NPPA revises ceiling price of 80 scheduled formulations, details

Published On 2023-03-03 12:30 GMT | Update On 2023-10-13 10:56 GMT

New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemical & Fertilizers, the Government of India has revised the ceiling pricing of the 80 scheduled formulations under Drug (Price Control)Order 2013.

The list of 80 scheduled formulations includes Sodium Valproate, Nifedipine, Noradrenaline, Halothine, Cyclosporin, Adrenaline, Morphine, Filgrastim, Midazolam, Erythropoietin, Furosemide, Actinomycin D, Calcium Folinate, Glucose, Iron sucrose, Fluphenazine, Hydroxy propyl methyl cellulose, Alprostadil, Cisplatin, Prednisolone, Meglumine diatrizoate, Thiamine, Carboplatin, Gemcitabine, Magnesium sulphate, Trihexyphenidyl, Atropine, Lignocaine, Povidone Iodine and others.

This came in line with the decision of the 109th Authority meeting dated 21.02.2023, where the ceiling price fixation of scheduled formulation, under the Drug (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.

The notice declared that 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 (hereinafter referred as NPPA) hereby fixes 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	Sodium Valproate	Tablet 200mg	1 Tablet	3.20
2	Sodium Valproate	Modified Release – Tablet 500mg	1 Tablet	8.28
3	Sodium Valproate	Tablet 500mg	1 Tablet	7.24
4	Nifedipine	Tablet 10mg	1 Tablet	1.37
5	Noradrenaline	Injection 2mg/mL	1 ML	17.99
6	Halothane	Liquid for inhalation	1 ML	5.44
7	Cyclosporine	Capsule 50 mg	1 Capsule	49.15
8	Cyclosporine	Capsule 100mg	1 Capsule	91.96
9	Adrenaline	Injection1mg/mL	1 ML	10.91
10	Morphine	Injection 10mg/mL	1 ML	17.48
11	Morphine	Injection 15mg/mL	1 ML	13.32
12	Filgrastim	Injection 300mcg	1 Vial	1034.51
13	Midazolam	Injection 1mg/mL	1 ML	5.28
14	Midazolam	Injection 5mg/mL	1 ML	9.70
15	Erythropoietin	Injection 2000IU/mL	1 ML	490.14

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
16	Erythropoietin	Injection 10000 IU/mL	1 ML	1756.13
17	Furosemide	Injection 10mg/mL	1 ML	2.67
18	Actinomycin D	Powder for Injection 0.5mg	1 Vial	295.22
19	Calcium folinate	Tablet 15mg	1 Tablet	42.40
20	Glucose	Injection 25%	1 ML	0.18
21	Iron sucrose	Injection 20mg/mL	1 ML	51.20
22	Fluphenazine	Injection 25mg/mL	1 ML	49.29
23	Hydroxy propylmethyl cellulose	Injection 2%	1 ML	26.05
24	Alprostadil	Injection 0.5mg/mL	1 ML	5446.23
25	Cisplatin	Injection 1mg/mL	1 ML	6.32
26	Prednisolone	Drops 1%	1 ML	5.14
27	Meglumine diatrizoate	Injection 60%w/v	1 ML	8.45
28	Meglumine diatrizoate	Injection 76%w/v	1 ML	9.10
29	Thiamine	Injection 100 mg/mL	1 ML	20.15
30	Carboplatin	Injection 10mg/mL	1 ML	52.68
31	Gentamicin	Injection 10mg/mL	1 ML	2.15
32	Magnesium sulphate	Injection 500mg/mL	1 ML	4.34
33	Trihexyphenidyl	Tablet 2mg	1 Tablet	1.22
34	Atropine	Drops 1%	1 ML	3.51
35	Atropine	Ointment 1%	1 GM	4.20
36	Atropine	Injection 0.6mg/mL	1 ML	4.08
37	Lignocaine	Topical forms 2-5 %	1 GM/ML	1.01
38	Lignocaine	Injection 2%	1 ML	0.93
39	Povidone iodine	Solution 5%	1 ML	0.39
40	Povidone iodine	Solution 7.5%	1 ML	0.73
41	Povidone iodine	Solution 10% (	1 ML	0.86
42	Sodium Valproate	Modified Release – Tablet 300mg	1 Tablet	5.44
43	Sodium Valproate	Injection 100mg/mL	1 ML	6.02
44	Metoclopramide	Injection 5mg/mL (Less than 10ML Pack)	1 ML	2.38
45	Betamethasone valerate	Cream 0.05%	1 GM	0.60
46	Betamethasone valerate	Cream 0.1%	1 GM	0.93
47	Protamine Sulphate	Injection 10mg/mL	1 ML	8.72
48	Fusidic acid	Cream 2 %	1 GM	8.77
49	Propofol	Injection 10mg/mL	1 ML	5.80
50	Pilocarpine	Drops 2 %	1 ML	9.66

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price (Rs.)
51	Dinoprostone	Gel 0.5mg	1 GM	75.56
52	Tiotropium	Inhalation (MDI) 9 mcg/dose	1 MD	2.48
53	Tiotropium	Inhalation (DPI) 18mcg/dose	1 DP	9.55
54	Ciprofloxacin	Ointment 0.3%	1 GM	1.15
55	Benzoyl peroxide	Gel 2.5	1 GM	3.23
56	Benzoyl peroxide	Gel 5 %	1 GM	7.11
57	Ispaghula	Granules/Husk/Powder	1 GM	0.84
58	Insulin Intermediate Acting (NPH)	Injection 40IU/mL	1 ML	15.15
59	Potassium chloride	Injection 150mg/mL	1 ML	2.14
60	Rifampicin	Oral liquid 100mg/5mL(p)	1 ML	0.42
61	Rabies vaccine	As licensed	1 Vial	337.75
62	Salicylic acid	Ointment 3-6% (6%)	1 GM	1.80
63	Acyclovir	Ointment 3%	1 GM	10.41
64	Phytomenadione (Vitamin K1)	Injection 10mg/mL	1 ML	47.35
65	Human chorionic gonado tropin	Injection 5000 IU	1 Vial	372.32
66	Levothyroxine	Tablet 12.5mcg	1 Tablet	1.32
67	Levothyroxine	Tablet 100mcg	1 Tablet	1.18
68	Levothyroxine	Tablet 125mcg	1 Tablet	1.51
69	Diethylcarbamazine (DEC)	Tablet 50mg	1 Tablet	0.50
70	Isosorbide dinitrate	Tablet 10mg	1 Tablet	0.72
71	Levodopa (A) +Carbidopa(B)	Modified Release–Tablet 100 mg (A) + 25 mg (B)	1 Tablet	2.49
72	Pyrazinamide	Tablet 1500mg	1 Tablet	10.53
73	Phenobarbitone	Oral liquid 20mg/5mL (p)	1 ML	0.44
74	Hydrocortisone	Tablet 10mg	1 Tablet	5.98
75	Neostigmine	Tablet 15mg	1 Tablet	4.09
76	Diethylcarbamazine (DEC)	Oral liquid 120mg/5mL(p)	1 ML	0.43
77	Hydrocortisone	Powder for Injection 200mg	1 Vial	58.51
78	Hydrocortisone	Tablet 5mg	1 Tablet	2.78
79	Hormone Releasing IUD	Contains 52 mg of Levonorgestrel	1 IUD	3456.44
80	IUD containing Copper	As licensed	1 IUD	250.62

The notification 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 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 a 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 fixes retail price of 74 formulations

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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 80 scheduled formulations, details

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