(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 Pharmaceutical Pricing Authority

New Delhi, the 29^th March, 2016

ORDER

S.O. 1254(E)- In exercise of the powers, conferred by paragraph 4, 10, 11, 14, 16 and 17 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30^th May, 2013 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 ceiling prices as specified in column (5) with immediate effect and revised ceiling prices as column (6) of the table herein below, 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 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.)	Revised Ceiling Price  (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
--	--	Each Controlled Release (CR)/ Extended Release (ER)/ Sustained Release (SR)/ Immediate Release (IR) tablet contains:	--	--	--
1.	Carbamazepine CR Tablet	Carbamazepine-200mg	1 Tablet	1.48	1.44
2.	Carbamazepine CR Tablet	Carbamazepine-400mg	1 Tablet	2.91	2.83
3.	Levetiracetam ER Tablet	Levetiracetam-750mg	1 Tablet	16.58	16.13
4.	Phenytoin ER Tablet	Phenytoin-300mg	1 Tablet	5.54	5.39
5.	Levodopa+  Carbidopa CR Tablet	Levodopa-100mg Carbidopa-25mg	1 Tablet	3.19	3.10
6.	Diltiazem SR Tablet	Diltiazem-90mg	1 Tablet	8.90	8.66
7.	Isosorbide-5-mononitrate  SR Tablet	Isosorbide-5-   mononitrate -30mg	1 Tablet	4.67	4.54
8.	Isosorbide-5-mononitrate SR Tablet	Isosorbide-5-   mononitrate -60mg	1 Tablet	6.09	5.92
9.	Metoprolol SR Tablet	Metoprolol-25mg	1 Tablet	3.85	3.75
10.	Metoprolol SR Tablet	Metoprolol-50mg	1 Tablet	5.50	5.35
11.	Metformin CR Tablet	Metformin-500mg	1 Tablet	1.82	1.77
12.	Metformin CR Tablet	Metformin-1000mg	1 Tablet	3.47	3.38
13.	Metformin IR Tablet	Metformin-1000mg	1 Tablet	3.43	3.34
--	--	Each tablet contains:	--	--	--
14.	Paracetamol Tablet	Paracetamol-650mg	1 Tablet	1.76	1.71
15.	Allopurinol Tablet	Allopurinol-300mg	1 Tablet	7.13	6.94
16.	Hydroxychloroquine Tablet	Hydroxychloroquine-400mg	1 Tablet	11.39	11.08
17.	Carbamazepine Tablet	Carbamazepine-400mg	1 Tablet	3.16	3.07
18.	Clobazam Tablet	Clobazam-5mg	1 Tablet	4.90	4.77
19.	Clobazam Tablet	Clobazam-10mg	1 Tablet	8.61	8.38
20.	Levetiracetam Tablet	Levetiracetam-250mg	1 Tablet	5.58	5.43
21.	Levetiracetam Tablet	Levetiracetam-500mg	1 Tablet	11.28	10.97
22.	Levetiracetam Tablet	Levetiracetam-750mg	1 Tablet	17.33	16.86
23.	Lorazepam Tablet	Lorazepam-1mg	1 Tablet	1.97	1.92
24.	Lorazepam Tablet	Lorazepam-2mg	1 Tablet	2.39	2.33
25.	Phenytoin Tablet	Phenytoin-300mg	1 Tablet	4.51	4.39
26.	Sodium Valproate Tablet	Sodium Valproate-300mg	1 Tablet	3.79	3.69
27.	Mebendazole Tablet	Mebendazole-100mg	1 Tablet	2.80	2.72
28.	Diethylcarbamazine Tablet	Diethylcarbamazine-100m	1 Tablet	1.30	1.26
29	Cefadroxil Tablet	Cefadroxil-500mg	1 Tablet	3.85	3.75
30	efixime Tablet	Cefixime-400mg	1 Tablet	21.05	20.48
31	Clarithromycin Tablet	Clarithromycin-250mg	1 Tablet	26.70	25.98
32	Clarithromycin Tablet	Clarithromycin-500mg	1 Tablet	47.07	45.79
33	Ethionamide Tablet	Ethionamide-250mg	1 Tablet	15.06	14.65
34	Ethionamide Tablet	Ethionamide-250mg	1 Tablet	1.91	1.86
35	Levofloxacin Tablet	Levofloxacin-250mg	1 Tablet	4.20	4.09
36	Levofloxacin Tablet	Levofloxacin-500mg	1 Tablet	6.40	6.23
37	Linezolid Tablet	Levofloxacin-750mg	1 Tablet	10.42	10.14
38	Linezolid Tablet	Linezolid-600mg	1 Tablet	31.51	30.66
39	Moxifloxacin Tablet	Moxifloxacin-400mg	1 Tablet	24.16	23.51
40	Fluconazole Tablet	Fluconazole-400mg	1 Tablet	29.80	28.99
41	Abacavir Tablet	Abacavir-300mg	1 Tablet	44.98	43.76
42	Abacavir+  Lamivudine Tablet	Abacavir-600mg    Lamivudine-300mg	1 Tablet	45.95	44.70
43	Tenofovir +   Lamivudine Tablet	Tenofovir-300mg     Lamivudine-300mg	1 Tablet	41.05	39.94
44	Tenofovir + Lamivudine+  Efavirenz Tablet	Tenofovir-300mg  Lamivudine-300mg  Efavirenz-600mg	1 Tablet	94.27	91.71
45	Nevirapine Tablet	Nevirapine-200mg	1 Tablet	13.65	13.28
46	Raltegravir Tablet	Raltegravir-400mg	1 Tablet	143.13	139.25
47	Atazanavir + Ritonavir Tablet	Atazanavir-300mg   Ritonavir-100mg	1 Tablet	94.15	91.60
48	Darunavir Tablet	Darunavir-600mg	1 Tablet	159.20	154.88
49	Lopinavir+Ritonavir Tablet	Lopinavir-200mg  Ritonavir-50mg	1 Tablet	43.47	42.29
50	.     Entecavir Tablet	Entecavir-0.5mg	1 Tablet	72.98	71.00
51	Entecavir Tablet	Entecavir-1mg	1 Tablet	115.95	112.81
52	Sofosbuvir Tablet	Sofosbuvir-400mg	1 Tablet	636.56	619.31
53	Tenofovir Tablet	Tenofovir-300mg	1 Tablet	45.01	43.79
54	Artemether+  Lumefantrine Tablet	Artemether-20mg   Lumefantrine-120mg	1 Tablet	11.94	11.62
55	Artemether+  Lumefantrine Tablet	Artemether-40mg        Lumefantrine-240mg	1 Tablet	15.39	14.97
56	Artemether+   Lumefantrine Tablet	Artemether-80mg Lumefantrine-480mg	1 Tablet	22.10	21.50
57	Flunarizine Tablet	Flunarizine-5mg	1 Tablet	2.63	2.56
58	Flunarizine Tablet	Flunarizine-10mg	1 Tablet	4.50	4.38
59	Propranolol Tablet	Propranolol-80mg	1 Tablet	4.76	4.63
60	Tranexamic Acid Tablet	Tranexamic Acid-500mg	1 Tablet	15.89	15.46
61	Warfarin Tablet	Warfarin-1mg	1 Tablet	2.30	2.24
62	Acetylsalicylic Acid Tablet	Acetylsalicylic Acid-150mg	1 Tablet	0.39	0.38
63	Isosorbide Dinitrate Tablet	Isosorbide Dinitrate-5mg	1 Tablet	0.73	0.71
64	Isosorbide Dinitrate Tablet	Isosorbide Dinitrate-10mg	1 Tablet	0.71	0.69
65	Amlodipine Tablet	Amlodipine-10mg	1 Tablet	4.84	4.71
66	Ramipril Tablet	Ramipril-2.5mg	1 Tablet	4.74	4.61
67	.     Ramipril Tablet	Ramipril-5mg	1 Tablet	7.48	7.28
68	Telmisartan Tablet	Telmisartan-20mg	1 Tablet	3.47	3.38
69	Telmisartan Tablet	Telmisartan-40mg	1 Tablet	6.29	6.12
70	Telmisartan Tablet	Telmisartan-80mg	1 Tablet	9.59	9.33
71	.     Atorvastatin Tablet	Atorvastatin-10mg	1 Tablet	5.23	5.09
72	Atorvastatin Tablet	Atorvastatin-20mg	1 Tablet	12.68	12.34
73	Atorvastatin Tablet	Atorvastatin-40mg	1 Tablet	18.41	17.91
74	Donepezil Tablet	Donepezil-5mg	1 Tablet	10.72	10.43
75	Donepezil Tablet	Donepezil-10mg	1 Tablet	15.30	14.89
76	Ranitidine Tablet	Ranitidine-150mg	1 Tablet	0.71	0.71
77	Methylprednisolone Tablet	Methylprednisolone-8mg	1 Tablet	4.87	4.74
78	Methylprednisolone Tablet	Methylprednisolone-16mg	1 Tablet	8.51	8.28
79	Glimepiride Tablet	Glimepiride-1mg	1 Tablet	3.42	3.33
80	Glimepiride Tablet	Glimepiride-2mg	1 Tablet	5.44	5.29
81	Levothyroxine Tablet	Levothyroxine-12.5mcg	1 Tablet	1.30	1.26
82	Levothyroxine Tablet	Levothyroxine-25mcg	1 Tablet	1.25	1.22
83	Levothyroxine Tablet	Levothyroxine-50mcg	1 Tablet	0.94	0.91
84	Levothyroxine Tablet	Levothyroxine-75mcg	1 Tablet	1.24	1.21
85	Levothyroxine Tablet	Levothyroxine-88mcg	1 Tablet	1.46	1.42
86	Levothyroxine Tablet	Levothyroxine-100mcg	1 Tablet	1.14	1.11
87	Levothyroxine Tablet	Levothyroxine-125mcg	1 Tablet	1.46	1.42
88	Levothyroxine Tablet	Levothyroxine-150mcg	1 Tablet	1.47	1.43
89	Baclofen Tablet	Baclofen-5mg	1 Tablet	5.07	4.93
90	Baclofen Tablet	Baclofen-10mg	1 Tablet	9.83	9.56
91	Baclofen Tablet	Baclofen-20mg	1 Tablet	13.54	13.17
92	Misoprostol Tablet	Misoprostol-200mcg	1 Tablet	15.92	15.49
93	Cholecalciferol Tablet	Cholecalciferol-1000IU	1 Tablet	3.58	3.48
94	Cholecalciferol Tablet	Cholecalciferol-60000IU	1 Tablet	23.87	23.22
95	Pyridoxine Tablet	Pyridoxine-100mg	1 Tablet	5.34	5.20
--	--	Each effervescent/ dispersible/enteric coated tablet contains:	--	--	--
96	Acetylsalicylic Acid Tablet	Acetylsalicylic Acid-75mg	1 Tablet	1.17	1.14
97	.     Acetylsalicylic Acid Tablet	Acetylsalicylic Acid-150mg	1 Tablet	1.15	1.12
--	--	Each capsule contains:	--	--	--
98	Cycloserine Capsule	Cycloserine-250mg	1 Tablet	51.78	50.38
99	Rifampicin Capsule	Rifampicin-600mg	1 Tablet	11.07	10.77
100	Ribavirin Capsule	Ribavirin-200mg	1 Tablet	76.50	74.43
101	Clindamycin Capsule	Clindamycin-150mg	1 Tablet	13.24	12.88
102	Clindamycin Capsule	Clindamycin-300mg	1 Tablet	21.61	21.02
103	Hydroxyurea Capsule	Hydroxyurea-500mg	1 Tablet	11.73	11.41

 

Note :

1. The above mentioned ceiling prices mentioned at column (5) shall stand revised as per column (6) in accordance with applicable Wholesale Price Index (WPI), with effect from 1^st April, 2016.
2. 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 till 31^st March, 2016 and they shall further make corresponding reduction in MRP as per WPI @2.7105% with effect from 1^st April, 2016.
3. 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 the column (5) of the above said table.
4. 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) and column (6) of the above table as per provisions contained in paragraph 11 of the Drugs (Price Control) Order, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.
5. The manufacturer shall follow revised ceiling price as mentioned in column (6) 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 as per WPI 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.
6. 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 prescribed under Schedule-II of the DPCO, 2013.
7. 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 as prescribed under 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 as prescribed under Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
8. The manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount alongwith the interest thereon under the provisions of the Drugs (Price Control) Order, 2013 read with the Essential Commodities Act, 1955.
9. 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 in respect of such scheduled formulations, issued prior to the above said date of notification, stand superseded.

PN/159/27/2016/F

F. No. 8(27)/2016/D.P./NPPA-Div.-II
(BALJIT SINGH)
Assistant Director

Last Page Updated: 09-01-2019