NPPA revises ceiling prices of 14 drug formulations including Injections, Inhalators; Details

New Delhi: Through a recent notification, the government regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) revises the ceiling price of 14 drug formulations used for treating various ailments, including bacterial infection, arthritis, allergic reactions.

Some of the formulations whose price has been revised by the NPPA are Gentamicin in dosage form and strength of Injection 40mg/ml, Dexamethasone in dosage form and strength of an injection 4mg/ml.

The notification released by NPPA added that the manufacturer may add goods and services tax(GST) only if they have paid actually or it is payable to the Government on the retail price as mentioned.

Sl. No.	Name of the Scheduled Formulation	Dosage form & Strength	Unit	Ceiling Price (Rs.)	Review Order number and date	Existing SO number and date
(1)	(2)	(3)	(4)	(5)	(6)	(7)
1.	Budesonide	Inhalation	Per Metered	1.19	i. 31015/27/2016- PI.I dated 14.09.2016 ii. 31015/52/2017- Pricing dated 30.10.2017 iii. 31015/54/2017- Pricing dated 26.06.2018	1461(E) dated
		(MDI) 100 mcg	Dose			02.04.2018
		/ dose				(at Sl. No. 112)
2.	Budesonide	Inhalation (MDI) 200 mcg	Per Metered Dose	1.48		1461(E) dated 02.04.2018
		/ dose				(at Sl. No. 113)
3.	Budesonide	Inhalation	Per Metered	1.77		1461(E) dated
	(A)+ Formoterol (B)	(MDI) 100 mcg (A) + 6 mcg (B)	Dose			02.04.2018 (at Sl. No. 118)
4.	Budesonide	Inhalation	Per Metered	2.51		1461(E) dated
	(A)+	(MDI) 200 mcg	Dose			02.04.2018
	Formoterol (B)	(A) + 6 mcg (B)				(at Sl. No. 119)
5.	Budesonide	Inhalation	Per Metered	2.86		1461(E) dated
	(A)+	(MDI) 400 mcg	Dose			02.04.2018
	Formoterol (B)	(A) + 6 mcg (B)				(at Sl. No. 120)
6.	Budesonide	Inhalation (DPI) 100	Per Dose	1.87		1461(E) dated 02.04.2018
		mcg/dose				(at Sl. No. 112)
7.	Budesonide	Inhalation (DPI) 200 mcg/dose	Per Dose	2.71		1461(E) dated 02.04.2018 (at Sl. No. 113)
8.	Budesonide (A)+ Formoterol (B)	Inhalation (DPI) 100 mcg (A) + 6 mcg (B)	Per Dose	3.56		1461(E) dated 02.04.2018 (at Sl. No. 118)
9.	Budesonide (A)+ Formoterol (B)	Inhalation (DPI) 200 mcg (A) + 6 mcg (B)	Per Dose	4.73		1461(E) dated 02.04.2018 (at Sl. No. 119)
10.	Budesonide (A)+ Formoterol (B)	Inhalation (DPI) 400 mcg (A) + 6 mcg (B)	Per Dose	6.04		1461(E) dated 02.04.2018 (at Sl. No. 120)
11.	Tiotropium	Inhalation (MDI) 9 mcg/dose	Per Metered Dose	2.08		1461(E) dated 02.04.2018 (at Sl. No. 799)
12.	Tiotropium	Inhalation (DPI) 18 mcg/dose	Per Dose	8.72		1461(E) dated 02.04.2018 (at Sl. No. 798)
13.	Dexamethasone	Injection 4mg/ml	Per 2ML Pack	8.75	i. 31015/15/2017- Pricing dated 10.01.2019 ii. 31015/16/2017- Pricing dated 10.01.2019	1461(E) dated 02.04.2018 (at Sl. No. 243)
14.	Gentamicin	Injection 40mg/ml	Per 2ML Pack	7.89	31015/21/2017- Pricing dated 10.01.2019	1461(E) dated 02.04.2018 (at Sl. No. 353)

The notice further added,

• All manufacturers of scheduled formulations, 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


• 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,


• 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


• 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


• 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


• 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.


• 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


• 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,


• Consequent to the issue of ceiling prices of such formulations 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