Union Government, Extraordinary, 2018-01-01, Part II-Section 3-Sub-Section(ii), Ref. SO 02 E

1.6 MB·English

by  Government of India

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EXTRAORDINARY
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PART II—Section 3—Sub-section (ii)
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PUBLISHED BY AUTHORITY
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No. 02] NEW DELHI, MONDAY, JANUARY 1, 2018/PAUSHA 11, 1939
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04 GI/2018 (1)
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

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

MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 1st January, 2018
S.O. 02(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices
Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March,
2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National
Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in
column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation
to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit
and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4)
and (5) thereof;
TABLE
Sl. Name of the Strength Unit Manufacturer & Retail
No. Scheduled Marketing Company Price (Rs.)
Formulation/Brand
Name
1. Cilnidipine + Each film coated Bi- Layered tablet 1 Tablet M/s. Pure and Cure 7.346
Metoprolol Tablet contains: Healthcare Pvt Ltd. /
Cilnidipine 10mg, M/s Intas
Metoprolol Succinate IP 47.5mg eq. Pharmaceuticals Pvt.
to Metoprolol Tartrate 50mg (ER) Ltd.
2. Metformin + Each tablet contains: 1 Tablet M/s. Sunglow 8.17
Glimepiride + Metformin HCL 500mg Pharmaceuticals Pvt.
Voglibose Tablets (as sustained release form) Ltd. / M/s Intas
Glimepiride 1mg Pharmaceuticals Ltd.
Voglibose 0.3mg
3. Rosuvastatin + Each Hard gelatin capsule contains: 1 Capsule M/s. Synokem 7.80
Clopidogrel Capsule Rosuvastatin Calcium IP eq. to Pharmaceuticals Ltd. /
Rosuvastatin 20mg, M/s Cadila
Clopidogrel Bisulphate IP eq. to Pharmaceuticals Ltd.
Clopidogrel 75mg
4. Telmisartan + Each film coated tablet contains: 1 Tablet M/s. Sun Pharma 6.713
Chlorthalidone Tablet Telmisartan IP 80mg, Laboratories Limited
(Tigatel CH 80) Chlorthalidone IP 12.5mg
5. Rosuvastatin + Each hard gelatin capsule contains: 1 Capsule M/s. Synokem 7.80
Clopidogrel Capsule Rosuvastatin Calcium IP eq. to Pharmaceuticals Ltd. /
Rosuvastatin 20mg (As pellets) M/s Zydus Healthcare
Clopidogrel Bisulphate IP eq. to Ltd.
Clopidogrel 75mg (As pellets)
6. Paracetamol+Caffeine+ Each uncoated tablet contains: 1 Tablet M/s. Dales 2.57
Phenylephrine+ Paracetamol-500mg Laboratories Pvt. Ltd.
Diphenhydramine Caffeine (anhydrous)-30mg
Tablet (Sinus77) Phenylephrine HCl-5mg
Diphenhydramine HCl-25mg
7. Atorvastatin + Each hard gelatin capsule contains: 1 Capsule M/s. Synokem 8.394
Clopidogrel Capsule Atorvastatin Calcium IP eq. to Pharmaceuticals Ltd. /
Atorvastatin 10mg, M/s Eris Lifesciences
Clopidogrel Bisulphate IP eq. to Limited
Clopidogrel 75mg
8. Atorvastatin + Each hard gelatin capsule contains: 1 Capsule M/s. Synokem 10.596
Clopidogrel Capsule Atorvastatin Calcium IP eq. to Pharmaceuticals Ltd. /
Atorvastatin 20mg, M/s Eris Lifesciences
Clopidogrel Bisulphate IP eq. to Limited
Clopidogrel 75mg
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5

9. Gliclazide + Each uncoted tablet contains: 1 Tablet M/s. Akums Drugs & 4.354
Metformin Tablet Gliclazide IP 40mg, Pharmaceuticals Ltd. /
(Glychek M +) Metformin Hydrochloride IP M/s Indoco Remedies
500mg Limited
10. Atorvastatin + Each hard gelatin capsule contains: 1 Capsule M/s. Windlas Biotech 10.596
Clopidogrel Capsule Atorvastatin Calcium IP eq. to Pvt. Ltd. / M/s Dr.
(Atocor CV 20mg) Atorvastatin 20mg (As two film Reddy’s Laboratories
coated tablet Each containing Ltd.
Atorvastatin 10mg)
Clopidogrel Bisulphate IP eq. to
Clopidogrel 75mg (As 2 film
coated 37.5mg each tablet)
11. Atorvastatin + Each capsule contains: 1 Capsule M/s Micro Lab. Ltd. 10.596
Clopidogrel Capsule Atorvastatin Calcium IP eq. to
(Avas 20 Gold) Atorvastatin 20mg (As film coated
tablet)
Clopidogrel Bisulphate IP eq. to
Clopidogrel 75mg (As 2 film
coated 37.5mg each tablet)
12. Atorvastatin + Each capsule contains: 1 Capsule M/s Micro Lab. Ltd. 10.596
Clopidogrel Capsule Atorvastatin Calcium IP eq. to
(Astin 20 Gold) Atorvastatin 20mg (As film coated
tablet)
Clopidogrel Bisulphate IP eq. to
Clopidogrel 75mg (As 2 film
coated 37.5mg each tablet)
13. Rosuvastatin + Each hard gelatin capsule contains: 1 Capsule M/s Synokem 13.37
Clopidogrel Capsule Rosuvastatin Calcium IP eq. to Pharmaceuticals Ltd. /
Rosuvastatin 10mg, M/s Eris Lifesciences
Clopidogrel Bisulphate IP eq. to Limited
Clopidogrel 75mg
14. Rosuvastatin + Each hard gelatin capsule contains: 1 Capsule M/s Synokem 7.80
Clopidogrel Capsule Rosuvastatin Calcium IP eq. to Pharmaceuticals Ltd. /
Rosuvastatin 20mg, M/s Eris Lifesciences
Clopidogrel Bisulphate IP eq. to Limited
Clopidogrel 75mg
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.
6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

(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/184/52/2017/F/F. No. 8(52)/2017/D.P./NPPA-Div.-II]
BALJIT SINGH, Assistant Director

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