Feb 6, 2018 - 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by th
(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 6th February, 2018
ORDER S. O. 544(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. 2.
3. 4.
Name of the Formulation / Brand Name (2) Paracetamol + Dicyclomine Tablet (Pacimol Spas) Amoxicilin Potasium Clavulanate Tablet (Clavam Forte DT)
Telmisartan + Chlorthalidone Tablet (Tigatel CH40) Cilnidipine + Telmisartan tablet (Telvacil 80mg)
5.
Metoprolol ER Tablet
6.
Paracetamol + Caffeine Tablate (Pacimol Active) Doxycyclilne + Lactic Acid Bacillus capsules
7. 8.
Doxycyclilne + Lactic Acid Bacillus capsules
Strength
Unit
Manufacturer & Marketing Company
(3) Each Uncoated tablet contains: Paracetamol IP 500mg, Dicyclomine Hydrochloride IP 20 mg Each uncoated dispersible tablet containing: Amoxicilin Trihydrate IP eq. to Amoxicilin 400mg, Potasium Clavulanate diluted IP eq. To Clavulanic acid 57 mg Each film coated Tablet contains: Telmisartan IP 40mg, Chlorthalidone IP 12.5mg Each Tablet contains: Cilnidipine 10mg , Telmisartan IP 80mg
(4) 1 Tablet
(5) M/s Akums Drugs and Pharmaceutical Ltd. / M/s IPCA Laboratories Ltd. M/s Alkem HealthscienceA unit of Alkem Laboratories / M/s Alkem Laboratories Ltd.
Each film coated extended release Tablet contains: Metoprolol Succinate IP 71.25mg eq. to Metoprolol Tartrate 75mg. Each film coated Tablet contains: Paracetamol IP 650mg, Caffeine Anhydrous IP 50mg Each hard Gelatin capsule contains: Doxycycline Hyclate eq. to Doxycycline 100mg, Lactic Acid Bacillus 5 Billion Spores Each hard Gelatin capsule contains: Doxycycline Hyclate eq. to Doxycycline (Pellets) 100mg, Lactic Acid Bacillus (enteric coated Pellets) 5 Billion Spores
1 Tablet
1 Tablet
Retail Price (Rs.) (6) 1.64 16.35
1 Tablet
M/s Sun Pharma Laboratories Limited
7.64
1 Tablet
M/Pure and Cure Healthcare Pvt. Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. M/s Intas Pharmaceuticals Limited
10.54
M/s Ipca Laboratories Limited
1.88
1 Capsule
M/s Mascot Health Series Pvt. Ltd. / M/s Zydus Healthcare Limited.
5.56
1 Capsule
M/s Bennet Pharmaceuticals Ltd.
5.56
1 Tablet
8.39
9.
Cilnidipine + Telmisartan Tablet
Each filmcoated tablet contains: Cilnidipine 10mg, Telmisartan IP 40mg Each filmcoated tablet contains: Cilnidipine 10mg, Telmisartan IP 40mg
1 Tablet
M/s Safteb Life Science / M/s Lupin Limited
7.11
10.
Cilnidipine + Telmisartan Tablet
1 Tablet
7.11
Levetiracetam Tablet
Each film coated tablet contains: Levetiracetam IP 1000mg
1 Tablet
12.
Levetiracetam Tablet
Each film coated prolonged release tablet contains: Levetiracetam IP 1000mg
1 Tablet
13.
Phenylephrine + Chlorpheniramine Syrup
Each 5 ml Contains: Phenylephrine Hydrochloride IP 5mg, Chlorpheniramine Maleate IP 2mg
1 ML
14.
Sumatriptan + Naproxen Tablet (NAXCOM)
1 Tablet
15.
Cilnidipine + Telmisartan + Chlorthalidone Tablet
16.
Telmisartan + Amlodipine + Chlorthalidone Tablet
17.
Telmisartan + Amlodipine + Chlorthalidone Tablet (Tigatel ACH 40)
18.
Telmisartan + Amlodipine + Chlorthalidone Tablet (Tigatel ACH 80)
Each uncoated bilayer tablet contains: Sumatriptan Succinate IP eq. to Sumatriptan 85mg, Naproxen Sodium USP 500mg Each film coated tablet contains: Cilnidipine 10mg, Telmisartan IP 40mg, Chlorthalidone IP 6.25mg Each film coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Chlorthalidone IP 12.5mg Each film coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Chlorthalidone IP 12.5mg Each uncoated tablet contains: Telmisartan IP 80mg, Amlodipine Besylate IP Eq. to Amlodipine 5mg & Chlorthalidone IP 12.5mg
M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. M/s Mascot Health Series Pvt. Ltd. / M/s Zydus Healthcare Limited M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Emcure Pharmaceuticals Limited M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Lifestar Pharma Pvt. Ltd. M/Sun Pharma Laboratories Limited.
11.
Insulin Biophasic Isophane Ph. Eur./ USP (50% as soluble Insulin Injection and 50% as Isophane Insulin Injection) Each ml contains: r-human Insulin (Regular) 100 IU/vial, m-Cresol USP – 0.16% w/v, Phenol IP 0.065% w/v Soluble Insulin Ph. Eur./USP Each ml contains: r-human Insulin (Regular) 100IU/vial
19.
Human Insulin Injection
20.
Human Insulin Injection
21.
Human Insulin Injection
Insulin Biophasic Isophane Ph. Eur./ USP (30% as soluble Insulin Injection and 70% as Isophane Insulin Injection) Each ml contains: r-human Insulin (Regular) 100 IU/vial, m-Cresol USP – 0.16% w/v, Phenol IP 0.065% w/v
1 Tablet
23.37 23.37 0.75 30.82
M/s Synokem Pharmaceuticals Ltd. / M/s Mankind Pharma Limited M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Abbott India Limited
9.79
1 Tablet
M/s Sun Pharma Laboratories Limited
8.75
1 Tablet
M/s Sun Pharma Laboratories Ltd.
14.00
1 ML
M/s MJ Biopharma Pvt. Ltd. / M/s Koye Pharmaceuticals Pvt. Ltd.
63.66
1 ML
M/s MJ Biopharma Pvt. Ltd. / M/s Koye Pharmaceuticals Pvt. Ltd.
63.66
1 ML
M/s MJ Biopharma Pvt. Ltd. / M/s Koye Pharmaceuticals Pvt. Ltd.
63.66
1 Tablet
8.75
22.
Docetaxel Injection (Docetaxel IP 120mg/3ml)
23.
Escitalopram + Clonazepam Tablet (Szetalo Plus 5)
24.
Telmisartan + Amlodipine Tablet (Telmiduce AM)
25.
Telmisartan + Hydrocholrothiazide Tablet (Telmiduce H 40) Rosuvastatin + Aspirin + Clopidogrel Capsule (Rozucor Gold 10)
26.
27.
Rosuvastatin + Aspirin + Clopidogrel Capsule (Rozucor Gold 20)
28.
Amoxycillin + Clavulante Suspension
29.
Paracetamol + Mafenamic Suspension (Pacimol MF 125)
30.
Etoricoxib + Paracetamol Tablet (Etomax P)
Note:
Each ml of concentrate contains: Docetaxel (as anhydrous) 40mg, Polysorbate 80 – 566mg, Ethanol Anhydrous 326mg, Citric Acid Monohydrate 2mg (for PH adjustment), water for injection
Each Pack (120mg/3 ml)
M/s Venus Remedies Ltd. / M/s Cadila Healthcare Ltd.
10280.34
Each film coated tablet contains: Escitalopram Oxalate IP eq. to Escitalopram 5mg, Clonazepam IP 0.5mg
1 Tablet
M/s Accent Pharma / M/s Abbott Healthcare Pvt. Limited.
3.83
Each uncoated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg
1 Tablet
M/s Macleods Pharmaceuticals Ltd.
4.30
Each uncoated tablet contains: Telmisartan USP 40mg, Hydrocholrothiazide USP 12.50mg
1 Tablet
M/s Macleods Pharmaceuticals Ltd.
4.15
1 Capsule
M/s Synokem Pharmaceuticals Limited / M/s Torrent Pharmaceuticals Limited
9.97
1 Capsule
M/s Synokem Pharmaceuticals Limited / M/s Torrent Pharmaceuticals Limited
18.00
1 ML
M/s Twenty First Century Pharmaceuticals Pvt. Ltd. / M/s Glenmark Pharmaceuticals Ltd.
2.91
1 ML
M/s Tirupati Medicare Limited / M/s IPCA Laboratories Pvt. Ltd.
0.48
M/s Ravenbhel Healthcare (P) Limited / M/s IPCA Laboratories Pvt. Ltd.
5.14
Each Hard Gelatine Capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastation 10mg (As pellets), Aspirin IP 75mg (As Gastro - resistant pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) Each Hard Gelatine Capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastation 20mg (As pellets), Aspirin IP 75mg (As Gastro - resistant pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) Each combipack contains: (a) One bottle of Amoxycillin & Potassium Clavunate Oral Suspension I.P. Each 5ml of reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulante Diluted IP eq. to Clavulnic Acid 57mg Each 5ml contains: Paracetamol IP 125mg, Mafenamic acid IP 50mg Flavoured Syrup base Each film coated tablet contains: Etoricoxib IP 60mg, Paracetamol IP 325mg
1 Tablet
(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 accordancee 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 Form from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA th 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 appli applied for the same by submitting Form-II 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 licen permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing /marketing companies. (f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant inst 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 Commo Commodities Act, 1955. (g) 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/186/54/2018/F
F. No. 8(54)/201 )/2018/D.P./NPPA-Div.-II
(BALJIT SINGH) Assistant Director
