(Published in Part II, Section 3, Sub-section (ii) of the Gazette ... - NPPA

(Published in Part II, Section 3, Sub-section (ii) of the Gazette of India, Extraordinary) Government of India Ministry of Chemicals and Fertilizers Department of Pharmaceuticals National Pharmaceutical Pricing Authority New Delhi, the 16th January, 2018 ORDER S. O. 270(E) In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof; Table

Sl. No . (1) 1.

Name of the Scheduled Formulation / Brand Name (2) Glimepiride + Metformin Tablet

2.

Glimepiride + Metformin Tablet

3.

Cilnidipine + Metoprolol Tablet

4.

Escitalopram + Clonazepam Tablet (CENSPRAM MINI) Ceftriaxone sodium & Tazobactam Sodium Injection

5.

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(3) Each uncouted Bi- Layered tablet contains: Glimepiride IP 1mg, Metformin HCL IP 850mg (As sustained release form) Each uncouted Bi- Layered tablet contains: Glimepiride IP 2mg, Metformin HCL IP 850mg (As sustained release form) Each film couted Bi- Layered tablet contains: Cilnidipine 10mg, Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate 25mg (ER) Each film coated tablet contains: Escitalopram Oxalate IP eq. to Esccitalopram 5mg Clonazepam IP 0.5mg

(4) (5) 1 Tablet M/s Windlas Biotech Ltd. / M/s Intas Pharmaceuticals Pvt. Ltd. 1 Tablet M/s Windlas Biotech Ltd. / M/s Intas Pharmaceuticals Pvt. Ltd. 1 Tablet M/s Safetab Life Science and Marketer /M/s Intas Pharmaceuticals Pvt. Ltd. 1 Tablet M/s Accent Pharma / M/s USV Limited

(6) 4.89

Each combipack contains: Ceftriaxone sodium (sterile) eq. to anhydrous Ceftriaxone 500mg Tazobactam Sodium (sterile) eq. to anhydrous Tazobactam 62.5mg, And

Each pack

76.69

M/s Mankind Pharma Ltd.

7.23

6.98

5.73

6.

Olmesartan + Amlodipine Tablet (Tripinom 40)

7.

Rosuvastatin + Aspirin Capsule (Rozucorn Asp 20 Forte)

8.

Rosuvastatin + Aspirin + Clopidogrel Capsule (Unistar Gold 10/75)

9.

Rosuvastatin + Aspirin + Clopidogrel Capsule (Zyrova Gold 10)

10.

Rosuvastatin + Aspirin + Clopidogrel Capsule

11.


12.


One FFS Ampoule containing Sterile water for injection 5ml Each uncoated tablet contains: Olmesartan Medoxomil 40mg, Amlodipine Besylate eq. to Amlodipine 5mg, Hydrochlorothizide 12.5mg Each hard gelatine capsule contains: Rosuvastatin Calcium eq. to Rosuvastatin 20mg (As film coated tablet) Aspirin IP 150mg (as enteric coated tablet) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As Pellets), Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As granules), Aspirin IP 75mg (As enteric Coated Tablets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two film coated tablets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As granules), Aspirin IP 75mg (As enteric Coated Tablets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two film coated tablets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As Pellets), Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As Pellets),

Per Tablet

M/s Accent Pharma / M/s Lupin Ltd.

12.29

1 Capsule

M/s Torrent Pharmaceuticals Ltd.

8.78

1 Capsule

M/s GKM New Pharma / M/s Unichem Laboratories Ltd.

11.70

1 Capsule

M/s GKM New Pharma M/s Cadila Healthcare Ltd.

11.70

1 Capsule

M/s GKM New Pharma / M/s Zuventus Healthcare Limited

11.70

1 Capsule

M/s Synokem Pharmaceuticals Ltd /M/s Zydus Healthcare Limited

11.70

1 Capsule

M/s Synokem Pharmaceuticals Ltd / M/s Mankind Pharma Limited

11.70

13.


14.


15.


16.

Rosuvastatin + Aspirin + Clopidogrel Capsule (Unistar Gold 20/75)

17.

Rosuvastatin + Aspirin + Clopidogrel Capsule (Zyrova Gold 20)

18.


Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg, Aspirin IP 75mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As film coated tablet), Aspirin IP 75mg (As Gastro – resistant tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As film coated tablet) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg, Aspirin IP 75mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Pellets), Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As granules), Aspirin IP 75mg (As enteric Coated Tablets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two film coated tablets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As granules), Aspirin IP 75mg (As enteric Coated Tablets), Clopidogrel Bisulphate IP eq. to

1 Capsule

M/s Synokem Pharmaceuticals Ltd / M/s Cadila Pharmaceuticals Limited

11.70

1 Capsule

M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Jubilant Life Sciences Limited

11.70

1 Capsule

M/s Synokem Pharmaceuticals Ltd / M/s Eris Lifesciences Ltd.

11.70

1 Capsule

M/s GKM New Pharma / M/s Unichem Laboratories Ltd.

18.00

1 Capsule

M/s GKM New Pharma /M/s Cadila Healthcare Ltd.

18.00

1 Capsule

M/s GKM New Pharma /M/s Zuventus Healthcare Limited

18.00

19.


20.


21.


22.

Rosuvastatin + Aspirin + Clopidogrel Capsule (Jubira Gold 20)

23.


24.


25.

Voglibose +

Clopidogrel 75mg (As two film coated tablets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Pellets), Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Pellets), Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Pellets), Aspirin IP 75mg (As enteric Coated Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As film coated tablet), Aspirin IP 75mg (As Gastro – resistant tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As film coated tablet) Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg, Aspirin IP 75mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As film coated tablet), Aspirin IP 75mg (As enteric coated tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As film coated tablet) Each uncoated bilayer tablets

1 Capsule

M/s Synokem Pharmaceuticals Ltd /M/s Zydus Healthcare Limited

18.00

1 Capsule

M/s Synokem Pharmaceuticals Ltd/ M/s Mankind Pharma Limited

18.00

1 Capsule

M/s Synokem Pharmaceuticals Ltd /M/s Lifestar Pharma Limited

18.00

1 Capsule

M/s Pure and Cure Healthcare Pvt. Ltd. /M/s Jubilant Life Sciences Limited

18.00

1 Capsule

M/s Synokem Pharmaceuticals Ltd /M/s Eris Lifesciences Ltd.

18.00

1 Capsule

M/s Safetab Lifescience M/s Lupin Limited

18.00

1 Tablet M/s ACME Generics

6.786

Glimeperide + Metformin Tablet (Glimy MVI) 26.

Voglibose + Glimeperide + Metformin Tablet (Glimy MV2)

27.

Cefixime + Ofloxacin Tablet (Stancef-O Plus)

28.

Trypsin + Bromelain + Rutoside + Diclofenac Tablet (Volitra Enzo)

29.

Gliclazide + Metformin Tablet (GLZ MEX)

30.

Rosuvastatin +Clopidogrel Capsule (Turbovas C)

contains: Voglibose IP 0.2mg, Glimeperide IP 1mg & Metformin Hydrochloride IP 500mg (SR) Each uncoated bilayer tablet contains: Voglibose IP 0.2mg, Glimeperide IP 2mg & Metformin Hydrochloride IP 500mg (SR) Each film coated tablet contains: Cefixime Trihydrate eq. to Cefixime Anhydrous IP 200mg, Ofloxacin IP 200mg Each enteric coated tablet contains: Trypsin BP 48mg, Bromelain 90mg, Rutoside Trihydrate BP 100mg Diclofenac Sodium IP 50mg Each film coated tablet contains: Gliclazide IP 60mg (In modified release form), Metformin HCL 500mg (extended release form) Each hard gelatine capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (as film coated tablet),Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as 2 film coated tablet)

/ M/s Dr. Reddy's Laboratories Limited 1 Tablet M/s ACME Generics / M/s Dr. Reddy's Laboratories Limited

8.571

1 Tablet M/s Theon Pharmaceuticals Limited a/ M/s Sun Pharmaceutical Industrial Limited 1 Tablet M/s Synokem Pharmaceuticals Limited / M/s Sun Pharmaceuticals Industries Limited

9.46

1 Tablet M/s Mascot Health Seris Pvt. Ltd. / M/s Alembic Pharmaceuticals Limited 1 M/s Micro Labs Capsule Limited

13.85

7.65

12.95

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/184/52/2017/F

F. No. 8(52)/2017/D.P./NPPA-Div.-II

(BALJIT SINGH) Assistant Director