NPPA fixes retail price of 59 combo drug formulations including Paracetamol, Metformin, Atorvastatin; Details

New Delhi: Through a recent notification, the apex drug price regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 59 drug formulations in combination with Paracetamol, Metformine, Atorvastatin, Rosuvastatin and others under the Drugs Prices Control Order (DPCO), 2013, exclusive of goods and services tax (GST).

The formulations whose prices have been fixed by NPPA are combination drugs. The list mentions a combination of Acetaminophen (Paracetamol) and Tramadol Hydrochloride Tablets, Glimepiride and Metformine Tablet (Gluformin G 0.5), Telmisartan and Metoprolol Tablet, Metformin Hydrochloride, Gliclazide and Pioglitazone Tablet (Reclimet PG-60 ), Atorvastatin Calcium and Clopidogrel Capsule (MACTOR CV 10), Vildagliptin and Metformin Tablet (GLUVILDA M 500 / VIGLUCOZ M 500), Rosuvastatin and Clopidogrel Capsule, Paracetamol and Phenylephrine Sachet and so on.

Various drugmakers including Dr Reddy's Laboratories (Dr Reddys Labs), Cipla, Torrent Pharma, Emcure, Abbott, Intas Pharma, Eris Lifesciences, Sun Pharma, Macleods Pharma, Hetero Labs, Wockhardt, Panacea Biotech are involved in manufacturing the said formulations under different brand names.

For instance, formulations mentioned in the list is indicated for the treatment of Type 2 Diabetes, to reduce the level of bad cholesterol, treat low blood calcium levels, upset stomach, pain management drug, decrease the amount of HIV in body and so on.

The details of the NPPA notification read;

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
1.	Acetaminophen (Paracetamol) + Tramadol Hydrochloride Tablets	Each film-coated tablet contains: Acetaminophen IP (Paracetamol) 325mg, Tramadol Hydrochloride Tablets IP 37.5mg	1 Tablet	M/s Pure & Cure Healthcare Pvt. Ltd. / Dr. Reddy's Laboratories Ltd.	4.91
2.	Amoxycillin + Potassium Clavulanate suspension	Each 5ml Reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 57mg	1 ML	M/s Medicef Pharma / M/s Emcure Pharmaceuticals Limited	3.35
3.	Glimepiride + Metformine Tablet (Gluformin G 0.5)	Each film-coated tablet contains: Glimepiride IP 0.5mg Metformine Hydrochloride IP 500mg (As prolonged-release form)	1 Tablet	M/s Anphar Organics Private Limited / M/s Abbott Healthcare Pvt. Ltd.	3.65
4.	Emtricitabine + Tenofovir Alafenamide Tablet	Each film-coated tablet contains: Emtricitabine IP 200mg. Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 10mg	1 Tablet	M/s Hetero Labs Ltd. / M/s Emcure Pharmaceuticals Ltd.	31.17
5.	Cefixime + Potassium Clavulanate suspension	Each 5ml of reconstituted suspension contains: Cefixime IP (As Trihydrate) eq. to Anhydrous Cefixime 100mg, Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 62.50mg	1 ML	M/s Brooks Laboratories Ltd. / M/s Intas Pharmaceuticals Limited	3.04
6.	Calcium Carbonate + Vitamin D3+ Mecobalamin + LMethylfolate + Pyridoxal – 5- Phosphate Tablet	Each film-coated tablet contains: Calcium Carbonate IP 1250mg, eq. to Elemental Calcium 500mg, Vitamin D3 IP 2000 IU Mecobalamin IP (Methylcobalamin) 1500mcg L-Methylfolate Calcium 1mg, Pyridoxal – 5-Phosphate 20mg	1 Tablet	M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Torrent Pharmaceuticals Ltd.	18.58
7.	Budesonide Capsule	Each hard gelatine capsule contains: Budesonide (as controlled release pellets) IP 3mg	1 Capsule	M/s Cipla Limited	14.50
8.	Diclofenac Diethylamine + Methyl Salicylate + Menthol + Absolute Alcohol Spray	Spray contains: Diclofenac Diethylamine IP 2.32%w/v eq. to Diclofenac Sodium IP 2.00%w/v, Methyl Salicylate IP 10% w/v, Menthol IP 5%w/v, Absolute Alcohol IP 10%v/v	Per GM for 25gm Pack	M/s Pontika Aerotech Limited / M/s Cipla Limited	3.96
9.	Dolutegravir + Lamivudine + Tenofovir Disoproxil Tablet	Each film coated tablet contains: Dolutegravir Sodium eq. to Dolutegravir 50mg, Lamivudine IP 300mg, Tenofovir Disoproxil Fumarate IP 300mg eq. to Tenofovir Disproxil 245mg	1 Tablet	M/s Cipla Limited	114.06
10.	Telmisartan + Metoprolol Tablet	Each uncoated Bilayered Tablet contains: Telmisartan IP 40mg Metoprolol Succinate IP 23.75 eq. to Metoprolol Tartrate (in Prolonged Release form) 25mg	1 Tablet	M/s Eris Lifesciences Ltd.	9.93
11.	Telmisartan + Metoprolol Tablet	Each uncoated Bilayered Tablet contains: Telmisartan IP 40mg Metoprolol Succinate IP 47.5 eq. to Metoprolol Tartrate (in Prolonged Release form) 50mg	1 Tablet	M/s Eris Lifesciences Ltd.	12.23
12.	Metformin Hydrochloride + Gliclazide + Pioglitazone Tablet (Reclimet PG-30 )	Each uncoated bilayered tablet contains: Metformin Hydrochloride IP (in-sustained release form) 500mg, Gliclazide IP (in-sustained release form) 30mg, Pioglitazone HCL IP eq. to Pioglitazone 15mg	1 Tablet	M/s Inventia Healthcare Ltd. / Dr. Reddy's Laboratories Limited	5.98
13.	Metformin Hydrochloride + Gliclazide + Pioglitazone Tablet (Reclimet PG-60 )	Each uncoated bilayered tablet contains: Metformin Hydrochloride IP (in sustained-release form) 500mg, Gliclazide IP (in-sustained release form) 60mg, Pioglitazone HCL IP eq. to Pioglitazone 15mg	1 Tablet	M/s Inventia Healthcare Ltd. / Dr. Reddy's Laboratories Limited	8.30
14.	Diclofenac Diethylamine + Methyl Salicylate + Menthol + Absolute Alcohol Spray	Spray contains: Diclofenac Diethylamine IP 2.32%w/v eq. to Diclofenac Sodium IP 2.00%w/v, Methyl Salicylate IP 10% w/v, Menthol IP 5%w/v, Absolute Alcohol IP 10%v/v	Per GM for 55gm Pack	M/s Pontika Aerotech Limited / M/s Cipla Limited	3.54
15.	Dextromethorphan Hydrobromide + Chlorpheniramine Maleate Syrup	Each 5ml Contains: Dextromethorphan Hydrobromide IP 5mg, Chlorpheniramine Maleate IP 1mg	1 ML	M/s Tirupati Medicare Ltd. / M/s Intas Pharmaceuticals Limited	1.25
16.	Dextromethorphan Hydrobromide + Chlorpheniramine Maleate Syrup	Each 5ml Contains: Dextromethorphan Hydrobromide IP 10mg, Chlorpheniramine Maleate IP 2mg	1 ML	M/s Tirupati Medicare Ltd. / M/s Intas Pharmaceuticals Limited	0.59
17.	Gatifloxacin + Prednisolone Eye Drops	Each ml contains: Gatifloxacin 3.0mg, Prednisolone Acetate IP 10.0mg, Benzalkonium Chloride Solution (as preservative) 0.06mg	1 ML	M/s Micro Labs Limited	3.35
18.	Budesonide Nebuliser respule	Each 2ml respule Contains: Budesonide IP 0.5mg	Per 2ml Respule	M/s Sun Pharmaceutical Medicare Ltd. / M/s Sun Pharmaceutical Industries Ltd.	17.09
19.	Clarithromycin for Oral Suspension	Each 5ml of reconstituted suspension contains: Clarithromysin coated eq. to Charithromycin IP 250mg	1 ML	M/s Medibios Laboratories Limited / M/s Abbott Healthcare Pvt. Ltd.	5.59
20.	Metformin Hydrochloride + Glimepiride Tablet (O GLIMADAY FORTE 1)	Each film-coated tablet contains: Metformin Hydrochloride IP 1000mg (in prolonged-release form) Glimepiride IP 1mg	1 Tablet	M/s Wockhardt Limited	6.61
21.	Metformin Hydrochloride + Glimepiride Tablet (O GLIMADAY FORTE 2)	Each film-coated tablet contains: Metformin Hydrochloride IP 1000mg (in prolonged-release form) Glimepiride IP 2mg	1 Tablet	M/s Wockhardt Limited	9.08
22.	Pantoprazole Tablet	Each Dual-Release Gastro-Resistant tablet contains: Pantoprazole Sodium IP eq. to Pantoprazole 80mg	1 Tablet	M/s Sun Pharma Laboratories Limited	18.22
23.	Atorvastatin Calcium + Clopidogrel Capsule (MACTOR CV 10)	Each hard gelatine capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets)	1 Capsule	M/s Synokem Pharmaceuticals Limited / M/s Macleods Pharmaceuticals Limited	11.14
24.	Telmisartan + Amlodipine + Hydrochlorothiazide Tablet (Telmiduce AMH)	Each uncoated bi-layered tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg Hydrochlorothiazide IP 12.5mg	1 Tablet	M/s Macleods Pharmaceuticals Limited	8.36
25.	Darunavir + Ritonavir Tablet	Each film-coated tablet contains: Darunavir Ethanolate eq. to Darunavir 800mg, Ritonavir IP 100mg Tablet	1 Tablet	M/s Hetero Labs Limited / M/s Emcure Pharmaceuticals Ltd.	197.55
26.	Amoxycillin + Docloxacillin Capsule (Almox C LB)	Each hard gelatin capsule contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 250mg Dicloxacillin Sodium IP eq. to Dicloxacillin 250mg Lactic Acid Bacillus 2.5 billion spores	1 Capsule	M/s Theon Pharmaceuticals Ltd. / M/s Alkem Laboratories Limited	7.64
27.	Atorvastatin + Aspirin + Clopidogrel Capsule	Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg (As coloured pellets), Aspirin IP 75mg (As enteric coated white coloured pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two brown coloured film-coated, each containing 37.5mg Clopidogrel tablet IP)	1 Capsule	M/s Windlas Biotech Private Limited / M/s Intas Pharmaceuticals Limited	12.78
28.	Glycopyrronium + Formoterol Dry powder for inhalation (Capsule)	Each capsule contains: Glycopyrronium (as Glycopyrrolate USP) 25mcg, Formoterol Fumarate (As Formoterol Fumarate Dihydrate) 12mcg	1 Capsule	M/s Cipla Limited	10.96
29.	Levetiracetam in 0.82% Sodium Chloride Injection	Each 100ml infusion contains: Levetiracetam IP 500mg	Each Pack	M/s Intas Pharmaceuticals Limited	98.98
30.	Levetiracetam in 0.75% Sodium Chloride Injection	Each 100ml infusion contains: Levetiracetam IP 1000mg	Each Pack	M/s Intas Pharmaceuticals Limited	160.68
31.	Levetiracetam in 0.54% Sodium Chloride Injection	Each 100ml infusion contains: Levetiracetam IP 1500mg	Each Pack	M/s Intas Pharmaceuticals Limited	222.39
32.	Vildagliptin + Metformin Tablet	Each Tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 500mg	1 Tablet	M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited	22.82
33.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 500mg	1 Tablet	M/s Emcure Pharmaceuticals Ltd.	22.82
34.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg, Metformin Hydrochloride IP 500mg	1 Tablet	M/s Micro Labs Limited	17.85
35.	Vildagliptin + Metformin Tablet	Each uncoated tablet contains: Vildagliptin 50mg, Metformin Hydrochloride IP 500mg	1 Tablet	M/s Torrent Pharmaceuticals Ltd.	16.10
36.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg, Metformin Hydrochloride IP 500mg,	1 Tablet	M/s Natco Pharma Limited	6.07
37.	Vildagliptin + Metformin Tablet (GLUVILDA M 500 / VIGLUCOZ M 500)	Each film-coated tablet contains: Metformin Hydrochloride IP 500mg Vildagliptin IP 50mg	1 Tablet	M/s Alkem Health Science / M/s Alkem Laboratories Ltd.	19.54
38.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg, Metformin Hydrochloride IP 500mg	1 Tablet	M/s Panacea Biotec Ltd.	8.48
39.	Vildagliptin + Metformin Tablet (Vildamac M50/500)	Each film-coated tablet contains:Vildagliptin 50mg, Metformin Hydrochloride IP 500mg	1 Tablet	M/s Macleods Pharmaceuticals Limited	20.00
40.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 500mg	1 Tablet	M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Obsurge Biotech Limited	15.00
41.	Vildagliptin + Metformin Tablet	Each Tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 850mg	1 Tablet	M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited	22.68
42.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 850mg	1 Tablet	M/s Emcure Pharmaceuticals Ltd.	22.68
43.	Vildagliptin + Metformin Tablet	Each uncoated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 850mg	1 Tablet	M/s Torrent Pharmaceuticals Ltd.	16.10
44.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 850mg	1 Tablet	M/s Panacea Biotec Ltd.	8.61
45.	Vildagliptin + Metformin Tablet (Vildamac M50/850)	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 850mg	1 Tablet	M/s Macleods Pharmaceuticals Limited	20.60
46.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 850mg	1 Tablet	M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Obsurge Biotech Limited	18.00
47.	Vildagliptin + Metformin Tablet	Each Tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited	22.94
48.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Emcure Pharmaceuticals Ltd.	23.37
49.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Micro Labs Limited	18.92
50.	Vildagliptin + Metformin Tablet	Each uncoated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Torrent Pharmaceuticals Ltd.	16.10
51.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Natco Pharma Limited	6.16
52.	Vildagliptin + Metformin Tablet (GLUVILDA M 1000 / VIGLUCOZ M 1000)	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Alkem Health Science / M/s Alkem Laboratories Ltd.	20.83
53.	Vildagliptin + Metformin Tablet	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Panacea Biotec Ltd.	8.70
54.	Vildagliptin + Metformin Tablet (Vildamac M50/1000)	Each film-coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Macleods Pharmaceuticals Limited	21.33
55.	Cilnidipine + Metoprolol Succinate Tablet	Each film-coated Bilayerd Tablet contains: Cilnidipine IP 10mg, Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (As Extended Release)	1 Tablet	M/s Micro Labs Limited	8.89
56.	Rosuvastatin + Clopidogrel Capsule	Each Hard Gelatine capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets)	1 Capsule	M/s Synokem Pharmaceuticals Ltd. / M/s Cipla Limited	13.75
57.	Rosuvastatin + Clopidogrel Capsule	Each Hard Gelatine capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets)	1 Capsule	M/s Synokem Pharmaceuticals Ltd. / M/s Cipla Limited	18.04
58.	Linezolid Suspension	Each 5ml of reconstituted suspension contains: Linezolid IP 100mg	1 ML	M/s Innova Captab Ltd. / M/s Brinton Pharmaceuticals Limited	3.04
59.	Paracetamol + Phenylephrine Sachet	Each 6gm sachet contains: Paracetamol IP 500mg, Phenylephrine Hydrochloride IP 10mg	1 Sachet	M/s Maneesh Pharmaceuticals Ltd.	1.89

Also Read: NPPA fixes retail price of 14 drug formulations; Details

The NPPA notice further added;

(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 / marketer 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) 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.

(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.