New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 28 formulations, including those used to prevent heart attack and stroke in the future and to treat chest pain (angina), heart failure, and high blood pressure, seizures, and type 2 diabetes, asthma.These include...

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 28 formulations, including those used to prevent heart attack and stroke in the future and to treat chest pain (angina), heart failure, and high blood pressure, seizures, and type 2 diabetes, asthma.

These include Sun Pharma's Cyclosporine Ophthalmic Solution which is used to increase tear production in people with dry eye disease, Zydus Healthcare's Glycopyrronium plus Formoterol Fumarate plus Budesonide Powder for Inhalation.

In addition to this, the list also includes Alkem Healthscience and Alkem Laboratories' Amoxicillin plus Potassium Clavulanate Oral Suspension IP, Ravenbhel Healthcare and Sun Pharma Laboratories' Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet, Windlas Biotech and Torrent Pharmaceuticals' Atorvastatin plus Clopidogrel plus Aspirin Capsule.

Further, the list contains Acetylcysteine plus Acebrophylline Tablet manufactured and marketed by Pure and Cure Healthcare and Cipla limited, Levetiracetam Tablet IP manufatured and marketed by Pure and Cure Healthcare and Mankind Pharma.

This price fixation is followed by the decisions made by the National Pharmaceutical Pricing Authority at its 94th Authority meeting held on 23rd December 2021, where the Authority discussed new drug application price fixation under para 5 and para 15 of DPCO 2013.

This comes after 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), 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;

Each ml contains: Cyclosporine IP 0.9mg Aqueous Buffered Vehicle q.s.

M/s Sun Pharmaceutical Industries Limited

Amoxicillin + Potassium Clavulanate Oral Suspension IP

Each 5ml of reconstituted suspension contains: Amoxicillin Trihydrate eq. to Amoxicillin IP 600mg

Potassium Clavulanate Diluted IP eq. to Clavulanic Acid

M/s Alkem Healthscience / M/s Alkem Laboratories Ltd.

Composition: Povidone-Iodine IP 5%w/w (Available Iodine 0.5%w/w) Ornidazole IP 1% w/w In an Ointment base

M/s Innova Captab Ltd. / M/s Emcure Pharmaceuticals Ltd.

Pharmabutor Pvt. Ltd. / M/s Win Medicare Pvt. Ltd.

Each hard gelatin capsule Contains: Atorvastatin Calcium IP eq to Atorvastatin 40mg (As green coloured spherical pellets)

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two brown coloured film coated tablets Each containing

M/s Windlas Biotech Limited / M/s Intas Pharmaceuticals Ltd.

Diclofenac Diethylamine + Methyl Salicylate + Menthol Gel

Gel contains: Diclofenac Diethylamine IP 2.32% w/w (equivalent to Diclofenac Sodium IP 2.0% w/w)

Methyl Salicylate IP 10% w/w

/M/s Unison Pharmaceuticals Pvt. Ltd.

Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet

Each film coated bilayered tablet contains:

Telmisartan IP 40mg, Chlorthalidone IP 6.25mg

Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate (as extended release) 25mg

M/s Ravenbhel Healthcare Pvt. Ltd. /M/s Sun Pharma Laboratories Limited

Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet

Each film coated bilayered tablet contains:

Telmisartan IP 40mg, Chlorthalidone IP 6.25mg

M/s Ravenbhel Healthcare Pvt. Ltd. /M/s Sun Pharma Laboratories Limited

IP 47.50mg eq. to Metoprolol Tartrate (as extended release)

Each hard gelatine capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg (As coloured pellets),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two brown coloured film coated tablet each containing 37.5mg clopidogrel tablet IP),

Aspirin IP 75mg (As enteric coated white coloured pellets)

M/s Windlas Biotech Limited / M/s Torrent Pharmaceuticals Limited

Each hard gelatine capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg (As coloured pellets),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two reddish brown coloured film coated tablet each containing 37.5mg clopidogrel tablet IP), Aspirin IP 75mg (As enteric coated white

M/s Windlas Biotech Pvt. Ltd.

/ M/s USV Pvt. Ltd.

Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet

Each film coated bilayered tablet contains:

Telmisartan IP 40mg, Chlorthalidone IP 6.25mg

Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate

M/s Ravenbhel Healthcare Pvt. Ltd. /M/s Lupin Limited

Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet

Each film coated bilayered tablet contains:

Telmisartan IP 40mg, Chlorthalidone IP 6.25mg

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (as extended release) 50mg

M/s Ravenbhel Healthcare Pvt. Ltd. /M/s Lupin Limited

Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet

Each film coated bilayered tablet contains:

Telmisartan IP 40mg, Chlorthalidone IP 12.50mg

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (as extended release)

M/s Ravenbhel Healthcare Pvt. Ltd. /M/s Lupin Limited

Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet

Each film coated bilayered tablet contains:

Telmisartan IP 40mg, Chlorthalidone IP 12.50mg

Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate (as extended release)

M/s Ravenbhel Healthcare Pvt. Ltd. /M/s Lupin Limited

Each ml contains: Diclofenac Sodium IP 75mg

M/s Nitin Lifesciences Ltd./ M/s Modi- Mundipharma

Amoxycillin + Potassium Clavulanate Oral Suspension IP

Each 5ml of the reconstituted suspension contains: Amoxycillin Trihydrate eq. to Amoxycillin IP 400mg

M/s Associated Biotech./ M/s Eris Healthcare Pvt. Limited

Mefenamic Acid+ Tranexamic Acid Tablet

Each film coated tablet contains:

M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Eris Healthcare Pvt. Limited

Each hard gelatine capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg (As green coloured spherical pellets),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two brown coloured film coated tablets Each containing 37.5mg Clopidogrel

M/s Windlas Biotech Limited / M/s Torrent Pharmaceuticals Limited

Each uncoated bilayer tablet contains : Glimepiride IP - 1 mg Metformin Hydrochloride IP - 500 mg (Sustained Release Form)

M/s Theon Pharmaceuticals Limited / M/s FDC Limited

Metoprolol Succinate prolonged Released Tablets IP

Each film coated prolonged release tablet contains: Metoprolol Succinate IP 95mg eq. to Metoprolol Tartrate

M/s Micro Labs Limited

Each uncoated bilayer tablet contains : Glimepiride IP - 2 mg Metformin Hydrochloride IP - 500 mg (Sustained

Release Form) Voglibose IP - 0.2 mg

M/s Theon Pharmaceuticals Limited / M/s FDC Limited

M/s Pure & Cure

Healthcare Pvt. Ltd. / M/s Intas Pharmaceuticals

Each film coated tablet contains: Acetylcysteine BP 600mg

M/s Pure and Cure Healthcare Pvt. Ltd. / M/ Cipla limited

Each film coated tablet contains: Levetiracetam IP 1000mg

M/s Pure and Cure Healthcare Pvt. Ltd. / M/s

Each film coated tablet contains: Levetiracetam IP 1000mg

M/s Swiss Garnier Genexiaa Sciences Pvt. Ltd. / M/s Wockhardt

+ Formoterol Fumarate + Budesonide Powder for Inhalation

Each capsule contains: Glycopyrrolate IP eq. to Glycopyrronium 25mcg

Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate 12mcg

M/s Zydus Healthcare Limited

Each hard Gelatin Capsule Contains: Esomeprazole Magnesium Trihydrate IP eq. to Esomeprazole 40mg (as gastro-resistant pellets)

M/s Indu Drugs Private Limited

Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin

M/s Windlas Biotech Limited / M/s Zydus Healthcare Ltd.

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two brown coloured film coated tablets Each containing 37.5mg Clopidogrel

(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.

To view the official notice, click the link below:

https://www.nppaindia.nic.in/wp-content/uploads/2021/12/Retail_English.pdf

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