NPPA fixes Retail Price of 4 scheduled formulations: January 2023

Download NPPA notification No. S.O. S.O. 88(E) dt 06-01-2023, the link is given below:

January 13, 2023

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Last Updated on October 9, 2024 by The Health Master

Download NPPA notification No. S.O. S.O. 88(E) dt 06-01-2023, the link is given below: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 4 scheduled formulations vide vide S.O. 88(E) dt 06-01-2023 based on the decision of 106th Authority meeting dated 30.12.2022

Download notification No. S.O. 88(E) dt 06-01-2023

This price fixation followed the decision of the 106th Authority meeting on December 30, 2022.

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 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 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 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:

Table

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)
1.	Buprenorphine (A) +Naloxone (B)	Tablet (Sub-lingual) 2mg(A)+0.5mg(B)	1 Tablet	32.98
2.	Buprenorphine (A) +Naloxone (B)	Tablet (Sub-lingual) 0.4mg(A)+0.1mg(B)	1 Tablet	10.54
3.	Buprenorphine	Tablet (Sub-lingual)0.4mg	1 Tablet	8.41
4.	Tenofovir Alafenamide Fumarate (TAF)	Tablet 25mg	1 Tablet	43.59

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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.

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(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 DPCO 2013. The manufacturer shall issue a price list in Form–V from the date of the 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 the 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 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 returns to the NPPA, in respect of the 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 DPCO 2013 read with Essential Commodities Act, 1955.

(i) Consequent to the issue of the 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.

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