Union Government, Extraordinary, 2018-01-23, Part II-Section 3-Sub-Section(ii), Ref. SO 352 E to SO 353 E

1.6 MB·English

by  Government of India

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EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (ii)
PART II—Section 3—Sub-section (ii)
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PUBLISHED BY AUTHORITY
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No. 302] NEW DELHI, TUESDAY, JANUARY 23, 2018/MAGHA 3, 1939
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1- eVS ªkfsuMktkys bta Ds ’ku 500 fexzk-@100 1 0-12140 31015@22@2017 2058¼v½ fnukda 30-06-2017
fefy- fefy- eYw ; fu/kkZj.k dh fnukda ¼Ø-l-a 398½
24.08.2017
466 GI/2018 (1)
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

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[dk-al-a@185@53@2018@एफ@Qk- l-a 8¼53½@2018@Mhih@,uihih,&fMoh--II]
cythr flga ]]]] lgk;d fun's kd

MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 23rd January, 2018
S.O. 352(E).—In implementation of directions given in line with review orders issued by the Department of
Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of
Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and in exercise of the powers conferred by paragraphs 4,
10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and
S.O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in
supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical
Pricing Authority) specified in the column (7) of the table regarding formulation specified in mentioned in the table in so far as
it relates to formulation pack mentioned in the table below, except in respect of things done or omitted to be done before such
supersession, the National Pharmaceutical Pricing Authority, hereby fixes/revises the price as specified in column (5) of the table
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herein below as ceiling price exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulation(s)
specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified
respectively in the corresponding entries in columns (3) and (4) thereof:

TABLE
Sl. Name of the Dosage form & Unit Ceiling Review Order Existing SO number
No. Scheduled Strength Price number and date and date
Formulation (Rs.)
(1) (2) (3) (4) (5) (6) (7)
1. Metronidazole Injection 1 ML 0.12140 31015/22/2017- 2058(E) dated 30.6.2017
500mg/100ml Pricing dated (at Sl. No. 398)
24.8.2017

Note:
(a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled
formulations at a price higher than the ceiling price (plus goods and services tax as applicable) so fixed and notified by the
Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column
(5) in the above table plus goods and services tax as applicable, if any.
(b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price
specified in column (5) in the above table plus goods and services tax as applicable, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on
the ceiling price mentioned in column (5) of the above said table.
(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance
with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs
(Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per
paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
(e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any,
as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to
be easily accessible to any person wishing to consult the same.
(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table
launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price
approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.
(g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of
production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS.
Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to
the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II
of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
(h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the
overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with
Essential Commodities Act, 1955.
(i) Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this
notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification,
stand(s) superseded.
[PN/185/53/2018/F/F. No. 8(53)/2018/D.P./NPPA-Div.-II]

BALJIT SINGH, Assistant Director

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4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

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ORDER
New Delhi, the 23rd January, 2018
S. O. 353(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the
Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority
(hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail
price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in
column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the
corresponding entries in columns (3), (4) and (5) thereof;

TABLE

Sl. Name of the Scheduled Strength Unit Manufacturer & Retail
No. Formulation / Brand Marketing Company Price
Name (Rs.)
(1) (2) (3) (4) (5) (7)
1. Olmesartan Medoxomil Each film coated tablet contains: 1 Tablet M/s Akums Drugs and 13.88
+ Amlodipine + Olmesartan Medoxomil IP 40mg Pharmaceutical Ltd. /
Hydrochlorothiazide Amlodipine Besylate IP eq. to M/s Zuventus
Tablet Amlodipine 5mg Healthcare Limited
Hydrochlorothiazide IP 12.5mg
2. Olmesartan Medoxomil Each film coated tablet contains: 1 Tablet M/s Akums Drugs and 9.15
+ Amlodipine + Olmesartan Medoxomil IP 20mg Pharmaceutical Ltd. /
Hydrochlorothiazide Amlodipine Besylate IP eq. to M/s Zuventus
Tablet Amlodipine 5mg Healthcare Limited
Hydrochlorothiazide IP 12.5mg
3. Tiotropium Bromide + Each capsule contains: 1 Capsule M/s Lupin Ltd. 14.67
Formoterol Fumarate + Tiotropium (as Tiotropium
Ciclesonide
Bromide Monohydrate) 18mcg
Powder for Inhalation
Formoterol Fumarate Dihydrate
12mcg Ciclesonide 400mcg
4. Isosobide Dinitrate + Each film coated tablet contains: 1 Tablet M/s Windlas Biotech 5.61
Hydralazine HCl tablet Diluted Isosorbide Dinitrate eq. Ltd. / M/s Abbott
(Sorbitrate HF) to Isosorbide Dinitrate 20mg Healthcaere Pvt. Ltd.
Hydralazine Hydrochloride
37.5mg
5. Olmesartan Medoxomil Each film coated tablet contains: 1 Tablet M/s Synokem 12.87
+ Amlodipine + Tablet Olmesartan Medoxomil IP 40mg Pharmaceuticals Ltd. /
Amlodipine Besylate IP eq. to M/s Zuventus
Amlodipine 5mg Healthcare Limited
6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

Note:
(a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013
shall fix the retail price as specified in column (6) of the table hereinabove.
(b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the
Government on the retail price mentioned in column (6) of the above said table.
(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in
accordance with the retail price specified in column (6) of the above table as per provisions contained in
paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification
as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller
and dealers.
(d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price
list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business
in a manner so as to be easily accessible to any person wishing to consult the same.
(e) The above mentioned retail price is applicable only to the individual manufacturer / marketeer as mentioned
above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under
DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt.
under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the
Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.
(f) The concerned manufacturer of above said formulations shall furnish quarterly return to the NPPA, in respect of
production/import and sale of product in Form-III of Schedule-II of the DPCO, 2013 through IPDMS.
Manufacturer, in case intending to discontinue above said formulations, 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 intended date of discontinuation.
(g) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification
and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit
the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the
Essential Commodities Act, 1955.
(h) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this
notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of
notification, stand(s) superseded.

[PN/185/53/2018/F/F. No. 8(53)/2018/D.P./NPPA-Div.-II]
BALJIT SINGH, Assistant Director

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.