NPPA fixes price of 84 formulations, revises 1

Published On 2022-05-13 09:30 GMT | Update On 2023-10-19 10:21 GMT

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 84 formulations and has revised the retail price of 1 formulation under the Drugs (Prices Control) Order, 2013.The price fixation is based on the decision of the 96th and 97th Authority meetings.Out of 84 formulations, the authority has fixed the retail prices of 40...

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 84 formulations and has revised the retail price of 1 formulation under the Drugs (Prices Control) Order, 2013.

The price fixation is based on the decision of the 96th and 97th Authority meetings.

Out of 84 formulations, the authority has fixed the retail prices of 40 formulations which are fixed dose combinations (FDCs) of 2 molecules Linagliptin and Sitagliptin with metformin. The two drugs in question are soon going to become off-patent in July and the price authority has already fixed the price of their combination with the other popular drug metformin that is already under price control.

Apart from these 40 formulations, the authority has fixed retail prices of another 44 formulations ie., diabetes drug, underactive thyroid drug, heart ailment drug, Gastrointestinal drug, cough, painkiller etc.

This comes 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;

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
1.	Glimepiride and Metformin Hydrochloride sustained release tablets	Each uncoated bilayer tablet contains: Glimepiride IP 2mg Metformin Hydrochloride IP 500mg (As sustained release)	1 Tablet	M/s Indu Drugs Private Limited / M/s. Maxbien Pharma Private Limited	9.55
2.	Glimepiride and Metformin Hydrochloride sustained release tablets	Each uncoated bilayer tablet contains: Glimepiride IP 1mg Metformin Hydrochloride IP 500mg (As sustained release)	1 Tablet	M/s Indu Drugs Private Limited / M/s. Maxbien Pharma Private Limited	6.78
3.	Gastro-Resistant Omeprazole and Domperidone Sustained Release Capsules	Each hard gelatin capsule contains: Omeprazole IP 20mg (as gastro-resistant pellets) Domperidone IP 30mg (as sustained release pellets)	1 Capsule	M/s Indu Drugs Private Limited / M/s. Ma Lara Healthcare Pvt. Ltd.	9.53
4.	Gastro-Resistant Pantoprazole and Domperidone Sustained Release Capsules	Each hard gelatin capsule contains: Pantoprazole Sodium IP eq. to Pantoprazole 40mg (as gastro-resistant pellets) Domperidone IP 30mg (as sustained release pellets)	1 Capsule	M/s Indu Drugs Private Limited / M/s. Ma Lara Healthcare Pvt. Ltd.	9.21
5.	Gastro-Resistant Rabeprazole and Domperidone Sustained Release Capsules	Each hard gelatin capsule contains: Rabeprazole Sodium IP 20mg (as gastro-resistant pellets) Domperidone IP 30mg (as sustained release pellets)	1 Capsule	M/s Indu Drugs Private Limited / M/s. Ma Lara Healthcare Pvt. Ltd.	9.67
6.	Gastro-Resistant Esomeprazole and Domperidone Sustained Release Capsules	Each hard gelatin capsule contains: Esomeprazole Magnesium Trihydrate IP eq. to Esomeprazole 40mg (As gastro-resistant pellets) Domperidone IP 30mg (As Sustained Release pellets)	1 Capsule	M/s Indu Drugs Private Limited / M/s. Ma Lara Healthcare Pvt. Ltd.	10.17
7.	Thyroxine Sodium Tablets	Each uncoated tablet contains: Thyroxine Sodium IP eq. to anhydrous Thyroxine Sodium 200mcg (Synthetic Thyroid Hormone)	1 Tablet	M/s Abbott India Ltd.	1.98
8.	Atorvastatin & Ezetimibe Tablets	Each film coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 10mg Ezetimibe IP 10mg	1 Tablet	M/s Akums Drugs & Pharmaceuticals Ltd. /M/s German Remedies Pharmaceuticals Private Limited	16.23
9.	Atorvastatin & Clopidogrel Tablets	Each Uncoated Bilayered tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 10mg Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg	1 Tablet	M/s Pure and Cure Healthcare Pvt. Ltd. /M/s German Remedies Pharmaceuticals Private Limited	11.62
10.	Dextromethorphan hydrobromide, Chlorpheniramine Maleate & Phenylephrine Hydrochloride Syrup	Each 5 ml contains: Dextromethorphan hydrobromide IP 10mg Chlorpheniramine Maleate IP 2mg Phenylephrine Hydrochloride IP 5mg	1 ML	M/s Akums Drugs & Pharmaceuticals Ltd. /M/s German Remedies Pharmaceuticals Private Limited	0.86
11.	Atorvastatin, Clopidogrel & Aspirin Capsules	Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As film coated tablet IP) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg Aspirin IP 75mg (As Gastro- Resistant Tablet IP)	1 Capsule	M/s Safetab Life Science / M/s Ajanta Pharma Ltd.	4.68
12.	Atorvastatin, Clopidogrel & Aspirin Capsules	Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As film coated tablet IP) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg Aspirin IP 75mg (As Gastro- Resistant Tablet IP)	1 Capsule	M/s Safetab Life Science / M/s Ajanta Pharma Ltd.	6.32
13.	Paracetamol Infusion IP	Each 100ml contains: Paracetamol IP 1000mg water for Injection IP	1 ML	M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Mankind Life Sciences Pvt. Ltd.	2.88
14.	Norethisterone Acetate controlled release Tablets	Each film coated controlled release tablet contains: Norethisterone Acetate BP 15mg	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Obsurge Biotech Ltd.	19.20
15.	Atorvastatin & Clopidogrel Capsules	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 37.5mg Clopidogrel Tablets)	1 Capsule	M/s Windlas Biotech Limited. / M/s Mankind Pharma Ltd.	30.74
16.	Ivermectin & Albendazole Tablets	Each uncoated Chewable tablet contains: Ivermectin IP 6mg Albendazole IP 400mg	1 Tablet	M/s Next Wave (India) / M/s Mankind Prime Labs Pvt. Ltd.	22.52
17.	Aceclofenac, Paracetamol & Thiocolchicoside tablets	Each film coated tablet contains: Aceclofenac IP 100mg Paracetamol IP 325mg Thiocolchicoside IP 4mg	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Troikaa Pharmaceuticals Ltd.	16.27
18.	Etoricoxib & Paracetamol Tablets	Each Film Coated tablet contains: Etoricoxib IP 60 mg Paracetamol IP 325 mg	1 Tablet	M/s Haelwood Laboratories Pvt. Ltd. / M/s Eris Healthcare Pvt. Ltd.	7.67
19.	Metformin Hydrochloride prolonged- release and Glimepiride Tablets	Each uncoated bilayered tablet contains: Glimepiride IP 1 mg Metformin Hydrochloride IP 500 mg (as prolonged-release form)	1 Tablet	M/s Akum Drugs & Pharmaceuticals Limited/M/s German Remedies Pharmaceuticals Pvt. Ltd.	6.93
20.	Ivermectin & Albendazole Oral Suspension	Each 5 ml contains: Ivermectin IP 1.5 mg Albendazole IP 200 mg	1 ML	M/s Next Wave (India) / M/s Mankind Prime Labs Pvt. Ltd.	2.20
21.	Cilnidipine & Telmisartan tablets	Each film coated tablet contains: Cilnidipine IP 10mg Telmisartan IP 40 mg	1 Tablet	M/s Mediforce Healthcare Pvt. Ltd./ M/s Mankind Prime Labs Pvt. Ltd.	9.92
22.	Nimesulide & Paracetamol tablets	Each uncoated tablet contains: Nimesulide BP 100mg Paracetamol IP 325 mg	1 Tablet	M/s Softdeal Pharmaceutical Private Limited	4.27
23.	Travoprost & Timolol Maleate Eye Drops	Each ml contains: Travoprost IP 40 mcg Timolol Maleate eq. to Timolol IP 5 mg	1 ML	M/s East African (India) Overseas/ M/s Alkem Laboratories Limited	123.68
24.	Dorzolamide & Timolol Eye Drops	Composition: Dorzolamide Hydrochloride IP eq. to Dorzolamide 2% w/v Timolol Maleate eq. to Timolol IP 0.5 % w/v Water for Injection	1 ML	M/s East African (India) Overseas/ M/s Alkem Laboratories Limited	63.67
25.	Brimonidine Tartrate & Timolol Maleate Ophthalmic Solution	Each ml contains: Brimonidine Tartrate IP 2 mg Timolol Maleate eq. to Timolol IP 5 mg	1ML	M/s East African (India) Overseas/ M/s Alkem Laboratories Limited	49.04
26.	Atorvastatin & Clopidogrel Tablets	Each uncoated bilayered tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 20 mg Clopidogrel Bisulphate eq. to Clopidogrel IP 75 mg	1 Tablet	M/s Pure and Cure Healthcare Pvt. Limited/M/s German Remedies Pharmaceuticals Pvt. Ltd.	17.17
27.	Telmisartan & Chlorthalidone Tablets	Each film coated tablet contains: Telmisartan IP 80mg Chlorthalidone IP 12.5mg	1 Tablet	M/s Akums Drugs & Pharmaceuticals Limited/M/s Abbott Healthcare Pvt. Ltd.	10.55
28.	Voglibose, Glimepiride and Metformin Hydrochloride (sustained release)Tablets	Each uncoated bilayered tablet contains: Voglibose IP 0.2mg Glimepiride IP 2mg Metformin Hydrochloride IP 1000mg (as sustained release form)	1 Tablet	M/s Swiss Garnier Genexiaa Sciences Pvt Ltd. / M/s Mankind Pharma Ltd.	13.31
29.	Vitamin D3 Oral Solution	Each 5ml contains: Cholecalciferol IP (In nano Droplet form) 60000IU	1 ML	M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Limited	13.94
30.	Vitamin D3 Oral Solution	Each 5ml contains: Cholecalciferol IP (In nano Droplet form) 60000IU	1 ML	M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Prime Labs Pvt. Ltd.	13.94
31.	Calcium & Vitamin D3 Suspension	Each 5ml contains: 625mg Calcium Carbonate from an Organic Source (Oyster Shell) eq. to Elemental Calcium 250mg Vitamin D3 IP 125IU	1 ML	M/s Shivalik Remedies Pvt. Ltd. / M/s Mankind Prime Labs Pvt. Ltd.	0.51
32.	Voglibose, Glimepiride and Metformin Hydrochloride (sustained release) Tablets	Each uncoated bilayered tablet contains: Voglibose IP 0.2mg Glimepiride IP 1mg Metformin Hydrochloride IP 1000mg (as sustained release form)	1 Tablet	M/s Swiss Garnier Genexiaa Sciences Pvt Ltd. / M/s Mankind Pharma Ltd	11.43
33.	Diclofenac Diethylamine, Methyl Salicylate, Linseed Oil & Menthol Tropical Spray	Composition: Diclofenac Diethylamine IP 1.16% w/w eq. to Diclofenac Sodium IP 1% w/w Virgin Linseed Oil BP 3% w/w Methyl Salicylate IP 10% w/w Menthol IP 5% w/w	1GM	M/s Pontika Aerotech Ltd./M/s Zuventus Healthcare Ltd.	2.69
34.	Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate & Menthol Gel	Composition: Diclofenac Diethylamine IP 1.16% w/w eq. to Diclofenac Sodium IP 1% w/w Virgin Linseed Oil(Oleum Lini) BP 3% w/w Methyl Salicylate IP 10% w/w Menthol IP 5% w/w	1GM	M/s Nanz Med Science Pharma Pvt. Ltd./M/s Zuventus Healthcare Ltd.	2.83
35.	Tramadol & Paracetamol Tablets	Each film coated tablet contains: Tramadol Hydrochloride IP37.5mg Paracetamol IP 325mg	1 Tablet	M/s Hab Pharmaceuticals & Research Limited / M/s German Remedies Pharmaceuticals Private Limited	8.35
36.	Telmisartan & Amlodipine Tablets	Each uncoated bilayered tablet contains: Telmisartan IP 40mg Amlodipine Besylate IP eq. to Amlodipine 5mg	1 Tablet	M/s Indchemie Health Specialities Pvt. Ltd.	9.49
37.	Telmisartan & Metoprolol Succinate ER Tablets	Each film coated bilayered tablet contains: Telmisartan IP 40mg Metoprolol Succinate IP eq. to Metoprolol Tartrate 50mg (as Extended Release form)	1 Tablet	M/s Akum Drugs & Pharmaceuticals Limited/M/s German Remedies Pharmaceuticals Pvt. Ltd.	13.66
38.	Telmisartan + Hydrochlorothiaz ide Tablets	Each uncoated bilayered tablet contains: Telmisartan IP 40mg Hydrochlorothiazide IP 12.50mg	1 Tablet	M/s Indchemie Health Specialities Pvt. Ltd.	9.95
39.	Paracetamol & Chlorzoxazone Tablets	Each uncoated tablet contains: Paracetamol IP 500mg Chlorzoxazone USP 250mg	1 Tablet	M/s The Madras Pharmaceuticals/M/ s Sun Pharmaceutical Industries Ltd.	10.31
40.	Diclofenac Diethylamine, Methyl Salicylate, Menthol & Absolute Alcohol Topical Spray	Composition: Diclofenac Diethylamine IP 2.32% w/v eq. to Diclofenac Sodium IP 2% w/v Methyl Salicylate IP 10% w/v Menthol IP 5% w/v Absolute Alcohol IP 10% v/v	1 GM	M/s Pontika Aerotrch Limited / M/s Mankind Pharma Ltd.	3.22
41.	Vildagliptin + Metformin Hydrochloride Tablet	Each film coated tablet contains: Vildagliptin 50mg Metformin Hydrochloride IP 500mg	1 Tablet	M/s Associated Biotech / M/s Unistretch Pharmaceuticals Pvt. Ltd.	6.75
42.	Vildagliptin + Metformin Hydrochloride Tablet	Each film-coated tablet contains: Vildagliptin IP 50mg Metformin Hydrochloride IP 1000mg	1 Tablet	M/s Windlas Biotech Limited / M/s Mankind Prime Labs Pvt. Lttd.	7.60
43.	Vildagliptin (as Immediate release) and Metformin Hydrochloride (as sustained release) Tablets	Each uncoated bilayer tablets contains: Vildagliptin IP (as Immediate release) 50mg Metformin Hydrochloride IP (as sustained release) 1000mg	1 Tablet	M/s Pure and Cure Healthcare Pvt. Ltd. M/s German Remedies Pharmaceuticals Pvt. Ltd.	8.06
44.	Vildagliptin (as Immediate release) and Metformin Hydrochloride (as sustained release) Tablets	Each uncoated bilared tablets contains: Vildagliptin IP (as Immediate release) 50mg Metformin Hydrochloride IP (as sustained release) 500mg	1 Tablet	M/s Pure and Cure Healthcare Pvt. Ltd. M/s German Remedies Pharmaceuticals Pvt. Ltd.	7.21

Note:

(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.

Besides these, the authority has also revised the retail price of Hetero Labs and Emcure Pharma's Darunavir plus Ritonavir tablet at Rs 212.91.

The revision comes in line with the directions given by the Department of Pharmaceuticals (DOP) vide review order and letter specified in column (6) of the table herein below and 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, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (5) 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 (8) thereof;

Sl.

No.

Name of the Formulation

Dosage form & Strength

Unit

Retail Price (Rs.)

DoP (i) Review no. & Date (ii) Letter no. and

Date

Existing SO number & date

Manufacturer & Marketing Company

respectively

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

Darunavir + Ritonavir tablet

Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 800mg, Ritonavir IP 100mg Tablet

1 Tablet

212.91

(i)31015/16/2019- Pricing dated 25.06.2021 (ii)31015/16/2019- Pricing (E-14046) dated 05.04.2022

4062(E) dated 08.11.2019 (at Sl. No. 25)

M/s Hetero Labs Limited / M/s Emcure Pharmaceuticals Ltd.

Note:

(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 (5) 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 (5) 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 (5) 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.

(e) The above mentioned retail prices are applicable only to the manufacturer / marketer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, 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 manufacturers/marketing companies.

To view the official notices, click on the links below:

https://medicaldialogues.in/pdf_upload/nppa-1-222104.pdf

https://medicaldialogues.in/pdf_upload/nppa-2-222106.pdf

https://medicaldialogues.in/pdf_upload/nppa-3-222107.pdf

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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NPPA fixes price of 84 formulations, revises 1

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