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

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