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    • NPPA fixes retail...

    NPPA fixes retail price of 14 drug formulations; Details

    Farhat NasimWritten by Farhat Nasim Published On 2019-11-13T11:23:02+05:30  |  Updated On 16 Aug 2021 2:38 PM IST

    New Delhi: Through a recent notification, the apex drug price regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 14 drug formulations under the Drugs Prices Control Order (DPCO), 2013, exclusive of goods and services tax (GST).


    The formulations whose prices have been fixed by NPPA include combination drug Emtricitabine and Tenofovir (Tafmune-EM), Tenofovir Alafenamide tablet, Tenofovir + Emtricitabine Tablet (TAFICITA), Tenofovir Alafenamide Tablet (Tenocruz
    AF) and so on.


    Various drugmakers including Sun Pharma, Natco Pharma, Mylan, Hetero Labs, Cadila Healthcare, Cipla, Emcure Pharma, Abbott, Dr Reddy's Labs, Torrent Pharma are involved in manufacturing the said formulations under different brand names.


    The formulations mentioned in the list are indicated for the treatment of HIV-1 infection in adults and chronic hepatitis B infection, a viral infection of the liver,


    The details of the list of all 14 formulations released by NPPA read;







































































































































































































































































































































































































































































































































































    Sl.

    No.
    Name of the FormulationDosage form & StrengthUnitRetail Price (Rs.)Review Order number and dateExisting SO number &

    date
    Manufacturer & Marketing Company

    respectively
    (1)(2)(3)(4)(5)(6)(7)(8)
    1.Emtricitabine + Tenofovir tabletEach film-coated tablet contains:1

    Tablet
    57.69











































    31015/10/2019-

    Pricing dated 30.08.2019
    1489(E) dated 29.03.2019M/s Hetero Labs Ltd. / M/s Cipla Ltd.
    (Tafmune – EM)Emtricitabine IP 200 mg(at Sl. No. 9)
    Tenofovir Alafenamide
    Hemifumarate eq to Tenofovir
    Alafenamide 25 mg
    2.Emtricitabine +Each film-coated tablet132.491489(E) datedM/s Hetero Labs Ltd. /
    Tenofovircontains:Tablet29.03.2019M/s Cipla Ltd.
    Alafenamide tabletEmtricitabine IP 200 mg +(at Sl. No. 21)
    Tenofovir Alafenamide
    Hemifumarate eq to Tenofovir
    Alafenamide 10mg tablet
    3.TenofovirEach film-coated tablet146.181489(E) datedM/s Hetero Labs Ltd. /
    Alafenamide tabletcontains:Tablet29.03.2019M/s Cipla Ltd.
    Tenofovir Alafenamide(at Sl. No. 12)
    Hemifumarate eq to Tenofovir
    Alafenamide 25 mg tablet
    4.Tenofovir +Each film-coated tablet1489(E) datedM/s Mylan Laboratories Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd.
    Emtricitabinecontains:29.03.2019
    Tablet (TAFICITA)Tenofovir Alafenamide

    fumarate eq. to Tenofovir
    1

    Tablet
    57.69(at Sl. No. 10)
    Alafenamide 25mg,
    Emtricitabine 200mg ,
    5.TenofovirEach film-coated tablet11489(E) datedM/s Mylan

    Laboratories Ltd./ M/s Mylan Pharmaceuticals Pvt. Ltd.
    Alafenamidecontains:Tablet29.03.2019
    TabletTenofovir Alafenamide46.18(at Sl. No. 11)
    fumarate eq. to Tenofovir
    Alafenamide 25 mg
    6.TenofovirEach film-coated tablet146.181489(E) datedM/s Hetero Labs Ltd./
    Alafenamidecontains:Tablet29.03.2019M/s Cadila Healthcare
    TabletTenofovir Alafenamide(at Sl. No. 13)Ltd.
    Hemifumarate eq. to Tenofovir
    Alafenamide 25 mg
    7.TenofovirEach film-coated tablet146.181489(E) datedM/s Hetero Labs Ltd./
    Alafenamidecontains:Tablet29.03.2019M/s Emcure
    TabletTenofovir Alafenamide(at Sl. No. 14)Pharmaceuticals Ltd.
    Hemifumarate eq. to Tenofovir
    Alafenamide 25 mg
    8.TenofovirEach film-coated tablet146.181489(E) datedM/s Natco Pharma Ltd.
    Alafenamidecontains:Tablet29.03.2019/ M/s Sun Pharma
    TabletTenofovir Alafenamide(at Sl. No. 15)Laboratories Ltd.
    fumarate eq. to Tenofovir
    Alafenamide 25 mg
    9.Tenofovir Alafenamide TabletEach film-coated tablet contains:

    Tenofovir Alafenamide
    1

    Tablet
    46.181489(E) dated 29.03.2019

    (at Sl. No. 16)
    M/s Natco Pharma Ltd.

    / M/s Abbott India Ltd.
    fumarate eq. to Tenofovir
    Alafenamide 25 mg
    10.Tenofovir Alafenamide TabletEach film-coated tablet contains:

    Tenofovir Alafenamide
    1

    Tablet
    46.181489(E) dated 29.03.2019

    (at Sl. No. 17)
    M/s Natco Pharma Ltd.
    fumarate eq. to Tenofovir
    Alafenamide 25 mg
    11.Tenofovir Alafenamide TabletEach film-coated tablet contains:

    Tenofovir Alafenamide
    1

    Tablet
    46.181489(E) dated 29.03.2019

    (at Sl. No. 18)
    M/s Natco Pharma Ltd/ M/s Cadila Healthcare Ltd.
    fumarate eq. to Tenofovir
    Alafenamide 25 mg
    12.Tenofovir Alafenamide TabletEach film-coated tablet contains:

    Tenofovir Alafenamide
    1

    Tablet
    46.181489(E) dated 29.03.2019

    (at Sl. No. 19)
    M/s Natco Pharma Ltd./ Dr Reddy's Laboratories Ltd.
    fumarate eq. to Tenofovir
    Alafenamide 25 mg
    13.Tenofovir Alafenamide TabletEach film-coated tablet contains:

    Tenofovir Alafenamide fumarate eq. to Tenofovir
    1

    Tablet
    46.181489(E) dated 29.03.2019

    (at Sl. No. 20)
    M/s Natco Pharma Ltd./ M/s Aprazer Healthcare Pvt. Ltd.
    Alafenamide 25 mg
    14.TenofovirEach film-coated tablet146.181690(E) datedM/s Hetero Labs Ltd./
    Alafenamidecontains:Tablet02.05.2019M/s Torrent
    Tablet (Tenocruz

    AF)
    Tenofovir Alafenamide

    Hemifumarate eq. to Tenofovir
    (at Sl. No. 17)Pharmaceuticals

    Limited
    Alafenamide 25 mg

    The NPPA notice further added;




    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.


    Also Read: NPPA fixes retail price of 10 combo drugs including Metformin, Rosuvastatin; Details
    AbbottCadila HealthcareCiplaDPCODr Reddy'sDr Reddy's Labsdrug mrpdrug priceDrugs Prices Control OrderEmcure Pharmaemtricitabinehepatitis BHetero LabsHIVHIV drugHIV infectionliver infectionMylanNatco pharmaNational Pharmaceutical Pricing AuthorityNPPAretail priceSun PharmaTAFICITATafmuneTenofovirtenofovir alafenamideTorrent Pharma

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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