7485 GI/2018

(1)

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- 5013]

ubZ fnYyh] 'kqØokj] fnlEcj 21] 2018@vxzgk;.k 30] 1940

No. 5013]

NEW DELHI, FRIDAY, DECEMBER 21, 2018/AGRAHAYANA 30, 1940

jlk;u vkSj moZjd ea=ky;

¼vkS"k/k foHkkx½

¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½

vkns’k

ubZ fnYyh] 21 fnlEcj] 2018

dk-vk- 6252¼v½-—vkS"k/k foHkkx }kjk vkS”k/k ¼ewY; fu;a=.k½] 2013 ds iSjk 31 ds varxZr ikfjr

blesa uhps lkj.kh ds LraHk ¼6½ esa fofufnZ”V vkns’kksa ds }kjk tkjh iqufoZyksdu vkns’kksa ds lanHkZ esa fn;s

x, funsZ’kksa ds dk;kZUo;u esa vkSj Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk-

1394¼v½ rkjh[k 30 ebZ] 2013 vkSj dk0 vk0 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS”k/k ¼dher

fu;a=.k½ vkns’k] 2013 ds iSjk 4, 6, 10, 11, 14, 16, 17 vkSj 18 }kjk iznRr ‘kfDr;ksa dk iz;ksx djrs gq,

vkSj lkj.kh ds LraHk ¼7½ esa fofufnZ”V Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky;] (jk”Vªh; vkS”k/k ewY;

fu/kkZj.k izkf/kdj.k) ds vkns’kksa ds vf/kdze.k esa] tgk¡ rd mldk lEcU/k uhps dh lkj.kh ds fofufeZfr

iSdksa ls gS] mu ckrksa ds flok;] vf/kØkUr djrs gq, ftUgsa ,sls vf/kØe.k ds iwoZ fd;k x;k gS ;k djus

dk yksi fd;k x;k gS] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk

tkrk gS½ uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ”V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj

¼4½ esa Øe’k% rRLFkkuh izfof”V;ksa esa fofufnZ”V [kqjkd :i ,oa izcyrk vkSj bdkbZ lfgr ml lkj.kh ds

LraHk ¼2½ esa dh rRLFkkuh izfof”V esa fofufnZ”V vuqlwfpr fofufeZfr;ksa esa ls izR;sd ij ykxw oLrq ,oa lsok

dj] ;fn dksbZ gS] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gS%

lkj.kh

dz-

la-

vuqlwfpr

fofufeZfr dk

uke

[kqjkd :i

,oa izcyrk

bdkbZ

vf/kdre

dher

¼#-½

iqufoZyksdu vkns’k

la- ,oa rkjh[k

ekStwnk dk- vk- la-

,oa rkjh[k

(1)

(2)

(3)

(4)

(5)

(6)

(7)

1.

ikWfoMu vk;ksMhu lksyq'ku 10%

1 fefy-

0.87

31015/24/2018-

ewY; fu/kkZj.k dh

rkjh[k 08.10.2018

1461(v) fnukad

02.04.2018

(at Sl. No. 662)

2

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEC. 3(ii)]

uksV %

¼d½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku oLrq ,oa lsok

dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufeZfr;ksa ds czkaMsM ;k tsusfjd ;k nksuksa :ikarjksa dks

csp jgs vuqlwfpr fofufeZfr;ksa ds lHkh fofuekZrk] mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vf/kdre dher

¼/ku oLrq ,oa lsok dj] tks ykxw gksa½ ls vf/kd lHkh ,slh fofufeZr;ksa dh dher dk v/kkseq[kh la’kks/ku

djsaxsA

¼[k½ mi;qZDr lkj.kh ¼/ku oLrq ,oa lsok dj] tks ykxw gS] ;fn dksbZ gS½ ds LraHk ¼5½ esa fofufnZ”V

vf/kdre ewY; dh vis{kk de [kqnjk ewY; okyh Åij of.kZr vuqlwfpr fofufeZfr;ksa ds lHkh ekStwnk

fofuekZrk Mhihlhvks] 2013 ds iSjk 13¼2½ ds vuqlkj oLrq ,oa lsok dj ds dk;kZUo;u ij mRikn ‘kqYd

vkSj djksa ds varj ds dkj.k vf/kdre [kqnjk ewY; esa gqbZ o`f) ds vykok ekStwnk vf/kdre [kqnjk ewY;

dks fujarj cuk, j[ksaxsA

¼x½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa

Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA

¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr lEcfU/kr

fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr

fofufeZfr;ksa ds iSdksa ds fy, vf/kdre dher fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013

ds iSjkxzkQ 24 ds rgr QkWeZ&V esa vf/klwpuk dh rkjh[k ls vkbZihMh,e,l ds ek/;e ls Hkjdj

,uihih, dks ,d ewY; lwph tkjh djsa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dksa vkSj fofuekZrk forjdksa

dks tkjh djsaA

¼M+½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj

forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjksckj dks bl izdkj fd;k tk jgk gS fd

mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij

dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkA

¼p½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa

ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap

djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼;w½ ds vuqlkj vkS"k/k ¼ewY;

fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq

vkosnu djuk gksxkA

¼N½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa fuekZrkvksa dks vkS"k/k

¼ewY; fu;a=.k½ vkns'k] 2013 ds lwph II ds QkWeZ III dks vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih,

dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr vuqlwfpr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk

mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcU/k esa vxj

vuqlwfpr fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N%

eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA

¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vf/kdre ewY; vkSj 'krks± dk ikyu

ugha djrh gSa rks os vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuksa ds

v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA

¼>½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V ,slh fofufeZfr;ksa ds

iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo:i] vf/kdre ;k [kqnjk ewY; fu/kkZfjr vkns'k ;fn

dksbZ gks] tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk,axsA

[dka- la-@193@61@2018@,Q@Qk- la- 8¼61½@2018@Mhih@,uihih,&fMoh-II]

cythr flag] lgk;d funs'kd

¹Hkkx IIµ[k.M 3(ii)º

Hkkjr dk jkti=k % vlk/kj.k

3

MINISTRY OF CHEMICALS AND FERTILIZERS

(Department of Pharmaceuticals)

(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)

ORDER

New Delhi, the 21st December, 2018

S.O. 6252(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 in 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

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.

Sl.

No.

Name of the

Scheduled

Formulation

Dosage form

& Strength

Unit

Ceiling

Price

(Rs.)

Review Order

number and date

Existing SO number

and date

(1)

(2)

(3)

(4)

(5)

(6)

(7)

1.

Povidone Iodine

Solution 10%

1 ml

0.87

31015/24/2018-

Pricing dated

08.10.2018

1461(E) dated

02.04.2018

(at Sl. No. 662)

4

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEC. 3(ii)]

(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 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/193/61/2018/F /F. No. 8(61)/2018/D.P./NPPA-Div.-II]

BALJIT SINGH, Asstt. Director

vkns’k

ubZ fnYyh] 21 fnlEcj] 2018

dk-vk- 6253¼v½-—Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k

30 ebZ] 2013 vkSj dk-vk- 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds

iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks

laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼6½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds

LraHk ¼3½] ¼4½] vkSj ¼5½ eas rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk] bdkbZ ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku

dEifu;ksa ds uke lfgr LraHk ¼2½ esa dh rRLFkkuh izfof"V esa ls izR;sd dh] oLrq ,oa lsok dj] ;fn dksbZ gS] dks

NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA

lkj.kh

dz-

la-

vuqlwfpr fofufeZfr dk

uke@czkaM dk uke

izcyrk

bdkbZ

fofuekZrk vkSj foi.ku

daiuh

[kqnjk

ewY; ¼#-½

(1)

(2)

(3)

(4)

(5)

(6)

1.

VsyfelkVZu $

,eyksfMfiu $

gkbMªksDyksjFkkbtkbM

xksyh

¼VsyfejkbM&,,e,p½

izR;sd fQYe fyfir fcys;MZ xksyh esa%

VsyfelkVZu vkbZih 40 fexzk-]

,eyksfMfiu fclkbysV vkbZih ds cjkcj

,eyksfMfiu 5 fexzk-]

gkbMªksDyksjFkkbtkbM vkbZih 12-50 xksyh

1 xksyh

eSllZ ;wuhlu

QkekZL;wfVdYl izk- fy-

3.21

2.

VsyfelkVZu $

esVksizksyksy xksyh

¼VsyfejkbM&,eVh 25½

izR;sd vfyfir fcys;MZ xksyh esa%

VsyfelkVZu vkbZih 40 fexzk-]

esVksizksyksy lqLlkbusV vkbZih 23-75 fexzk-

ds cjkcj esVksizksyksy VkjVªsV vkbZih 25

fexzk- ¼,DlVsaMsM fjfyt esa½

1 xksyh

eSllZ ;wuhlu

QkekZL;wfVdYl izk- fy-

3.13

3.

VsyfelkVZu $

esVksizksyksy xksyh

¼VsyfejkbM&,eVh 50½

izR;sd vfyfir fcys;MZ xksyh esa%

VsyfelkVZu vkbZih 40 fexzk-]

esVksizksyksy lqLlkbusV vkbZih 47-50 fexzk-

ds cjkcj esVksizksyksy VkjVªsV vkbZih 50

fexzk- ¼,DlVsaMsM fjfyt esa½

1 xksyh

eSllZ ;wuhlu

QkekZL;wfVdYl izk- fy-

3.57

4.

vksesizktksy $

MkseisjhMksu dSIlwy

¼vksts,lvks,u&Mh½

izR;sd gkMZ tsysVkbu dSIlwy esa%

vksesizktksy 20 fexzk- ¼buVsfjd fyfir

isysVl esa½

MkseisjhMksu vkbZih 10 fexzk- ¼fyfir

isysVl esa½ dSIlwy

1 dSIlwy

eSllZ ;wuhlu

QkekZL;wfVdYl izk- fy-

1.79

¹Hkkx IIµ[k.M 3(ii)º

Hkkjr dk jkti=k % vlk/kj.k

5

5.

ysehoqMkbu $

VsuksQksohj $

MksyqxsVªohj xksyh

¼fMyVªk½

izR;sd fQYe fyfir xksyh esa%

ysehoqMkbu vkbZih 300 fexzk-]

VsuksQksohj fMlksizkDlhy QqekjsV vkbZih

300 fexzk-]

MksyqxsVªohj lksfM;e ds cjkcj MksyqxsVªohj

50 fexzk-

1 xksyh

eSllZ vkSjksfcaMks QkekZ fy-

114.06

6.

esVQksfeZu $

fi;ksXyhVktksu xksyh

izR;sd vfyfir xksyh esa%

esVQksfeZu gkbMªksDyksjkbM vkbZih 1000

fexzk- ¼lLVsaM fjfyt QkWeZ esa½]

fi;ksXyhVktksu gkbMªksDyksjkbM vkbZih ds

cjkcj fi;ksXyhVktksu 15 fexzk-

1 xksyh

eSllZ ,jhl ykbQlkbal

9.04

7.

DyhuhfMikbu $

esVksizksyksy xksyh

izR;sd fQYe fyfir fcys;MZ xksyh esa%

DyhuhfMikbu vkbZih 10 fexzk-]

esVksizksyksy lDlhusV vkbZih 23-75 fexzk-

ds cjkcj esVksizksyksy VkjVªsV 25 fexzk-

¼izksyksxsM fjfyt QkWeZ esa½

1 xksyh

eSllZ lQsVc ykbQ

lkbal@eSllZ ,tark QkekZ

fy-

6.79

8.

DyhuhfMikbu $

esVksizksyksy xksyh

izR;sd fQYe fyfir fcys;MZ xksyh esa%

DyhuhfMikbu vkbZih 10 fexzk-]

esVksizksyksy lDlhusV vkbZih 47-50 fexzk-

ds cjkcj esVksizksyksy VkjVªsV 50 fexzk-

¼izksyksxsM fjfyt QkWeZ esa½

1 xksyh

eSllZ lQsVc ykbQ

lkbal@eSllZ ,tark QkekZ

fy-

8.19

9.

jkstqokLVkfVu $

,fLifju $ DyksfiMksxzsy

dSIlwy

izR;sd gkMZ tsysVkbu dSIlwy esa%

jkstqokLVkfVu dSfY’k;e vkbZih ds cjkcj

jkstqokLVkfVu 20 fexzk- ¼isysVl esa½]

,fLifju vkbZih 75 fexzk- ¼,uVsfjd

fyfir isysVl esa½ DyksfiMksxzsy ckbZlYQsV

vkbZih ds cjkcj DyksfiMksxzsy 75 fexzk-

¼isysVl esa½

1 dSIlwy

eSllZ lk;uksdse

QkekZL;wfVdYl fy-@eSllZ

ekbØks yScl fy-

17.88

10.

jkstqokLVkfVu $

,fLifju $ DyksfiMksxzsy

dSIlwy

izR;sd gkMZ tsysVkbu dSIlwy esa%

jkstqokLVkfVu dSfY’k;e vkbZih ds cjkcj

jkstqokLVkfVu 20 fexzk- ¼isysVl esa½]

,fLifju vkbZih 75 fexzk- ¼,uVsfjd

fyfir isysVl esa½ DyksfiMksxzsy ckbZlYQsV

vkbZih ds cjkcj DyksfiMksxzsy 75 fexzk-

¼isysVl esa½

1 dSIlwy

eSllZ lk;uksdse

QkekZL;wfVdYl fy-@eSllZ

ekbØks yScl fy-

11.46

11.

blhVkyksizke $

Dyksuktsike xksyh

¼jslhVk ,yMh½

izR;sd fQYe fyfir xksyh esa%

blhVkyksizke vksDlkysV ds cjkcj

blhVkyksizke 5 fexzk-]

Dyksuktsike vkbZ 0-25 fexzk-

1 xksyh

eSllZ vkbZihlh,

yscksjsVjht fy-

5.88

12.

XyhesihjkbM $

fi;ksXyhVktksu xksyh

izR;sd vfyfir xksyh esa%

XyhesihjkbM vkbZih 1 fexzk-]

fi;ksXyhVktksu gkbMªksDyksjkbM vkbZih ds

cjkcj fi;ksXyhVktksu 15 fexzk-

1 xksyh

eSllZ foaMykl ck;ksVsd izk-

fy-@eSllZ yqfiu fy-

6.38

13.

XyhesihjkbM $

fi;ksXyhVktksu xksyh

izR;sd vfyfir xksyh esa%

XyhesihjkbM vkbZih 2 fexzk-]

fi;ksXyhVktksu gkbMªksDyksjkbM vkbZih ds

cjkcj fi;ksXyhVktksu 15 fexzk-

1 xksyh

eSllZ foaMykl ck;ksVsd izk-

fy-@eSllZ yqfiu fy-

8.20

14.

fMDyksQsud $

lsjkfV;ksiks,VhMkl

xksyh ¼fMDyksVky ,l½

izR;sd ,uVsfjd fyfir xksyh esa%

fMDyksQsud lksfM;e vkbZih 50 fexzk-]

lsjkfV;ksiks,VhMkl vkbZih 10 fexzk- ds

cjkcj 20000 ,utkbeh ,DVhohVh ;wfuVl

vkWQ lsjkfV;ksiks,VhMkl

1 xksyh

eSllZ ,dEl MªXl ,aM

QkekZL;wfVdYl fy-@eSllZ

Cyw Øksl yscksjsVjht izk-

fy-

5.00

15.

,eksDlhflYyhu $

DykoqysuV ,flM

lLisa’ku

izR;sd dkWEchiSd esa%

¼d½ ou cksVy vkWQ ,eksDlhflYyhu ,aM

iksVsf’k;e DykoqysuV vksjy lLisa’ku

vkbZih izR;sd 5 fefy- vkWQ fjdalfVVwM

lLisa’ku esa%

,eksDlhflYyhu VªhgkbMªsV vkbZih ds

cjkcj ,eksDlhflYyhu 400 fexzk-]

iksVsf’k;e DykoqysuV fMyqfVM vkbZih ds

1 fefy-

eSllZ efyd ykbQ

lkbaflt fy-@eSllZ

oksdgkMZV fy-

3.28

6

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEC. 3(ii)]

cjkcj DykoqysuV ,flM 57 fexzk-]

¼[k½ ou ok;y vkWQ LVhfjy okWVj QkWj

batsD’ku vkbZih izR;sd ok;y esa%

LVhfjy okWVj QkWj batsD’ku vkbZih 30

fefy-

16.

isjkflVkeksy $

QsuhysQjhu $ dSQhu

$ fMQsugkMªkekbu

xksyh

¼useks&dksYM&,u,Q½

izR;sd vfyfir xksyh esa%

isjkflVkeksy vkbZih 500 fexzk-]

QsuhysQjhu gkbMªksDyksjkbM vkbZih 5

fexzk-]

dSQhu ¼,ugkbMªkst½ vkbZih 30 fexzk-]

fMQsugkMªkekbu gkbMªksDyksjkbM vkbZih 25

fexzk-

1 xksyh

eSllZ lselu yscksjsVjht

izk-fy-@eSllZ xYQk

yscksjsVjht fy-

2.70

17.

MsDykVklohj $

lksQkscqohj xksyh

izR;sd fQYe fyfir xksyh esa%

MsDykVklohj fMgkbMªksDyksjkbM ds cjkcj

MsDykVklohj 60 fexzk-]

lksQkscqohj 400 fexzk-

1 xksyh

eSllZ eSllZ ukVdks QkekZ

fy-@eSllZ ,izktj

gsYFkds;j izk- fy-

556.442

18.

dksyhu lSfyflysV

lksyq’ku $

csutkydksfu;e

DyksjkbM lksyq’ku $

fyXuksdsu

gkbMªksDyksjkbM tsy

¼myQzh tsy½

dksyhu lSfyflysV lksyq’ku ch-ih- ds

cjkcj dksyhu lSfyflysV 8-7%

MCY;w@MCY;w]

csutkydksfu;e DyksjkbM lksyq’ku vkbZih

0001% MCY;w@MCY;w]

fyXuksdsu gkbMªksDyksjkbM vkbZih 2-0

1 xzke

eSllZ xzqi QkekZL;wfVdYl

fy-@eSllZ gsVsjks gsYFkds;j

fy-

4.29

19.

cqfiokdkbu $ QsaVfuy

batSD’ku

izR;sd fefy- esa%

cqfiokdkbu gkbMªksDyksjkbM vkbZih 1-00

fexzk- ds cjkcj bugkbMªkst cqfiokdkbu

gkbMªksDyksjkbM 0-948 fexzk-]

QsaVfuy lkbVªsV vkbZih ds cjkcj QsaVfuy

2-0 ,elhth

20 fefy-

ok;y

eSllZ Vªksbdk

QkekZL;wfVdYl fy-

71.43

20.

cqfiokdkbu $ QsaVfuy

batSD’ku

izR;sd fefy- esa%

cqfiokdkbu gkbMªksDyksjkbM vkbZih 1-25

fexzk- ds cjkcj bugkbMªkst cqfiokdkbu

gkbMªksDyksjkbM 1-185 fexzk-]

QsaVfuy lkbVªsV vkbZih ds cjkcj QsaVfuy

2-0 ,elhth

20 fefy-

ok;y

eSllZ Vªksbdk

QkekZL;wfVdYl fy-

75.89

21.

fMIFkhfj;k VksDlkW;M $

VsVul VksDlkW;M $

fufӯ; MCY;w&ch

ijVqLlhl cYd $ fgc

¼ihvkjih&VhVh½ ¼fgc

ihvkjih dutxVhM

fon dSfj;j izksVhu

VsVul VksDlkW;M½ $

,Y;wfefu;e lkexzh ¼,

13½ ¼,Y;wfefu;e

QkWLQsV tsy ds :i esa½

fFk;ksekjly 0-025

fexzk- ¼bth Qksj½

izR;sd iSd esa%

fMIFkhfj;k VksDlkW;M 20 ,y,Q ¼30

vkbZ;w½]

VsVul VksDlkW;M 7-5 ,y,Q ¼30 vkbZ;w½]

fufӯ; MCY;w&ch ijVqLlhl cYd 10

vkbZvks;w ¼4 vkbZ;w½]

fgc ¼ihvkjih&VhVh½ ¼fgc ihvkjih

dutxVhM fon dSfj;j izksVhu VsVul

VksDlkW;M½ 10 ;wth]

,Y;wfefu;e lkexzh ¼, 13$½ ¼,Y;wfefu;e

QkWLQsV tsy ds :i esa½ 0-25 fexzk-]

fFk;ksekjly 0-025 fexzk-

0-5 fefy-

eSllZ isusfl;k ck;ksVsd fy-

340.15

22.

QkWeksZVsjksy Q~;wejsV $

cqMslksukbM bugsys’ku

lLisa’ku ¼LekVZwyl½

izR;sd 2 fefy- bugsys’ku lLisa’ku esa%

QkWeksZVsjksy Q~;wejsV fMgkbMªsV vkbZih ds

cjkcj QkWeksZVsjksy Q~;wejsV 20 ,elhth]

cqMslksukbM vkbZih 0-5 fexzk- bu ,u

blksVksfud lksyq’ku

2 fefy-

eSllZ ,dEl MªXl ,aM

QkekZL;wfVdYl fy-@eSllZ

XysuekdZ QkekZL;wfVdYl

fy-

36.04

23.

QkWeksZVsjksy Q~;wejsV $

cqMslksukbM bugsys’ku

lLisa’ku ¼LekVZwyl½

izR;sd 2 fefy- bugsys’ku lLisa’ku esa%

QkWeksZVsjksy Q~;wejsV fMgkbMªsV vkbZih ds

cjkcj QkWeksZVsjksy Q~;wejsV 20 ,elhth]

cqMslksukbM vkbZih 1 fexzk- bu ,u

blksVksfud lksyq’ku

2 fefy-

eSllZ ,dEl MªXl ,aM

QkekZL;wfVdYl fy-@eSllZ

XysuekdZ QkekZL;wfVdYl

fy-

42.12

¹Hkkx IIµ[k.M 3(ii)º

Hkkjr dk jkti=k % vlk/kj.k

7

uksV %

¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku ds fofuekZrk vFkkZr tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼;w½ ds

rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA

¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (6) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku

fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA

¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr

lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY;

fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh

rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djsaA

¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd

fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds

bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph]

;fn dksbZ gks] dks laiznf’kZr djsxkA

¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus

vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewY; fu/kkZj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k

Fkk vkSj ljdkj }kjk fu/kkZfjr lHkh ykxw oS/kkfud vko';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds

vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsal eatwjh ds

rgr lacaf/kr fofufeZr [email protected] dEifu;ka tks vuqikyu djrh gSA

¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os

vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr

jkf'k dks tek djus ds fy, nk;h gksaxsA

¼N½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V fofufeZfr;ksa ds iSdksa dh

[kqnjk ewY; fu;r gksus ds ifj.kkeLo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks

tk;saxsA

[dka- la-@193@61@2018@,Q@Qk- la- 8¼61½@2018@Mhih@,uihih,&fMoh-II]

cythr flag] lgk;d funs'kd

ORDER

New Delhi, the 21st December, 2018

S.O. 6253(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.

No.

Name of the

Formulation /

Brand Name

Strength

Unit

Manufacturer &

Marketing Company

Retail

Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

1.

Telmisartan +

Amlodipine +

Hydrochlorthaiazide

Tablets

(Telmiride – AMH)

Each film coated bilayered tablet

contains:

Telmisartan IP 40mg,

Amlodipine Besylate IP eq. to

Amlodipine 5mg,

Hydrochlorthaiazide IP 12.50mg

Tablets

1 Tablet

M/s Unison

Pharmaceuticals Pvt.

Ltd.

3.21

8

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEC. 3(ii)]

2.

Telmisartan +

Metoprolol Tablet

(Telmiride – MT 25)

Each uncoated bilayered tablet

contains:

Telmisartan IP 40mg,

Metoprolol Succinate IP 23.75mg,

eq. to Metoprolol Tartrate IP 25mg

(as Extended Release)

1 Tablet

M/s Unison

Pharmaceuticals Pvt.

Ltd.

3.13

3.

Telmisartan +

Metoprolol Tablet

(Telmiride – MT 50)

Each uncoated bilayered tablet

contains:

Telmisartan IP 40mg,

Metoprolol Succinate IP 47.50mg,

eq. to Metoprolol Tartrate IP 50mg

(as Extended Release)

1 Tablet

M/s Unison

Pharmaceuticals Pvt.

Ltd.

3.57

4.

Omeprazole +

Domperidone

Capsule (OZSON-D)

Each hard gelatin capsule contains:

Omeprazole 20mg (As enteric coated

pellets) +

Domperidone IP 10mg (As coated

pellets) Capsule

1 Capsule

M/s Unison

Pharmaceuticals Pvt.

Ltd.

1.79

5.

(Diltra Tablets)

Lamivudine +

Tenofovir +

Dolugetravir Tablets

Each film coated tablet contains:

Lamivudine IP 300mg,

Tenofovir Disoproxil Fumarate IP

300mg

Dolugetravir Sodium eq. to

Dolutegravir 50mg

1 Tablet

M/s Aurobindo Pharma

Limited

114.06

6.

Metformin +

Pioglitazone Tablet

Each uncoated tablet contains:

Metformin Hydrochloride IP

1000mg (in sustained release form),

Pioglitazone Hydrochloride IP eq. to

Pioglitazone 15mg

1 Tablet

M/s Eris Lifesciences

Ltd.

9.04

7.

Clinidipine +

Metoprolol Tablet

Each Film coated bilayered tablet

contains:

Clinidipine IP 10mg,

Metoprolol Succinate IP 23.75mg eq.

to Metoprolol tartrate 25mg (In

prolonged release form)

1 Tablet

M/s Safetab Life

Science / M/s Ajanta

Pharma Limited

6.79

8.

Clinidipine +

Metoprolol Tablet

Each Film coated bilayered tablet

contains:

Clinidipine IP 10mg,

Metoprolol Succinate IP 47.50mg eq.

to Metoprolol tartrate 50mg (In

prolonged release form)

1 Tablet

M/s Safetab Life

Science / M/s Ajanta

Pharma Limited

8.19

9.

Rosuvastatin +

Aspirin +

Clopidogrel Capsule

Each Hard Gelatine Capsule

contains:

Rosuvastatin Calcium IP eq. to

Rosuvastation 20mg (As pellets)

Aspirin IP 75mg (As enteric coated

pellets)

Clopidogrel Bisulphate IP eq. to

Clopidogrel 75mg (As pellets)

1 Capsule

M/s Synokem

Pharmaceuticals Ltd. /

M/s Micro Labs

Limited

17.88

10.

Rosuvastatin +

Aspirin +

Clopidogrel Capsule

Each Hard Gelatine Capsule

contains:

Rosuvastatin Calcium IP eq. to

Rosuvastation 10mg (As pellets)

Aspirin IP 75mg (As enteric coated

pellets)

Clopidogrel Bisulphate IP eq. to

Clopidogrel 75mg (As pellets)

1 Capsule

M/s Synokem

Pharmaceuticals Ltd. /

M/s Micro Labs

Limited

11.46

¹Hkkx IIµ[k.M 3(ii)º

Hkkjr dk jkti=k % vlk/kj.k

9

11.

Escitalopram +

Clonazepam Tablet

(Recita LD)

Each film coated tablet contains:

Escitalopram Oxalate eq. to

Escitalopram 5mg,

Clonazepam IP 0.25mg

1 Tablet

M/s IPCA Laboratories

Ltd.

5.88

12.

Glimepiride +

Pioglitazone Tablet

Each uncoated tablet contains:

Glimepiride IP 1mg

Pioglitazone Hydrochloride IP eq. to

Pioglitazone 15mg

1 Tablet

M/s Windlas Biotech

Pvt. Ltd. / M/s Lupin

Limited

6.38

13.

Glimepiride +

Pioglitazone Tablet

Each uncoated tablet contains:

Glimepiride IP 2mg

Pioglitazone Hydrochloride IP eq. to

Pioglitazone 15mg

1 Tablet

M/s Windlas Biotech

Pvt. Ltd. / M/s Lupin

Limited

8.20

14.

Diclofenac +

Serratiopeotidase

Tablets

(Diclotal S)

Each enteric coated Tablet Contains:

Diclofenac Sodium IP 50mg,

Serratiopeotidase IP 10mg eq. to

20000 enzyme activity units of

Serratiopeptidase.

1 Tablet

M/s Akums Drugs &

Pharmaceuticals Ltd. /

M/s Blue Cross

Laboratories Pvt. Ltd.

5.00

15.

Amoxycillin +

Clavulanic Acid

Suspension

Each combipack contains:

(a) One bottle of Amoxycillin &

Potassium Clavunate Oral

Suspension L.P.

Each 5ml of reconstituted suspension

contains:

Amoxycillin Trihydrate IP eq. to

Amoxycillin 400mg, Potassium

Clavulante Diluted IP eq. to

Clavulnic Acid 57mg

(b) One vial of Sterile water for

Injection IP Each vail contains:

Sterile water for injection IP 30ml

1 ml

M/s Malik Life

Sciences Ltd. / M/s

Wockhardt Limited

3.28

16.

Paracetamol +

Phenylephrine +

Caffeine +

Diphenhydramine

Tablet (NEMO-

KOLD-NF)

Each uncoated tablet contains:

Paracetamol IP 500mg,

Phenylephrine Hydrochloride IP

5mg,

Caffeine (Anhydrous) IP 30mg,

Diphenhydramine Hydrochloride IP

25mg

1 Tablet

M/s Samson

Laboratories Pvt. Ltd. /

M/s Galpha

Laboratories Limited

2.70

17.

Daclatasvir +

Sofosbuvir Tablet

Each film coated tablet contains:

Daclatasvir Dihydrochloride eq. to

Daclatasvir 60mg,

Sofosbuvir 400mg

1 Tablet

M/s Natco Pharma Ltd.

/ M/s Aprazer

Healthcare Pvt. Ltd.

556.442

18.

Choline Salicylate

Solution +

Benzalkonium

Chloride Solution +

Lignocaine

Hydrochloride Gel

(ULFREE Gel)

Choline Salicylate Solution B.P. eq.

to Choline Salicylate 8.7% w/w,

Benzalkonium Chloride Solution IP

0001% w/w,

Lignocaine Hydrochloride IP 2.0%

w/w

1 GM

M/s Group

Pharmaceuticals

Limited / M/s Hetero

Healthcare Ltd.

4.29

19.

Bupivacaine +

Fentanyl Injection

Each ml Contains:

Bupivacaine Hydrochloride IP

1.00mg eq. to anyhydrous

Bupivacaine Hydrochloride

0.948mg,

Fentanyl Citrate IP eq. to Fentanyl

2.0mcg

20 ML

Vial

M/s Troikaa

Pharmaceuticals Ltd.

71.43

10

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEC. 3(ii)]

20.

Bupivacaine +

Fentanyl Injection

Each ml Contains:

Bupivacaine Hydrochloride IP

1.25mg eq. to anyhydrous

Bupivacaine Hydrochloride

1.185mg,

Fentanyl Citrate IP eq. to Fentanyl

2.0mcg

20 ML

Vial

M/s Troikaa

Pharmaceuticals Ltd.

75.89

21.

Diphtheria Toxoid +

Tetanus Toxoid +

Inactivated w-B.

pertussis bulk +

Hib (PRP- TT) (Hib

PRP Conjugated

with carrier protein

Tetanus Toxoid) +

Aluminium content

(A13+) (as

Aluminium

Phosphate Gel) +

Thiomersal 0.025mg,

(Easy Four)

Each pack contains:

Diphtheria Toxoid 20Lf (30 IU),

Tetanus Toxoid 7.5Lf (60 IU),

Inactivated w-B. pertussis bulk 10

IOU (4 IU),

Hib (PRP- TT) (Hib PRP Conjugated

with carrier protein Tetanus Toxoid)

10 ug,

Aluminium content (A13+) (as

Aluminium Phosphate Gel) 0.25mg,

Thiomersal 0.025mg,

0.5 ML

M/s Panacea Biotech

Ltd.

340.15

22.

Formoterol Fumarate

+

Budesonide

Inhalation

Suspension

(Smartules)

Each 2ml Inhalation suspension

contains:

Formoterol Fumarate Dihydrate IP

eq. to Formoterol Fumarate 20mcg,

Budesonide IP 0.5mg in an Isotonic

Solution

2 ML

M/s Akums Drugs &

Pharmaceuticals Ltd. /

M/s Glenmark

Pharmaceuticals

Limited

36.04

23.

Formoterol Fumarate

+

Budesonide

Inhalation

Suspension

(Smartules)

Each 2ml Inhalation suspension

contains:

Formoterol Fumarate Dihydrate IP

eq. to Formoterol Fumarate 20mcg,

Budesonide IP 1.0mg in an Isotonic

Solution

2 ML

M/s Akums Drugs &

Pharmaceuticals Ltd. /

M/s Glenmark

Pharmaceuticals

Limited

42.12

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.

¹Hkkx IIµ[k.M 3(ii)º

Hkkjr dk jkti=k % vlk/kj.k

11

(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/193/61/2018/F/F. No. 8(61)/2018/D.P./NPPA-Div.-II]

BALJIT SINGH, Asstt. 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. ALOK

KUMAR

Digitally signed by

ALOK KUMAR

Date: 2018.12.21

23:01:54 +05'30'