HOSPITAL PHARMACY

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THE REQUIREMENT FOR IMMEDIATE IMPLEMENTATION OF DRAFT PHARMACY POLICY IN ALL OVER INDIA.

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A Story of Falling Behind Section 1 “The only service to be done for our lower classes is, to give them education, to develop their lost individuality. ! Swami "ive#ananda, in a letter from $hicago, written to the %ahara&a of %ysore. “' have underta#en this duty because at the present moment the economic story of British 'ndia has to be told, and the deep(seated cause of the poverty of the 'ndian people has to be e)plained*.. A nation prospers if the sources of its wealth are widened, and if the proceeds of ta)ation are spent among the people, and for the people. ! +omesh $hunder ,utt, The -conomic .istory of 'ndia /nder -arly British +ule “0oo# round and see, loo# at %agadha, 1asi, 1anchi, ,elhi, 1ashmir ! where do you find such misery as here2 ! Ban#im $handra $hatter&ee in Anandamath “3here the mind is without fear and the head is held high4 3here #nowledge is free4* 'nto that heaven of freedom, my Father, let my country awa#e. ! +abindranath Tagore “' #now that it will be argued that the continuance of a party in such circumstances, standing behind the State, will convert that State into a totalitarian one*The State will possibly become a totalitarian one if there be only one party as in countries li#e +ussia, 5ermany and 'taly. ! Subhas $handra Bose, in A 6rogram for +econstructing “6ost( 3ar 'ndia These are names, and possibly 7uotations, familiar to every Bengali. 'f one loo#s around and sees, one doesn8t find misery anywhere in 'ndia comparable to that in 3est Bengal state. The mind is not without fear. The head is not held high. 9or is #nowledge free. The lower classes don8t have access to education. A party standing behind the State has converted the State into a totalitarian one. 3e have underta#en this duty because the economic story of 3est Bengal under 0eft +ule has to be told. The sources of wealth are not being widened. The proceeds of ta)ation are not being spent among the people, for the people. 3e are documenting the story of 3est Bengal8s decline so that the agenda can be changed, so that people possess the information re7uired for e)ercising choice, so that an agenda for change can be articulated. :nce upon a time, it used to be said that what Bengal thin#s today, 'ndia thin#s tomorrow.

't is unli#ely that anyone will say this today. 'nstead, what 'ndia thin#s today, 3est Bengal doesn8t thin# about even tomorrow. 't doesn8t even thin# about it day after tomorrow. The fault doesn8t lie in 3est Bengal8s citi;ens, who are as talented and enterprising as elsewhere in the country. 'nstead, the fault lies with the stars that they elect once every five years. 'n the early 1<=>s, 3est Bengal was one of the more successful States in 'ndia, irrespective of the criterion used to measure development. 'n ?>>@, 3est Bengal is &ust below average, irrespective of the criterion used to measure under(development. :ther States perform better and 3est Bengal falls consistently behind. 3hat has changed between the early 1<=>s and ?>>@2 State governments have changed and since the late 1<=>s, and more so since 1<AA, this is what several decades of 0eft Front rule has done to 3est Bengal. 'n the /nited States, people have recently voted for a change, because they are sic# and tired of old governments and old policies. That is what one also needs in 3est Bengal. The /nited States is a country people want to migrate to, witness the 7ueues outside /S -mbassies everywhere in the world. 'ndian States are no different. 6eople migrate to States that perform well ! States li#e .aryana, %aharashtra and 5u&arat. 'n contrast, between the two $ensuses of 1<<1 and ?>>1, net outmigration for 3est Bengal was >.>BC a year. .owever, every one of 3est Bengal8s citi;ens cannot migrate out of 3est Bengal. That can8t be a solution. The solution is to change the State of governance within 3est Bengal. -conomic reforms were introduced in 'ndia in 1<<1. +eforms introduced before 1<<1 weren8t that comprehensive or systematic. Since the 1<<1 reforms, growth rates have increased throughout 'ndia. ,uring the Si)th D1<@>(@BE and Seventh D1<@F(@<E 6lans, annual rate of 5,6 growth was around F.FC. But during the -ighth 6lan D1<<?(<=E, this increased to =.FC and during the Tenth 6lan D?>>?(>=E, it increased to A.AC. The -leventh 6lan D?>>A(1?E hopes for <C growth, since that is what the 'ndian economy has achieved since ?>>G. :f course, there is a global slowdown now and this has affected 'ndia adversely, as has the increase in

interest rates before the 3all Street(triggered financial crisis caught most people unawares. This means it will ta#e the country ?(G years before 'ndia again resumes the <C growth tra&ectory. But that is a transient point. The more important point is one about 3est Bengal8s absolute and relative performance. .ow has 3est Bengal performed since 1<<12 There is an impression that 3est Bengal hasn8t performed that badly in the 1<<>s, with a growth rate that is &ust about the all('ndia average. That8s roughly correct, since 3est Bengal8s real 5ross State ,omestic 6roduct D5S,6E growth was =.GC during the -ighth 6lan D1<<?(<=E and =.<C during the 9inth 6lan D1<<A(?>>1E and one shouldn8t forget that the country didn8t grow all that fast during the 9inth 6lan. But this is only one part of the story. Since ?>>G, the country8s growth bro#e into the <C league and 3est Bengal was left out, as the accompanying graph clearly illustrates. For e)ample, during the Tenth 6lan, 3est Bengal was supposed to grow at @.@C. But only managed to grow at =.1C. ,uring the -leventh 6lan, 3est Bengal is pro&ected to grow at <.AC. This is a figure accepted by the 6lanning $ommission in the -leventh 6lan document and therefore, is a figure endorsed and suggested by the government of 3est Bengal. .owever, is there any guarantee that the State won8t again fall short, as it did during the Tenth 6lan2 9one whatsoever.

A government is meant to govern. ,ifferent people mean different things when they use the word governance. 'rrespective of that, the least a government can do is to ensure a facilitating environment for growth, without blaming everything on the centre8s step(motherly treatment or partition and refugee influ)es in 1<BA and 1<A1. This is not to suggest that these factors were unimportant. But they were important historically. :ne can8t continuously point to these and loo# bac#wards and blame everything that has not happened in the State on history. The finger must be pointed inwards and at the 0eft Front government. 't has only been able to ensure a facilitating environment that ensures growth at roughly the all('ndia average. 't has not been able to ensure a facilitating environment that catapults growth to a faster tra&ectory. 'f it has not succeeded in the past, why should it succeed in the future2 5rowth is important because that is the only long(lasting solution to problems of poverty and unemployment. 5rowth increases the si;e of the ca#e and ensures prosperity and advancement for everyone. As growth increases, poverty declines. .ealth and education indicators improve. So do a host of other governance indicators. This doesn8t mean that growth is an end in itself, or that the composition of growth is unimportant. 5rowth is never a sufficient condition. But it is certainly a necessary one, even more so in a State that has a population of @? million

by the ?>>1 $ensus. This #ind of population figure means that the population density per s7 #m is <>B and is one of the highest in the country. Because growth hasn8t been fast enough, 3est Bengal8s per capita 5S,6 was +s ?<,BFA in ?>>A(>@. This gives 3est Bengal 1@th ran# in the country, not a ran# one can inordinately be proud of. And one shouldn8t forget that there is a considerable amount of variation across 3est Bengal8s 1@ districts. 1ol#ata isn8t representative of 3est Bengal. 3est Bengal8s .uman ,evelopment +eport D.,+E, published in ?>>B and endorsed by the 0eft Front government, ac#nowledges this too. The .,+ identified si) northern districts D,ar&eeling, Halpaiguri, 1och Behar, %aldah, /ttar ,ina&pur, ,a#shin ,ina&purE, three western districts D6urulia, Ban#ura, BirbhumE and the Sunderbans area of the two ?B 6arganas districts as particularly bac#ward. /nderstandably, 1ol#ata is 3est Bengal8s richest district and /ttar ,ina&pur, which is 3est Bengal8s poorest district, has a per capita S,6 that is only GG.=C of that of 1ol#ata. For all its tal# about e7uity and removal of ine7ualities, the 3est Bengal government hasn8t been able to improve the lot of the people in the worst(off and bac#ward districts. 6overty ratios are calculated on the basis of large(sample 9SS D9ational Sample SurveyE data and these are available at infre7uent intervals, the last one dating to ?>>B(>F. 'n ?>>B(>F, from the

6lanning $ommission8s estimates, the percentage of population below the poverty line in 3est Bengal was ?B.AC. 3hich States performed worse than 3est Bengal2 The answer is Bihar, 1arnata#a Dmarginally worseE, %adhya 6radesh, %aharashtra, :rissa, /ttar 6radesh, $hhattisgarh, Hhar#hand, /ttara#hand and ,adra I 9agar .aveli. Barring the inclusion of 1arnata#a and %aharashtra, this isn8t a list a citi;en of 3est Bengal should be proud of. B?.BC of 3est Bengal8s rural scheduled tribe DSTE population is below the poverty line. The 3est Bengal .,+ used data from 9SS 1<<<(?>>> and computed that [email protected]?C of rural 6urulia8s population was below the poverty line. =1.FGC of urban Halpaiguri8s population was below the poverty line. Two points emerge. First, growth hasn8t been significant enough to reduce poverty. Second, the situation is especially bad in bac#ward and deprived districts and this isn8t thrown up in aggregate State(level figures. 3hat empowers people and enables them to improve their lot and progress towards prosperity2 'n ?>>1, 3est Bengal8s literacy rate was =@.=C, slightly above the all('ndia literacy rate of =B.@C. This 3est Bengal figure of course mas#s a literacy rate of B@.=C in /ttar ,ina&pur. But that apart, .imachal 6radesh had a literacy rate of A=.FC, Tripura had a literacy rate of AG.?C and /ttara#hand had a literacy rate of A1.=C. A State that was once labeled as

the intellectual capital of the country performs worse than these States. Any literacy rate incorporates an element of adult literacy. 'n that sense, it is much more important to focus on what is happening to education among the young, since much of 'ndia is relatively young. The gross enrolment rate D$lasses '("'''E is <B.=AC in 3est Bengal, worse than Arunachal 6radesh, $hhattisgarh, .imachal 6radesh, %adhya 6radesh, :rissa, +a&asthan, Tripura and /ttara#hand. :ther States are doing far better in getting children into school. 9ot only are other States doing far better in getting children into school. They are also doing far better in retaining them there. The drop(out rate D$lasses '(JE is A@.>GC in 3est Bengal. 'n the entire country, only Bihar D@G.>=CE, %eghalaya DA<.1FCE, 9agaland D<A.?<CE and Si##im D@?.G>CE perform worse. 'n primary schools, 3est Bengal has FB pupils per teacher. .imachal 6radesh has ?B. 3est Bengal has =G elementary schools per la#h population. Assam has 1GA. 'n addition to education, health is also often a public good, warranting provisioning by the State. There are some 7uestion mar#s about the 7uality of maternal mortality data. Sub&ect to that, 3est Bengal8s maternal mortality ratio Dper 1>>,>>> live birthsE is 1<B. %aharashtra has managed to reduce it to 1B<. The infant mortality ratio Dper 1>>> live birthsE is G@ in 3est Bengal. Tripura has managed to reduce it to G1. 'n all fairness, in the inter(State comparisons,

3est Bengal performs better on health than on education, depending on the indicator used. But that is no argument for complacency, or for arguing that the government has done enough. For instance, children Dunder G yearsE who are under(weight for age amount to BG.FC in 3est Bengal. $hildren Daged >(F monthsE who are e)clusively breast(fed amount to F@.=C in 3est Bengal. =G.@C of women in the age(group 1F(B< years suffer from anemia. There were ?.= million cases of diarrhea in 3est Bengal in ?>>=, the highest in the country, followed by Andhra 6radesh with 1.? million. There were 11>,@GF cases of typhoid in ?>>=, the second highest in the country after Andhra 6radesh. There were 1AF deaths Dnot casesE from malaria in ?>>F, the second highest in the country after :rissa D?FFE. There were @?> deaths Dnot casesE from TB in ?>>=, the third highest in the country after Andhra 6radesh and ,elhi. .ealth indicators are a broader spectrum than education indicators. Therefore, there are some health indicators where 3est Bengal performs better than all('ndia averages. .owever, there are also health indicators where 3est Bengal performs worse than all('ndia averages. 9or should one forget the inter(district variations mentioned earlier. The infant mortality rate is as high as AB in both 6urulia and ,a#shin ,ina&pur. -ight districts D%aldah, %urshidabad, 9adia, 9orth ?B 6arganas, South ?B 6arganas, Bardhaman, .aora, .ugliE are seriously affected by arsenic poisoning.

The human development inde) D.,'E puts together three elements that affect human development and deprivation ! per capita income, education and health. Because of the reasons &ust mentioned, 3est Bengal8s .,' is >.=1>. This doesn8t loo# that bad when compared to most of 'ndia8s states. .owever, the district with the lowest .,' in 3est Bengal only has a value of >.BB>. This is nothing short of pathetic. :ne reason for that is a complete inability to target subsidies. 't is no one8s case that the poor should not be subsidi;ed. .owever, the poor have to be identified and targeted. All poor should get subsidies and no non(poor should be subsidi;ed. Such identification of the poor is attempted through B60 Dbelow the poverty lineE and AAK DAntyodaya Anna Ko&anaE cards. Ket, 9SS data from the =1st round D?>>B(>FE show that BA.GC of 3est Bengal8s poor have no card at all. 'n contrast, BG.GC of non( poor have B60 or AAK cards. This doesn8t say much about a government that is supposed to wor# in the name of the poor. 'n addition to social infrastructure, some elements of physical infrastructure can also be public goods. The 11th Finance $ommission wor#ed out an inde) of physical infrastructure for 'ndia8s states. 'n this, 3est Bengal had a score of 111.?F. A state li#e 6un&ab had a score of [email protected]. 6hysical infrastructure doesn8t always mean the e)tremely visible elements of ports, of either the air or sea variety. -ven for sea(ports, one doesn8t mean .aldia, which has tended to

perform relatively better. For 1ol#ata port, the Tenth 6lan target was one of handling ?1.B> million metric tons of cargo per year. 'n ?>>?(>G, 1ol#ata port handled A.?> million metric tons and in ?>>=(>A, the port handled 1?.=> million metric tons. 6erhaps one should mention that the 1G ma&or sea(ports collectively e)ceeded the Tenth 6lan target in ?>>=(>A. 0eaving ports aside, let us turn to road transport. This affects everyone, especially the poor. 0et us ta#e $alcutta ST$ as an instance. 'n ?>>=(>A, the all('ndia average of fleet utili;ation was @?.F>C, but $alcutta ST$ had F<.>C. The all('ndia average vehicle productivity Dearning per bus per #mE was +s ??<, but $alcutta ST$ had +s 1?@. The all('ndia average staff productivity Dearning per wor#er per dayE was +s G<.G<, but $alcutta ST$ had +s ??.?=. 0ess than F>C of households have electricity connections. F=.?C of habitations have still not been connected under the 6radhan %antri 5ram Sada# Ko&ana D6%5SKE. A government is also supposed to ensure law and order. 'n ,ecember ?>>A, ?@G,?GA cases were pending in $alcutta .igh $ourt, A.FC of the country8s bac#log in .igh $ourts. ?.? million cases were stuc# in $alcutta8s lower courts. Several States have e)perimented with bac#log reduction D0o# Adalats, Fast Trac# $ourts, Family $ourts, 6eople8s $ourts, %obile

SURVEY OF SELECTED DRUG REGULATORY AUTHORITIES
Penalties for spurious dru offen!es pro"ided in different !ountries

Country

Penalt# Re!o$$ended in t%e different !ountries for t%e offen!e of !ounterfeit & spurious dru s Fine of max. 7260 Euro, Max fine of 14,530 in case of recurrence Imprisonment for t e !istri"utor ran#in# from 3$10 years Imprisonment for t e !istri"utor ran#in# from 3$10 years 1% & fine not excee!in# 127,000 Euro 'or to imprisonment for a term not excee!in# 10 years or to "ot In case of a secon! or su"se(uent offence to a fine not excee!in# 300,000 Euro or to imprisonment for a term not excee!in# 10 years or to "ot Imprisonment for t e !istri"utor ran#in# from 3$10 years Imprisonment for t e !istri"utor ran#in# from 3$10 years Imprisonment for t e !istri"utor ran#in# from 3$10 years Minimum 5$10 years imprisonment )ai* term, compensation for t e fami*ies of t e !ea! peop*e is expecte! to "e pai! +u",ect to imprisonment -Execution. i.e. !eat pena*ty Imprisonment )ai* for a"out 4 years or more /unis ment cou*! "e from 3$7 years in ,ai* 0 e *e#a* punis ment is most*y 1eat or 2ife term For a counterfeit !ru#, i**e#a* income from its manufacture or sa*e s a** "e confiscate!, a fine impose! "et3een 2$5 times t e 4a*ue of t e i**e#a**y manufacture! or so*! !ru#s. 5io*ations of crimina* *a3 s a** "e prosecute!. 2%

Austria C'e!% R Estonia Ireland

Lat"ia Lit%uania Slo"a( R Spain )*oanEs!ofet+ ,ra'il

Fran!e Vietna$ -#an$ar Peru -e.i!o UAE/ O$an/,a%rain/ 0u1aitand 2ata r C%ina

E #pt

USA

Financia* pena*ty aroun! E6/ 50000. +entence! to "e ,ai*e! for maximum 3 years Maximum crimina* pena*ty of 3 years, !epen!in# upon t e seriousness of t e case, t is cou*! "e up to 10 years.

7o. 8.29015:112:2002$1:1M+;/F& 6o4ernment of In!ia -inistr# of Healt% 5 Fa$il# 6elfare )Depart$ent of Healt%+ 7irman < a4an, 7e3 1e* i 1ate! . t e 27t )anuary, 2003 1. 0 e / armaceutica* in!ustry represents one of t e In!ia=s stren#t . It as "een #ro3in# annua**y at t e rate of o4er 10> for t e *ast !eca!e an! current*y occupies t e fourt position in t e 3or*! in terms of 4o*ume. 0 e in!ustry as mo4e! from "ein# an importer of e4ery formu*ation in t e fifties to one t at as assume! presti#e in terms of its exports to!ay. &s t e num"er of !ru#s, as 3e** as t eir 4o*umes, ?eep increasin#, t e issue of (ua*ity 3i** assume permanent importance. &cross t e #*o"e, countries are a!optin# ri#orous !ru#s (ua*ity contro* systems an! enforcement mec anisms to a4oi! su"$ stan!ar!:spurious !ru#s in t eir respecti4e mar?ets. 2. +upreme Court of In!ia, t e 7ationa* @uman Ai# ts Commission an! t e +tan!in# Committee of /ar*iament a4e time an! a#ain recommen!e! impro4in# t e !ru# re#u*atory system. 0 e ne3 / armaceutica* /o*icy appro4e! "y t e Ca"inet recent*y a!!resses t ese (ua*ity concerns. 0 e @aat i Committee a! ear*ier recommen!e! t e settin# up of a 7ationa* 1ru# &ut ority. 0 e Mas e*?ar Committee on / armaceutica* Aesearc an! 1e4e*opment a! recommen!e! t e Esta"*is ment of a First C*ass 1ru# Ae#u*atory infrastructure. 3. 0 ere as not "een a compre ensi4e re4ie3 of t e 1ru#s ; Cosmetics &ct 1B40 since its enactment, a*t ou# Au*es a4e "een amen!e! from time to time to ?eep t em up to !ate. 0 ere is a*so a nationa* concern re#ar!in# t e pro"*em of spurious !ru#s. It is important to see a** t e issues in an inte#rate! manner. 4. 0 e 6o4ernment of In!ia as, t erefore, !eci!e! to set up an Expert Committee 3 ic 3i** *oo? into a** t ese issues 3it t e fo**o3in# 0erms of Aeference. 1. Aecommen! a ne3 structure for t e 1ru# Ae#u*atory +ystem in t e

Anne.ure 3 4

country inc*u!in# t e settin# up of a 7ationa* 1ru# &ut ority. 2. Aecommen! measures to stren#t en t e !ru# re#u*atory infrastructure in Centre an! +tates. 3. E4a*uate t e extent of t e pro"*em of spurious an! su"$stan!ar! !ru#s an! recommen! measures re(uire! to !ea* 3it t is pro"*em effecti4e*y. 4. Aecommen! c an#es re(uire! in t e 1ru#s an! Cosmetics &ct, 1B40 as 3e** as in ,u!icia* proce!ure re*ate! to offences committe! un!er t is &ct. 5. Aecommen! steps to "e ta?en "y t e / armaceutica* In!ustry an! / armacy &ssociation to tac?*e t e pro"*em of spurious !ru#s. 6. Consi!er an! a!4ise on any ot er issue inci!enta* to t e a"o4e. 7. 1e4ise roa! maps for imp*ementation of a** recommen!e! measures. CO-POSITIO7 OF E8PERT CO--ITTEE 0 e composition of t e Expert Committee 3i** "e as fo**o3s. C%air$an Dr9 R9 A9 -as%el(ar -e$:ers 1. 1r. +./. &#ar3a*, 16@+ 2. Aepresentati4es ')+ 2e4e* officers% of 1epartment of C emica*s ; /etro C emica*s, Ministry of @ome an! Ministry of 2a3. )oint +ecretary I:C !ru#s, 1epartment of @ea*t . 3. @ea*t +ecretaries : 1ru# contro**ers of t e +tates of Carnata?a, Dest <en#a*, Ma aras tra, 1e* i, <i ar an! Ma! ya /ra!es . 4. /resi!ents of t e fo**o3in# &ssociations . 'i% Er#anisations of / armaceutica* /ro!ucers of In!ia 'E//I% 'ii% In!ian 1ru# Manufacturers &ssociation 'I1M&% 'iii% In!ia / armaceutica* &**iance 'I/&% 'i4% &** In!ia +ma** +ca*e 1ru# Manufacturers &ssociation'&I++1M&% '4% &** In!ia Er#anisation of C emist ; 1ru##ist '&IEC1% '4i% In!ian / armaceutica* &ssociation 'I/&% 5. Eminent *a3yerF +ri &maren!ra + aran, +r. &!o4cate, +upreme Court, 105 7e3 C am"er <*oc?, +upreme Court, < a#3an 1as Aoa!, 7e3 1e* i 6. + ri )u*ius Ae"eiro, Ex$&!4isor to 6o4ernor. 7. + ri 5i,ay Caran, Ex CommissionerF 1e* i /o*ice 9. Aepresentati4e of Consumers. + ri <i,on Mis ra, 5ice C airman,

Consumer Coor!ination Counci*.

9. Eminent +cientist G 1r. M.1. 7air
-e$:er3Se!retar# -r9 As%1ini 0u$ar/ DCG )I+ 0 e Committee 3i** a4e t e free!om to co$opt 2$3 eminent scientist 3 o can ma?e contri"ution in t is fie*!. 0 e committee may a*so in4ite any"o!y as a +pecia* In4itee. 0 e Committee 3i** a*so ta?e into consi!eration reports of Committees set up ear*ier. 0 e Committee 3ou*! a*so examine t e "est internationa* practices 3 ic cou*! "e compara"*e to In!ia. 0 e Committee s ou*! su"mit its report 3it in six mont s. 0&:1& of officia* mem"ers 3i** "e "orne "y t eir respecti4e offices. 0&:1& to non$officia* mem"ers '+.7o. 5 to B a"o4e%, co$opte! mem"ers an! specia* in4itees 3i** "e pai! in accor!ance 3it +A 1B0 an! furt er instructions as containe! in &ppen!ix G 2 to /art$II of FA+A. 0 e expen!iture in4o*4e! 3i** "e met out of t e sanctione! "u!#et un!er 1eman! 7o. 42, Ma,or @ea! 2210, 09104$1ru#s Contro* 'Minor @ea!%, 02 C1+CE '/*an% for t e year 2002$03. 0 is issues 3it t e concurrence of Finance 1i4ision 4i!e 1y. 7o. C$721:IF1 !ate! 27.1.2003 +!:$ '7I0& CE)AED&2% H71EA +ECAE0&AI 0E 0@E 6E50. EF I71I& Copy to . 1. /rime Minister=s Effice, 7e3 1e* i '+ ri )arnai* +in# , )+%. 2. 1r. A. &. Mas e*?ar, 1irector 6enera*, C+IA an! +ecretary to t e 6o4t. of In!ia, 7e3 1e* i. 3. +ecretary, 1epartment of C emica*s an! /etro$C emica*s. 4. +ecretary, Ministry of @ome &ffairs 5. +ecretary, Ministry of 2a3 6. C ief +ecretaries, Carnata?a, Dest <en#a*, Ma aras tra, 1e* i <i ar an! Ma! ya /ra!es . 7. IF1, Ministry of @ea*t an! F.D. 9. &** Mem"ers of t e Committee Copy a*so to . 1. /+ to @FM:ME+ '@FD% 2. //+ to +ecretary '@ea*t %:16@+

Anne.ure 3 ;
Ter$s of Referen!e )T9O9R9+ of Su: Co$$ittee )Group3I+ and its -e$:ers

Ter$s of Referen!e • • 0o 4isit t e recommen!ations an! conc*usions of ear*ier Committees on simi*ar issues 0o stu!y t e specific pro#ress, if any ma!e an! t e "ott*enec?s experience! an! conceptua*iJe a re*e4ant mo!e* so t at t e areas of nationa* concerns can "e con4erte! to re#u*atory systems= sp ere of inf*uence E4a*uate t e extent of t e pro"*em of spurious me!icines in t e country E4a*uate t e pro"*em of manufacture an! sa*e of me!icines 3it out *icenses, 3it out in4oices an! peop*e "y 3 o are not (ua*ifie! 0o stu!y t e commercia*, an!*in#, stora#e, transportation practices an! met o!o*o#ies a!opte! "y t e commerce in !istri"ution 'inc*u!in# transit an! transit stora#e% of me!icines, "esi!es "usiness mo!a*ities a!opte! at ma,or transit points Aecommen! measures an! practices to "e fo**o3e! to ensure "etter !istri"ution of me!icines Aecommen! trainin# context an! out*ines for re#u*atory officia*s Aecommen! c an#es re(uire! in existin# *e#a* pro4isions 0o recommen! measures to ensure spee!y trai*s in courts 0o re4ie3 t e ro*e p*aye! "y t e in!ustry an! professiona* ; tra!e associations in t e #amut of !ru# manufacture ; !istri"ution 0o examine export re*ate! issues in t e contest of su"stan!ar! an! counterfeit !ru#s Aecommen! sur4ei**ance mec anism to contro* an! c ec? an! menace su"stan!ar! an! spurious me!icines in t e country.

• • •

• • • • • •



-e$:ers 1. + . 5i,ay Caran, Ex. Commissioner, 1e* i /o*ice 2. )oint +ecretary '@ea*t % Ministry of @ea*t ; FD 3. )oint +ecretary, 2a3 4. Commissioner, F1&, Ma aras tra 5. 1ru#s Contro**er, <i ar 6. 1ru#s Contro**er, M/ 7. 1ru#s Contro**er, 7C0 1e* i 9. In!ian 1ru#s Manufacture &ssociation 'I1M&% B. In!ian / armaceutica* &**iance 'I/&% 10. In!ian / armaceutica* &ssociation 'I/&% 11. Er#aniJation of / armaceutica* /ro!ucer of In!ia 'E//I% 12. Consumer Er#aniJation '5EICE% 13. &** In!ia Er#aniJation of C emists ; 1ru##ist 14. &** In!ia +ma** +ca*e / arma Manufacturin# &ssociation 15. 1ru#s Contro**er 6enera* 'In!ia%

Anne.ure 3 <
7o. 8$29015:112$1:1M+;/F& Go"ern$ent of India -inistr# of Healt% and Fa$il# 6elfare 7irman < a4an, 7e3 1e* i 1ate! t e 1st &u#ust, 2003

OFFICE -E-ORA7DUSu:=e!t > Constitution of t e Expert Committee un!er 1r. A. &. Mas e*?ar, 16, C+IA to re4ie3 t e !ru# re#u*atory system in t e country an! t e pro"*em of spurious !ru#s etc. In continuation of t is 1epartment=s E.M. of e4en no. !ate! 27.01.2003 on t e a"o4e Mentione! su",ect, t e un!ersi#ne! is !irecte! to say t at t e 6o4ernment as !eci!e! to exten! t e term of t e Expert Committee set up un!er 1r. A. &. Mas e*?ar, 16, C+IA to re4ie3 t e !ru# re#u*atory system in t e country an! t e pro"*em of spurious !ru#s etc "y a furt er perio! of t ree mont s. 0 e terms an! con!itions of t e Committee remain t e same as in!icate! in t e E.M. !ate! 27.01.2003.

+!:$ '7I0& CE)AED&2% Hn!er +ecretary to t e 6o4t. of In!ia -e$:ers Copy to . 1. /rime Minister=s Effice, 7e3 1e* i '+ ri )arnai* +in# , )+%. 2. 1r. A. &. Mas e*?ar, 1irector 6enera*, C+IA an! +ecretary to t e 6o4t. of In!ia, 7e3 1e* i. 3. +ecretary, 1epartment of C emica*s an! /etro$C emica*s. 4. +ecretary, Ministry of @ome &ffairs 5. +ecretary, Ministry of 2a3 6. C ief +ecretaries, Carnata?a, Dest <en#a*, Ma aras tra, 1e* i <i ar an! Ma! ya /ra!es . 7. IF1, Ministry of @ea*t an! F.D. 9. &** Mem"ers of t e Committee Copy a*so to . 1. /+ to @FM:ME+ '@FD% 2. //+ to +ecretary '@ea*t %:16@+

Anne.ure 3 ?
Stren t%enin Central Dru Re ulator# A en!#

49@ 7eed for Stren t%enin 1.1 1.2

of Central Dru

Re ulator# A en!#

It is t e "asic responsi"i*ity of t e 6o4ernment to ensure t at !ru#s to "e use! "y t e pu"*ic meet t e esta"*is e! stan!ar!s of (ua*ity, safety, "io!i4ersity an! efficacy. In In!ia, t e import, manufacture, sa*e an! !istri"ution of !ru#s an! cosmetics in In!ia is re#u*ate! un!er t e 1ru#s an! Cosmetics &ct 1B40, an! Au*es 1B45 ma!e t ereun!er, ' ereinafter referre! to as t e &ct an! t e Au*es% respecti4e*y. +tan!ar!s of i!entity, purity, free!om from toxicity an! stren#t in respect of e4ery me!icine an! re*ate! pro!ucts use! for !ia#nosis, prop y*axis an! treatment of !iseases in uman "ein#s or anima*s a4e to "e specifie!. Hn!er t e &ct, !istinct statutory functions an! responsi"i*ities a4e "een assi#ne! to Centra* an! +tate 6o4ernments. 0 e Centra* 1ru# +tan!ar!s Contro* Er#anisation 'C&1CE%, 1te. 6enera* of @ea*t +er4ices, Ministry of @ea*t ;FD is entruste! 3it t e enforcement of re#u*atory responsi"i*ity at t e 6o4ernment of In!ia *e4e*. +ome of t e important acti4ities of t e C1+CE inc*u!es !irect interface 3it A;1 acti4ities in p armasector at 7ationa* an! Internationa* *e4e* an! are !iscusse! "e*o3 from t e point of 4ie3 of pro4i!in# an efficient re#u*atory frame3or?. 0 e fast$c an#in# scenario in !ru#$re*ate! fie*!s re(uires t e C1+CE to "ecome a 4i"rant an! !ynamic or#anisation.

;9@ 2ualit# Control and Good -anufa!ture Pra!ti!es )G-Ps+ 2.1 0 e p armaceutica* in!ustry in In!ia as ma!e remar?a"*e pro#ress o4er t e years. In!ia is manufacturin# most of its re(uirements of !ru#s an! is a*so in a position to export a si#nificant (uantity of me!icines of internationa**y accepta"*e (ua*ity to many countries inc*u!in# t ose of t e !e4e*ope! 3or*!. 0 e (ua*ity of !ru#s as to "e c*ose*y monitore! so t at !ru#s of !ou"tfu* (ua*ity are not manufacture!. 0 e Au*es pro4i!e in +c e!u*e KM= t e 6oo! Manufacturin# /ractices '6M/s% 3 ic a manufacturer is o"*i#e! to fo**o3. & !ru# is of accepta"*e (ua*ity un!er t e &ct not on*y if it meets t e finis e! pro!uct specifications "ut a*so more important*y if it is manufacture! in a p*ant comp*yin# 3it 6M/s. 0 e responsi"i*ity for enforcement of 6M/s in respect of most !ru#s rests 3it t e state !ru# contro* aut orities "ut t e *e4e* of enforcement an! competence of au!itin# personne* !oes not appear to "e uniform amon# states. In 4ie3 of t e serious pro"*ems encountere! 3it certain cate#ories of !ru#s *i?e "*oo! an! "*oo! pro!ucts, *ar#e 4o*ume parentera*s '25/s%, 4accines,

2.2

2.3

etc, ,oint inspections are re(uire! to "e carrie! out un!er Au*e 69& of t e Au*es "y inspectors of t e C1+CE an! t e concerne! +tate 6o4ernment "efore a *icence for a manufacture of t e notifie! !ru#s can "e #rante! or rene3e! "y t e Centra* 2icence &ppro4in# &ut ority 'C2&&% appointe! "y t e Centra* 6o4ernment un!er t e &ct. 0 is *ist is expecte! to "e en*ar#e! as ot er specia*iJe! items *i?e me!ica* !e4ices inc*u!in# transfusion sets, steri*e syrin#es, etc. are notifie! in t is cate#ory. E4en for t is reme!y, t e infrastructura* support as to ?eep pace 3it t e 3or? !eman!. 0 ou# t e 1ru#s Contro**ers of t e states are empo3ere! to *icence t e manufacture an! sa*e of !ru#s in t eir respecti4e states un!er t e &ct, t e 1C6'I% in or!er to ensure uniform imp*ementation of Au*es, is en,oine! 3it t e responsi"i*ity of coor!inatin# t eir acti4ities an! !ecisions un!er t e 1ru#s an! Cosmetics t rou# t e 1ru#s Consu*tati4e Committee '1CC%. In a!!ition, t e 1ru#s 0ec nica* &!4isory <oar! '10&<%, a statutory "o!y un!er t e &ct, is re(uire! to a!4ise t e Centra* 6o4ernment an! +tate 6o4ernment on tec nica* matter arisin# out of t e a!ministration of t e &ct. For a manufacturer inten!in# to export !ru#s, a 6M/ certificate un!er t e D@E Certification +c eme on t e (ua*ity of p armaceutica* pro!ucts mo4in# in internationa* commerce is t e #enera**y accepte!. 0 e D@E Certification +c eme is a mec anism "y 3 ic t e importin# country is in a position to ascertain 3 et er it as "een manufacture! in accor!ance 3it internationa**y accepte! 6M/s. 0 ese certificates are issue! after ,oint inspections "y teams from t e Centra* an! +tate 6o4ernments. Many importin# countries, o3e4er, *ay !o3n t eir o3n strin#ent proce!ures of inspection an! appro4a* of t e p*ant, faci*ities, manpo3er, proce!ures, etc. "efore a !ru# manufacture! "y t e app*icant is a**o3e! to "e importe!. De may consi!er to intro!uce simi*ar proce!ures in respect of import !ru#s into In!ia to safe#uar! t e ea*t of t e citiJens an! to a4e *e4e* p*ayin#. Dit t e #ro3t of t e p armaceutica* in!ustry, t ere as "een consi!era"*e impetus to researc an! !e4e*opment acti4ity on !ru#s. & num"er of me!icines are no3 exporte!. 0 is re(uires proper re#u*ation so t at safety, efficacy an! (ua*ity issues are atten!e! to in a #*o"a**y accepte! manner. 0 is as "ecome a** t e more important 3it t e comin# into existence of t e Internationa* Conference on @armoniJation of 0ec nica* Ae(uirements of / armaceutica*s for @ea*t Hse, common*y ?no3n as t e Internationa* Conference on @armoniJation 'IC@%, 3 ic promotes scientific an! tec nica* aspects of re#istration of p armaceutica* pro!ucts.

2.4

2.5

A9@ Re istration of dru s 3.1 Most countries of t e 3or*!, inc*u!in# !e4e*opin# ones, a4e a 3e**$ or#anise! system of re#istration of !ru#s permitte! to "e importe! or manufacture!. 0 us, master fi*es of pro!ucts are su"mitte! for e4a*uation "y t e re#u*atory a#encies. It is on*y after t e furnis e! !ata as "een foun! a!e(uate t at t e pro!uct is re#istere! in t e country. 7o suc certa*ise! system exists in In!ia. 0 ere is nee! for c ec?in# t is !eficiency "y intro!uction of t e re#istration proce!ures 3 ic 3i** a*so e*p in e*imination of irrationa*:su"$t erapeutic

pro!ucts. &!e(uate mac inery as to "e create! in t e C1+CE for t e purpose <9@ 2ualit# !ontrol and re istration of %er:al dru s & num"er of countries inc*u!in# 6ermany, France, Cana!a, H+&, C ina, etc. are re#isterin# stan!ar!iJe! p*ant extracts of pro4en c*inica* efficacy an! safety o"taine! from natura* sources as er"a* !ru#s or !ietary supp*ements. Inspite of t e fact t at In!ia as a 4ast resource of !ru#s of natura* ori#in, 3e are una"*e to exp*oit t e 4ast 3or*! mar?et "ecause 3e a4e an unsatisfactory system of t eir (ua*ity contro* an! re#istration. En account of t e importance of er"a* !ru#s an! 0+Ms in In!ia, it may "e necessary to create a separate !i4ision in C1+CE to re#u*ate t e (ua*ity of suc !ru#s, an! to pro4i!e proper focus on a** re*ate! aspects. & system of re#istration of 0+Ms 3it accepta"*e stan!ar!s of (ua*ity contro* an! 6M/=s nee! to "e put in position. ?9@ Appro"al for ne1 dru s 5.1 & ne3 !ru# is !efine! in Au*e 122 of t e Au*es as . (a% a ne3 su"stance of c emica*, "io*o#ica* or "iotec no*o#ica* ori#in in "u*? or as a prepare! !osa#e form, '"% a !ru# a*rea!y appro4e! "y t e *icensin# aut ority 3 ic is no3 propose! to "e mar?ete! 3it mo!ifie! or ne3 c*aims, 'c% a fixe!$!ose com"ination 'F1C% of t3o or more !ru#s, in!i4i!ua**y appro4e! ear*ier for certain c*aims, 3 ic are propose! to "e com"ine! in a fixe! ratio, '!% a** 4accines.

5.2

5.3

+c e!u*e KI= to t e Au*es specifies t e re(uirements an! #ui!e*ines on c*inica* tria*s for import an! manufacture of ne3 !ru#s, It is a set of compre ensi4e proce!ures t e primary o",ecti4e of 3 ic is to safe#uar! t e 3e**$"ein# of patients. 0 us, t ere is nee! for a proper re#u*atory an! mar?etin# en4ironment 3 ic encoura#es in4estment on researc an! !e4e*opment to3ar!s !isco4ery of inno4ati4e me!icines an! promotes t eir expe!itious intro!uction. 0 e present set up of C1+CE as not ?ept pace 3it t e increasin# !eman!s of mu*ti$!iscip*inary !ru# e4a*uation nee!s. &pp*ications su"mitte! to t e 1C6'I% for permission for c*inica* tria*s in respect of ne3 !ru# app*ications '71&% an! a""re4iate! ne3 !ru# app*ications '&71&% are often referre! to outsi!e a#encies *i?e t e In!ian Counci* of Me!ica* Aesearc 'ICMA% an! t e 1epartment of <iotec no*o#y, 6o4ernment of In!ia '1<0% for re4ie3. 0 is arran#ement often *ea4es 4ery *itt*e contro* 3it re#ar! to t e time runs. In or!er t at t e app*icant is ena"*e! to comp*ete t e in4esti#ations in t e s ortest possi"*e time, it is imperati4e t at a!e(uate infrastructure for fast trac? c*earances is create! in t e C1+CE. 0 e 1C6'I% s ou*! a4e un!er is !irect super4ision a num"er of !i4isions:!epartments 3it officers an! support staff a!e(uate an! competent for t e ,o". Eac !i4ision:!epartment may a4ai* of t e expertise !ra3n from 4arious or#aniations "ut t e responsi"i*ity an! accounta"i*ity for t e !ecisions an! t eir time*iness must rest on t e s ou*!ers of t e 1C6'I% an!:or t e !i4isiona* or !epartmenta* ea!s. It as to "e c*ear*y un!erstoo! t at aut ority an! responsi"i*ity must #o an! in an!. 0 is 3i** "e possi"*e on*y if t e ri# t systems, expertise an! infrastructure are create!. 0 e process of e4a*uation an! re4ie3 of app*ications of ne3 !ru#s nee!s c*ose co**a"oration 3 ic may inc*u!e t e fo**o3in# . • Hni4ersities, ospita*s an! ea*t care experts . For e4a*uatin# c*inica* tria* !ata an! ot er re*e4ant information. • • • In!ustry an! in!ustria* associations . For assistance in e4a*uation of !ata of ne3 !ru#s. /rofessiona* "o!ies . For c*arifications on re*e4ant professiona* issues affectin# t e (ua*ity of !ru#s. Centra* an! +tate 6o4ernments a#encies . For o"tainin# 4ie3s of t ese a#encies on matters re*atin# to intro!uction of a ne3 !ru#. Consumers an! consumer or#anisations . For inputs from t e consumer an#*e.



5.4

Forei#n #o4ernments an! internationa* or#anisations . 0 is may inc*u!e t e H+ F1&, D@E, etc. 3it a 4ie3 to armoniJin# t e re(uirements 3it t e internationa* stan!ar!s of (ua*ity of !ru#s. 0 us, t ere s ou*! "e c emists:p armaceutica* tec no*o#ists:c emica* en#ineers to re4ie3 areas connecte! 3it manufacture, in$process contro*, pac?a#in#, sta"i*ity, purity an! simi*ar parameters of t e pro!uct. <iotec no*o#y$"ase! an! #enetica**y$en#ineere! !ru#s are



5.5

#ettin# intro!uce! 3it #reater fre(uency. Many of t ese are proteinous mo*ecu*es an! nee! to "e !e*i4ere! "y in4asi4e:non$ in4asi4e routes re(uirin# non$con4entiona* !e*i4ery systems. De, t erefore, nee! to associate experts in t ese areas in t e e4a*uation process. / armaco*o#ists:toxico*o#ists s ou*! "e t ere to e4a*uate t e s ort term an! *on# terms effects, inc*u!in# terato#enic an! carcino#enic effects, in *a"oratory anima*s. 0o e4a*uate t e t erapeutic effects t e a!4erse !ru# reactions of a ne3 !ru#, p ysicians must "e associate! in t e re4ie3 process. 0 ere s ou*! a*so "e a!e(uate num"er of competent re#u*atory experts to ensure t at not on*y t e re(uirements of t e &ct are ta?en care of effecti4e*y "ut a*so to #uar! a#ainst t e possi"i*ity of an o4er$Jea*ous approac an! o4ers ootin# t e mar?. Many !ru#s a4e serious "ioa4ai*a"i*ity pro"*ems. 0 us t ere s ou*! "e "io$p armaceutica* scientists a4ai*a"*e to e4a*uate !ata on t e rate an! extent to 3 ic t e acti4e me!icament in t e preparation of actua**y a4ai*a"*e to t e "o!y as 3e** as on t e !istri"ution, meta"o*ism an! excretion of t e !ru# mo*ecu*e. &s t e app*ications su"mitte! are expecte! to contain consi!era"*e !ata statistica**y ana*yse! "y t e app*icants, statisticians capa"*e of e4a*uatin# t e !esi#n of statistica* tests performe! an! t e 4a*i!ity of statistica* ana*yses 3ou*! a*so "e necessary. &ssociations of micro"io*o#ists 3i** a*so "e necessary for e4a*uation of information in case of app*ications for anti$micro"ia* !ru#s. +imi*ar*y, persons 3it speca*ise! ?no3*e!#e in specific areas may a4e to "e "rou# t in for e4a*uation of t e !ata presente! "y t e app*icant. For instance, 4eterinary 4accines an! ot er 4eterinary pro!ucts may a4e to "e e4a*uate! "y 4eterinariansF "*oo! an! "*oo! pro!ucts 3ou*! nee! e*p from "*oo! transfusion experts an! aemato*o#istsF ra!iop armaceutica*s 3i** nee! expert e4a*uation "y nuc*ear scientists. In t is a#e of specia*iJations an! super$specia*isations, t ere 3i** a*3ays "e nee! for ta?in# e*p from experts in a particu*ar fie*! if 3e 3is to ac ie4e exce**ence. 0 e c*inica* tria* centre an! <ioe(ui4a*ence *a"oratories a*so nee! to "e au!ite! from time to time. In!ia as accepte! t e responsi"i*ities un!er t e 0DE re#ime. Dit t e 6o4ernment of In!ia appro4in# t e EMA route for imp*ementin# pro4isions of t e ne3 patent re#ime, app*ications for mar?etin# appro4a* 3i** start "ein# recei4e!. C1+CE must #et rea!y to meet t e situation 3e** in time "y creatin# a!e(uate infrastructure for t e critica* ro*e it 3i** a4e to p*ay as a re#u*atory aut ority for !e4e*opment of t e p armaceutica* sector. / armaco4i#i*ence acti4ities 3 ic inc*u!es /ost mar?etin# su4ei**ence, &!4erse 1ru# Aeaction Monitorin# etc. is a*so a critica* functionin# of 1ru# Ae#u*atory &#ency. For t is, a participati4e system in4o*4in# Me!ica* Community, / armacists an! t e In!ustry nee!s to "e !e4e*ope!. 0 is area appear to a4e remain ne#*ecte!. /ro4ision of c ar#in# fees from app*icants for !ru# e4a*uation acti4ities a*so nee!s to "e intro!uce!. 0 is amount can "e uti*iJe! to meet t e expenses incurre! in uti*iJin# t e ser4ices of externa* experts.

5.6

5.7

B9@ Continuin edu!ation and trainin 6.1 De nee! to re4ie3 t e continuin# e!ucation pro#rammes so t at a** cate#ories of staff from t e 6ra!e & officers !o3n to t e tec nica* assistants #et opportunities to up#ra!e t eir ?no3*e!#e "y suita"*e in$ ser4ice trainin# courses. 0 is is particu*ar*y important "ecause p armaceutica* sciences an! tec no*o#y are amon#st t e areas of fastest #ro3t an! !e4e*opment. <enefits from in4estment in t is acti4ity 3i** "e intan#i"*e in t e initia* sta#es "ut t e impro4ement in t e (ua*ity of 3or? 3i** u*timate*y #i4e a sense of satisfaction. It is common practice in re#u*atory a#encies a"roa! an! "y p armaceutica* manufacturers of #oo! stan!in# to or#aniJe re#u*ar trainin# an! continuin# e!ucation pro#rammes for t eir staff. C9@ Infrastru!ture !reation 7.1 It 3ou*! t us "e seen t at C1+CE, nee!s to "e #i4en an in!epen!ent status as a4ai*a"*e to 7ationa* 1ru# Ae#u*atory a#encies in most countries. 0 is a#ency is re(uire! to carry out mu*tifarious functions "ut expertise in tec nica*, a!ministrati4e an! 4i#i*ance functions is not sufficient. Fu**$time experts must "e t ere 3it C1+CE for time*y e4a*uation of t e papers su"mitte! "y t e parties. 0 e Committee, t erefore, recommen!s .

7.2 I.

0o create a!e(uate infrastructure for efficient mana#ement of 4arious acti4ities *iste! a"o4e II. 0o reor#aniJe t e C1+CE in suc a manner t at it is in a position to pro4i!e effecti4e re#u*atory safe#uar!s to ensure t at t e patient is protecte! from t e aJar!s to ea*t "y poor (ua*ity an! counterfeit me!icines "y compre ensi4e re#u*atory proce!ures an! effecti4e inspection an! enforcement arran#ements.. III. 0o ensure uniform stan!ar!s of !ru# pro!uctions as 3e** as t e re#u*atory systems t rou# out t e country. I5. 0o pro4i!e a!e(uate autonomy to mana#e t e 4arious acti4ities in accor!ance 3it t e re(uirements of t e &ct an! t e man!ates of t e Ministry.

Anne.ure 3 B
SURVEY OF SELECTED DRUG REGULATORY AUTHORITIES
USA
49 Title of t%e !ountr#Es dru re ulator # aut%orit#

CA7AD ,RADI AUSTRALITHAILA7 -ALAYSI CHI7A A L A D A
/resi!ent 0 erapeutic 1irector 6oo! &!ministrati on 06& $ 1irector 1irector$ 0 ai Foo! ; 1ru#s &!ministrati on 1irector, 1ru# Contro* &ut ority

SOUTH 0OREA

SOUTH I7DIA AFRICA
Ae#istrar G 1C6'I% at Me!icines Center Contro* an! +tate Counci* 1ru#s 3 ic is an Contro**er in!epen!e s at nt "o!y +tates appointe! "y t e Minister for @ea*t . 1irector 6enera* of @ea*t +er4ices

F1&Comm 1irector $issioner 6enera*

1irector$+1& 1irector G Corea Foo! ; 1ru#s &!ministrati on

;9 To +ecretary 1eputy 1%o$ of @ea*t Minister does t%e %ead of re ulator # aut%orit#r eport F A9 Is Dru Re ulator # Aut%orit# !entrali'e d for t%e 1%ole!ou ntr# F Centra* Centra*

Ministry: +ecretary of Ministry:1ep 1irector 1ept. of @ea*t t. of @ea*t 6enera* @ea*t of @ea*t +er4ices

5ice$/remier Ministry:1ep 1irector 3 o is t. of @ea*t 6enera* of responsi"*e for @ea*t @ea*t , Foo! '/resi!ent +er4ices an! 1ru#s 7ationa* &ssem"*y%

Centra*: Centra* +tate

Centra*

Centra*

Centra*

Centra*: +tate

Centra*

Centra*: +tate

<9Li!ensin Centra* of Dru $an ufa3 !turers

$

Centra*

Centra*

Centra*

Centra*

Centra*

Centra*

$

+tate

A STATE-E7T I7DICATI7G 7U-,ERS OF SA-PLES TESTED/ FOU7D SU,3STA7DARD& SPURIOUS DURI7G THE PERIOD OF 4GG?3;@@A

Year 1BB5$1BB6 1BB6$1BB7 1BB7$1BB9 1BB9$1BBB 1BBB$2000 2000$2001 2001$2002 2002$2003

Tested 32770 39B36 32B36 39B36 35570 36B47 39924 36314

7ot of Su: Standard 2ualit# 34B0 319B 2B7B 319B 3666 3099 3459 33B5

Spurious 100 B4 157 B4 115 112 B6 125

7ot of Su:3 Spurious Standard H 2ualit# H 10.64 9.1B B.04 9.1B 10.31 9.36 9.B6 B.34 0.30 0.24 0.47 0.24 0.32 0.30 0.25 0.34

Proposal for a s!ientifi! stud# of t%e e.tent of t%e spurious dru s $o"in in t%e $ar(et I ,ri=es% Re al/ Del%i P%ar$a!euti!al Trust/ 7e1 Del%i

0 e issue of spurious !ru#s ?eeps #ettin# !e"ate! 3it a *ot more emoti4e content t an factua* un!erstan!in# of t e situation. 0 e 4ery fact t at it is a matter of serious concern G particu*ar*y since it re*ates to ai*in# section of t e society G it ca**s for a scientific e4a*uation of t e extent 'in terms of num"er of units:"ran!s:amount% an! nature 'content *o3er t an c*aime! or missin# or content o?ay "ut misusin# some ot er fast se**in# "ran!% of counterfeitin#. &ny scientific exp*oration to compre en! an! su"se(uent*y !ea* 3it t e situation 3i** ca** for a scientific co**ation of situationa* information, a *o#ica* mo!e* to ana*yJe t e co**ate! !ata an! t en to extrapo*ate t e conc*usion to #et a c*earer un!erstan!in# of t e extent of t e pro"*em across t e country. 1% & pre4ie3 of t e stu!y process /repare a *ist of companies. a% Cno3n to a4e face! counterfeitin# pro"*ems "% +e**in# fast mo4in# pro!ucts 3 ic are prone to counterfeitin# c% +e**in# i# 4a*ue pro!ucts 3 ic are prone to counterfeitin#

2% I!entify pro!ucts to "e stu!ie! a% Fast mo4in# pro!ucts of not a 4ery i# 4a*ue "% +*o3 mo4in# pro!ucts of i# 4a*ue 3% +u"$c*assify pro!ucts 3it a% secure 'for e#. 3it o*o#rams sea*s% pac?s or "% stan!ar! pac?s 4% 1etermine approximate percenta#e of sa*es of eac of t ose pro!ucts in t e fo**o3in# four sections a% 0 rou# retai* p armacies 'promote! "y retai*ers% "% 0 rou# retai* p armacies 'on prescription% c% 6o4ernment purc ase system 'supp*ie! t rou# !istri"utors% !% 0 rou# !ispensin# me!ica* practitioners 5% 1etermine t e samp*e (uantity for eac !ru# "ase! on t e tota* num"er of units so*! t rou# eac of t e a"o4e four c anne*s G sprea!in# t e fi#ures across 4arious ma,or territories 'spurious !ru# operators may not "e acti4e in a** t e territories% 6% C*assify territories a% & 0erritories 'stron# enforcement% "% < 0erritories 'a4era#e enforcement G prone to spurious !ru# manufacturin# EA tra!e% c% C 0erritories '"e*o3 a4era#e enforcement $ i# *y prone to tra!e &71 manufacture of spurious !ru#s% 1istri"ution ta"*e may "e ma!e co4erin# & G Metros < G +u"ur"s C G Aura* &reas 1 G Micro Interior &reas. 0raine! !esi#nate! "uyers a4e to purc ase t3o units of eac of t e i!entifie! !ru#s from eac of t e i!entifie! territory 'an! su" territory%. 0 ey 3i** as? for t e "i** "ut not insist on it. +imi*ar*y, procurement 3i** "e ma!e from !ispensin# !octors, "y 4o*unteers posin# as patients or pre$i!entifie! patients an! specimens 3i** a*so "e o"taine! from 4arious !ispensaries:#o4ernment institutions 3 ic are ?no3n to procure me!icines t rou# !istri"utors rat er t an !irect*y from manufacturers. 0 e "uyers 3i** su"se(uent*y fi** a simp*e report form for eac !ru# procure! an! for3ar! "ot t e samp*es to a coor!inator in t eir territory. 0 e t3o units 3i** "e se#re#ate! an! one set for3ar!e! to a !esi#nate! *a". &t t e first instance t e !esi#nate! *a" 3i** *oo? for p ysica* si#ns of counterfeitin#. 0 e *a" 3i** ana*yJe 100> of suspecte! samp*es, 50> of pro"a"*e suspects an! 25> of not suspecte! specimens. 0 e samp*es 3i** "e ana*yJe! for. a% I!entification of acti4e in#re!ients

"% Content of acti4e in#re!ients c% +teri*ity 'if app*ica"*e% 0 e samp*es 3i** "e !ou"*e "*in!e! t rou# a co!in# system "efore t ey are sent for ana*ysis. 1ata o"taine! 3i** "e co**ate! an! extrapo*ate! o4er eac particu*ar pro!uct=s tota* sa*e across respecti4e territory as 3e** as across t e entire country. For o"tainin# a *ar#er picture t e !ata 3i** "e poo*e! an! extrapo*ate! o4er country=s o4er a** 4o*ume of p armaceutica* pro!ucts. 1ata may "e stratifie! to o"tain !esira"*e information perspecti4e. It is estimate! t at an expen!iture of a"out As. 15 2a? s 3i** a4e to "e incurre! on t is pro,ect.

Proposed A$end$ents to Dru s 5 Cos$eti!s A!t/ 4G<@

Se! J;C99 Penalt# for $anufa!turer/ sale/ et!9/ of dru s in !ontra"ention of t%is C%apter93 D oe4er , imse*f or "y any ot er person on is "e a*f, manufactures for sa*e or for !istri"ution, or se**s, or stoc?s or ex i"its or offers for sa*e or !istri"utes,$ )a+ any !ru# !eeme! to "e a!u*terate! un!er +ection 17& or spurious un!er +ection 17< or 3 ic 3 en use! "y any person for or in t e !ia#nosis, treatment, miti#ation, or pre4ention of any !isease or !isor!er is *i?e*y to cause is !eat or is *i?e*y to cause suc arm on is "o!y as 3ou*! amount to #rie4ous urt 3it in t e meanin# of +ection 320 of t e In!ian /ena* Co!e '45 of 1960%, so*e*y on account of suc !ru# "ein# a!u*terate! or spurious or not of stan!ar! (ua*ity, as t e case may "e, s a** "e punis a"*e 3it imprisonment for a term 3 ic s a** not "e *ess t en fi4e years "ut 3 ic may exten! to a term of *ife an! 3it fine 3 ic s a** not "e *ess t en ten t ousan! rupeesF

Se! J;C99 Penalt# for $anufa!ture/ sale/ et!9/ of dru s in !ontra"ention of t%is C%apter93D oe4er , imse*f or "y any ot er person on is "e a*f, manufactures for sa*e or for !istri"ution, or se**s, or stoc?s or ex i"its or offers for sa*e or !istri"utes,$ )a+ any !ru# !eeme! to "e a!u*terate! un!er +ection 17$& or spurious un!er +ection 17$< and 3 ic 3 en use! "y any person for or in t e !ia#nosis, treatment, miti#ation, or pre4ention of any !isease or !isor!er is *i?e*y to cause is !eat or is *i?e*y to cause suc arm on is "o!y as 3ou*! amount to #rie4ous urt 3it in t e meanin# of +ection 320 of t e In!ian /ena* Co!e '45 of 1960%, so*e*y on account of suc !ru# "ein# a!u*terate! or spurious, as t e case may "e, s%all :e punis%a:le 1it% deat% penalt# or i$prison$ent for a ter$ of life or i$prison$ent for a ter$ 1%i!% s%all not :e less t%an ten #ears and 1it% fine of rupees one la(% or up to t%ree ti$es t%e "alue of t%e oods sei'ed/ 1%i!%e"er is %i %er9 )aa+ 6%ere fine is reali'ed/ it s%all :e paid to t%e "i!ti$ or ne.t of %is ):+ (in9 any !ru#$ 'i% !eeme! to "e a!u*terate! un!er +ection17$&, "ut not "ein# a !ru# referre! to in c*ause 'a%, or 'ii% 3it out a 4a*i! *icence as re(uire! un!er cause 'c% of +ection 19,s a** "e punis a"*e 3it imprisonment for a term 3 ic s a** not "e *ess t en t%ree #ears :ut 1%i!% $a# e.tend to fi"e #ears and 1it% fine 1%i!% s%all not :e less t%en fift# t%ousand rupeesK /ro4i!e! t at t e Court may, for any a!e(uate an! specia* reasons to "e recor!e! in t e ,u!#ment, impose a sentence of imprisonment for a term of *ess t en t ree years an! 3it fine 3 ic s a** not "e *ess t an fifty )!+ t ousan! rupeesF An# dru dee$ed to :e spurious under Se!tion 4C3,/ :ut not :ein a dru referred to in !lause )a+ s%all :e punis%a:le 1it% i$prison$ent for a ter$ 1%i!% s%all not :e less t%en se"en #ears :ut 1%i!% $a# e.tend to ter$ of life and 1it% fine of fift# t%ousand rupees or upto t%ree ti$es t%e "alue of t%e oods sei'ed/ 1%i!%e"er is %i %er9 /ro4i!e! t at t e Court may, for any a!e(uate an! specia* reasons, to "e recor!e! in t e ,u!#ment, i$pose a senten!e of i$prison$ent for a ter$ of less t%en se"en #ears :ut not less t%an t%ree #earsK and )d+ 1it% a fine 1%i!% s%all not :e less t%an fift# t%ousand rupees9

any !ru#$ 'i% !eeme! to "e ):+ a!u*terate! un!er +ection 17$&, "ut not "ein# a !ru# referre! to in c*ause 'a%, or 'ii% 3it out a 4a*i! *icence as re(uire! un!er cause 'c% of +ection 19, s a** "e punis a"*e 3it imprisonment for a term 3 ic s a** not "e *ess t en one year "ut 3 ic may exten! to t ree years an! 3it fine 3 ic s a** not "e *ess t en fi4e t ousan! rupeesF

/ro4i!e! t at t e Court may, for any a!e(uate an! specia* reasons to "e recor!e! in t e ,u!#ment, impose a sentence of imprisonment for a term of *ess t en one year an! of fine of *ess t en fi4e t ousan! rupeesF any !ru# !eeme! to "e spurious un!er )!+ +ection 17$<, "ut not "ein# a !ru# referre! to in c*ause 'a% s a** "e punis a"*e 3it imprisonment for term 3 ic s a** not "e *ess t en t ree years "ut 3 ic may exten! to fi4e years an! 3it fine 3 ic s a** not "e *ess t en fi4e t ousan! rupees. /ro4i!e! t at t e Court may, for any a!e(uate an! specia* reasons, to "e recor!e! in t e ,u!#ment, impose a sentence of imprisonment for a term of *ess t en t ree years "ut not *ess t en one yearF

any !ru#, ot er t en a !ru# referre! to in c*ause ' a % or c*ause '"% or )d+ c*ause ' c %, in contra4ention of any ot er pro4ision of t is C apter or any

Anne.ure 3 C

SURVEY O7 STATE DRUG REGULATORY AUTHORITIES I7 I7DIA

YOUR PARTICULARS

7a$e

>

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

Title&Position

>

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

State

>

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

Postal Address

>

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

Telep%one '3it co!es% >

LLLLLLLLLLLLLLLLLLLLLLL Fa.> LLLLLLLLLLLLLLLL

E3$ail

>

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

SECTIO7 A> STATE DE-OGRAPHICS

1.

6opulation LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

?.

Annual budget of ,rug control ,epartment during the last three years

a. ?>>>(?>>1 LLLLLLLLL

bE ?>>1(?>>? LLLLLLLLL

cE ?>>?(?>>G LLLLLLLLL

3.

Is t e "u!#et a!e(uate for efficient functionin# of your !epartmentM IE+ 7E

B.

7um"er of !istricts

LLLLLLLLLLLLLLLLLLLLLLLLLL

SECTIO7 ,> DRUG CO7TROL I7FRASTRUCTURE

I9 E7FORCE-E7T

5.

7um"er of 1ru# inspectors LLLLLLLLLLLLLLLLLLLL

6.

7um"er of super4isory officers

a.&ssistant !ru#s contro**ers : assistant commissioners LLLLLLLLLLLLLLLLLLL

".1eputy !ru#s contro**ers:!eputy commissioners LLLLLLLLLLLLLLLLLLLLLLL

c. )oint !ru#s contro**ers:,oint commissioners LLLLLLLLLLLLLLLLLLLLLLLLLLL

!.

7um"er of non$tec nica* staff LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

7.

0ren! of tota* manpo3er increase !urin# *ast t ree years

a.2000$2001 LLLLLLLLL "% 2001$2002 LLLLLLLLc% 2002$2003 LLLLLLLLL

II. TESTING

@.

,o you have a separate full(fledged testing laboratory2 IE+ 7E

<.

.as additional space been added during last five years2 IE+ 7E

1>. Annual budget during last three years

a. ?>>>(?>>1 LLLLLLLLL

bE ?>>1(?>>? LLLLLLLLL

cE ?>>?(?>>G LLLLLLLLL

11. 9umber of technical staff LLLLLLLLLLLLLLLLLLLLL

1?. 9umber of non(technical staff LLLLLLLLLLLLLLLLL

1G. Trend in manpower increase during last three years

a. ?>>>(?>>1 LLLLLLLLL

bE ?>>1(?>>? LLLLLLLLL

cE ?>>?(?>>G LLLLLLLLL

1B. 9umber of drug samples tested during last three years

a. ?>>>(?>>1 LLLLLLLLL

bE ?>>1(?>>? LLLLLLLLL

cE ?>>?(?>>G LLLLLLLLL

1F. 9umber of samples found not of standard 7uality

a. ?>>>(?>>1 LLLLLLLLL

bE ?>>1(?>>? LLLLLLLLL

cE ?>>?(?>>G LLLLLLLLL

1=. Action ta#en on not of standard 7uality drugs

aE 0icenses suspended LLLLLLLLL bE licenses cancelled LLLLLLL

cE 6rosecutions launched LLLLLLL dE $onvictions, if any LLLLLLL

1A. 9umber of private testing laboratories LLLLLLLLLLLLLLLLLLLL SECTIO7 C> STATUS O7 DRUG PRODUCTIO7

19. 2oca* pro!uction in 4a*ue LLLLLLLLLLL

1B. 0ota* num"er of !ru# manufacture *icenses LLLLLLLLLL a% <u*? !ru#sLLLLLLLLLL "% 1ru# formu*ations LLLLLLLLLLLLLLLL i% 2ar#e 4o*ume parentera*s LLLLLLLLL ii% 5accines LLLLLLLLLLLLLLLLLLLLLL iii% +ur#ica* !ressin#s LLLLLLLLLLLLLL c% Cosmetics LLLLLLLLLLLLLLLLLLLLLL !% 2oan *icenses LLLLLLLLLLLLLLLLLLL e% Misce**aneous LLLLLLLLLLLLLLLLLL

SECTIO7 D> Status on Dru

Distri:ution

20.

7um"er of retai* *icenses LLLLLLLLLLLLLLLLLLLL

21.

7um"er of 3 o*esa*e *icenses LLLLLLLLLLLLLLLL

22.

7um"er of re#istere! p armacists LLLLLLLLLLLLL

SECTIO7 E> POLICY O7 SPURIOUS DRUGS

I9 E8TE7T OF SPURIOUS DRUGS

23.

7um"er of cases of spurious !ru#s !etecte! !urin# *ast t ree years.

a.

2000$2001 LLLLLLLLL "% 2001$2002 LLLLLLLLL c% 2002$2003 LLLLLLLLL

24.

6i4e "rea?up of 3 ere t ey 3ere !etecte!.

i%

Aetai* out*ets

LLLLLLLLLLLLL

ii%

D o*esa*e out*ets

LLLLLLLLLLLLL

iii%

Manufacturin# units

LLLLLLLLLLLLL

i4% 25.

@ospita*s:practitioners LLLLLLLLLLL4% Hn*icense! premises LLLLLLLLLLLL Das t e !etection of spurious cases "ase! on information t rou# .

aE

Iour o3n inte**i#ence or sur4ei**ance

IE+

7E

bE

0ra!e

IE+

7E

cE

1ru# manufacturer

IE+

7E

dE

/u"*ic

IE+

7E

e%

&ny ot er source

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

26.

1o you t in? t e !efinition of Kspurious !ru#= #i4en in 1ru#s an! Cosmetics &ct is a!e(uateM IE+ 7E

27.

If no, any su##estions for mo!ifications

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

II9 RESULTS OF TESTI7G

29.

D et er acti4e in#re!ient 3as.

a% /resent LLLLLLLLLLLLL "% &"sent LLLLLLLLLLLLLL c% 1eficientLLLLLLLLLLLLL

2B.

D et er t e samp*e 3as a copy of.

a% & ?no3n "ran! 3it acti4e in#re!ient LLLLLLLor 3it out acti4e in#re!ient LLLLLL

III9 ACTIO7 TA0E7 A7D RESULTS THERE OF

30.

7um"er of cases prosecute! LLLLLLLLLLLLLLLLL

31.

7um"er of cases con4icte!

LLLLLLLLLLLLLLLLLL

32.

6i4e !etai*s of con4iction

a% +imp*e imprisonment LLLLL "% Imprisonment 3it fine LLLLL or 3it out fine LLLLL

33.

Hn!er tria* LLLLLLLLLLLLLLLLLL

Cases pen!in# for more t an. 0 ree years 34.

Fi4e years

0en years

&4era#e time ta?en to comp*ete t e tria* LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

35. For e*imination:re!uction of t e menace of spurious:counterfeit !ru#s, p*ease #i4e your su##estions:recommen!ations in respect of.

i%

Impro4in# t e system of !istri"ution.

ii%

+pee!y tria*s in courts LLLLLLLLLLLLLLLLLLLLLLLLLLLLL

iii%

Ao*e p*aye! "y in!ustry LLLLLLLLLLLLLLLLLLLLLLLLLLLL

i4%

Ao*e p*aye! "y tra!e LLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

4%

Ao*e p*aye! "y t e professiona* associations LLLLLLLLLLL

4i%

C an#es re(uire! in existin# *e#a* pro4isions LLLLLLLLLLL

4ii% 0rainin# of re#u*atory officia*s LLLLLLLLLLLLLLLLLLLLLLL

4iii% +ee?in# cooperation of po*ice LLLLLLLLLLLLLLLLLLLLLLL

ix%

+ur4ei**ance mec anism LLLLLLLLLLLLLLLLLLLLLLLLLLL

IV9 SETTI7G UP OF I7TELLIGE7CE3CU-3LEGAL CELL

36.

@a4e you setup inte**i#ence$cum$*e#a* ce** an! anti spurious s(ua!M IE+ 7E

37.

If yes, #i4e composition of t e ce** an! name of t e officer in$c ar#e LLLLLLLLLL

39.

D et er t e po*ice officia*s are attac e! exc*usi4e*y to t e ce**M IE+ 7E

3B.

D et er experience! *a3 officer attac e! to t e ce**M IE+ 7E

V9 6ATCHERS ACTIVITY

40. @a4e you emp*oye! 3atc ers for test purc ase of !ru# samp*esM IE+ 7E

41. D et er t ere is a4ai*a"i*ity of secret fun!sM

IE+

7E

VI9 TRAI7I7G OF PERSO77EL

42. D et er officers a4e un!er#one any specia* trainin# for !etection an! in4esti#ation of spurious !ru#sM IE+ 7E

43.

If yes, p*ease state 3 ere t e trainin# 3as ta?enM In$ ouse E*se3 ere

44.

1o you t in? t ere is a nee! for a specia*iJe! trainin# pro#ramme "y centra* #o4ernmentM

IE+

7E

SECTIO7 F> 7ET6OR0I7G

45.

D et er state !ru# contro* a!ministration as efficient communication net3or?in# 3it $

a%

Et er state !epartments inc*u!in# po*ice in your stateM

IE+

7E

"%

Dit C1+CEM

IE+

7E

c% Dit state !ru# contro* !epartments in ot er statesM IE+ 7E

!%

If no, 3 at action is "ein# ta?enM LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

SECTIO7 G> SURVEY O7 2UALITY OF DRUGS

46.

1o you a4e any sur4ey pro#ramM

IE+

7E

47. If yes, num"er of suc sur4eys un!erta?en !urin# *ast t ree years

a%. 2000$2001 LLLLLLLLL "% 2001$2002 LLLLLLLLL c% 2002$2003 LLLLLLLLL

49. 7um"er of samp*es teste!.

a%LLLLLLLLLL"%LLLLLLLLLc% LLLLLLLL

0este! at. a% E3n faci*ity LLLLLLLLLL "% E*se3 ere LLLLLLLLLLL

4B. 0ime ta?en to ana*yJe sur4ey samp*es

03o 3ee?s 50.

Four 3ee?s

More t an t at

6i4e summary of t e resu*ts of suc sur4ey.LLLLLLLLLLLLLLLLLLLLLLLLLLLLL

LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL SECTIO7 H> SURVEILLA7CE OVER DISTRI,UTIO7

51. D et er t ere is any mec anism to i!entify !ea*ers:3 o*esa*ers suspecte! to "e in!u*#in# in sa*e of spurious !ru#sM IE+ 7E

52.

If yes, t e num"er of suc !ea*ers i!entifie! LLLLLLLLLLLLLLLLLLLLLLLLLLLLL

SECTIO7 I> SETTI7G UP OF DESIG7ATED COURTS FOR SPURIOUS DRUGS

53.

D et er specia* courts a4e "een !esi#nate! for summary tria*sM IE+ 7E

54.

If no, as t e process "een initiate! 3it t e state #o4ernmentM IE+ 7E

SECTIO7 *> REACTIVATIO7 OF STATE DRUG ADVISORY CO--ITTEE

55.

@a4e you setup or reacti4ate! state !ru# a!4isory committeeM IE+ 7E

56.

If yes, !o t ey meet re#u*ar*yM

IE+

7E

SECTIO7 0> Stren t%enin

of re ulator# infrastru!ture

57.

/*ease *ist t e pro"*ems face! "y you for effecti4e enforcement

i%

LLLLLLLLLLLLLLLLLLLL

ii%

LLLLLLLLLLLLLLLLLLLL

iii%

LLLLLLLLLLLLLLLLLLLL

i4% 59.

LLLLLLLLLLLLLLLLLLLL In your perception, is t e enforcement of 1ru#s an! Cosmetics &ct an! Au*es uniform t rou# out t e countryM IE+ 7E

5B.

1o you support *icensin# of !ru# manufacturin# units in t e country "y a Centra* &ut orityM

IE+ 60. If no, #i4e reasons

7E

i%

LLLLLLLLLLLLLLLLLLL

ii%

LLLLLLLLLLLLLLLLLLL

iii%

LLLLLLLLLLLLLLLLLLL

i4%

LLLLLLLLLLLLLLLLLLL

SECTIO7 L> DRUG POLICY A7D CREATIO7 OF 7ATIO7AL DRUG AUTHORITY )7DA+

61.

&re you a3are of t e recommen!ation in 1ru# /o*icy in 1BB4 for creation of 71&M IE+ 7E

62.

If yes, in your 4ie3 3 ic of t e fo**o3in# functions s ou*! 71& performM

a%

2icensin# of Manufacturin# units

IE+

7E

"%

Ae#istration:appro4a* of ne3 !ru#s

i% Mo!ern !ru#s

IE+

7E

ii% 0ra!itiona* !ru#s

IE+

7E

iii% r$17& "ase! !ru#s

IE+

7E

i4% 7eutraceutica*s

IE+

7E

c%

Monitorin# of C*inica* tria*s

IE+

7E

!%

Monitorin# of <ioe(ui4a*ence stu!ies

IE+

7E

e%

Monitorin# of &!4erse 1ru# Aeactions

IE+

7E

f%

/ost mar?etin# sur4ei**ance

IE+

7E

#%

/ro!uct reca**s

IE+

7E

%

Mar?et comp*aint an!*in#

IE+

7E

i%

Mana#in# trainin# centers for.

i%

1ru#s inspectors

IE+

7E

ii%

Nua*ity contro* ana*ysts

IE+

7E

iii%

Et er re#u*atory staff

IE+

7E

,%

&nima* toxicity stu!ies of ne3 !ru#s

IE+

7E

?%

Ae#u*ation of !ia#nostic ai!s

IE+

7E

*%

Ae#u*ation of me!ica* !e4ices

IE+

7E

m% Ae#u*ation of me!ia* e(uipment

IE+

7E

n%

Contro* on t e manufacture an! sa*e of 7eutraceutica*s

IE+

7E

o%

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Self-prescription, overuse of drugs increases resistance risk
TNN Aug 15, 2010, 08.15pm IST

!perts are alarmed "ecause t#e $%&-1 en'(me can make "acteria resistant to most last-resort drugs. T#e gene is also capa"le of eas( replication in ot#er "acteria strains )#ic# ma( result in t#e formation of anot#er super"ug, resistant to man( ot#er anti"iotics How do bacteria develop resistance to a drug? %evelopment of drug resistance in "acteria is a tussle "et)een science and nature. *#ile an anti"iotic kills "acteria or slo)s do)n t#eir gro)t#, natural selection e+uips t#em in developing traits )#ic# aid survival and reproduction. $atural selection, a ke( mec#anism of evolution, is also one of t#e main processes )#ic# creates geneticall(-#erita"le traits, or c#aracteristics )#ic# pass from one generation to t#e ne!t. If a group of "acteria is e!posed to some anti"iotic, it is possi"le t#at a fe) of t#em )ill possess a "etter survival and reproduction mec#anism t#an t#e ot#ers. T#is information stored in a "acterium,s gene -unit of #eredit(. can pass on to t#e ot#er mem"ers of t#e group and continuation of t#e process can ultimatel( result in t#e development of complete resistance against t#e particular anti"iotic in all mem"ers of t#e group. If a "acterium carries several resistance genes t#en it "ecomes multi-resistant, commonl( kno)n as a ,super"ug,.

What factors increase the rate of development of drug resistance? It is generall( o"served t#at a larger duration of e!posure to an anti"iotic increases t#e risk of development of resistance. T#e )idespread use of anti"iotics #as pla(ed an important role in evolution of t#e drug resistant "acterium. Apart from "eing used as medicine for #umans, anti"iotics are also used on farm animals eit#er to treat diseases or for promoting gro)t#, )#ic# increase t#e e!posure of "acteria to t#e drug. Inappropriate treatment, overuse, self-prescription, failure in completing t#e prescri"ed course and misuse / like taking anti"iotics to treat common colds, )#ic# is actuall( a viral infection / result in t#e undue e!posure of "acteria to t#e drug facilitating t#e evolution of anti"iotic-resistant population. It is also o"served t#at t#e inappropriate disposal of p#armaceutical industr( )aste ma( result in environmental pollution )it# "road spectrum anti"iotics #elping "acteria develop resistance. When was the now-famous 'superbug' discovered?

Pharmacy education in West Bengal

There is an urgent need for colleges in West Bengal to begin post-graduate courses to cater to the increasing demand for pharmacy in the state, suggests Prof A K Bandyopadhyay Pharmacy education in West Bengal started about fifty-five years ago at the Institute of Pharmacy, Jalpaiguri in Diploma level Degree !ollege in Pharmacy started in the year "#$% at Jadavpur &niversity The Indian Pharmaceutical 'ssociation (Bengal branch( too) initiative to start Pharmacy *ducation in West Bengal in degree level and under the guidance of Dr Triguna +en, the then ,ector of Jadavpur &niversity and the programme started -ith ". students Prof / 0 +chroff, the father of pharmacy in India became the first 1ead of the department of this institute 1e inducted a fe- eminent scholars in the field of pharmacy and allied sciences as teachers of this department In "#$2, the department had its o-n building at the northern side of the campus 't that time admission in Jadavpur &niversity used to be on the basis of mar)s obtained in 1igher +econdary *3aminations &nder an agreement -ith 4ovt of West Bengal, fifty percent of the seats -ere under reserved category and /inistry of 1ealth 4ovt of West Bengal used to nominate these students Prof / 0 +chroff -as associated -ith the Department for about five years and Prof D 5 ,oy became the ne3t permanent 1ead of this Department The Post-4raduate (/ Pharm( pharmacy course -as started in the year "#$2 -ith t-o students only +ubse6uently the number of post-graduate seats -as increased to si3 The students -ho ran)ed first to si3th in B Pharm *3amination -ere admitted to the / Pharm programme The number of students admitted to B Pharm course at that time -as .7 &nder the initiative of the highly 6ualified teachers of the department, research activities at pharmacy department -ere started The teachers at that time felt that for the development of this profession research activities are an essential component along -ith 6uality teaching It proved their vision for the future 4radually, Diploma Pharmacy course -as started at 5alyani Institute of Pharmacy by the state government, due to the need of such health professionals in government sectors 't a much later stage another diploma college -as started at Ban)ura +eats of B Pharm course -as increased to si3ty and ten seats -ere )ept reserved for Diploma students of West Bengal because the process of admission of fifty percent students nominated by government of West Bengal -as stopped +ubse6uently, &4! increased the number of post-graduate seats to "7 't present, this department has seventy seats in undergraduate course and 82 seats in post-graduate course 9ut of these 82 seats, five seats are reserved for sponsored

category :oreign students are also admitted through central government Different pharmaceutical companies sponsor students for higher studies 'dmission in B Pharm course is done through ;oint entrance e3amination and admission in post-graduate course is through 4'T* e3amination 4ate candidates receive ,s 2777 pm as scholarship for their studies along -ith contingency grant of ,s "7,777 'I!T* has identified this Department as /odel !entre and every year they sponsor about si3 to eight students for / Pharm course and .-2 students for doctoral programme This department has seven specialisation namely pharmaceutical chemistry, pharmaceutics, pharmacology, pharmacognosy, pharmaceutical engineering, microbiology and biochemistry In post-graduate course students are re6uired to ta)e one of the above sub;ects as his ma;or (specialised( sub;ect and underta)e his dissertations -or) on the selected sub;ect /ean-hile, several polytechnics in West Bengal li)e 4yan !handra 4hosh Polytechnic !alcutta, Women<s Polytechnic at !handannagore, Polytechnic at !ontai, +uri, !oochbehar and +iliguri also have started diploma course in pharmacy under World Ban) pro;ect 9ther states in India li)e 5arnata)a, 'ndhra Pradesh, /aharastra, 5erala, 9rissa encouraged private entrepreneurs in the field of education and several private pharmacy colleges in degree as -ell as in diploma level -ere established West Bengal lagged behind for many years in this regard When private entrepreneurship -as encouraged in this field, only t-o degree level pharmacy colleges -ere established in West Bengal 9ne is 4upta !ollege of Technology +ciences at 'sansol and the other !alcutta Institute of Pharmaceutical Technology and 'llied 1ealth +ciences at &lubera :rom this year, B Pharm course has also started at the Institute of Pharmacy, Jalpaiguri This is a state government sponsored college 'll these colleges are affiliated to the West Bengal &niversity of Technology It is apparent from the data given in Table-" West Bengal is still lagging a behind in pharmacy education in comparison to many other states 0arge number of students every year goes to neighboring 9rissa and far a-ay state li)e 5arnata)a to study pharmacy Private entrepreneurs should come for-ard to start more degree colleges of pharmacy in West Bengal since the demand of pharmacy professionals -ill be very high is coming years It is predicted that it -ill be ne3t to IT professionals 1o-ever, 6uality education is imperative and there -ill be no dearth of 6ualified teachers in West Bengal In 5arnata)a and 9rissa, many pharmacy colleges and staffed by pharmacy 6ualified students from Jadavpur &niversity In fact, e3-students of the Pharmacy Department of, Jadavpur &niversity are holding top positions in many pharmaceutical companies

in India In the &+, about %27 students of the Dept of Pharmacy, Jadavpur &niversity, are employed in pharma industries, academic and research institutes and :D' It is felt that colleges of West Bengal should start post-graduate courses immediately to fulfill the demand of this programme Jadavpur &niversity cannot alone accommodate more that 87 4'T* 6ualified students and cannot meet the huge demand for admission The Pharmacy Department of Jadavpur &niversity has a long history of research 'bout .7-27 sponsored research scholars al-ays -or) in this department and eighty per cent of the faculty members have more than t-o research pro;ects from different funding agencies li)e D+T, 'I!T* &4!, I!/,, !+I, and other private bodies 9ther pharmacy colleges of West Bengal should also start research programmes as early as possible They can al-ays ta)e help and advice from Jadavpur &niversity because most of the faculty members of these colleges are e3-students of the Dept of Pharmaceutical Technology of Jadavpur &niversity
+tate 'ndhra Pradesh 4u;arat 5arnata)a /aharastra Tamil ?adu West Bengal Diploma Inta)e Degree Inta)e 87 # =2 $> .8 # "787 $.7 2%87 .727 8#77 %=7 8" # .> ." %2 . ""=7 287 82.7 88"7 "##7 8.7

+ource@ Pharmacy !ouncil of India Bulletin Aol BBII (give in Table I, no@ %(, 877%

14. The Role of Pharmacists

$ontents

• •

9e)t page 6revious page 1B.1 6harmacists wor#ing in 6rimary $are, in the community and in hospitals have a central role in the safe and effective use of medicines for children and young people. 1B.? 5reater use could be made of community pharmacies as a community health resource. %any consultations with general practitioners or practice nurses for minor illness, could be dealt with by the community pharmacist. +ecent evidence also shows that ?>C of calls to a primary care out(of(hours centre and at least @C accident and emergency department consultations could be handled by a community pharmacist. 1B.G .ospital pharmacists, wor#ing as part of multidisciplinary teams, may specialise in neonatal or paediatric pharmacy or in particular specialties, such as oncology, intensive care, cardiac and renal medicine. They have an important role in the provision of a comprehensive hospital service for children and young people. This may include arrangements for the childMs treatment following discharge including liaising with community services. Future developments, such as robotic dispensing and electronic prescribing will enhance the contribution that hospital pharmacies and others can ma#e to the multi(disciplinary care of children. 1B.B There are e)amples of local schemes in around => 6rimary $are Trusts where community pharmacists advise on minor ailments and supply medicines from a limited formulary for children on the 9.S. ,ata from the first such scheme now span over four years, and evaluation showed a B>C transfer of consultations from general practitioners to pharmacists D?1E. Building on the BestN $hoice +esponsiveness and -7uity in the 9.S D??E, recommends that all 6rimary $are Trusts consider carefully targeted schemes to meet the needs of patients who would otherwise visit their doctor for a prescription. 1B.F 6harmacists may provide Stop Smo#ing advice and, where appropriate, referral to an 9.S Stop Smo#ing service. They may also act as Stop Smo#ing advisers and are well(placed to do so. DSee ,epartment of .ealthMs national target on 'mproving the health of the population.E 1B.= 6harmacists who wor# in the heart of the community should be encouraged to focus on the most hard(to(reach and vulnerable families in their community, wor#ing with health visitors, midwives and others to provide support, information and advice to those who need it most. They also have an important part to play in promoting healthy lifestyle messages in relation to nutrition, physical activity and reducing alcohol inta#e. 1B.A %ost teenagers D@>CE using community pharmacies to access emergency hormonal contraception generally find the level of privacy acceptable. .owever, there is room for improvement through premises design and the use of consultation areas. $ommunity pharmacists are sub&ect to the +oyal 6harmaceutical Society of 5reat BritainMs D+6S5BE $ode of -thics D?GE in relation to confidentiality. There is evidence that some D?>CE young women accessing emergency hormonal contraception through pharmacies have concerns about confidentiality. 6romoting the confidentiality re7uirements that apply to pharmacists through the +6S5B $ode of -thics could increase young peopleMs confidence to approach them for advice. See Standard G 6rimary $are Trust pharmacists are engaged in commissioning medicine management services for children, influencing prescribing by general practitioners, developing shared care guidelines and ensuring that policies e)ist for the safe and effective use of medicines across the primary, secondary and tertiary care interfaces. $ommunity

pharmacists are used as an appropriately informed and s#illed resource to support self(care for parents, children and young people and sign(posting to other services. 6rimary $are Trusts and 9.S Trusts ma)imise the contribution of pharmacists, their staff and the premises in which they wor# to improve health and reduce health ine7ualities. 6harmacists should ta#e opportunities to provide healthy lifestyle advice including advice on physical activity, stopping smo#ing, reducing alcohol inta#e and substance misuse, especially in areas of deprivation. .ospital pharmacists ensure that medicines are managed safely and effectively and that they are appropriate for the age, development and clinical status of the child or young person. They can also provide advice on the clinical and costeffectiveness of medicines.

Footnotes
?1 .assell 1, 3hittington O, $antrill H, et al, %anaging demandN transfer of self(limiting conditions from general practice to community pharmacy British %edical Hournal G?GN 1B=(A ?>>1 ?? ,epartment of .ealth P 9.S, Building on the BestN $hoice +esponsiveness and -7uity in the 9.S ,ecember ?>>G The Stationery :ffice

3or#ing as a hospital pharmacist

This page describes the wor# of hospital pharmacists in more detail, showing how the e)pertise of pharmacists in various areas is integral to the care and treatment of patients.

.ospital pharmacists

.ospital pharmacists are e)perts in the field of medicines. They are responsible for the purchase, manufacture, dispensing, 7uality testing and supply of all the medicines used in the hospital. They wor# closely with medical and nursing staff to ensure patients receive the most appropriate treatment, and provide help and advice to patients in all aspects of their medicines.

They advise on the selection of medicines and the dose and route of administration for individual patients. They provide information about potential side effects and ensure that new treatments are compatible with e)isting medication. 'n addition, they monitor the effects of treatment to ensure that it is safe and effective.

As the medicines e)pert in the healthcare team, you are able to provide advice about the effects that a medicine or combination of medicines may produce. Kou will give advice on dosage, suggest the most appropriate form of medication ! such as tablet, in&ection, ointment, inhaler ! and discuss with the medical staff the potential problems patients may e)perience with their medicines.

Kou will be e)pected to provide specialist advice on medicines for patients with conditions such as heart failure, #idney or liver disease, and for pregnant or breast( feeding women who should not ta#e some medicines.

Kou will wor# with individual patients to help select the most appropriate therapy, ta#ing account of factors including their e)isting medication, their medical history, their lifestyle and their ability to understand and adhere to a treatment plan.

As well as wor#ing on the wards with patients, there are several roles that are underta#en within the pharmacy itself. Kour main role in the dispensary is to “professionally chec# all prescriptions to ensure that the dispensed medicines are appropriate and safe for the individual patient.

'n the medicines information department, pharmacists use a range of reference sources, including electronic databases and the 'nternet, to provide detailed information to healthcare professionals and patients about all aspects of medicines usage. 9ew drugs are evaluated and compared to e)isting treatments before the hospital decides whether to purchase them.

6harmacists are also involved in the manufacture of medicines when ready(made preparations are not available. For e)ample, certain cancer treatments and intravenous feeding solutions need to be tailor made under sterile conditions for individual patients.

Specialised roles in other areas such as procurement, radiotherapy, 7uality assurance and education also e)ist.

%any pharmacists combine their professional role with some form of managerial responsibility, and also often will be involved in monitoring and reporting on e)penditure from the budget for medicine usage within the hospital.

%ost hospital pharmacists are involved in a range of activities and wor# with a variety of healthcare staff and 9.S managers so team wor#ing, together with the ability to communicate well at all levels, is essential.

Accuracy and attention to detail are important, as is the ability to use your foundation in science when solving problems.

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