NPPA Fixes Retail Price Of 23 Formulations, Details
New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), has fixed the retail prices of the 23 formulations including those used to lower the levels of triglycerides in the blood, prevent heart attack and stroke, treat high blood pressure, type 2 diabetes, and others.
This came in line with the decision of the 113 rd authority meeting dated 26.05.2023, where the authority discussed the new drug applications for price fixation under para 5 and 15 of DPCO 2013.
These include Ravenbhel Healthcare and Mankind Pharma's Gliclazide ER and Metformin Hydrochloride (ER) Tablets, Alps Communication and Mankind Prime Lab's Amoxycillin and Potassium Clavulanate Oral Suspension IP, Akums Drugs & Pharmaceuticals and German Remedies Pharmaceutical's Aceclofenac plus Paracetamol plus Serratiopeptidase Tablet, Windlas Biotech and Zydus Healthcare's Atorvastatin, Clopidogrel & Aspirin Capsule, Troikaa Pharmaceutical's Paracetamol and Caffeine Tablets IP.
This comes in the 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. 5249(E) dated 11th November 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), has fixed, 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;
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
1 | Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets | Each enteric coated tablet contains: Trypsin BP 48mg Bromelain 90mg Rutoside Trihydrate BP 100mg Diclofenac Sodium IP 50mg | 1 Tablet | M/s Synokem Pharmaceuticals Limited / M/s Troikaa Pharmaceuticals Ltd. | 20.51 |
2 | Gliclazide ER and Metformin Hydrochloride (ER) Tablets | Each uncoated bilayer tablet contains: Gliclazide IP 60mg (as extended-release form) Metformin Hydrochloride IP 1000mg (as extended- release form) | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Ltd. | 10.03 |
3 | Telmisartan, Chlorthalidone & Cilnidipine tablets | Each film coated tablet contains: Telmisartan IP 40mg Chlorthalidone IP 6.25mg Cilnidipine IP 10mg | 1 Tablet | M/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited | 13.17 |
4 | Amoxycillin and Potassium Clavulanate Oral Suspension IP | Each 5ml of constituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 57mg | 1 ml | M/s Alps Communication Pvt. Ltd. / M/s Mankind Prime Labs Pvt. Ltd. | 4.05 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
5 | Aceclofenac + Paracetamol + Serratiopeptidas e Tablet | Each film coated tablet contains: Aceclofenac IP 100mg, Paracetamol IP 325mg Serratiopeptidase IP 10mg (As enteric coated granules eq. to 20000 enzyme actuvity unity of serratiopeptidase) | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. /M/s German Remedies Pharmaceuticals Pvt. Ltd. | 5.23 |
6 | Aceclofenac + Paracetamol + Serratiopeptidas e Tablet | Each film coated tablet contains: Aceclofenac IP 100mg, Paracetamol IP 325mg Serratiopeptidase IP 15mg (As enteric coated granules eq. to 30000 enzyme actuvity unity of serratiopeptidase) | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. /M/s German Remedies Pharmaceuticals Pvt. Ltd. | 8.09 |
7 | Ofloxacin and Metronidazole suspension | Each 5ml contains: Ofloxacin IP 50mg Metronidazole Benzoate IP eq. to Metronidazole 100mg | 1 ml | M/s Skymap Pharmaceuticals Pvt. Ltd./ M/s German Remedies Pharmaceuticals Pvt. Ltd. | 0.72 |
8 | Diclofenac Diethylamine, Methyl Salicylate, Menthol & Virgin Linseed Oil Topical Spray | Composition: Diclofenac Diethylamine IP 1.16%w/w eq. to Diclofenac Sodium IP 1% Virgin Linseed Oil BP 3% w/w Methyl Salicylate IP 10% w/w Menthol IP 5%w/w | 1 Gm | M/s Pontika Aerotech Limited / M/s Abbott Healthcare Pvt. Ltd. | 2.69 |
9 | Alpha Lipoic Acid, Methylcobalami n, Vitamin B6, Folic Acid, Benfotaimine, Biotin & Chromium Picolinate Capsule | Each hard gelatin capsule contains: Alpha Lipoic Acid USP 100mg Methylcobalamin IP 1500mcg Vitamin B6 IP 3mg Folic Acid IP 1.5mg Benfotaimine 50mg Biotin USP 5mg Chromium Picolinate USP eq. to Chromium 200mcg | 1 Capsule | M/s Theon Pharmaceuticals Ltd. / M/s German Remedies Pharmaceuticals Pvt. Ltd. | 13.57 |
10 | Lidocaine & Prilocaine Spray | Each actuation spray contains:Lidocaine 7.5mgPrilocaine 2.5mg | 1 Gm | M/s Pontika Aerotech / M/s Mankind Pharma Ltd. | 34.52 |
11 | Sodium Alginate, Sodium Bicarbonate & Calcium | Each 5ml contains: Sodium Alginate IP 250mg Sodium Bicarbonate IP 133.5mg | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mankind Pharma | 0.88 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
Carbonate Oral Suspension | Calcium Carbonate IP 80mg | Ltd. | |||
12 | Atorvastatin, Clopidogrel & Aspirin Capsule | Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg (As white coloured pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two reddish brown coloured film coated tablets, each containing 37.5mg clopidogrel tablets IP) Aspirin IP 75mg (As enteric coated white-coloured pellets) | 1 Capsule | M/s Windlas Biotech Limited / M/s Zydus Healthcare Limited | 13.22 |
13 | Telmisartan and Bisoprolol Fumarate Tablets | Each film coated tablet contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 2.5mg | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Emcure Pharmaceuticals Limited | 10.97 |
14 | Telmisartan and Bisoprolol Fumarate Tablets | Each film coated tablet contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 5mg | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Emcure Pharmaceuticals Limited | 12.62 |
15 | Telmisartan and Bisoprolol Fumarate Tablets | Each film coated tablet contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 2.5mg | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Alembic Pharmaceuticals Ltd. | 9.82 |
16 | Telmisartan and Bisoprolol Fumarate Tablets | Each film coated tablet contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 5mg | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Alembic Pharmaceuticals Ltd. | 11.60 |
17 | Azelnidipine and Telmisartan Tablet | Each uncoated bilayered tablet contains: Azelnidipine IP 16mg Telmisartan IP 40mg. | 1 Tablet | M/s Mascot Health Series Pvt. Ltd. / M/s Torrent Pharmaceuticals Limited | 17.96 |
18 | Azelnidipine and Telmisartan Tablet | Each uncoated bilayered tablet contains: Azelnidipine IP 16mg Telmisartan IP 40mg. | 1 Tablet | M/s Mascot Health Series Pvt. Ltd. / M/s Glenmark Pharmaceuticals Limited | 17.82 |
19 | Paraccetamol and Caffeine Tablets IP | Each uncoated tablet contains: Paracetamol IP 500mg Caffeine IP 50mg | 1 Tablet | M/s Troikaa Pharmaceuticals Limited | 1.77 |
20 | Atorvastatin and Bempedoic Acid | Each film coated tablet contains: | 1 Tablet | M/s Exemed Pharmaceuticals / | 52.97 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
Tablets | Bempedoic Acid 180mg Atorvastatin Calcium IP eq. to Atorvastatin 80mg | M/s Eris Lifesciences Limited | |||
21 | Ofloxacin & Dexamethasone Sodium Phosphate Eye/Ear Drops | Composition: Ofloxacin IP 0.3%w/v Dexamethasone Sodium Phosphate IP 0.1% w/v Sterile aqueous Vehicle q.s. | 1 ml | M/s Skymap Healthcare Pvt. Ltd. /M/s Healing Pharma India Pvt. Ltd. | 5.80 |
22 | Bilastine and Montelukast Oral Suspenssion | Each 5ml suspension contains: Bilastine 10mg Montelukast Sodium IP eq. to Monelukast 4mg | 1 ml | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 1.71 |
23 | Formoterol Fumarate and Budesonide Respirator Suspension | Each 2ml pulmule contains: Formoterol Fumarate Dihydrate IP eq. to Foroterol Fumarate 20mcg Budesonide IP 1mg | Per Pulmule of 2 ml | M/s Alkem Laboratories Limited | 56.20 |
The notification further added,
(a) The manufacturer of the above-mentioned formulations i.e., “new drug” under paragraph 2(1)(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 the 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 the 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 has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment 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 fixation of the retail price of such formulation as specified in column (2) of the above table with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries in Columns (3) & (5) thereof, the price order(s) fixing the retail price of the formulation with specified strength for that Manufacturer & Marketing Companies as specified in corresponding entries in Column (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.
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