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 27^th April, 2016

ORDER

S.O.1560(E) – In exercise of the powers conferred by paragraphs 4, 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 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. 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 formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:

Table

Sl. No.	Name of the Scheduled Formulation	Strength	Unit	Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)
1	Mefenamic Acid Oral liquid	Mefenamic acid -100mg/5ml	1 ml	0.48
2	Prednisolone Oral liquid	Prednisolone-5mg/5ml	1 ml	0.40
3	Prednisolone Oral liquid	Prednisolone-15mg/5ml	1 ml	0.71
4	Mebendazole Oral liquid	Mebendazole -100mg/5ml	1 ml	0.73
5	Diethylcarbamazine Oral Liquid	Diethylcarbamazine-120mg/5ml	1 ml	0.43
6	Amoxicillin Oral liquid	Amoxicillin-250mg/5ml	1 ml	1.26
7	Amoxicillin+ Clavulanic Acid Dry Syrup	Amoxicillin-125mg + Clavulanic Acid-31.25mg/5ml	1 ml	2.00
8	Cefadroxil Oral liquid	Cefadroxil-125mg/5ml	1 ml	0.58
9	Clarithromycin Oral liquid	Clarithromycin-125mg/5ml	1 ml	4.01
10	Metronidazole Oral liquid	Metronidazole-200mg/5ml	1 ml	0.25
11	Nitrofurantoin Oral liquid	Nitrofurantoin-25mg/5ml	1 ml	0.76
12	Ranitidine Oral liquid	Ranitidine-75mg/5ml	1 ml	0.54
13	Capecitabine Tablet	Capecitabine-500mg/tablet	1 Tablet	117.27
14	Paclitaxel Injection	Paclitaxel-100mg/16.7ml	1 ml	207.08
15	Lactulose Oral liquid	Lactulose-10gm/15ml	1 ml	0.98
16	Sucralfate Oral liquid	Sucralfate -1gm	1 ml	0.66
17	Levetiracetam Oral liquid	Levetiracetam-100mg/ml	1 ml	3.53
18	Mesna Injection	Mesna-100mg/ml	1 ml	14.93
19	Labetalol Injection	Labetalol-5mg/ml	1 ml	47.03
20	Xylometazoline Nasal Drops	Xylometazoline-0.1 %	1 ml	4.82
21	Xylometazoline Nasal Drops	Xylometazoline-0.05 %	1 ml	3.65
22	Cyclosporine Oral liquid	Cyclosporine-100 mg/ml	1 ml	79.43
23	Alprostadil Injection	Alprostadil-0.5 mg/ml	1 ml	5254.55
24	Caffeine Injection	Caffeine-20 mg/ml	1 ml	232.89
25	Natamycin Drops	Natamycin-5 %	1 ml	21.16
26	Proparacaine Drops	Proparacaine-0.5%	1 ml	9.26
27	Hydroxypropyl Methylcellulose Injection	Hydroxypropyl Methylcellulose-2%	1 ml	34.79
28	Carboxymethylcellulose Drops	Carboxymethylcellulose-0.5%	1 ml	11.59
29	Carboxymethylcellulose Drops	Carboxymethylcellulose-1%	1 ml	13.03
30	Fluphenazine Depot Injection	Fluphenazine-25 mg/ml	1 ml	46.42
31	Risperidone Oral Liquid	Risperidone-1 mg/ml	1 ml	1.78
32	Budesonide Respirator Solution for use in Nebulizer	Budesonide-0.5mg/ml	1 ml	9.93
33	Budesonide Respirator Solution for use in Nebulizer	Budesonide-1mg/ml	1 ml	11.98
34	Potassium Chloride Injection	Potassium Chloride-150 mg/ml	1 ml	2.25
35	Thiamine Injection	Thiamine-100 mg/ml	1 ml	23.02
36	Ipratropium Respirator Solution for use in Nebulizer	Ipratropium -250 mcg/ml	1 ml	2.35
37	Fusidic Acid Cream	Fusidic Acid-2%	1 Gm	8.46
38	Benzoyl Peroxide Gel	Benzoyl Peroxide-2.5%	1 Gm	3.48
39	Dinoprostone Gel	Dinoprostone-0.5mg	1 Gm	75.21
40	Acyclovir Ointment	Acyclovir-3%	1 Gm	9.66
41	Salicylic Acid Ointment	Salicylic Acid -6%	1 Gm	1.67
42	Human Chorionic Gonadotropin Injection	Human Chorionic Gonadotropin -1000 IU	Each Pack	189.11
43	Human Chorionic Gonadotropin Injection	Human Chorionic Gonadotropin -5000 IU	Each Pack	371.39
44	Vecuronium Powder for Injection	Vecuronium-10 mg	Each Pack	168.24
45	Vecuronium Powder for Injection	Vecuronium-4 mg	Each Pack	81.20
46	Budesonide Inhalation	Budesonide-100 mcg/Dose	Each Metered Dose	1.22
47	Budesonide Inhalation	Budesonide-200 mcg/Dose	Each Metered Dose	1.50
48	Budesonide+ Formoterol Inhalation	Budesonide-400 mcg + Formoterol-6 mcg/Dose	Each Metered Dose	2.74
49	Budesonide+ Formoterol Inhalation	Budesonide-200 mcg + Formoterol-6 mcg/Dose	Each Metered Dose	2.19
50	Budesonide+ Formoterol Inhalation	Budesonide-100 mcg + Formoterol-6 mcg/Dose	Each Metered Dose	1.74

NOTE :

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 local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the ceiling price mentioned in ccolumn (5) of the above said table.
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 as per paragraph 24 (2) of the DPCO, 2013.
The manufacturer shall follow ceiling price as mentioned in column (5) and report to the Government in Form II as prescribed under Schedule II of the Drugs (Price Control) Order, 2013 within a period of 15 days of such revision. Non submission of Form II in this regard shall be construed as non-revision in MRP and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised/revised MRP, as the case may be, along with interest thereon from the date of overcharging.
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 then 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 formulation shall furnish 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. Any manufacturer intending to discontinue 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 manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Price Control) Order, 2013 read with the Essential Commodities Act, 1955.
Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand superseded.

PN/161/29/2016/F

F.No. 8(29)/2016/D.P./NPPA-Div.II

(BALJIT SINGH)
Assistant Director
National Pharmaceutical Pricing Authority

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