NPPA revises ceiling price of 111 scheduled drugs, Details

Published On 2023-01-16 12:30 GMT | Update On 2023-10-19 06:44 GMT

New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemicals and Fertilizers, Government of India has revised the ceiling price of 111 scheduled formulations under the Drug( Price Control) Order,2013.

The list of 111 Scheduled formulations includes Levothyroxine, Ondansetron, Clindamycin, Prednisolone, Zolendronic Acid, Adenosine, Ciprofloxacin, Isoflurane, Cytosinearabinoside, Metronidazole, Amiodarone, Azithromycin, Vancomycin, Acyclovir, Methylergometrine, Streptokinase, D-Penicillamine, Thiamine, Etoposide, Spironolactone, Salbutamol, Domperidone, Amoxicillin, Fluconazole, Cetrizine, Phenobarbitone and others.

This came in line with the decision of 107th Authority meeting dated 11.01.2023, where the ceiling price fixation of scheduled formulation under the Drugs (Price Control) Order,2013 ( National List of Essential Medicine 2022) was discussed.

Scheduled formulation means any formulation, included in the First Schedule whether referred to by generic versions or brand name (mainly products covered under National List of Essential Medicines are Scheduled Formulation). In other words, all medicines that are covered in National List of Essential Medicine, which are notified in Schedule 1, by the Govt. are scheduled formulation.

"Ceiling Price" refers to a price fixed by the Government for Scheduled Formulations in accordance with the provisions of drugs (prices control) order, 2013. Ceiling Price is the Maximum Price to Retailer (excluding Taxes, if any)for the given product.

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 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 SO 1499(E) dated 30th March, 2022 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 has fixed the price 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:

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)
1	Levothyroxine	Tablet 62.5mcg	1 Tablet	1.44
2	Ondansetron	Tablet 4 mg	1 Tablet	4.58
3	Clindamycin	Tablet 300mg	1 Tablet	16.92
4	Prednisolone	Tablet 40mg	1 Tablet	3.04
5	Zoledronic acid	Powder for Injection 4mg	1 Vial	2133.32
6	Adenosine	Injection 3mg/mL	1 ML	82.81
7	Ciprofloxacin	Drops 0.3 %	1 ML	1.37
8	Isoflurane	Liquid for inhalation	1 ML	8.61
9	Cytosinearabinoside	Injection 1000mg/vial	1 Vial	1008.07
10	Metronidazole	Injection 500mg/100mL	1 ML	0.19
11	Ciprofloxacin	Injection 200mg/100mL	1 ML	0.18
12	Amiodarone	Injection 50mg/mL	1 ML	18.85
13	Lopinavir (A) + Ritonavir(B)	Tablet 200 mg (A) + 50mg (B)	1 Tablet	42.78

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
14	Artemether (A) + Lumefantrine(B)	Tablet 40 mg (A) + 240 mg (B)	1 Tablet	16.09
15	Azithromycin	Powder for Injection 500mg	1 Vial	182.58
16	Vancomycin	Powder for Injection 500 mg	1 Vial	283.28
17	Vancomycin	Powder for Injection 1000mg	1 Vial	419.40
18	Acyclovir	Powder for Injection 250 mg	1 Vial	380.28
19	Methylergometrine	Tablet 0.125mg	1 Tablet	7.97
20	Streptokinase	Injection 15,00,000IU	1 Vial	1674.28
21	D-Penicillamine	Capsule 250 mg	1 Capsule	13.96
22	Thiamine	Tablet 100 mg	1 Tablet	3.98
23	Vancomycin	Powder for Injection 250 mg	1 Vial	224.08
24	Etoposide	Capsule 50mg	1 Capsule	50.51
25	Spironolactone	Tablet 50mg	1 Tablet	3.90
26	Salbutamol	Oral liquid 2mg/5mL	1 ML	0.16
27	Domperidone	Oral Liquid 1mg/mL	1 ML	1.11
28	Amoxicillin	Capsule 250mg	1 Capsule	2.18
29	Fluconazole	Tablet 150mg	1 Tablet	10.76
30	Cetirizine	Tablet 10mg	1 Tablet	1.68
31	Phenobarbitone	Tablet 60mg	1 Tablet	1.69
32	Artesunate (A) + Sulphadoxine - Pyrimethamine (B)	Combi pack (A+B) 1 Tablet 50mg (A) + 1Tablet (500mg + 25mg) (B)	1 Combi Pack	20.11
33	Hydrochlorothiazide	Tablet 25 mg	1 Tablet	1.56
34	Efavirenz	Tablet 600mg	1 Tablet	62.96
35	Chloroquine	Tablet 150 mg	1 Tablet	1.04
36	Prednisolone	Oral liquid 5mg/5mL(p)	1 ML	0.44
37	Prednisolone	Oral liquid 15mg/5mL(p)	1 ML	0.77
38	Misoprostol	Tablet 100mcg	1 Tablet	8.85
39	Tenofovir Disproxil Fumarate (A) + Lamivudine (B)	Tablet 300mg (A) + 300mg(B)	1 Tablet	40.65
40	Tenofovir Disproxil Fumarate (A) +Lamivudine (B)+ Efavirenz(C)	Tablet 300mg(A)+ 300mg (B) + 600mg(C)	1 Tablet	91.72
41	Tenofovir Disproxil Fumarate (TDF)*	Tablet 300mg	1 Tablet	40.88
42	Lithium	Tablet 300mg	1 Tablet	1.45
43	Amoxicillin (A) + Clavulanic acid (B)	Powder for Injection 500mg (A) + 100mg (B)	1 Vial	90.38
44	Streptomycin	Powder for Injection 750 mg	1 Vial	9.01

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
45	Bleomycin	Powder for Injection 15units	1 Vial	604.14
46	Cyclophosphamide	Powder for Injection 500mg	1 Vial	65.54
47	Dacarbazine	Powder for Injection 500mg	1 Vial	462.71
48	Hydrochlorothiazide	Tablet 12.5mg	1 Tablet	0.93
49	Cyclosporine	Capsule 25 mg	1 Capsule	25.01
50	Acyclovir	Powder for Injection 500 mg	1 Vial	471.29
51	Risperidone	Oral liquid 1mg/mL	1 ML	1.97
52	Haloperidol	Oral liquid 2mg/5mL	1 ML	2.00
53	Caffeine	Oral liquid 20 mg/mL	1 ML	219.11
54	Cholecalciferol	Oral liquid 400 IU/mL	1 ML	2.33
55	Temozolomide	Capsule 100mg	1 Capsule	1345.52
56	Artesunate	Powder for Injection 60 mg	1 Vial	218.26
57	Artesunate	Powder for Injection 120mg	1 Vial	405.28
58	Diazepam	Tablet 5 mg	1 Tablet	1.45
59	Levetiracetam	Oral liquid 100 mg/mL (p)	1 ML	3.54
60	Mebendazole	Oral liquid 100mg/5mL(p)	1 ML	0.75
61	Cefadroxil	Oral liquid 125mg/5mL(p)	1 ML	0.61
62	Clarithromycin	Oral liquid 125mg/5mL(p)	1 ML	4.11
63	Metronidazole	Oral liquid 200mg/5mL(p)	1 ML	0.46
64	Amoxicillin (A) + Clavulanic acid (B)	Dry Syrup 125mg (A) + 31.25 (B)/5mL(p)	1 ML	1.83
65	6-Mercaptopurine	Tablet 50mg	1 Tablet	4.69
66	Cyclosporine	Oral liquid 100mg/mL(p)	1 ML	71.87
67	Labetalol	Injection 5mg/mL	1 ML	44.58
68	Glycopyrrolate	Injection 0.2mg/mL	1 ML	12.96
69	Tranexamic acid	Injection 100 mg/mL	1 ML	12.23
70	Diazepam	Injection 5mg/mL	1 ML	4.94
71	Paracetamol	Oral Liquid 125 mg/5 mL (p)	1 ML	0.33
72	Metoclopramide	Oral liquid 5mg/5mL(p)	1 ML	0.45
73	Naloxone	Injection 0.4mg/mL	1 ML	82.70
74	Pralidoxime chloride (2-PAM)	Injection 25mg/mL	1 ML	4.07
75	Neostigmine	Injection 0.5mg/mL	1 ML	4.47
76	Phenobarbitone	Injection 200mg/mL	1 ML	19.75
77	Trastuzumab	Injection 440mg/50mL	1 Vial	48806.02
78	Bortezomib	Powder for Injection 2mg	1 Vial	4691.51
79	Imatinib	Tablet 400mg	1 Tablet	178.03
80	Docetaxel	Powder for Injection 80mg	1 Vial	9215.98
81	Ribavirin	Capsule 200 mg	1 Capsule	23.63

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
82	Tranexamic acid	Tablet 500 mg	1 Tablet	16.54
83	Levodopa (A) + Carbidopa (B)	Modified Release–Tablet 200mg (A) + 50mg (B)	1 Tablet	4.22
84	Amitriptyline	Tablet 10mg	1 Tablet	2.13
85	Mifepristone	Tablet 200mg	1 Tablet	312.96
86	Folic Acid	Tablet 5 mg	1 Tablet	1.35
87	Rifampicin	Capsule 150mg	1 Capsule	2.04
88	Rifampicin	Capsule 300mg	1 Capsule	4.11
89	Ibuprofen	Tablet 400mg	1 Tablet	1.07
90	Potassium chloride	Oral liquid 500mg/5mL	1 ML	0.27
91	Lactulose	Oral liquid 10 g/15mL	1 ML	1.10
92	Chloroquine	Oral liquid 50mg/5mL	1 ML	0.30
93	Carbamazepine	Oral liquid 100mg/5mL(p)	1 ML	0.28
94	Oxaliplatin	Injection 5 mg/mL in 10 mL vial	1 Vial	1992.32
95	Proparacaine	Eye Drops0.5%	1 ML	9.14
96	Paracetamol	Oral Liquid 250 mg/5 mL (p)	1 ML	0.60
97	Ondansetron	Oral liquid 2mg/5mL(p)	1 ML	1.12
98	Etoposide	Injection 20mg/mL	1 ML	30.78
99	Tropicamide	Eye drop 1 %	1 ML	8.41
100	Timolol	Drops 0.5 %	1 ML	11.95
101	Mannitol	Injection 20 %	1 ML	0.31
102	Glyceryl trinitrate	Injection 5mg/mL	1 ML	5.52
103	Phenytoin	Injection 50mg/mL	1 ML	5.31
104	Diclofenac	Injection 25mg/mL	1 ML	1.51
105	N-acetylcysteine	Injection 200 mg/mL	1 ML	21.08
106	Dopamine	Injection 40mg/mL	1 ML	4.25
107	Streptomycin	Powder for Injection 1000mg	1 Vial	9.69
108	Paracetamol	Oral liquid 120 mg/5 mL (p)	1 ML	0.54
109	Clomiphenecitrate	Tablet 100 mg	1 Tablet	12.44
110	Clomiphenecitrate	Tablet 50mg	1 Tablet	7.88
111	Medroxyprogesterone acetate	Tablet 10 mg	1 Tablet	5.57

The notice further added:

(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 the 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.

(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 Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from 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 so as 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(1)(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 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 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 Drugs (Prices Control) Order, 2013 read with Essential Commodities Act,1955.

(i) Consequent to the issue of 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.

Also Read:NPPA revises ceiling prices of 93 scheduled formulations, Details

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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NPPA revises ceiling price of 111 scheduled drugs, Details

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