National Pharmaceutical Pricing Authority

(Published in Part II, Section 3, Sub Section (ii) of the
Gazette of India Extraordinary)

Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
(National Pharmaceuticals Pricing Authority)

New Delhi, the 3^rd June, 2016

ORDER

S.O.1993(E) – In implementation of directions given in line with review order issued vide letter no. 31015/9/2013/PI.I dated 05.05.2016 passed by the Department of Pharmaceuticals in respect of applications from various pharmaceutical companies against S.O. No. 3127(E) dated 10th December, 2014 for revision of ceiling prices of I.V. Fluids; in exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 and paragraph 4, 6, 10, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013, S.O. 701(E) dated 10th March, 2016 and S.O. 1192(E) dated 22nd 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) No. S.O. 3127(E) dated 10th December, 2014, S.O. 619(E) dated 26th February, 2015 and S.O. 644(E) dated 2nd March, 2016, 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, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit/packaging specified respectively in the corresponding entries in columns (3) and (4) thereof:

Table

Sl. No.	Name of the Scheduled Formulation	Strength	Unit/ Packaging	Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)
1	Glucose Injection	Glucose-5%	100ml Glass	10.84
2	Glucose Injection	Glucose-5%	250ml Glass	15.33
3	Glucose Injection	Glucose-5%	500ml Glass	25.23
4	Glucose Injection	Glucose-5%	1000ml Glass	32.25
5	Glucose Injection	Glucose-5%	100ml PVC	12.00
6	Glucose Injection	Glucose-5%	250ml PVC	18.33
7	Glucose Injection	Glucose-5%	500ml PVC	22.45
8	Glucose Injection	Glucose-5%	1000ml PVC	38.94
9	Glucose Injection	Glucose-5%	500ml Non-PVC	61.32
10	Glucose Injection	Glucose-5%	1000ml Non-PVC	70.88
11	Sodium Chloride Injection	Sodium Chloride-0.9%	100ml Glass	13.06
12	Sodium Chloride Injection	Sodium Chloride-0.9%	250ml Glass	15.18
13	Sodium Chloride Injection	Sodium Chloride-0.9%	500ml Glass	24.50
14	Sodium Chloride Injection	Sodium Chloride-0.9%	1000ml Glass	32.26
15	Sodium Chloride Injection	Sodium Chloride-0.9%	100ml PVC	11.36
16	Sodium Chloride Injection	Sodium Chloride-0.9%	250ml PVC	17.49
17	Sodium Chloride Injection	Sodium Chloride-0.9%	500ml PVC	20.41
18	Sodium Chloride Injection	Sodium Chloride-0.9%	1000ml PVC	37.75
19	Sodium Chloride Injection	Sodium Chloride-0.9%	100ml Non-PVC	31.35
20	Sodium Chloride Injection	Sodium Chloride-0.9%	250ml Non-PVC	46.28
21	Sodium Chloride Injection	Sodium Chloride-0.9%	500ml Non-PVC	65.55
22	Sodium Chloride Injection	Sodium Chloride-0.9%	1000ml Non-PVC	73.41
23	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	250ml Glass	18.47
24	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	500ml Glass	24.20
25	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	1000ml Glass	30.76
26	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	100ml PVC	9.18
27	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	250ml PVC	17.68
28	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	500ml PVC	22.79
29	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	1000ml PVC	38.47
30	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	500ml Non-PVC	63.73
31	Glucose+ Sodium Chloride Injection	Glucose-5% Sodium Chloride-0.9%	1000ml Non-PVC	74.49

NOTE :

All the existing 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 local taxes 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 local taxes as applicable, if any.
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 local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
The manufacturers may add local taxes 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.
The manufacturer shall issue a price list in Form-V as per paragraph 24 (2) of the DPCO, 2013.
For formulation in Non-PVC packaging, ceiling price mentioned in column (5) of the above said table shall be admissible provided such packs are (i) self collapsible; (ii) not having air-vent; and (iii) there is no chance of contamination at manufacturing as well as admixing levels. Otherwise the ceiling price for PVC packs shall be applicable for such Non-PVC packaging also.
For any other pack size manufactured, the manufacturer shall approach NPPA for specific price approval for its formulations.
For any other packaging material used or special features claimed, the manufacturer shall approach NPPA for specific price approval for its formulations. Otherwise the ceiling price for PVC or Glass packs, as the case may be, shall be applicable.
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. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the 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.
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 (Price Control) Order, 2013 read with Essential Commodities Act, 1955.
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.

PN/164/32/2016/F

F.No. 8(32)/2016/D.P./NPPA-Div.II

(BALJIT SINGH)
Assistant Director
National Pharmaceutical Pricing Authority

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