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- 2526]
ubZ fnYyh] cq/okj] fnlEcj 10] 2014@vxzgk;.k 19] 1936
No. 2526]
NEW DELHI, WEDNESDAY, DECEMBER 10, 2014/AGRAHAYANA 19, 1936
4893 GI/2014
(1)
jlk;u vkSj moZjd ea=kky;
¼vkS"kèk foHkkx½
¼jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k½
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3126¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 10, 11, 14 vkSj 16 }kjk iznRr
'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼laf{kIr :i
esa ,uihih, gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr
fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1.
fcfyfpax ikmMj ¼30 % MCY;w@MCY;w miyCèk
--
1 fdyksxzke
17.42
Dyksjhu ls lkexzh de ugha gS] vkbZ-ih- ds vkèkkj ij½
2.
fdVkekbu gkbMªksdyksjkbM bUtsD'ku
10 fexzk-@fefy
1 fefy
10.54
3.
ftad lYQsV flji
20 fexzk-@fefy
1 fefy
0.61
fVIi.k %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
2
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka-la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 10th December, 2014
S.O. 3126(E).—In exercise of the powers, conferred by paragraph 4, 10, 11, 14 and 16 of the Drugs (Prices
Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 prices exclusive of local tax applicable, if any
in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the
strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Bleaching Powder (Contains not Less
—
1 kg
17.42
than 30% w/w of available chlorine as per I.P.)
2.
Ketamine Hydrochloride Injection
10mg/ml
1 ml
10.54
3.
Zinc Sulfate Syrup
20mg/5ml
1 ml
0.61
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding
the ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO,
2013.
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
3
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the
retail price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2)
of the DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA,
in respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-
II of the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs
(Prices Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3127¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 10, 11, 14 vkSj 16 }kjk
iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] ds
vkns'k dk- vk- la- 146¼v½ fnukad 21 tuojh] 2010, la- 181¼v½ fnukad 7 Qjojh] 2006, la- 2034¼v½ fnukad 30 uoEcj] 2007,
la- 2710¼v½ fnukad 28 uoEcj] 2011, vkSj la- 893 ¼v½ fnukad 5 twu] 2007 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk
¼5½ esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj
bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh;
dj] ;fn dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1.
,Ldksjfcd ,sflM xksfy;ka
500 fexzk-
1 xksyh
0.94
2.
DyksDlklhfyu dSilwy
250 fexzk-
1 dSilwy
1.29
3.
tSUVkekbflu bUtsD'ku
10 fexzk-@fefy
1 fefy
3.18
4.
Xywdksl bUtsD'ku
5%
1 fefy
0.06446
5.
Xywdksl$uksjey lsykbu bUtsD'ku
5%+0.9%
1 fefy
0.06167
6.
xzslks;wysfou xksfy;ka
125 fexzk-
1 xksyh
0.75
7.
uksjey lsykbu bUtsD'ku
0.9%
1 fefy
0.08596
4
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
fVIi.k %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3127(E).—In exercise of the powers, conferred by paragraph 4, 10, 11, 14 and 16 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of
Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and
Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 146(E), dated 21st January, 2010, S.O. 181(E), dated 7th
February, 2006, S.O. 2034(E), dated 30th November, 2007, S.O. 2710(E), dated 28th November, 2011, S.O. 893(E), dated 5th
June, 2007, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax
applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said
Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Ascorbic Acid Tablet
500mg
1 Tablet
0.94
2.
Cloxacillin capsule
250mg
1 Capsule
1.29
3.
Gentamycin Injection
10mg/ml
1 ml
3.18
4.
Glucose Injection
5%
1 ml
0.06446
5.
Glucose+ Normal Saline Injection
5%+0.9%
1 ml
0.06167
6.
Griseofulvin Tablet
125mg
1 Tablet
0.75
7.
Normal Saline Injection
0.9%
1 ml
0.08596
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
5
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3128¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk0vk0 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10, 11, 14 vkSj 16 }kjk iznRr
'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼laf{kIr :i
esa ,uihih, gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr
fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1.
dksfMu QksLQsV flji
15 fexzk-@5 fefy
1 fefy
0.63
2.
fM;kt+kike LiksflVjh
5 fexzk-
1 LiksflVjh
5.48
3.
,sQkfojsUt+ dSilwy
600 fexzk-
1 dSilwy
59.50
4.
gkWjeksu fjfyftax vkbZ;wMh
--
1 vkbZ;wMh
455.01
5.
vk;ksfMu lksY;w'ku
8 fexzk-@5 fefy
1 fefy
0.32
6.
vkbZlkslksjfcM MkbZukbVªsV xksfy;ka
20 fexzk-
1 xksyh
2.00
6
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3128(E).—In exercise of the powers, conferred by paragraph 4, 6, 10, 11, 14 and 16 of the Drugs (Prices
Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 prices exclusive of local tax applicable, if any in respect
of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof:
Table
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Codeine Phosphate Syrup
15mg/5ml
1 ml
0.63
2.
Diazepam Suppository
5 mg
1 Suppository
5.48
3.
Efavirenz capsule
600 mg
1 Capsule
59.50
4.
Hormone Releasing IUD
—
1 IUD
455.01
5.
Iodine Solution
8mg/5ml
1 ml
0.32
6.
Isosorbide Dinitrate Tablet
20 mg
1 Tablet
2.00
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
7
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3129¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10, 11, 14 vkSj 16 }kjk
iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] ds
vkns'k dk- vk- la- 1641¼v½ fnukad 27 flrEcj] 2007, la- 606¼v½ fnukad 27 ebZ] 2003, la- 770¼v½ fnukad 10 vizSy] 2012,
la- 301¼v½ fnukad 4 ekpZ] 2004, dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher dks mDr lkj.kh
ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa
dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre dher ds
:i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1.
,Ldksjfcd ,sflM xksfy;ka
100 fexzk-
1 xksyh
0.14
2.
Dyksjizksekt+kbu bUtsD'ku
25 fexzk-@fefy
1 fefy
1.22
3.
feFkk;yMksik xksfy;ka
250 fexzk-
1 xksyh
1.69
4.
foVkfeu , dSilwy
50000 vkbZ;w
1 dSilwy
0.51
8
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3129(E).—In exercise of the powers, conferred by paragraph 4, 6, 10, 11, 14 and 16 of the Drugs (Prices
Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry
of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and
Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 1641(E), dated 27th September, 2007, S.O. 606(E), dated 27th
May, 2003, S.O. 770(E), dated 10th April, 2012, S.O. 301(E), dated 4th March, 2004, hereby fixes the prices as specified in
column (5) of the table herein below as ceiling prices exclusive of local tax applicable, if any in respect of the Scheduled
formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified
respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Ascorbic Acid Tablet
100mg
1 Tablet
0.14
2.
Chlorpromazine Injection
25mg/ml
1 ml
1.22
3.
Methyldopa Tablet
250mg
1 Tablet
1.69
4.
Vitamin A capsule
50000 IU
1 Capsule
0.51
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
9
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3130¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 1017¼v½ fnukad 02.04.2014
ds flizks¶yksDlhu gkbMªksDyksjkbM Mªksi 0.30%@fefy fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/15/2014-ihvkbZ-I fnukad 16.9.2014
ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA
blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd
ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10,
11, 14 vkSj 16 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY;
fuèkkZj.k izkfèkdj.k] ds vkns'k dk- vk- la- 2095¼v½ fnukad 20 vxLr] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ
¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn
dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1
flizks¶yksDlhu gkbMªksDyksjkbM Mªksi
0.30%@fefy
1 fefy
1.49
10
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
fVIi.k %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3130(E).—In implementation of directions given in line with review order passed by the Department of
Pharmaceuticals on 16.09.2014 vide letter No. 31015/15/2014/PI.I in respect of S.O. No. 1017(E) dated 02.04.2014 for
Ciprofloxacin Hydrochloride Drops 0.30%/ml.
Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4,
6, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by
the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government
of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. 2095(E), dated 20th
August, 2014, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local
tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said
Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Ciprofloxacin Hydrochloride Drops
0.30%/ml
1 ml
1.49
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
11
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3131¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 1156¼v½ fnukad 28.04.2014
ds Xywdksl bUtsD'ku 10% fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/24/2014-ihvkbZ-I fnukad 16.9.2014 ij fn;s x;s vkns'k esa
vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA
blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd
ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10,
11, 14 vkSj 16 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY;
fuèkkZj.k izkfèkdj.k] ds vkns'k dk- vk- la- 1156¼v½ fnukad 28 vizSy] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ
¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn
dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1
Xywdksl bUtsD'ku
10%
1 fefy
0.05316
12
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3131(E).—In implementation of directions given in line with review order passed by the Department of
Pharmaceuticals on 16.09.2014 vide letter no. 31015/24/2014/PI.I in respect of S.O. No. 1156(E) dated 28.04.2014 for Glucose
Injection 10%.
Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4,
6, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by
the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government
of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. 1156(E), dated 28th
April, 2014, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax
applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said
Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Glucose Injection
10%
1 ml
0.05316
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
13
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3132¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 2092¼v½ fnukad 20.08.2014
ds lksfM;e esxY;wekbu MkbZ,fVªtks,sV bUtsD'ku 60% vkSj 76% fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/48/2014-ihvkbZ-I vkSj
31015/49/2014-ihvkbZ-I fnukad 5.11.2014 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k
x;kA
blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd
ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10,
11, 14 vkSj 16 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY;
fuèkkZj.k izkfèkdj.k] ds vkns'k dk- vk- la- 2092¼v½ fnukad 20 vxLr] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ
¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn
dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1
lksfM;e esxY;wekbu MkbZ,fVªtks,sV bUtsD'ku
60% ¼vk;ksfMu
1 fefy
8.05
dUd-=292 fexzk-@fefy½
2
lksfM;e esxY;wekbu MkbZ,fVªtks,sV bUtsD'ku
76% ¼vk;ksfMu
1 fefy
9.81
dUd-=370 fexzk-@fefy½
14
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3132(E).—In implementation of directions given in line with review order passed by the Department of
Pharmaceuticals on 5.11.2014 vide letter no. 31015/48/2014/PI.I and 31015/49/2014/PI.I in respect of S.O. No. 2092(E) dated
20.08.2014 for Sodium Meglumine Diatrizoate Injection 60% and 76%.
Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4,
6, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by
the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government
of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. 2092(E), dated 20th
August, 2014, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local
tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said
Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Sodium Meglumine Diatrizoate Injection
60% (Iodine
1 ml
8.05
Conc.=292 mg/ml)
2.
Sodium Meglumine Diatrizoate Injection
76%(Iodine
1 ml
9.81
Conc.=370 mg/ml)
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
15
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3133¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 1157¼v½ fnukad 28.04.2014
ds dks&VªkbZeksDlkt+ksy ¼VªkbZfeFkksfize$lYQkfeFkkDlkt+ksy½ xksfy;ka 160 fexzk-$800 fexzk- fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/
28/2014-ihvkbZ-I fnukad 7.7.2014 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA
blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd
ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10,
11, 14 vkSj 16 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY;
fuèkkZj.k izkfèkdj.k] ds vkns'k dk- vk- la- 2095¼v½ fnukad 20 vxLr] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ
¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn
dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1
dks&VªkbZeksDlkt+ksy ¼VªkbZfeFkksfize$
160 fexzk-$800 fexzk-
1 xksyh
1.32
lYQkfeFkkDlkt+ksy½ xksfy;ka
16
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3133(E).—In implementation of directions given in line with review order passed by the Department of
Pharmaceuticals on 7.7.2014 vide letter No. 31015/28/2014/PI.I in respect of S.O. No. 1157(E) dated 28.04.2014 for Co-
Trimoxazole (Trimethoprim + Sulphamethoxazole) 160mg+ 800mg Tablet.
Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4,
6, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by
the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government
of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. 2095(E), dated 20th
August, 2014, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local
tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said
Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Co-Trimoxazole (Trimethoprim+
160mg + 800mg
1 Tablet
1.32
Sulphamethoxazole) Tablet
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
17
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3134¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 2062¼v½ fnukad 5.7.2013 ds
esfuuVksy bUtsD'ku 20% fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/43/2013-ihvkbZ-I fnukad 23.12.2013 ij fn;s x;s vkns'k esa
vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA
blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk
tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 6, 10, 11, 14 vkSj 16
}kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k]
ds vkns'k dk- vk- la- 1156¼v½ fnukad 28 vizSy] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre
dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml
lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj
vfèkdre dher ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
vfèkdre dher
¼#-½
1
2
3
4
5
1
esfuuVksy bUtsD'ku
20%
1 fefy
0.55
18
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
mi;qZDr lkj.kh ds LraHk ¼5½ esa vfèkdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks
Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vfèkdre dher ls vfèkd LFkkuh; dj] tgka dgha Hkh ykxw gks]
ds vuqlkj vukfèkd vfèkd [kqnjk dher dks la'kksfèkr djsxkA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa
fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds
iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA
¼M-½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds
vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼p½
mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa 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 lEcUèk 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d
oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus
ds fy, nk;h gksaxsA
¼t½
bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vfèkdre
dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3134(E).—In implementation of directions given in line with review order passed by the Department of
Pharmaceuticals on 23.12.2013 vide letter No. 31015/43/2013/PI.I in respect of S.O. No. 2062(E) dated 5.7.2013 for Mannitol
Injection 20%.
Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4,
6, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by
the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government
of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. 1156(E), dated 28th
April, 2014, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax
applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said
Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Ceiling Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Mannitol Injection
20%
1 ml
0.55
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
19
Note :
(a)
The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the
ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the
ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
(c)
The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the
DPCO, 2013.
(d)
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 local taxes as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(e)
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 DPCO, 2013 then 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.
(f)
The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of
production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any
manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in
respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of
the DPCO, 2013 at least six months prior to the indented date of discontinuation.
(g)
The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall
be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices
Control) Order, 2013 read with the Essential Commodities Act, 1955.
(h)
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table
in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3135¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,ydksu isjsUVsjYl
¼vkbZ½ fyfeVsM( eSllZ ,ydksu isjsUVsjYl ¼vkbZ½ fyfeVsM vkSj eSllZ ck;ksdse QkekZL;wfVdYl( eSllZ dsfMyk gsYFkds;j fyfeVsM
¼tk;M~l dsfMyk½] fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre
[kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fefy esa
1.
iSjkflVkeksy bu¶;wt+u@bUtsD'ku
iSjkflVkeksy-10 fexzk-
1 fefy
2.10
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
20
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsaflax
vkWFkkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3135(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Ahlcon Parenterals (I) Ltd.; M/s. Ahlcon Parenterals (I) Ltd. and M/s. Biochem Pharmaceuticals Ltd.; M/s. Cadila
Healthcare Limited (Zydus Cadila) respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each ml contains
1.
Paracetamol Infusion/ Injection
Paracetamol 10mg
1 ml
2.10
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
21
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3136¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ekijk ysc fyfeVsM
fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa
fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd xksfy;ksa esa
1.
,eksDlhflfyu$iksVkf'k;e
,eksDlhflfyu VªkbZgkbMªsV
6 xksyh
160.00
DysO;wysusV xksfy;ka
,eksDlhflfyu-875 fexzk- ds cjkcj
iksVkf'k;e DysO;wysusV MkbZY;wVsM
DysO;wysfud ,sflM-125 fexzk- ds cjkcj
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
22
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3136(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Mapra Lab. Ltd.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each tablet contains
1.
Amoxycilline +
Amoxycillin Trihydrate eq. to
6 Tablet
160.00
Potassium Clavulanate
Amoxycillin 875mg
tablet
Potassium Clavulanate Diluted
eq. to Clavulanic Acid 125mg
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
23
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3137¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,des QksjE;wys'ku
izkbosV fyfeVsM vkSj eSllZ ,yfEcd QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh]
LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fQYe fyfir xksfy;ksa esa
1.
esVksizksyksy lDlhusV $
esVksizksyksy lDlhusV
1 xksyh
7.66
fdYuhfMikbu xksfy;ka
esVksizksyksy VkjVsjsV-50 fexzk- ds cjkcj
¼dkfMZ;ksfly ,e½
¼,DlVsUMsM fjfyt+ QkWeZ esa½
fdYuhfMikbu-10 fexzk-
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
24
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3137(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Acme Formulation Pvt. Ltd. and M/s. Alembic Pharmaceuticals Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each film coated tablet contains
1.
Metoprolol Succinate+
Metoprolol Succinate eq. to
1 Tablet
7.66
Cilnidipine Tablet
Metoprolol Tartarate– 50mg
(Cardiocil M)
(in extended release form)
Cilnidipine 10mg
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
25
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3138¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fFk;ksu QkekZL;wfVdYl
fyfeVsM vkSj eSllZ T;wosUVl gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fQYe fyfir xksfy;ksa esa
1.
lsQsfDle $
lsQsfDle
1 xksyh
15.88
,ftFkzksekbflu xksfy;ka
,ugkbMªl lsQsfDle-200 fexzk- ds cjkcj
¼VªLVsu&,tsM xksfy;ka½
,ftFkzksekbflu MkbZgkbMªsV
,ugkbMªl ,ftFkzksekbflu -250 fexzk- ds cjkcj
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
26
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3138(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s.
Theon Pharmaceuticals Ltd. and M/s. Zuventus Healthcare Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each film coated tablet contains
1.
Cefixime +
Cefixime eq. to
1 Tablet
15.88
Azithromycin Tablets
Anhydrous Cefixime 200mg
(Trusten AZ tablet)
Azithromycin as Dihydrate eq. to
Anhydrous Azithromycin 250mg
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
27
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3139¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ gsVjks ysc fyfeVsM
vkSj eSllZ ekbØks ysc fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj
vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fQYe fyfir xksfy;ksa esa
1.
ysoks¶ykslhu $
ysoks¶ykslhu gsfeMkbZMªsV
1 xksyh
12.15
,ftFkzksekbflu xksfy;ka
ysoks¶ykslhu-250 fexzk- ds cjkcj
¼ysokscsDV&,tsM 250½
,ftFkzksekbflu MkbZgkbMªsV
,ugkbMªl ,ftFkzksekbflu -250 fexzk- ds cjkcj
2.
ysoks¶ykslhu $
ysoks¶ykslhu gsfeMkbZMªsV
1 xksyh
21.55
,ftFkzksekbflu xksfy;ka
ysoks¶ykslhu-500 fexzk- ds cjkcj
¼ysokscsDV&,tsM 500½
,ftFkzksekbflu MkbZgkbMªsV
,ugkbMªl ,ftFkzksekbflu -500 fexzk- ds cjkcj
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
28
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3139(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s.
Hetero Labs Ltd. and M/s. Micro Lab. respectively.
TABL
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each film coated tablet contains
1.
Levofloacin +
Levofloacin Hemidhydrate
1 Tablet
12.15
Azithromycin Tablets
eq. to Levofloxacin 250mg
(Levobact AZ 250)
Azithromycin Dihydrate eq. to
Anhydrous Azithromycin 250mg
2.
Levofloacin +
Levofloacin Hemidhydrate
1 Tablet
21.55
Azithromycin Tablets
eq. to Levofloxacin 500mg
(Levobact AZ 500)
Azithromycin Dihydrate eq. to
Anhydrous Azithromycin 500mg
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
29
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3140¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,Mksj QkekZL;wfVdYl
izkbosV fyfeVsM vkSj eSllZ vtUrk QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fefy esa
1.
xsfV¶yksDlhu$izsMuhlksyksu
xsfV¶yksDlhu
1 fefy
2.47
vkSj csUtkWydksfu;e
xsfV¶yksDlhu ¼,ugkbMªl½-3 fexzk- ds cjkcj
DyksjkbM vk¡[kksa dk Mªksi
izsMuhlksyksu ,sflVsV-10 fexzk-
csUtkWydksfu;e DyksjkbM-0.01% MCY;w@oh ¼izsljosfVo ds leku½
30
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3140(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s.
Adore Pharmaceuticals Pvt. Ltd. and M/s. Ajanta Pharma Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each ml contains
1.
Gatifloxacin +
Gatifloxacin eq. to
1 ml
2.47
Prednisolone and
Gatifloxacin (anhydrous) – 3mg
Benzalkonium
Prednisolone Acetate – 10mg
Chloride Eye drops
Benzalkonium Chloride 0.01% w/v (as preservative)
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
31
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3141¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ vksjfcV ykbQlkablsl
izkbosV fyfeVsM vkSj eSllZ tsu,Dl QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd gkMZ ts+ysfVu dSilwy esa
1.
,VksjokLVsfVu dSfY'k;e$
,VksjokLVsfVu dSfY'k;e
10 dSilwy
87.52
DyksfiMksxjsy ck;lYQsV
,VksjokLVsfVu-10 fexzk- ¼isysV~l ds leku½
dSilwy
DyksfiMksxjsy ck;lYQsV
¼DyksfiM a,Vh10½
DyksfiMksxjsy-75 fexzk- ¼isysV~l ds leku½
32
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
2.
,VksjokLVsfVu dSfY'k;e$
,VksjokLVsfVu dSfY'k;e
10 dSilwy
110.48
DyksfiMksxjsy ck;lYQsV
,VksjokLVsfVu-20 fexzk- ¼isysV~l ds leku½
dSilwy
DyksfiMksxjsy ck;lYQsV
¼DyksfiM a,Vh20½
DyksfiMksxjsy-75 fexzk- ¼isysV~l ds leku½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3141(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s. Orbit
Lifescience Pvt. Ltd. and M/s. Genx Pharma Ltd. respectively.
1
2
3
4
5
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
33
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each hard gelatin capsule contains
1.
Atorvastatin calcium+
Atorvastatin calcium eq. to
10’s Capsule
87.52
Clopidogrel Bisulphate
Atorvastatin 10mg (As pellets)
Capsules
Clopidogrel bisulphate eq. to
(Clopid AT10)
Clopidogrel 75mg (As pellets)
2.
Atorvastatin Calcium+
Atorvastatin Calcium eq. to
10 Capsule
110.48
Clopidogrel bisulphate
Atrovastatin 20 mg (as pellets)
Capsule
Clopidogrel bisulphate eq. to
(CLOPID AT 20)
Clopidogrel 75 mg (as pellets)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3142¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
34
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,uQkj vkWjxsfuDl
vkSj eSllZ ;w,loh fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj
vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd vfyfir ck;ys;MZ xksfy;ksa esa
1.
fxfyDykt+kbM$
fxfyDykt+kbM-60 fexzk-
1 xksyh
6.61
esVQksjfeu xksfy;ka
esVQksjfeu-500 fexzk-
¼fxfydh ,e,Q 60½
¼lLVsUM fjfyt+ QkWeZ esa½
2.
fxfyDykt+kbM$
fxfyDykt+kbM-80 fexzk-
1 xksyh
4.63
esVQksjfeu xksfy;ka
esVQksjfeu-500 fexzk-
¼fxfydh ,e,Q 80½
¼lLVsUM fjfyt+ QkWeZ esa½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
35
ORDER
New Delhi, the 10th December, 2014
S.O. 3142(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s.
Anphar Organics and M/s. USV Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each uncoated bilayered tablet contains
1.
Gliclazide+
Gliclazide 60mg
1 Tablet
6.61
Metformin Tablet
Metformin 500mg
(Glikey MF 60)
(in sustained release form)
2.
Gliclazide+
Gliclazide 80mg
1 Tablet
4.63
Metformin Tablet
Metformin 500mg
(Glikey MF 80)
(in sustained release form)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
36
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3143¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fFk;ksu QkekZL;wfVdYl
fyfeVsM vkSj eSllZ dsfMyk QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fQYe fyfir xksfy;ksa esa
1.
lsQiksMksDlkbe izksDlsfVy$
lsQiksMksDlkbe izksDlsfVy
1 xksyh
17.70
,ftFkzksekbflu xksfy;ka
lsQiksMksDlkbe-200 fexzk- ds cjkcj
,ftFkzksekbflu MkbZgkbMªsV
,ftFkzksekbflu-250 fexzk- ds cjkcj D;w-,l-
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
37
ORDER
New Delhi, the 10th December, 2014
S.O. 3143(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s.
Theon Pharmaceuticals Ltd. and M/s. Cadila Pharmaceuticals Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each film coated tablet contains
1.
Cefpodoxime Proxetil+
Cefpodoxime Proxetil
1 Tablet
17.70
Azithromycin Tablets
Eq. to Cefpodoxime - 200 mg
Azithromycin Dihydrate
Eq. to Azithromycin Anhydrous - 250 mg q.s
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
38
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3144¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ buksok dsiVsc izkbosV
fyfeVsM vkSj eSllZ T;wosUVl gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd xzke esa
1.
iksohMksu vk;ksfMu$
iksohMksu vk;ksfMu-5% MCY;w@MCY;w
1 xzke
3.00
vksjfuMkt+ksy vkW;uVesUV~
¼miyCèk vk;ksfMu-0.5% MCY;w@MCY;w½
¼T;wosfUVMkbu vkstsM½
vksjfuMkt+ksy-1% MCY;w@MCY;w
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
39
ORDER
New Delhi, the 10th December, 2014
S.O. 3144(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Innova Captab Pvt. Ltd. and M/s. Zuventus Healthcare Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each gm contains
1.
Povidone Iodine+
Povidone Iodine 5% w/w
1 gm
3.00
Ornidazole Ointment
(Available Iodine 0.5% w/w)
(Zuventdine OZ)
Ornidazole 1% w/w
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
40
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3145¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ foaMykl ck;ksVsd
fyfeVsM vkSj eSllZ dsfMyk QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd vfyfir ck;ys;MZ xksfy;ksa esa
1.
VsyfelkjVu$
VsyfelkjVu-40 fexzk-
1 xksyh
7.80
gkbMªksDyksjksfFk;kt+kbM$
gkbMªksDyksjksfFk;kt+kbM-12.5 fexzk-
,eyksfMfiu xksfy;ka
,eyksfMfiu fclk;yV
,eyksfMfiu-5 fexzk- ds cjkcj
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
41
ORDER
New Delhi, the 10th December, 2014
S.O. 3145(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Windlas Biotech Ltd. and M/s. Cadila Pharmaceuticals Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each uncoated bilayered tablet contains
1.
Telmisartan +
Telmisartan 40mg
1 Tablet
7.80
Hydrochlorothiazide +
Hydrochlorothiazide 12.5mg
Amlodipine Tablet
Amlodipine besylate eq. to Amlodipine 5mg
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
42
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3146¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ dsfMyk QkekZL;wfVdYl
fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY;
ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fQYe fyfir xksfy;ksa esa
1.
ykslkjVu iksVkf'k;e$
ykslkjVu iksVkf'k;e-50 fexzk-
1 xksyh
4.55
s
DyksjFkkfyMksu xksfy;ka
DyksjFkkfyMksu-12.5 fexzk-
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
43
ORDER
New Delhi, the 10th December, 2014
S.O. 3146(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Cadila Pharmaceuticals Ltd.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each film coated tablet contains
1.
Losartan Potassium+
Losartan Potassium 50mg
1 Tablet
4.55
Chlorthalidone Tablet
Chlorthalidone 12.5mg
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
44
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3147¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ isusf'k;k ck;ksVsd
fyfeVsM vkSj VksjsUV QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn
dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd ok;y esa
1.
isdfyVsDly bUtsD'ku
isdfyVsDly-100 fexzk-
1 bUtsD'ku
7954.28
¼,u,ch VksjVsDly½
¼áweu ,yC;wfeu½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
45
ORDER
New Delhi, the 10th December, 2014
S.O. 3147(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Panacea Biotec Ltd. and M/s.Torrent Pharmaceuticals Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each vial contains
1.
Paclitaxel Injection
Paclitaxel 100mg
1 Injection
7954.28
(NAB Tortaxel)
(Human Albumin)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
46
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3148¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ LVªkby&tsus ykbQ
lkbalsl izkbosV fyfeVsM vkSj eSllZ edZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj]
;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd vfyfir xksfy;ksa esa
1.
,y&Fkk;jksDlkbu lksfM;e
,y&Fkk;jksDlkbu lksfM;e
1 xksyh
1.14
xksfy;ka
,ugkbMªl ,y&Fkk;jksDlkbu-25 ,elhth ds cjkcj
¼;wFkk;jsDl 25½
2.
,y&Fkk;jksDlkbu lksfM;e
,y&Fkk;jksDlkbu lksfM;e
1 xksyh
1.25
xksfy;ka
,ugkbMªl ,y&Fkk;jksDlkbu-75 ,elhth ds cjkcj
¼;wFkk;jsDl 75½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
47
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3148(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Sterile-Gene Life Sciences Pvt. Ltd. and M/s. Merck Limited respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each uncoated tablet contains
1.
L-Thyroxine Sodium
L-Thyroxine Sodium IP
1 Tablet
1.14
Tablet
Equivalent to anhydrous
(Uthyrox 25)
L-Thyroxine Sodium 25 mcg
Approved colours used
2.
L-Thyroxine Sodium
L-Thyroxine Sodium IP
1 Tablet
1.25
Tablet
Equivalent to anhydrous
(Uthyrox 75)
L-Thyroxine Sodium 75 mcg
Approved colours used
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
48
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3149¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ thds,e U;w QkekZ(
eSllZ ,;ksu QkWewZys'ku izkbosV fyfeVsM vkSj eSllZ baV~kl QkekZ fyfeVsM( eSllZ vtUrk QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V
fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd gkMZ tsysfVu dSilwy esa
1.
jksL;wokLVsfVu$
jksL;wokLVsfVu dSfY'k;e
1 dSilwy
4.55
,lfizu dSilwy
jksL;wokLVsfVu-10 fexzk-¼xzsU;wYl½ ds cjkcj
,lfizu-150 fexzk-
¼,afVªd fyfir xksfy;ksa ds leku½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
49
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3149(E).—In exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. GKM New Pharma; M/s. Aeon Formulations Pvt. Ltd. and M/s. Intas Pharma Ltd.; M/s. Ajanta Pharma Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each hard gelatin capsule contains
1.
Rosuvastatin +
Rosuvastatin calcium eq. to
1 Capsule
4.55
Aspirin capsule
Rosuvastatin 10mg (as granules)
Aspirin 150mg
(as enteric coated tablets)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
50
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3150¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 6, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ D;ksjVsd Ldhuds;j
vkSj eSllZ Y;wfiu fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj
vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd xzke esa
1.
DyksfcVklksy izksfi;ksusV$
DyksfcVklksy izksfi;ksusV-0.05% MCY;w@MCY;w
1 xzke
2.06
fu;ksekbflu lYQsV$
fu;ksekbflu lYQsV
fedksukt+ksy ukbVªsV Øhe
fu;ksekbflu-0.1% MCY;w@MCY;w ds cjkcj
¼DyksfcVkosV ,u,e½
fedksukt+ksy ukbVªsV-2.0% MCY;w@MCY;w
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
51
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3150(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Curetech Skincare and M/s. Lupin Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each gm contains
1.
Clobetasol Propionate+
Clobetasol Propionate 0.05% w/w
1 gm
2.06
Neomycin Sulphate+
Neomycin Sulphate eq to
Miconazole Nitrate Cream
Neomycin 0.1% w/w
(Clobetavate NM)
Miconazole Nitrate - 2.0%w/w
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
52
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3151¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 6, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,;ksu QkWewZys'ku
izkbosV fyfeVsM vkSj eSllZ ,fjLVks QkWekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd
dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd gkMZ tsysfVu dSilwy esa
1.
bykizkt+ksy$
bykizkt+ksy-10 fexzk-
1 dSilwy
4.37
MkseisfjMksu dSilwy
¼,afVªd fyfir xksfy;ksa ds leku½
¼psdflM&Mh ,lvkj½
MkseisfjMksu-30 fexzk-
¼fQYe fyfir lLVsUM fjfyt+ xksfy;ksa ds leku½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
53
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3151(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Aeon formulations Pvt. Ltd. and M/s. Aristo Pharmaceuticals Pvt. Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each hard gelatin capsule contains
1.
Ilaprazole +
Ilaprazole 10mg
1 Capsule
4.37
Domperidone Capsules
(as enteric coated tablet)
(Chekcid-D SR)
Domperidone 30mg
(as film coated sustained release tablet)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
54
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3152¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 6, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ vtUrk QkekZ fyfeVsM
fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa
fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fefy esa
1.
lkbDyksliksfju$
lkbDyksliksfju-0.5 fexzk-
3 fefy ok;y
266.25
csUtkWydksfu;e vk¡[kks
csUtkWydksfu;e DyksjkbM-0.01% MCY;w@oh
dk Mªksi
¼izsljosfVo ds leku½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
55
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3152(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Ajanta Pharma Ltd.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each ml contains
1.
Cyclosporine+
Cyclosporine 0.5mg
3ml Vial
266.25
Benzalkonium Eye Drop
Benzalkonium Chloride 0.01% w/v
(as preservative)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above table.
56
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
(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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3153¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 6, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ QkekZ QksZl ysc-
vkSj eSllZ esudkabM QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS]
dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fQYe fyfir xksfy;ksa esa
1.
fMDyksQsusd iksVkf'k;e$
fMDyksQsusd iksVkf'k;e-50 fexzk-
1 xksyh
2.70
lsjkfV;ksisfIVMst+ xksfy;ka
lsjkfV;ksisfIVMst-15 fexzk-
¼lsjkfV;ksisfIVMst dh 30,000 ;wfuV½
¼,afVªd fyfir xzsU;wYl ds leku½
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
57
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3153(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Pharma Force Lab. and M/s. Mankind Pharma Ltd. respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each film coated tablet contains
1.
Diclofenac Potassium+
Diclofenac Potassium – 50mg
1 Tablet
2.70
Serratiopeptidase tablet
Serratiopeptidase – 15mg
(30,000 units of Serratiopeptidase)
(as enteric coated granuals)
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
58
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3154¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 6, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ D;ksjVsd Ldhuds;j
vkSj eSllZ Y;wfiu fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj
vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd xzke esa
1.
DyksfcVklksy izksfi;ksusV$
DyksfcVklksy izksfi;ksusV-0.05% MCY;w@MCY;w
1 xzke
1.77
fu;ksekbflu lYQsV$
fu;ksekbflu lYQsV
fedksukt+ksy ukbVªsV$
fu;ksekbflu-0.5% MCY;w@MCY;w ds cjkcj
ftad lYQsV Øhe
fedksukt+ksy ukbVªsV-2.0% MCY;w@MCY;w
¼DyksfcVkosV th,e½
ftad lYQsV-2.0% MCY;w@MCY;w
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
59
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3154(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Curetech Skincare and M/s. Lupin Limited respectively.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each gm contains
1.
Clobetasol propionate+
Clobetasol propionate 0.05% w/w
1 gm
1.77
Neomycin Sulphate+
Neomycin sulphate eq. to
Miconazole Nitrate+
Neomycin 0.5% w/w
Zinc Sulphate Ceam
Miconazole Nitrate 2.0% w/w
(Clobetavate GM)
Zinc Sulphate 2.0% w/w
60
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3155¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh
dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 6, 11 vkSj 15 }kjk iznRr 'kfDr;ksa
dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i
esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh
izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ esudkbaM QkekZ
fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY;
ds :i esa fu;r djrh gSA
lkj.kh
Ø-la- vuqlwfpr fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd lkW¶V tsysfVu dSilwy esa
1.
dSfY'k;e$fedksckykfeu$
dSfY'k;e dkcksZusV
1 dSilwy
7.68
dSfY'kfVª;ksy$
,fyesUVy dSfY'k;e-200 fexzk- ds cjkcj
Qksfyd ,flM$
fedksckykfeu-1500 ,elhth
ik;fjMksDlhu dSilwy
dSfY'kfVª;ksy-0.25 ,elhth
Qksfyd ,flM-1.5 fexzk-
ik;fjMksDlhu ,plh,y-3 fexzk-
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
61
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr [email protected] dEifu;ka tks
vuqikyu djrh gSA
¼p½
mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013
ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ
fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj 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
¼N½
fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA
¼t½
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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3155(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any in relation to
each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit
specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by
M/s. Mankind Pharma Limited.
TABLE
Sl.
Name of the Schedule Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each soft gelatin capsule contains
1.
Calcium+Mecobalamin
Calcium carbonate eq. to
1 Capsule
7.68
Calcitriol+ Folic Acid +
Elemental Calcium 200mg
Pyridoxine Capsule
Calcitriol 0.25mcg
Mecobalamin 1500mcg
Folic Acid 1.5mg
Pyridoxine HCl 3mg
62
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment 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 manufacturers/marketing companies.
(f)
The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of
its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to
discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of
the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six
months prior to the indented date of discontinuation.
(g)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h)
Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
vkns'k
ubZ fnYyh] 10 fnlEcj] 2014
dk-vk- 3156¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx us dk-vk- 945¼v½ fnukad 27.03.2014 ds
lqijLikl&vkj,Q bUtsD'ku ds [kqnjk ewY; fuèkkZj.k ds lEcUèk esa eSllZ fufru ykbQ lkbalsl }kjk nk;j iqufoZyksdu vkns'k ij
i=k la- 31015/11/2014-ihvkbZ-I fnukad 7.7.2014 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq ikfjr fd;k x;k vkSj
jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013
ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj
ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½ us mi;qZDr
fn;s x;s vkns'k dk- vk- la- 945¼v½ fnukad 27 ekpZ] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk
ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk
¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fufru ykbQ lkbalsl fyfeVsM vkSj eSllZ flxy QkekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj
foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r
djrh gSA
¹Hkkx IIµ[k.M 3(ii)º
Hkkjr dk jkti=k % vlk/kj.k
63
lkj.kh
Ø-la- fofufeZfr dk uke
izcyrk
bZdkbZ
[kqnjk ewY;
¼#-½
1
2
3
4
5
izR;sd fefy esa
1.
MkbZlkbDyksekbu ,plh,y$
MkbZlkbDyksekbu ,plh,y-10 fexzk-
1 ,Ei;wy
8.06
fMDyksQsusd lksfM;e$
fMDyksQsusd lksfM;e-25 fexzk-
¼2 fefy½
csUtkWydksfu;e DyksjkbM
csUtkWydksfu;e DyksjkbM lksY;w'ku-0.05% MCY;w@oh
bUtsD'ku
¼izsljosfVo ds leku½
¼lqijLikl&vkj,Q½
bUtsD'ku ds fy, ikuh & D;w-,l-
uksV %
¼d½
fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ
lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA
¼[k½
vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g
ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA
¼x½
vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½
esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA
¼?k½
mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk
ls fHkUu vxj ekStwnk lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k]
2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls
,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA
¼M-½
mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY;
fu;a=k.k½ vkns'k] 2013 ds rgr vuqc) ewY; fuèkkZj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fuèkkZfjr
lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax
vkWfFkfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr 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,¡ vfèkfu;e]
1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[dka- la-@151@19@2014@fo@Qk- la- 8¼19½@2014@Mhih@,uihih,-&fMoh--II]
ujs'k vk;Z] mi&funs'kd
ORDER
New Delhi, the 10th December, 2014
S.O. 3156(E).—In implementation of directions given in review order passed by the Department of Pharmaceuticals
on 7.7.2014 vide letter No. 31015/11/2014/PI.I on review application filed by M/s. Nitin Life Sciences Ltd. in respect of
S.O. No. 945(E) dated 27.03.2014 for fixation of Retail Price of Superspas-RF Injection under DPCO, 2013 and, in exercise of
the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated
the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of
the above same Order i.e. S.O. 945(E), dated 27th March, 2014, the Government of India in the Ministry of Chemicals and
Fertilizers, National Pharmaceutical Pricing Authority (hereby referred as the NPPA), hereby fixes, the price as specified in
column (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any, in relation to each of the formulation
specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the
corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s. Nitin Life Sciences Ltd. and
M/s. Seagull Pharmaceuticals Pvt. Ltd. respectively.
64
THE GAZETTE OF INDIA : EXTRAORDINARY
[PART II—SEC. 3(ii)]
TABLE
Sl.
Name of the Formulation
Strength
Unit
Retail Price
No.
(Rs.)
(1)
(2)
(3)
(4)
(5)
Each ml contains
1.
Dicyclomine HCl+
Dicyclomine HCl-10 mg
1 Ampoule
8.06
Diclofenac Sodium+
Diclofenac Sodium - 25 mg
(2ml)
Benzalkonium Chloride
Benzalkonium Chloride Solution - 0.05% w/v
Injection
(as preservative)
(Superspas –RF)
Water for Injections – q.s.
Note :
(a)
The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall
fix the retail price as specified in column (5) of the table hereinabove.
(b)
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail
price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO,
2013.
(d)
Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above
table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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.
(e)
The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above
i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013
and subject to fulfillment of all the applicable statutory requirements as laid down by the Government 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 manufacturers/marketing companies.
(f)
In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified
hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit
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 retail price of the aforesaid formulation as specified in column (2) of the above
mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to
the above said date of notification, stand withdrawn.
[PN/151/19/2014/F/F. No. 8(19)/2014/D.P./NPPA-Div.-II]
NARESH ARYA, Dy. Director
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.