cost !3!cti/! ,s! o+ dr,-siii1 Cr!at! a cond,ci/! !n/ironm!nt +or 0artn!rshi0 !tw!!n -o/!rnm!nta. and non;-o/!rnm!nta. 0ro/id!rs in th! 0harmac!,tica. s!ctor y m!ans o+ an a00ro0riat! r!-,.atory and administrati/! +ram!wor9%OTS*ANA NATIONAL (RUG POLIC' B%N(PCi/1 O0timis! th! ,s! o+ scarc! r!so,rc!s and +aci.itat! cross +!rti.isation o+ id!as thro,-h co;o0!ration with int!rnationa. and r!-iona. a-!nci!s/1 Promot!2 s,00ort and !nco,ra-! th! d!/!.o0m!nt o+ .oca. 0harmac!,tica. ind,stry and th! 0rod,ction and distri,tion o+ !ss!ntia. dr,-s and raw mat!ria.s/i1 Promot! 9now.!d-!2 !?ci!ncy2 mana-!m!nt s9i..s and 0rod,cti/ity in th! 0harmac!,tica. s!ctor1 ASSURANCE O& (RUG EUALIT'(E&5A syst!m +or monitorin- th! !ntir! 0roc!ss +rom th! ac4,isition o+ th! raw mat!ria.s to its con/!rsion into a 8nish!d 0rod,ct which is mad! a/ai.a.! to th! cons,m!rASSURANCE O& (RUG EUALIT'PURPOSE5To !ns,r! that th! cons,m!r r!c!i/!s a 0rod,ct that m!!ts a.. !sta.ish!d o?cia. s0!ci8cations and standards1AIM5Th! minim,m acc!0ta.! 4,a.ity +or dr,-s sho,.d ! th! sam! in !ach co,ntry1 ASSURANCE O& (RUG EUALIT'ELEMENTS O& A (RUG ASSURANCE S'STEML!-a. as!R!-,.atory +ac!tT!chnica. +ac!t3egal (ase5 th! .!-is.ation sho,.d 0ro/id! th! n!c!ssary a,thority +or th! d!/!.o0m!nt o+ s0!ci8c r!-,.ations r!.atin- to 4,a.ity ass,ranc! and ass!ssm!nt d,rin- man,+act,r!2 im0ortation and distri,tion o+ dr,- 0rod,cts1 E1-1 (RSA1ASSURANCE O& (RUG EUALIT'4egulator& facet5 sho,.d ha/! a c!ntra. administrati/! ody ha/in- a 0ro/ision +or ins0!ction and r!ca.. as w!.. as a dr,- 4,a.ity contro. .aoratory1 E1-1 (r,- R!-,.atory Unit B(RUC1Tec%nical facet5 inc.,d!s 4,a.ity s0!ci8cations and asic t!sts and r!4,ir!m!nts +or Good Man,+act,rin- Practic!s BGMPC1 E1-1 Nationa. (r,- E,a.ity Contro. Laoratory BN(ECLC and CMS1 ASSURANCE O& (RUG EUALIT'56# certication !c%eme on 7ualit& of p%armaceutical products5Und!r this c!rti8cation th! !70ortin- co,ntry m,st c!rti+y that th! dr,- is r!-ist!r!d and committ!d to ! so.d in that co,ntryR!asons m,st ! stat!d i+ not r!-ist!r!dTh! im0ortin- co,ntry m,st a.so c!rti+y that th! man,+act,r!rFs +aci.iti!s ar! ins0!ct!d r!-,.ar.y and that th!y com0.y with *HO standards o+ GMP and 4,a.ity contro. BECCASSURANCE O& (RUG EUALIT'56# (asic standards of G*P for p%armaceutical productsi1 %asic standards +or 0!rsonn!.ii1 Pr!mis!siii1 E4,i0m!nti/1 Sanitation and hy-i!n!/1 Man,+act,rin- 0roc!d,r!s/i1 E,a.ity contro./ii1 %atch man,+act,rin- r!cords/iii1R!t!ntion o+ r!cordsi71 Com0.aints71 S!.+ a,ditASSURANCE O& (RUG EUALIT'". Basic standards for personnelaC Sha.. ha/! a r!s0onsi.! 0!rson a00ro/!d y th! a,thoriti!sC H!ad +or man,+act,r! and 4,a.itycC Ad!4,at! 0!rsonn!. with t!chnica. and sci!nti8c ac9-ro,nd and 0ractica. !70!ri!nc!dC S0!cia. att!ntion dir!ct!d to contin,in- trainin- o+ 0!rsonn!. at a.. .!/!.s!C P!rsonn!. in contact with th! 0rod,ct sha.. ,nd!r-o 0!riodic m!dica. ch!c9sASSURANCE O& (RUG EUALIT''. Premises i1 Sha.. ! o+ s,ita.! constr,ctionii1 S,?ci!nt siA! +or th! int!nd!d +or 0,r0os!iii1 Sha.. ha/! s,ita.! i..,mination and /!nti.ationi/1 Sha.. ha/! +aci.iti!s +or chan-in- c.oth!s2 washin- and toi.!t 0,r0os!s). E7uipmenti1 S,ita.! +or its int!nd!d 0,r0os!sii1 Easy to c.!aniii1 Non;r!acti/! to raw mat!ria.si/1 *!i-hin- and m!as,rin- !4,i0m!nt sha.. ! acc,rat!/1 R!-,.ar.y /a.idat!d ASSURANCE O& (RUG EUALIT',. !anitation and %&gienei1 (!tai.!d sanitation 0ro-ramm!s sha.. ! ada0t!d to !ach 0.antii1 *ritt!n c.!anin- 0ro-ramm! +or 0r!mis!s and !4,i0m!ntiii1 Instr,ctions +or hy-i!nic man,+act,r! and hand.in- o+ -oods and 0roc!d,r!s r!.atin- to h!a.th2 hy-i!nic !ha/io,r and c.othin- o+ 0!rsonn!.ASSURANCE O& (RUG EUALIT'.. *anufacturing proceduresi. T%e master formula5 s!ttin- o,t in writin- th! com0on!nts o+ man,+act,rin- and EC 0roc!d,r!s +or !ach 0rod,ct1 Th! +orm,.a sha.. not contain any hand writt!n am!ndm!ntsor comm!nts ii. !tarting material5 in/!ntory sha.. ! maintain!d2 s,ch mat!ria.s sha.. !5 id!nti8!d and contain!rs stor!d ,nti. r!.!as!d y EC d!0t2 0ro0!r.y sam0.!d y ECand t!st!d +or com0.ianc! with o?cia. r!4,ir!m!nts2 r!.!as!d or r!>!ct!d y EC y writt!n instr,ction1iii. Bul+ products5 sha.. norma..y ! t!st!d !+or! 8..in-2 0ac9a-in- and .a!..in-ASSURANCE O& (RUG EUALIT'iv.3a(elling and pac+aging5 a.. 0ac9a-!s and contain!rs o+ 8nish!d 0rod,cts sha.. ! id!nti8!d y a00ro0riat! .a!..in-1 Ta.!s2 0ac9a-in- ar!as2 0rintin- machin!s and oth!r !4,i0m!nt sha.. ! c.!ar!d o+ .a!.s and oth!r mat!ria.s ,s!d in th! 0r!/io,s o0!rationsv. 8inis%ed products5 sha.. ! 0ro0!r.y stor!d and h!.d s!0arat!.y ,nti. r!.!as!d +or sa.!vi.Distri(ution5 sha.. maintain writt!n instr,ctions conc!rnin- distri,tion and r!ca..1vii.4e-ected materials5 sha.. maintain writt!n instr,ctions conc!rnin- th! dis0osa. o+ r!>!ct!d mat!ria.s2ASSURANCE O& (RUG EUALIT'/. 9ualit& controli1 E/!ry man,+act,r!r sha.. maintain a EC o+ a00ro0riat! ca0acity1ii1 Sha.. contro. a.. startin- mat!ria.s and 4,a.ity and stai.ity o+ 0harmac!,tica. 0rod,cts accordin- to o?cia. r!4,ir!m!nts1iii1 Sha.. 0.an2 !sta.ish and monitor contro. ch!9s at a.. sta-!si/1 Sam0.!s +or startin- mat!ria.s sha.. ! 9!0t +or a 0!riod o+ 8/! y!ars1/1 Sam0.!s o+ 8nish!d 0rod,cts sha.. ! r!tain!d +or a 0!riod o+ at .!ast on! y!ar !yond th! !70iry dat!1ASSURANCE O& (RUG EUALIT'1. Batc% manufacturing records5 sha.. ! 0r!0ar!d +or !ach atch o+ 0rod,ct and it sha.. inc.,d!= Nam! o+ 0r!0aration and atch n,m!r (at! o+ man,+act,rin- Man,+act,rin- d!tai.s %atch n,m!r o+ startin- mat!ria. A r!cord o+ in;0roc!ss contro. +o..ow!d and r!s,.ts otain!d Si-nat,r! o+ 0!rson r!s0onsi.! +or man,+act,r! and dat! o+ si-nat,r! A.. ana.ytica. r!cords r!.atin- to th! atch and a r!+!r!nc! to !na.! th! r!tri!/a.ASSURANCE O& (RUG EUALIT'2. 4etention of records5 a.. r!cords sha.. ! .!-i.y writt!n and r!adi.y trac!d at a.. tim!s:. 0omplaints5 th! man,+act,r! sha.. maintain a writt!n instr,ction +or d!a.in- with com0.aints o+ 4,a.ity2 r!0orts o+ A(R r!s,.tin- +rom im0ro0!r man,+act,r! or 0rod,ct d!t!rioration sha.. ! +orward!d to a00ro0riat! a,thority";. !elf audit5 sha.. d!si-nat! an !70!rt or a t!am o+ to cond,ct r!-,.ar ind!0!nd!nt ins0!ctions +or its o/!ra.. man,+act,rin- and contro. 0roc!d,r!s