NPPA fixes retail prices of 15 formulations, ceiling price of Framycetin

Written by Ruchika Sharma Published On 2022-04-19T16:06:01+05:30 | Updated On 6 Oct 2023 5:01 PM IST

NPPA fixes retail prices of 15 formulations, ceiling price of Framycetin

New Delhi: National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India has fixed retail prices of 15 formulations and a ceiling price of 1 scheduled formulation under Drugs (Prices Control) Order, 2013.

The authority has fixed the prices based on the decision of the 96th Authority meeting dated 24.03.2022.

Retail prices of 15 formulations

The formulations include Exemed Pharma and Emcure Pharma's Dapagliflozin plus Metformin Hydrochloride Extended release Tablet, Synokem Pharma and Natco Pharma's Dapagliflozin plus Metformin Hydrochloride (As Extended release form) Tablet, MSN Labs and USV Limited's Dapagliflozin plus Metformin Hydrochloride Extended release Tablet, Intas Pharma's Human Normal Immunoglobulin for Intravenous use IP 5% (Ig M Enriched), Synokem Pharma and Serum Institute of India's Medroxyprogestero ne Acetate sustained release Tablet.

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 30^th May 2013 and S. O. 701(E) dated 10^th 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.	Metformin (extended-release) + Teneligliptin Tablet	Each uncoated bilayered tablet contains: Metformin Hydrochloride IP 500mg (as Extended- Release) Teneligliptin Hydrobromide hydrate eq. to Teneligliptin 20mg	1 Tablet	M/s Associated Biotech / M/s Dales Laboratories	7.14
2.	Dapagliflozin + Metformin Hydrochloride Extended release Tablet	Each film-coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form)	1 Tablet	M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited	10.70
3.	Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet	Each film-coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form)	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Natco Pharma Ltd.	7.97
4.	Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet	Each film-coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form)	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Apex Laboratories Private Limited	10.70
5.	Dapagliflozin + Metformin Hydrochloride Extended release Tablet	Each film-coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As Extended release form)	1 Tablet	M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited	9.18
6.	Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet	Each film-coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As Extended release form)	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Natco Pharma Ltd.	7.30
7.	Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet	Each film-coated bilayer tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As extended release form)	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Apex Laboratories Private Limited	9.18
8.	Dapagliflozin + Metformin Hydrochloride Extended release Tablet	Each film-coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 1000mg (As extended release form)	1 Tablet	M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited	7.29
9.	Dapagliflozin + Metformin Hydrochloride Extended release Tablet	Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride IP/USP 1000mg (As extended release form)	1 Tablet	M/s MSN Laboratories Pvt. Ltd. / M/s USV Limited	7.29
10.	Dapagliflozin + Metformin Hydrochloride Extended release Tablet	Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride IP/USP 500mg (As extended release form)	1 Tablet	M/s MSN Laboratories Pvt. Ltd. / M/s USV Limited	6.16
11.	Human Normal Immunoglobulin for Intravenous use IP 5% (Ig M Enriched)	Each vial contains: Total Protein 50 g/L, Immunoglobulin M 6g/L, Immunoglobulin A 6g/L, Immunoglobulin G 38g/L, Glucose Monohydrate (as stabilizer) 27.5g/L, Sodium Chloride 4.56g/L, Water for injection q. s. Distribution of Ig G subclass is approx. 62%IgG1,27%IgG2,1%IgG3, 10%IgG4	Per 1 ml (for 10 ml vial)	M/s Intas Pharmaceuticals Ltd	177.85
12.	Medroxyprogestero ne Acetate sustained release Tablet	Each uncoated sustained release tablet contains: Medroxyprogesterone Acetate IP 30mg	1 Tablet	M/s Synokem Pharmaceuticals Ltd. / M/s Serum Institute of India Pvt. Ltd.	14.04
13.	Medroxyprogestero ne Acetate SR Tablet	Each uncoated sustained release tablet contains: Medroxyprogesterone Acetate IP 30mg	1 Tablet	M/s Synokem Pharmaceuticals Limited / M/s Torrent Pharmaceuticals Ltd.	14.04
14.	Glycopyrrolate + Formoterol Fumarate + Budesonide Inhalation	Each actuation delivers: Glycopyrrolate IP 9mcg Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate 4.8mcg Budesonide IP 160mcg	1 MDI	M/s Zydus Healthcare Ltd.	8.63
15.	Folic Acid, Pyridoxine Hydrochloride, Methylcobalamin & Vitamin D3 Tablet	Each uncoated mouth dissolving tablet contains: Folic Acid IP 5mg Pyridoxine Hydrochloride IP 3mg Methylcobalamin IP 1500mcg Vitamin D3 IP 1000 IU	1 tablet	M/s Unison Pharmaceuticals Pvt. Ltd.	6.70

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.

For more details, check out the full notice on the link below:

https://medicaldialogues.in/pdf_upload/retaileng15-222114.pdf

The ceiling price of scheduled formulation

The authority has also fixed the ceiling price of Framycetin at Rs 1.19.

This comes after in exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 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 of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) at Sl. No. 6 of SO 1503(E) dated 30th March, 2022 in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulation specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:

Sl.

No.

Name of the Scheduled Formulation

Dosage form & Strength

Unit

Ceiling Price (Rs.

(1)

(2)

(3)

(4)

(5)

Framycetin

Cream 0.5%

1 GM

1.19

Note: (a) All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any.

(b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.

(c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table. Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Framycetin Cream 0.5% 1 GM 1.19

(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 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) 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.

(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.

(g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.

(h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.

(i) 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.

For more details, check out the full notice on the link below:

https://medicaldialogues.in/pdf_upload/nppa-fixes-retail-prices-of-15-formulations-ceiling-price-of-framycetin-222112.pdf

nppanational pharmaceutical pricing authorityretail pricesceiling pricesEmcure PharmaNatco PharmaMSN LabsIntas PharmaSerum Institute of Indiazydus healthcaremetforminframycetindapagliflozin

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent 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