NPPA has fixed the ceiling prices of 2 formulations under Drugs (Prices Control) Order, 2013 relating to the 80th Authority meeting dated 26.10.2020, the DPCO price of Praziquantel tablet list contains Praziquantel tablet 600 mg and Sodium Nitrite 30mg/ml injection. The notification out on 3rd November 2020 on NPPA official website.
New Delhi, the 3rd November, 2020
S.O. 3977(E):- 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 item specified at Sl. No. 11 & 13 of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. 1214(E), dated 25th March 2020, 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 to as NPPA) hereby fixes the prices 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:
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DPCO price of Praziquantel Tablet and Sodium Nitrite Injection.
|Sl. No.||NAME OF THE SCHEDULED|
|DOSAGE FORM & STRENGTH||UNIT||CEILING PRICE|
|1||Praziquantel Tablet||Praziquantel 600 mg||Per tablet||34.63|
|2||Sodium nitrite Injection||30 mg/ml||Per ml||25.91|
(a) All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled formulation 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 formulation 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 formulation 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.
(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 the above said scheduled formulation shall furnish a quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation 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.
PN/212/80/2020/F F. No. 8(80)/2020/DP/NPPA-Div.-II
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The author has 18 years of experience in the Quality Control, and Quality Assurance departments of Pharmaceutical Manufacturing Companies. Have exposure of all documents for WHO-GMP audits, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments.