See Full Document Text
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99
vlk/kj.k
EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (ii)
PART II—Section 3—Sub-section (ii)
izkf/dkj ls izdkf'kr
PUBLISHED BY AUTHORITY
la- 1924] ubZ fnYyh] cq/okj] twu 26] 2019@vk"kk<++ 5] 1941
No. 1924] NEW DELHI, WEDNESDAY, JUNE 26, 2019/ ASHADHA 5, 1941
jlk;u vkSj moZjd ea=ky;
¼vkS"k/k foHkkx½
¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½
vkns'k
ub Z fnYyh] 26 tuw ] 2019
dk-vk-2136¼v½-&Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 eb]Z 2013
vkSj dk0 vk0 701¼v½ rkjh[k 10 ekp]Z 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 4] 6] 10] 11] 14] 16]
17 vkSj 18 }kjk iznRr 'kfDr;ksa dk i;z kxs djr s g,q ] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftl s laf{kIr :i l s ,uihih,
dgk tkrk g½S uhp s dh lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher dk s mDr lkj.kh d s LrHa k ¼3½ vkSj ¼4½ e sa Øe“k%
rRLFkkuh ifzof"V;k sa e sa fofufn"ZV [kqjkd :i ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa
fofufn"ZV vuqlwfpr fofufeZfr;ksa e sa l s iRz ;ds dh] oLr q ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s :i e sa
fu;r djrh gS%
lkj.kh
Ø-l-a vuqlwfpr fofufeZfr dk uke [kqjkd :i ,o a icz yrk bdkb Z vf/kdre
dher ¼#-½
¼1½ ¼2½ ¼3½ ¼4½ ¼5½
1- vkbcZ iw zkQs us dSIlyw 200 fexzk- 1 lkWQV~ 2-62
tys fsVu dSIlyw
uksV %
¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gk½sa l s
vf/kd dher ij vuqlwfpr fofufeZfr;k sa d s czkMa Ms ;k tsufsjd ;k nkus ksa :ikra jk sa dk s cps jgs vuqlwfpr fofufefZr;k sa d s lHkh
fofuekZrk] mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gks½a l s vf/kd lHkh ,slh
fofufeZr;k sa dh dher dk v/kkes q[kh iuq jh{k.k djsaxsA
3119 GI/2019 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
¼[k½ lHkh ekStnw k fuekZrkvk sa dks mi;qZDr dfFkr vulq wfpr fofufefZr;k sa d s vf/kdre [knq jk dher mi;qZDr lkj.kh d s LrHa k ¼5½
e sa fofufn"ZV vf/kdre dher oLr q ,o a lsok dj lfgr l s de gS rk]s tgk a dgh Hkh ykx w gk]s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013
d s iSjkxzkQ 13¼2½ d s vuqlkj mldk s ekStnw k vf/kdre [knq jk dher dk s cuk, j[kuk gkxs kA
¼x½ vxj fuekZrkvksa u s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k
;g n;s gS rk s o s oLr q ,o a lsok dj dk s tkMs + ldr s gSAa
¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuks a d s rgr lEcfU/kr fuekZrkvk sa dk s mi;qZDr lkj.kh
d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlwfpr fofufeZfr;ks a d s iSdk sa d s fy, vf/kdre dher fu/kkZfjr djAsa
fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V e sa vf/klpw uk dh rkjh[k l s vkbiZ hMh,e,l d s
ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vkS"kf/k fu;a=dksa vkSj fofuekZrk forjdksa dk s
tkjh djsaA
¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s 24 ¼4½ d s mic/a kk sa d s vuqlkj iRz ;ds QVq dj foØsrk vkSj forjd fofuekZrk }kjk
fn, x, :i e sa ,sl s ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke“kZ d s bPNdq fdlh O;fDr d s fy,
igpqa vklku gk]s ogk a mld s fdlh lgtn“` ; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia nz f“kZr djxs kA
¼p½ mi;qZDr lkj.kh e sa ;Fkk fofufn"ZV [knq jk ;k icz yrk ;k nksuka s d s lkFk vuqlwfpr fofufeZfr dk dkbs Z ekStnw k fofuekZrk
vkS"k/k eYw ; fu;=.a k vkns“k] 2013 d s iSjk 2¼;½w d s vuqlkj dkbs Z ubZ vkS"kf/k dk s ykpa djrk gS rk s ,l ss ekStnw k fofuekZrk dks
vkS"k/k ¼eYw ; fu;a=.k½ vkns“k 2013 dh vulpqw h&II d s varxZr ;Fkk fofufn"ZV Qke&Z I e sa ,uihih, dk s ,slh ub Z vkS"kf/k d s eYw ;
iwo Z vueq kns u gsr q vkons u djuk gkxs kA
¼N½ mi;DqZ r vuqlfwpr fofufefZr;ks a dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvksa dk s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k]
2013 d s lpw h II d s QkWe Z III dk s vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djsxkA
mi;qZDr vuqlwfpr fofufeZfr;k sa d s fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNdq gk s rk s bldh lpw uk ,uihih, dk s
voxr djk;xs kA bld s lEcU/k e sa vxj vuqlwfpr fofufefZr;ksa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn
dju s dh frfFk l s N% eghu s igy s lpw h II d s QkWe Z IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA
¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh e sa n'kk;Z s vf/kdre ewY; vkSj 'krks± dk ikyu ugh a djrh g Sa rk s o s
vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek
dju s d s fy, nk;h gksaxsA
¼>½ bl vkn's k e sa mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV ,slh fofufeZfr;k sa d s iSdk sa dh vf/kdre
dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre ;k [knq jk eYw ; fu/kkZfjr vkn's k ;fn dkbs Z gk]s tk s fd bl vkn's k l s iwo Z tkjh g,q
gS] Lor% gh vf/kØe.k gk s tk;xsa sA
[dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-II ]
izlus thr nkl] lgk;d fun's kd
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 26th June, 2019
S.O. 2136(E).—In exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs
(Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March,
2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical
Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) of the table herein
below as ceiling price exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulations
specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified
respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl. No. Name of the Scheduled Dosage form & Strength Unit Ceiling Price
Formulation (Rs.)
(1) (2) (3) (4) (5)
1. Ibuprofen Capsule 200mg 1 soft gelatin 2.62
Capsule¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3
Note:
(a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled
formulations at a price higher than the ceiling price (plus goods and services tax as applicable) so fixed and
notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling
price specified in column (5) in the above table plus goods and services tax as applicable, if any.
(b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling
price specified in column (5) in the above table plus goods and services tax as applicable, if any, shall continue to
maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the
Government on the ceiling price mentioned in column (5) of the above said table.
(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in
accordance with the ceiling price specified in column (5) of the above table as per provisions contained in
paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from
date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State
Drug Controller and dealers.
(e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list,
if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a
manner so as to be easily accessible to any person wishing to consult the same.
(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above
table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for
prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.
(g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of
production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through
IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish
information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in
Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
(h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit
the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013
read with Essential Commodities Act, 1955.
(i) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this
notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of
notification, stand(s) superseded.
[PN/200/68/2019/F/F. No. 8(68)/2019/D.P./NPPA-Div.-II]
PRASENJIT DAS, Assistant Director
vkns'k
ub Z fnYyh] 26 tuw ] 2019
dk-vk- 2137¼v½-&vkS"k/k foHkkx }kjk vkS"k/k ¼ewY; fu;a=.k½] 2013 d s iSjk 31 d s varxZr ikfjr ble sa uhp s lkj.kh d s
LrHa k ¼6½ e sa fofufn"ZV vkns“kk s d s }kjk tkjh iuq foyZ kds u vkns“kk s d s lna Hk Z e sa fn; s x, funsZ“kk sa d s dk;kUZo;u e sa vkSj Hkkjr
ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk- vk- 701¼v½ rkjh[k
10 ekp]Z 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns“k] 2013 d s iSjk 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk inz Rr
“kfDr;k sa dk i;z ksx djr s g,q vkSj lkj.kh d s LrHa k ¼7½ e sa fofufn"ZV Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky;] ¼jk"Vªh;
vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k½ d s vkns“kk sa d s vf/kØe.k e]sa tgk¡ rd mldk lEcU/k uhp s dh lkj.kh d s fofufefZr iSdk sa l s gS]
mu ckrk sa d s flok;] vf/kØkUr djr s g,q ftUg sa ,sl s vf/kØe.k d s iow Z fd;k x;k gS ;k dju s dk ykis fd;k x;k g]S jk"Vªh;
vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s laf{kIr :Ik es a ,uihih, dgk tkrk gS½ uhp s dh lkj.kh d s LrHa k ¼5½ esa fofufn"ZV
vf/kdre dher dk s mDr lkj.kh d s LrHa k ¼3½ vkSj ¼4½ e sa Øe“k% rRLFkkuh ifzof"V;k sa e sa fofufn"ZV [kqjkd :Ik ,o a icz yrk vkSj
bdkb Z lfgr ml lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa fofufn"ZV vuqlfwpr fofufeZfr;ks a esa l s iRz ;ds ij ykx w oLrq
,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s :Ik e sa fu;r djrh gS%4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
lkj.kh
Ø- vuqlwfpr [kqjkd :Ik ,o a bdkb Z vf/kdre iuq foyZ kds u vkns“k l-a ekStnw k dk- vk- l-a ,o a
l-a fofufeZfr dk icz yrk dher ,o a rkjh[k rkjh[k
uke ¼#-½
¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ ¼7½
1- fVVul bta Ds “ku ifzr iSd 10-61 31015@46@2018- eYw ; 1485¼v½ fnukda
VkWDlkWbM ¼0-5 fefy-½ fu/kkZj.k rkjh[k 19-03- 29-03-2019
2019 ¼Ø-l-a 795½
2- fVVul bta Ds “ku ifzr iSd 22-94 31015@46@2018- eYw ; 1485¼v½ fnukda
VkWDlkWbM ¼5 fefy-½ fu/kkZj.k rkjh[k 19-03- 29-03-2019
2019 ¼Ø-l-a 796½
uksV %
¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gk½sa l s
vf/kd dher ij vuqlwfpr fofufeZfr;k sa d s czkMa Ms ;k tsufsjd ;k nkus ksa :ikra jk sa dk s cps jgs vuqlwfpr fofufefZr;k sa d s lHkh
fofuekZrk] mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gks½a l s vf/kd lHkh ,slh
fofufeZfr;k sa dh dher dk v/kkse[q kh l“a kk/s ku djsxa sA
¼[k½ mi;qZDr lkj.kh ¼/ku oLr q ,o a lsok dj] tk s ykx w gS] ;fn dkbs Z gS½ d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre eYw ; dh vi{s kk de
[knq jk ewY; okyh Åij of.kZr vuqlwfpr fofufefZr;ks a d s lHkh ekStnw k fofuekZrk Mhihlhvk]s 2013 d s iSjk 13¼2½ d s vuqlkj oLr q
,o a lsok dj d s dk;kUZ o;u ij mRikn “kYq d vkSj djk sa d s varj d s dkj.k vf/kdre [knq jk ewY; e sa gbq Z of`)+ d s vykok ekStnw k
vf/kdre [knq jk ewY; dk s fujarj cuk, j[kxsa sA
¼x½ vxj fuekZrkvksa u s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k
;g n;s gS rk s o s oLr q ,o a lsok dj dk s tkMs + ldr s gSAa
¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuks a d s rgr lEcfU/kr fuekZrkvk sa dk s mi;qZDr lkj.kh
d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlwfpr fofufeZfr;ks a d s iSdk sa d s fy, vf/kdre dher fu/kkZfjr djAsa
fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V e sa vf/klpw uk dh rkjh[k l s vkbiZ hMh,e,l d s
ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vkS"kf/k fu;a=dksa vkSj fofuekZrk forjdksa dk s
tkjh djsaA
¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s 24 ¼4½ d s mic/a kk sa d s vuqlkj iRz ;ds QVq dj foØsrk vkSj forjd fofuekZrk }kjk
fn, x, :i e sa ,sl s ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke“kZ d s bPNdq fdlh O;fDr d s fy,
igpqa vklku gk]s ogk a mld s fdlh lgtn“` ; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia nz f’kZr djxs kA
¼p½ mi;DqZ r lkj.kh ds LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vuqlfwpr fofufeZfr;ks a d s fofufn"ZV fofHkUu
rjhd s vkSj icz yrk l s fHkUu vxj ekStnw k fuekZrkvk sa }kjk ,d ub Z vkS"kf/k dk s ykpa djrk gS rk s ml s igy s vkS"k/k ¼eYw ; fu;a=.k½
vkn's k] 2013 d s iSjkxzkQ 2¼;½w d s vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s rgr lpw h II e sa fofufn"ZV Qke Z I d s ek/;e
l s ,uihih, e sa eYw ; fu/kkZj.k gsr q vkons u djuk gkxs kA
¼N½ mi;DqZ r vuqlfwpr fofufefZr;ks a dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvks a dk s vkS"k/k ¼eYw ; fu;=a .k½ vkn's k]
2013 d s lpw h II d s QkWe Z III dk s vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjiksV Z izLrqr djxs kA
mi;qZDr vuqlwfpr fofufeZfr;k sa d s fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNdq gk s rk s bldh lpw uk ,uihih, dk s
voxr djk;xs kA bld s lEcU/k e sa vxj vuqlwfpr fofufefZr;ksa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn
dju s dh frfFk l s N% eghu s igy s lpw h II d s QkWe Z IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA
¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh e sa n'kk;Z s vf/kdre ewY; vkSj 'krks± dk ikyu ugh a djrh g Sa rk s o s
vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek
dju s d s fy, nk;h gksaxsA
¼>½ fufeZr fdlh Hkh vU; iSd vkdkj ds fy, fuekZrk vf/kdre dher r; dju s d s fy, fof/kor iez k.khd`r izklfaxd cktkj
MsVk d s lkFk viuh fofufefZr ds fy, fof“k"V ewY; vueq kns u ds fy, ,uihih, l s lia d Z djxs kA
¼.k½ bl vkn's k e sa mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V es a fofufn"ZV ,slh fofufeZfr;k as d s iSdk sa dh vf/kdre
dher fu;r gksu s d s ifj.kkeLo:i] vf/kdre ;k [kqnjk eYw ; fu/kkZfjr vkn's k ;fn dkbs Z gk]s tk s fd bl vkn's k l s iwo Z tkjh gq,
gS] Lor% gh vf/kØe.k gk s tk;xsa sA
[dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-II]
izlus thr nkl] lgk;d fun's kd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5
ORDER
New Delhi, the 26th June, 2019
S.O.2137(E).—In implementation of directions given in line with review orders issued by the Department of
Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of
Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and in exercise of the powers conferred by
paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the
30th May, 2013 and S.O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of
Chemicals and Fertilizers, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals
and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table regarding
formulation specified as mentioned in the table in so far as it relates to formulation pack mentioned in the table below,
except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing
Authority, hereby fixes/revises the price as specified in column (5) of the table herein below as ceiling price exclusive of
goods and services tax applicable, if any, in respect of the Scheduled formulation(s) specified in the corresponding entry
in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding
entries in columns (3) and (4) thereof:
TABLE
Sl. Name of the Dosage form Unit Ceiling Review Order number Existing SO
No. Scheduled & Strength Price and date number and date
Formulation (Rs.)
(1) (2) (3) (4) (5) (6) (7)
1. Tetanus Toxoid Injection Each Pack 10.61 31015/46/2018-Pricing 1485(E) dated
(0.5ML) dated 19.03.2019 29.03.2019
(at Sl. No. 795)
2. Tetanus Toxoid Injection Each Pack 22.94 31015/46/2018-Pricing 1485(E) dated
(5ML) dated 19.03.2019 29.03.2019
(at Sl. No. 796)
Note:
(a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled
formulations at a price higher than the ceiling price (plus goods and services tax as applicable) so fixed and notified
by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price
specified in column (5) in the above table plus goods and services tax as applicable, if any.
(b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price
specified in column (5) in the above table plus goods and services tax as applicable, if any, shall continue to
maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the
Government on the ceiling price mentioned in column (5) of the above said table.
(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in
accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph
11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from date of
Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug
Controller and dealers.
(e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if
any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a
manner so as to be easily accessible to any person wishing to consult the same.
(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above
table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior
price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.
(g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of
production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through
IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish
information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in
Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
(h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the
overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read
with Essential Commodities Act, 1955.
(i) For any other pack size manufactured, the manufacturer shall approach NPPA for specific price approval for
its formulations along with the relevant market data duly authenticated for fixation of the ceiling price.
(j) Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this
notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification,
stand(s) superseded.
[PN/200/68/2019/F/F. No. 8(68)/2019/D.P./NPPA-Div.-II]
PRASENJIT DAS, Assistant Director
vkns'k
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nh xb Z lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV [knq jk eYw ; fu/kkZfjr djxsa sA
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;g n;s gS rk s o s oLr q ,o a lsok dj dk s tkMs + ldr s gSAa
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tk s vuiq kyu djrh gSA
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nk;h gkxsa As
¼N½ bl vkn's k es a mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV fofufeZfr;k sa d s iSdk sa dh [kqnjk eYw ; fu;r
gkus s d s ifj.kkeLo#i] vkn's k tk s fd bl vkn's k l s iow Z tkjh gq, g]S Lor% gh fujLr gk s tk;saxsA
[dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-II]
izlus thr nkl] lgk;d fun's kd
ORDER
New Delhi, the 26th June, 2019
S.O.2138(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the
Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority
(hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail
price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in
column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the
corresponding entries in columns (3), (4) and (5) thereof;
TABLE
Sl. Name of the Strength Unit Manufacturer & Retail
No. Formulation / Marketing Company Price
Brand Name (Rs.)
(1) (2) (3) (4) (5) (6)
1. Tacrolimus Each gm of Ointment contains: M/s Alina Healthcare 30.89
Ointment Tacrolimus IP 1mg (10gm pack) Pvt. Ltd. / M/s Mylan
1gm
(MYLIMUS 0.1% Pharmaceuticals Private
10gm) Limited
2. Tacrolimus Each gm of Ointment contains: M/s Alina Healthcare 30.89
Ointment Tacrolimus IP 1mg (20gm pack) Pvt. Ltd. / M/s Mylan
1gm
(MYLIMUS 0.1% Pharmaceuticals Private
20gm) Limited
3. Amoxycillin + Each 5ml of reconstituted suspension 3.28
Potassium contains: M/s Brooks
Clavulanate Amoxycillin Trihydarte IP eq. to Laboratories Ltd. / M/s
1 ML
Suspension Amoxycillin 400mg, Intas Pharmaceuticals
Potassium Clavulanate Diluted IP eq. Limited
to Clavulanic acid 57mg
4. Metoprolol+ Each film coated tablet contains: 5.58
+ Amlodipine Tablet Metoprolol Succinate IP 23.75mg eq. M/s Windlas Biotech
to Metoprolol Tartrate 25mg, (as 1 Tablet Limited / M/s Abbott
prolonged release form), Healthcare Pvt. Ltd.
Amlodipine Besylate IP eq. to¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9
Amlodipine 5mg.
5. Atorvastatin + Each hard gelatine capsule contains: 16.73
Clopidogrel Capsule Atorvastatin Calcium IP eq. to M/s Synokem
Atorvastatin 20mg (As Pellets), 1 Capsule Pharmaceuticals Ltd. /
Clopidogrel Bisulphate IP eq. to M/s Cipla Limited
Clopidogrel 75mg (As Pellets)
6. Atorvastatin + Each film coated tablet contains: 9.18
Vitamin D3 Tablet Atorvastatin Calcium IP eq. to
M/s Sun Pharma
Atorvastatin 10mg 1 Tablet
Laboratories Limited
Vitamin D3 (Cholecalciferol) IP 1000
IU
7. Atorvastatin + Each film coated tablet contains: 16.12
Vitamin D3 Tablet Atorvastatin Calcium IP eq. to
M/s Sun Pharma
Atorvastatin 20mg 1 Tablet
Laboratories Limited
Vitamin D3 (Cholecalciferol) IP 1000
IU
8. Olmesartan Each film coated tablet contains: 9.65
Medoxomil + Olmesartan Medoxomil IP 20mg
M/s Sun Pharma
Amlodipine + Amlodipine Besylate IP eq. to 1 Tablet
Laboratories Limited
Chlorthalidone Amlodipine 5mg
Tablet Chlorthalidone IP 12.5mg
9. Olmesartan Each film coated tablet contains: 15.83
Medoxomil + Olmesartan Medoxomil IP 40mg,
M/s Sun Pharma
Amlodipine + Amlodipine Besylate IP eq. to 1 Tablet
Laboratories Limited
Chlorthalidone Amlodipine 5mg
Tablet Chlorthalidone IP 12.5mg
10. Rosuvastatin + Each hard gelatin capsule contains: 11.15
Aspirin + Rosuvastatin Calcium IP eq. to
Clopidogrel Capsule Rosuvastatin 10mg (As Film coated M/s Akums Drugs &
Tablet), Pharmaceuticals
Aspirin IP 75mg (As Aspirin Gastro – 1 Capsule Limited / M/s Intas
resistant Tablets) Pharmaceuticals
Clopidogrel Bisulphate IP eq. to Limited
Clopidogrel 75mg (As film coated
tablet)
11. Rosuvastatin + Each hard gelatin capsule contains: 16.82
Aspirin + Rosuvastatin Calcium IP eq. to
Clopidogrel Capsule Rosuvastatin 20mg (As Film coated M/s Akums Drugs &
Tablet), Pharmaceuticals
Aspirin IP 75mg (As Aspirin Gastro – 1 Capsule Limited / M/s Intas
resistant Tablets) Pharmaceuticals
Clopidogrel Bisulphate IP eq. to Limited
Clopidogrel 75mg (As film coated
tablet)
12. Paracetamol + Each 5ml Suspension contains: M/s Tirupati Medicare 0.63
Mefenamic Acid Paracetamol IP 250mg Limited / M/s Intas
1 ML
Suspension Mefenamic Acid IP 100mg Pharmaceuticals
Limited
13. Clopidogrel + Each film coated tablet contains: 3.48
Aspirin Tablet Clopidogrel Bisulphate IP eq. to M/s Sun Pharma
1 Tablet
Clopidogrel 75mg Laboratories Limited
Aspirin IP (As enteric coated) 75mg
14.. Clopidogrel + Each film coated tablet contains: M/s Sun Pharma 3.55
Aspirin Tablet Clopidogrel Bisulphate IP eq. to 1 Tablet Laboratories Limited
Clopidogrel 75mg10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Aspirin IP (As enteric coated) 150mg
Note:
(a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013
shall fix the retail price as specified in column (6) of the table hereinabove.
(b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the
Government on the retail price mentioned in column (6) of the above said table.
(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in
accordance with the retail price specified in column (6) of the above table as per provisions contained in
paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification
as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller
and dealers.
(d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price
list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business
in a manner so as to be easily accessible to any person wishing to consult the same.
(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned
above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under
DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt.
under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the
Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.
(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification
and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit
the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this
notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of
notification, stand(s) superseded.
[PN/200/68/2019/F/F. No. 8(68)/2019/D.P./NPPA-Div.-II]
PRASENJIT DAS, Assistant Director
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.