drug and price control order 1995

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    DRUG AND PRICE CONTROLORDER (1995)

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    INTRODUCTION: The Drugs Price Contro Or!er (DPCO)" 1995 is #n or!er

    issue! $% the Go&ern'ent o In!i# un!er ection * o the

    Essenti# Co''o!ities Act" 1955 to regu#te the +rices o!rugs,

    The Or!er +ro&i!es:

    the ist o +rice controe! !rugs"

    +roce!ures or i-#tion o +rices o !rugs"

    'etho! o i'+e'ent#tion o +rices i-e! $% Go&ern'ent

    #n! +en#ties or contr#&ention o +ro&isions #'ong other

    things.

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    HISTORY OF DPCO 1. Drugs Prices (Dis+#% #n! Contro) Or!er"

    19..

    /, Drugs (Prices Contro) Or!er" 190

    *, Drugs (Prices Contro) Or!er" 1909

    2, Drugs (Prices Contro) Or!er" 1930

    5, Drugs (Prices Contro) Or!er" 1995

    ., Drugs (Prices Contro) Or!er" /1*

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    Year of Introduction of theDrug Price Control Order

    No. of Drugs under PriceControl

    190 13

    1909 *20

    1930 12/

    1995 02

    /1* *23 4 e!icines

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    C6EDULE O7 DPCO

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    C6EDULE: IIt consists of the list of bulk drugs, around 74 used in the treatment

    of different ailments,

    su+h#'etho-#8oe" +eniciins" tetr#c%cine" #n#gin" !o-%c%cine" ci+roo-#cin"

    ri#'+icin" ceot#-ine" stre+to'%cin" r#niti!ine" !e-#'eth#sone" e+he!rine"

    &it#'ins A" 1" /" C E" $et#'eth#sone" c#r$#'#8e+ine" 'etroni!#8oe"

    choro;uine" theo+h%ine" insuin" er%thro'%cin" e&o

    'eth% !o+#" #s+irin" h#ogen#te! h%!ro-%;uinoine" !e-tro+ro+o-%+hene"

    tri'etho+ri'" co-#ciin" +ent#8ocine" su+h#!i'i!ine" c#+to+ri" s#$ut#'o"

    n#+ro-en" +%rent#" su+h#!o-ine" #'oti!ine" i$u+roen" noro-#cin" ruse'i!e"

    c##!ro-%" +henir#'ine '#e#te" +#nthenos #n!, +#nthon#tes" choro-%enos"

    ur#8oi!one" $ec#'+iciin" +%rithio-ine" inco'%cin" chor+ro+#'i!e"

    su+h#!i#8ine" r#'%cetin" 'e$h%!roine" chor+ro'#8ine" &er#+#'i"'ethen!ienone" +hen%$ut#8one" gi+i8i!e" I%nestr#no" s+irono#ctone"

    s##8osu+h#+%rine" +ento-%=ine" !ios'ine" #'o!i#;uin" tri'i+r#'ine" #n!

    su+h#'o-oe

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    C6EDULE: II It consists o !ierent or's to $e su$'itte! such #s"

    i, 7or' o inor'#tion>#++ic#tion or i-#tion or re&ision o

    +rices o che!ue! $u? !rugs in !u+ic#te,

    ii, 7or' o inor'#tion in res+ect o +rice o non

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    Po@er to i- the '#-i'u' s#e +rices o

    $u? !rugs s+eciie! in the7irst che!ue : The Go&ern'ent '#%" @ith # &ie@

    to regu#te e;uit#$e !istri$ution

    incre#sing su++ies o # $u? !rug '#?ing it #i#$e #t # #ir +rice

    C#n i- ro' ti'e to ti'e" $% notiic#tion in the Oici#

    G#8ette" # '#-i'u' s#e +rice #t @hich such $u? !rug sh#$e so!

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    Cont

    Bhie i-ing the '#-i'u' s#e +rice o # $u?

    !rug :

    the Go&ern'ent sh# t#?e into consi!er#tion #

    +ost

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    Cont

    Bhere" #ter the co''ence'ent o this Or!er" #n%'#nu#cturer co''ences Pro!uction o #n% $u? !rug

    s+eciie! in the 7irst che!ue,

    h# @ithin iteen !#%s o the co''ence'ent o +ro!uction

    o such $u? !rug" urnish the !et#is to the Go&ern'ent in

    7or' I,or"

    #n% such #!!ition# inor'#tion #s '#% $e re;uire! $% the

    Go&ern'ent

    Go&ern'ent '#% #ter recei+t o the inor'#tion #n! #ter

    '#?ing such in;uir% #s it '#% !ee' it" '#% i- the '#-i'u'

    s#e +rice o $u? !rug $% notiic#tion in the Oici# G#8ette,

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    Inor'#tion to $e urnishe! $% the

    '#nu#cturer in re#tion to the

    che!ue! $u? !rugs

    E&er% '#nu#cturer" +ro!ucing # che!ue! $u? !rug

    sh# urnish to the Go&ern'ent:

    #) A ist o # che!ue! $u? !rugs +ro!uce! $% hi' #n!

    in!ic#te the !et#is o the cost o e#ch o such $u? !rug

    in 7or' I,

    $) The !et#is o the cost o e#ch che!ue! $u? !rug

    +ro!uce! $% hi'" incu!ing such $u? !rug @hich h#s

    $een +ro!uce! #ter the co''ence'ent o this Or!er" in

    7or' I $% the *th e+te'$er" e&er% %e#r,

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    Inor'#tion to $e urnishe! $% the

    '#nu#cturer in re#tion to theNon

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    Po@er to !irect '#nu#cturers o $u?

    !rugs to se $u? !rugs toother '#nu#cturers o or'u#tions Bith # &ie@ to #chie&ing #!e;u#te +ro!uction #n! regu#ting

    the e;uit#$e !istri$ution" the Go&ern'ent '#%" ro' ti'e to

    ti'e" $% gener# or s+eci# or!er" !irect #n% '#nu#cturer o #n%

    $u? !rug to se such $u? !rug to such other '#nu#cturers oor'u#tions #s '#% $e s+eciie! in such or!er:

    Bhie '#?ing #n% such or!er" the Go&ern'ent sh# h#&e

    reg#r! to # or #n% o the oo@ing #ctors" n#'e%:

    i, The re;uire'ent or c#+ti&e consu'+tion o such'#nu#cturer" #n!

    ii, the re;uire'ent o other '#nu#cturers,

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    C#cu#tion o ret#i +rice o

    or'u#tion The ret#i +rice o # or'u#tion sh# $e c#cu#te! $% the Go&ern'ent in #ccor!#nce

    @ith the oo@ing or'u# n#'e%: R,P, (,C, F C,C, F P,, F P,C,) - (1 F APE>1) F ED

    "R.P. 'e#ns ret#i +rice!.C. 'e#ns '#teri# cost #n! incu!es the cost o !rugs #n! other

    +h#r'#ceutic# #i!s use! incu!ing o&er#ges" i #n%" +us +rocess oss

    thereon s+eciie! #s # nor' ro' ti'e to ti'e $% notiic#tion in the

    Oici# G#8ette in this $eh#

    C.C. 'e#ns con&ersion cost @or?e! out in #ccor!#nce @ith est#$ishe!

    +roce!ures o costing #n! sh# $e i-e! #s # nor' e&er% %e#r $%

    notiic#tion in the Oici# G#8ette in this $eh#P.!. 'e#ns cost o the +#c?ing '#teri# use! in the +#c?ing o

    concerne! or'u#tion" incu!ing +rocess oss" #n! sh# $e i-e! #s #

    nor' e&er% %e#r $%" notiic#tion in the Oici# G#8ette in this $eh#

    P.C. 'e#ns +#c?ing ch#rges @or?e! out in #ccor!#nce @ith est#$ishe!

    +roce!ures o costing #n! sh# $e i-e! #s # nor' e&er% %e#r $%

    notiic#tion in the Oici# G#8ette in this $eh#

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    Cont

    "!"P# (#-i'u' Ao@#$e Post

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    Po@er to i- ret#i +rice o

    che!ue! 7or'u#tions Go&ern'ent i-es or re&ises the +rice o #n% $u? !rug #n! '#nu#cturer

    utiises such $u? !rug in his che!ue! or'u#tions he sh#" @ithin

    thirt% !#%s o such i-#tion or re&ision" '#?e #n #++ic#tion to the

    Go&ern'ent" in 7or'

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    ContNo '#nu#cturer or i'+orter sh# '#r?et # ne@

    +#c?" or # ne@ or'u#tion or # ne@ !os#ge or'

    o his e-isting che!ue! or'u#tion @ithout

    o$t#ining the +rior #++ro o its +rice ro' the

    Go&ern'ent,

    No +erson sh# se or !is+ose o #n% i'+orte!

    che!ue! or'u#tion @ithout o$t#ining the +rior

    #++ro o its +rice ro' the Go&ern'ent,

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    Po@er to i- ceiing +rice o

    che!ue! or'u#tions

    The Go&ern'ent '#%" ro' ti'e to ti'e" $% notiic#tion

    in the Oici# G#8ette" i- the ceiing +rice o #

    che!ue! or'u#tion ?ee+ing in &ie@ the cost oreicienc%" or $oth" o '#Hor '#nu#cturers o such

    or'u#tions #n! such +rice sh# o+er#te #s the ceiing

    s#e +rice or # such +#c?s

    The +rice i-e! $% Go&ern'ent or che!ue!

    or'u#tions in #ccor!#nce @ith the +ro&isions o the

    Or!er

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    Po@er to reco&er !ues

    Accrue!>O&erch#rge! #'ount Go&ern'ent '#% $% notice" re;uire the '#nu#cturer"

    i'+orter or !istri$utor" #s the c#se '#%$e" to !e+osit the

    #'ount @hich h#s #ccrue! un!er the +ro&isions o the !rugs

    (Prices Contro) Or!er The #'ount sh# $e utii8e! or +ro'oting +h#r'#ceutic#

    e!uc#tion #n! rese#rch,

    Go&ern'ent sh# $% notice" re;uire the '#nu#cturers"

    i'+orters or !istri$utors" #s the c#se '#%$e" to !e+osit the

    #'ount #ccrue! !ue to ch#rging o +rices higher th#n those

    i-e! or notiie! $% the Go&ern'ent un!er the +ro&isions o

    Drugs (Prices Contro) Or!er

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    I'+e'ent#tion o the +rice i-e!

    or re&ise! $% the Go&ern'ent

    E&er% '#nu#cturer or i'+orter sh# c#rr% into eect the +rice o #

    $u? !rug or or'u#tion" #s the c#se '#% $e" #s i-e! $% the

    Go&ern'ent ro' ti'e to ti'e" @ithin iteen !#%s ro' the !#te o

    notiic#tion in the Oici# G#8ette,

    E&er% '#nu#cturer" i'+orter or !istri$utor o # or'u#tion

    inten!e! or s#e sh# !is+#% in in!ei$e +rint '#r?" on the #$e o

    cont#iner o the or'u#tion @ith the @or!s ret#i +rice not to

    e-cee! +rece!ing it" #n! Joc# t#-es e-tr#K succee!ing it" in the

    c#se o che!ue! or'u#tions, E&er% '#nu#cturer or i'+orter sh# issue # +rice ist #n!

    su++e'ent#r% +rice ist" i re;uire!" in 7or' to the !e#ers" t#te

    Drugs Controers #n! the Go&ern'ent,

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    Contro o s#e +rices o $u? !rugs

    #n! or'u#tions:

    No +erson sh# se #n% $u? !rug or or'u#tion

    to #n% consu'er #t # +rice e-cee!ing the +rices+eciie! in the current +rice ist or +rice in!ic#te!

    on the #$e o the cont#iner,

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    #nu#cturer" !istri$utor or !e#er not

    to reuse s#e o !rug :

    No '#nu#cturer or !istri$utor sh# @ithho! ro'

    s#e or reuse to se to # !e#er #n% !rug @ithout

    goo! #n! suicient re#sons,

    No !e#er sh# @ithho! ro' s#e or reuse to se

    #n% !rug #i#$e @ith hi' to # custo'er

    inten!ing to +urch#se such !rug,

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    Price o or'u#tions so! to the !e#er

    :

    A '#nu#cturer" !istri$utor or @hoes#er sh# se

    # or'u#tion to # ret#ier" uness other@ise

    +er'itte! un!er the +ro&isions o this Or!er or #n%or!er '#!e thereun!er" #t # +rice e;u# to the ret#i

    +rice" #s s+eciie! $% #n or!er or notiie! $% the

    Go&ern'ent" (e-cu!ing e-cise !ut%" i #n%) 'inus

    1. thereo in the c#se o che!ue! !rugs,

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    #inten#nce o Recor!s:

    E&er% '#nu#cturer #n! i'+orter sh# '#int#in

    # recor!s incu!ing s#es turno&er o $u? !rugs

    '#nu#cture! or i'+orte! #n! turn o&er oor'u#tions #n! other recor!s #s '#% $e !irecte!,

    The Go&ern'ent h#s the +o@er to c# the recor!s

    or to ins+ect recor!s #t the +re'ises,

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    Po@er o Entr%" e#rch #n! ei8ure

    An% G#8ette! Oicer o the Centr# Go&ern'ent

    or # t#te Go&ern'ent #uthorise! $% the

    Go&ern'ent or ensuring co'+i#nce @ith thisOr!er '#% enter #n! se#rch +#ce" sei8e #n% !rug

    #ong @ith cont#iner" +#c?#ges" etc," ins+ect

    recor!" sei8e #n% !ocu'ent such #s c#sh 'e'o or

    'e'o" $oo?s o #ccounts i oun! to $e incontr#&ention @ith +ro&ision o the Or!er,

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    Po@er to re&ie@ :

    An% +erson #ggrie&e! $% #n% notiic#tion issue! or

    or!er '#!e '#% #++% to the Go&ern'ent or # re&ie@

    o the notiic#tion or or!er @ithin iteen !#%s o the!#te o +u$ic#tion o the notiic#tion in the Oici#

    G#8ette or the recei+t o the or!er $% hi'" #s the c#se

    '#% $e,

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    Po@er to issue gui!eines #n!

    !irections,

    The Go&ern'ent" '#% or the +ur+ose o i'+e'enting the

    +ro&isions o this Or!er" #uthorise #n% Oicer" $% # gener#

    or s+eci# or!er" to ins+ect the +re'ises o #n% '#nu#cturer"i'+orter" !istri$utor or !e#er #n! such '#nu#cturer"

    i'+orter" !istri$utor or !e#er sh# #o@ such #uthorise!

    oicer #n! '#?e #i#$e # reent inor'#tion re;uire!

    or the +ur+ose,

    The Go&ern'ent '#%" ro' ti'e to ti'e" issue such

    gui!eines #n! !irections" consistent @ith the +ro&isions o

    this Or!er to #n% '#nu#cturer or i'+orter #s '#% $e

    necess#r% to c#rr% out the +ro&isions,

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    Pen#ties:

    An% contr#&ention o #n% +ro&ision o the Or!er

    sh# $e +unish#$e in #ccor!#nce @ith the

    +ro&ision o the Essenti# Co''o!ities Act,

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    Pow! to "#$%t &n'D()&t*on o+ Pow!

    The Centr# Go&ern'ent un!er s+eci# con!itions"

    '#% e-e'+t #n% '#nu#cturer ro' the o+er#tion

    #ter t#?ing into consi!er#tion #ctors i?e" c#+it# in&este!"

    nu'$er o @or?ers e'+o%e!"

    s#es turno&er"

    t%+es o +ro!ucts '#nu#cture!" +ro!uction o # ne@ !rug #n! in!igenous #n! uni;ue

    +ro!uction.

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