India: NPPA Updates For The Month Of November 2018

The National Pharmaceutical Pricing Authority (NPPA), is an executive body under the Drugs (Prices Control) Order (DPCO), 2013, under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. NPPA regulates drug prices and availability of the medicines in the country by fixing/revising the prices of controlled bulk drugs and formulations. The NPPA's key announcements/notices of November 2018 are apprised and described below:

1. NPPA has fixed/revised ceiling prices/retail prices of 68 formulations: On November 06, 2018, NPPA fixed ceiling prices/retail prices of 68 formulations under DPCO, 20131. The formulations with revised price included drugs used in treating conditions like Pain, Infections, Hypertension, Diabetes and Cancer etc.

a. NPPA fixed ceiling prices of 3 scheduled formulation under para 31 of Drugs (Prices Control) Order, 2013

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
1 Dimercaprol Injection 50 mg/ml 1 ml
2 Phytomenadione (Vitamin K1) Tablet 10mg 1 tablet
3 Paracetamol Oral Liquid 100 mg/ml (pediatric) 1 ml

b. NPPA revised ceiling prices of 2 scheduled formulation under para 31 of Drugs (Prices Control) Order, 2013

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
4 Nitrous oxide Inhalation Cubic meter
5 Oxygen Inhalation (Medicinal gas) Cubic meter

c. NPPA revised retail price of 07 scheduled formulations of Schedule-I under Drugs (Prices Control) Order, 2013 (Review)

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
6 Ramipril + Amlodipine Tablet Each uncoated tablet contains: Ramipril IP 5mg, Amlodipine Besylate IP eq. to Amlodipine 5mg 1 tablet
7 Ferrous Ascorbate + Folic Acid + Cyanocobalamin + Zinc Sulphate Monohydrate tablet (AutrinXT) Each film coated tablet contains: Ferrous Ascorbate eq. to Elemental Iron 100mg, Folic Acid IP 1.5mg, Cyanocobalamin IP 15 mcg, Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 22.5mg 1 tablet
8 Amlodipine + Valsartan Tablet (Valembic 80 AM) Each film coated tablet contains: Amlodipine Besylate eq. to Amlodipine USP 5mg, Valsartan USP 80mg 1 tablet
9 Amlodipine + Valsartan Tablet (Valembic 160 AM) Each film coated tablet contains: Amlodipine Besylate eq. to Amlodipine USP 5mg, Valsartan USP 160mg 1 tablet
10 Olmesartan + Amlodipine + Chlorthalidone Tablet (Triolmezest CH 20) Each film coated tablet contains: Olmesartan IP 20mg Amlodipine Besylate IP eq. to Amlodipine 5mg Chlorthalidone IP – 12.5 mg 1 tablet
11 Olmesartan + Amlodipine + Chlorthalidone Tablet (Triolmezest CH 40) Each film coated tablet contains: Olmesartan IP 40mg Amlodipine Besylate IP eq. to Amlodipine 5mg Chlorthalidone IP – 12.5mg 1 tablet
12 Rosuvastatin + Clopidogrel Tablet (ROSUVAS CV 10) Each film coated tablet contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg, Clopidogrel Bisulfate IP eq. to Clopidogrel 75mg 1 tablet

d. NPPA revised Ceiling price of 01 scheduled formulation of Schedule-I under Drugs (Prices Control) Order, 2013(Review)

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
13 Anti-Tetanus Immunoglobulin 250IU Each Pack

e. NPPA fixed retail prices of 55 formulations under (Prices Control) Order, 2013

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
14 Teneligliptin Hydrobromide + Metformin HCL (SR) Tablet Each uncoated bilayer tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20 mg Metformin Hydrochloride IP 1000 mg (SR) 1 Tablet
15 Metformin HCL + Glimepiride Tablet (Semi Amaryl M) Each uncoated bilayer tablet contains: Metformin Hydrochloride IP (in prolonged release form) 500 mg Glimepiride IP 0.5 mg 1 Tablet
16 Telmisartan + Cilnidipine + Chlorthalidone tablet Each film coated tablet contains: Telmisartan IP 40 mg Chlorthalidone IP 6.25 mg Cilnidipine IP 10 mg 1 Tablet
17 Clarithromycin for Oral Suspension Each 5ml (after reconstitution) contains: Clarithromycin IP 250mg, Titanium Dioxide IP (-). 1 ml
18 Telmisartan + Amlodipine + Chlorthalidone Tablet (Telmelife 3D) Each film coated tablet contains: Telmisartan IP 40 mg Amlodipine Besylate IP eq. to Amlodipine 5 mg Chlorthalidone IP 12.5 mg 1 Tablet
19 Atorvastatin + Clopidogrel Capsule Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin (As film coated tablet) 20 mg 1 capsule
20 Amoxycillin + Potassium Clavulante tablet (Clanoxy DT) Each uncoated dispersible tablet contains: Amoxycillin Trihydrate eq. to Amoxycillin 200mg Potassium Clavulante Diluted IP eq. to Clavulanic Acid 28.5mg 1 Tablet
21 Tramadol + Paracetamol Tablet (Trson-P) Each film coated tablet contains: Tramadol Hydrochloride IP 37.5 mg Paracetamol IP 325 mg 1 Tablet
22 Voglibose + Metformin Tablet (Voglyson-M 0.3) Each uncoated bilayered tablet contains: Voglibose IP 0.3 mg

Metformin Hydrochloride IP 500 mg (as sustained release form)

1 Tablet
23 Rosuvastatin + Aspirin + Clopidogrel Capsules Each hard gelatin capsules contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10 mg (as pellets) Aspirin IP 75 mg (as enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (as pellets) 1 Capsule
24 Mycophenolate Mofetil Oral Suspension IP Each 5 ml of reconstituted suspension contains: Mycophenolate Mofetil IP 1 g, (1 bottle with 110gm powder for oral suspension containing 35gm Mycophenolate Mofetil) Each Pack
25 Bisacodyl Suppository Each Suppository contains: Bisacodyl IP 10 mg 1 Suppository
26 Telmisartan + Chlorthalidone Tablet (Telmelife CH 40) Each film coated tablet contains: Telmisartan IP 40 mg Chlorthalidone IP 12.5 mg
  1. Tablet
27 Cilnidipine + Telmisartan Tablet Each film coated tablet contains: Telmisartan IP 80 mg Cilnidipine 10 mg 1 Tablet
28 Divalproex Tablet (Diwok OD 750 mg) Each film coated extended release tablet contains: 1 Tablet
29 Clotrimazole + Beclomethasone Dipropionate Cream Cream contains: Clotrimazole IP 1.00% w/w Beclomethasone Dipropionate IP 0.025% w/w 1 gm
30 Telmisartan + Chlorthalidone Tablet (Cresar CT) Each uncoated bilayered tablet contains: Telmisartan IP 40 mg Chlorthalidone IP 6.25 mg 1 tablet
31 Baclofen Oral Solution Each 5 ml contains: Baclofen IP 5 mg 1 ML
32 Glimepiride + Metformin Hydrochoride Tablet Each uncoated bilayered tablet contains: Metformin Hydrochoride IP (as prolonged release) 500 mg Glimepiride IP 3 mg 1 tablet
33 Glimepiride + Metformin Hydrochoride Tablet Each uncoated bilayered tablet contains: Metformin Hydrochoride IP (as prolonged release) 500 mg Glimepiride IP 4 mg 1 tablet
34 Glimepiride + Metformin Hydrochoride Tablet Each uncoated bilayered tablet contains: Metformin Hydrochoride IP (as prolonged release) 1000mg Glimepiride IP 4 mg 1 tablet
35 Metformin HCL + Gliclazide + Pioglitazone Tablets Each uncoated bilayered tablet contains: Metformin Hydrochoride IP (sustained release) 500 mg Gliclazide IP (sustained release) 30 mg Pioglitazone HCL eq. to Pioglitazone 15 mg 1 Tablet
36 Metformin HCL + Gliclazide + Pioglitazone Tablets Each uncoated bilayered tablet contains: Metformin Hydrochoride IP (sustained release) 500 mg Gliclazide IP (sustained release) 60 mg Pioglitazone HCL eq. to Pioglitazone 15 mg 1 Tablet
37 Chlorthalidone + Telmisartan Tablet (Telsar CH 40/6.25) Each film coated tablet contains: Chlorthalidone IP 6.25 mg Telmisartan IP 40 mg 1 Tablet
38 Chlorthalidone + Telmisartan Tablet (Telsar CH 40/12.5) Each film coated tablet contains: Chlorthalidone IP 12.5mg Telmisartan IP 40 mg 1 Tablet
39 Chlorthalidone + Telmisartan Tablet (Telsar CH 80/12.5) Each film coated tablet contains: Chlorthalidone IP 12.5mg Telmisartan IP 80 mg 1 Tablet
40 Divalproex Tablet (Diwok OD 250 mg) Each film coated extended release tablet contains: Divalproex Sodium IP eq. to Valproic Acid 250 mg 1 Tablet
41 Voglibose + Metformin tablet Each uncoated tablet contains: Voglibose IP 0.2 mg Metformin HCL IP 500 mg 1 Tablet
42 Amoxycillin + Potassium Clavulnate Dry Syrup (Blumox-CA Forte) Each combipack containing: a) Amoxycillin and Potassium Clavulanate Oral Suspension IP Each 5 ml suspension containing Amoxycillin Trihydrate IP eq. to Amoxycillin 400 mg Potassium Clavulnate diluted IP eq. to Clavulanic Acid 57 mg b) 1 vial sterile water for injection IP Each vial containing Sterile water for injection IP 30 ml 1 ml
43 Rosuvastatin + Aspirin + Clopidogrel Capsule Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20 mg (as pellets) Aspirin IP 75 mg (as enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (as pellets) 1 Capsule
44 Rosuvastatin + Aspirin + Clopidogrel Capsule Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10 mg (as pellets) Aspirin IP 75 mg (as enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (as pellets) 1 Capsule
45 Diclofenac + Virgin Linseed Oil + Methyl Salicylate + Menthol + Capsaicin Gel (Diclofam Hot) Gel containing Diclofenac Diethylamine BP 1.16% w/w (eq. to Diclofenac Sodium 1% w/w) Virgin linseed Oil BP 3% w/w (containing predominantly Alpha Linolenic Acid) Methyl Salicylate IP 10% w/w Menthol IP 5% Capsaicin USP 0.0255w/w, Benzyl Alcohol IP 1%w/w 1 gm
46 Clotrimazole + Lignocaine Ear Drops (Triben) Ear drops contains: Clotrimazole IP 1.0% w/v Lignocaine Hydrochloride IP 2.0% w/v 1 ml
47 Timolol + Brinzolamide Eye Drops Each ml contains Brinzolamide IP 1.0 w/v Timolol Maleate IP eq. to Timolol 0.5% w/v, Benzalkonium Chloride IP 0.01% w/v (as preservative) 5ML
48 Diclofenac + Methyl + Menthol GEL (Volini Maxx Gel)

Contains: Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salcylate IP 10% w/w & Menthol IP 5% w/w

Each Pack (20 gram)
49 Diclofenac + Methyl + Menthol GEL (Volini Maxx Gel) Contains: Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salcylate IP 10% w/w & Menthol IP 5% w/w Each Pack (30 gram)
50 Olmesartan + Amlodipine + Chlorthalidone Tablet (TRIOLSAR 20) Each film coated tablet contains: Olmesartan Medoxomil 20mg, Chlorthalidone IP 6.25mg, Amlodipine Besylate IP eq. to Amlodipine 5mg tablets 1 Tablet
51 Olmesartan + Amlodipine + Chlorthalidone Tablet (TRIOLSAR 40) Each film coated tablet contains: Olmesartan Medoxomil 40mg, Chlorthalidone IP 6.25mg, Amlodipine Besylate IP eq. to Amlodipine 5mg tablets 1 Tablet
52 Losartan + Chlorthalidone + Amlodipine Tablet (TRILOSAR 6.25 ) Each film coated tablet contains: Losartan Potassium IP 50mg, Chlorthalidone IP 6.25mg, Amlodipine Besylate IP eq. to Amlodipine 5mg tablets 1 Tablet
53 Losartan + Chlorthalidone + Amlodipine Tablet (TRILOSAR 12.50) Each film coated tablet contains: Losartan Potassium IP 50mg, Chlorthalidone IP 12.50mg, Amlodipine Besylate IP eq. to Amlodipine 5mg tablets 1 Tablet
54 Darunavir + Ritonavir tablet Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg and Ritonavir IP 100mg tablet 1 Tablet
55 Telmisartan + Amlodipine + Chlorthalidone Tablet (Tazloc AC 12.5) Each uncoated bilayered tablet contains: Telmisartan IP 40 mg Amlodipine Besylate IP eq. to Amlodipine 5 mg Chlorthalidone IP 12.5 mg 1 Tablet
56 Darunavir + Ritonavir tablet (Durart – R 450) Each film coated tablet Contains: Darunavir 400mg & Ritonavir 50mg Tablets 1 Tablet
57 Diclofenac + Methyl + Menthol Salicylate + Menthol + Turpentine Oil Gel (Diclotal MR Gel) Each film coated tablet contains: Lamivudine IP 300mg, Tenofovir Disoproxil Fumarate IP 300mg eq. to Tenofovir Disoproxil 245mg, Dolugetravir Sodium eq. to Dolutegravir 50mg. 1 Tablet
58 Lamivudine + Tenofovir + Dolugetravir tablet Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 800mg, Ritonavir 100mg Tablet 1 Tablet
59 Darunavir + Ritonavir tablet (Danavir R) Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 800mg, Ritonavir 100mg Tablet 1 Tablet
60 Lamivudine + Tenofovir + Dolugetravir tablet (ACRIPTEGA) Each uncoated tablet contains: Lamivudine IP 300mg, Tenofovir Disoproxil Fumarate IP 300mg, Dolugetravir Sodium eq. to Dolutegravir 50mg. 1 Tablet
61 Daclatasvir + Sofosbuvir tablet (HEPCINAT PLUS) Each film coated tablet contains: Daclatasvir Dihydrochloride eq. to Daclatasvir 60mg, Sofosbuvir 400mg 1 Tablet
62 Daclatasvir + Sofosbuvir tablet Each film coated tablet contains: Daclatasvir Dihydrochloride eq. to Daclatasvir 60mg, Sofosbuvir 400mg 1 Tablet
63 Daclatasvir + Sofosbuvir tablet (MYHEP DVIR) Each film coated tablet contains: Daclatasvir Dihydrochloride eq. to Daclatasvir 60mg, Sofosbuvir 400mg 1 Tablet
64 Diclofenac + Methyl + Menthol GEL (Volini Maxx Gel) Contains: Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salicylate IP 10% w/w & Menthol IP 5% w/w Each Pack (15 gram)
65 Diclofenac + Methyl + Menthol GEL (Volini Maxx Gel) Contains: Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salicylate IP 10% w/w & Menthol IP 5% w/w Each Pack (10 gram)
66 Ceftriaxone 1 gm plus Tazobactum 125 mg injection Each injection vial contains: Ceftriaxone Sodium IP eq. Ceftriaxone 1 gm Tazobactum Sodium eq. Tazobactum 125 mg 1 vial
67 Cefpodoxime + Potassium Dry Syrup (Cefoprox CV) Each 5 ml of the reconstituted suspension contains: Cefpodoxime Proxetil IP eq. to Cefpodoxime 50 mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 31.25 mg 1ml
68 Cefpodoxime + Potassium Dry Syrup (Cefoprox CV) Each 5 ml of the reconstituted suspension contains: Cefpodoxime Proxetil IP eq. to Cefpodoxime 100 mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 62.5mg 1ml

2. NPPA fixed/revised ceiling/retail prices of 01 formulations: On November 13, 2018 NPPA National Pharmaceutical Pricing Authority (NPPA) In implementation of directions given in line with the review orders issued by the Department of Pharmaceuticals (DOP) under para 31 of Drugs (Prices Control) Order, 2013 has revised/fixed the ceiling price of Tetanus Toxoid Injection, 0.5ml and 5ml each pack2.

Footnotes

1. http://www.nppaindia.nic.in/wh-new-2018/wh-new-12-2018.html

2. http://www.nppaindia.nic.in/ceiling/press13November18/Formulation(1).pdf

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