NPPA fixes and revises ceiling price of 127 scheduled drugs, Details

New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemicals and Fertilizers, the Government of India has fixed and revised the ceiling price of 127 scheduled formulations under the Drug (Price Control) Order, 2013.

The list of 127 scheduled formulations includes Acetazolamide, Acetylsalicylic acid, Acyclovir, Albendazole, Amoxicillin, Amphotericin B, Ascorbic acid (Vitamin C), Atracurium, Azithromycin, Betamethasone, Budesonide, Bupivacaine, Caffeine, Calamine, Cefixime, Cholecalciferol, Ciprofloxacin, Clomipramine, Clotrimazole, Co-trimoxazole [Sulphamethox azole (A) plus Trimethoprim( B)]*, Cyclophosphamide, Cycloserine, Dexamethasone, Diazepam, Dicyclomine and others.

This came in line with the decision of the 111th Authority meeting dated 29.03.2023, where the ceiling price fixation of scheduled formulations 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 the 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) S.O. No.1499(E) dated 30th March 2022in 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 ceiling prices exclusive of goods and services tax applicable, if any, as specified in column (5) and increased by Wholesale Price Index (WPI) of 12.1218% under para 16 (1) of DPCO 2013, with effect from 1.04.2023 as specified in column (6) of the table in respect of the Scheduled formulations 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 Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
(1)	(2)	(3)	(4)	(5)	(6)
1	Acetazolamide	Capsule 250mg	1 Capsule	4.5	5.04
2	Acetylsalicylic acid	Enteric coated Tablet 75 mg	1 Tablet	0.31	0.34
3	Acetylsalicylic acid	Conventional/Effervescent/ Dispersible/ Enteric-coated Tablets 150 mg	1 Tablet	0.63	0.70
4	Acyclovir	Oral liquid 400mg/5mL (p)	1 ML	1.21	1.35
5	Albendazole	Oral liquid 200mg/5mL(p)	1 ML	1.6	1.79
6	Albendazole	Tablet 400mg	1 Tablet	6.28	7.04
7	Albendazole	Chewable Tablet 400mg	1 Tablet	7.25	8.12

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
8	Amoxicillin	Oral liquid 250 mg/5 mL (p)	1 ML	1.39	1.55
9	Amphotericin B	Amphotericin B (conventional) – Injection 50mg/vial	1 Vial	202.81	227.39
10	Ascorbic acid (Vitamin C)	Tablet 100mg	1 Tablet	0.21	0.23
11	Ascorbic acid (Vitamin C)	Tablet 500mg	1 Tablet	1.32	1.48
12	Atracurium	Injection 10 mg/ml	1 ML	15.14	16.97
13	Azithromycin	Capsule250mg	1 Capsule	9.47	10.61
14	Betamethasone	Injection 4mg/mL	1 ML	4.23	4.74
15	Budesonide	Respirator solution for use in nebulizer 0.5mg/mL	1 ML	10.61	11.89
16	Budesonide	Respirator solution for use in nebulizer 1mg/mL	1 ML	11.72	13.14
17	Bupivacaine	Injection 0.5 % with 7.5 % glucose	1 ML	6.59	7.38
18	Bupivacaine	Injection 0.5 %	1 ML	3.94	4.41
19	Bupivacaine	Injection 0.25%	1 ML	2.52	2.82
20	Caffeine	Injection 20mg/mL	Per ML	223.41	250.49
21	Calamine	Lotion (As per IP)	1 ML	0.85	0.95
22	Cefixime	Capsule 200mg	1 Capsule	13.09	14.67
23	Cholecalciferol	Capsule 60000 IU	1 Capsule	27.45	30.77
24	Cholecalciferol	Capsule 1000 IU	1 Capsule	4.36	4.88
25	Ciprofloxacin	Oral liquid 250mg/5mL(p)	1 ML	0.66	0.74
26	Clomipramine	Tablet 10 mg	1 Tablet	2.54	2.84
27	Clomipramine	Tablet 25 mg	1 Tablet	5.55	6.22
28	Clomipramine	Tablet 75 mg	1 Tablet	14.68	16.45
29	Clotrimazole	Lotion 1%	1 ML	3.47	3.89

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
30	Clotrimazole	Pessary 100mg	1 Pessary	8.93	10.01
31	Clotrimazole	Drops 1%	1 ML	3.01	3.37
32	Clotrimazole	Cream1%	1 GM	2.68	3.00
33	Co-trimoxazole [Sulphamethox azole (A) +Trimethoprim( B)]*	Tablet 400 mg (A) + 80 mg (B)	1 Tablet	0.8	0.89
34	Co-trimoxazole [Sulphamethox azole(A) +Trimethoprim( B)]*	Oral liquid 200 mg (A) + 40 mg(B)/5mL(p)	1 ML	0.31	0.34
35	Cyclophospha mide	Tablet 50mg	1 Tablet	3.33	3.73
36	Cycloserine	Tablet 250mg	1 Tablet	41.04	46.01
37	Dexamethasone	Injection 4mg/mL (Pack of 10ML)	1 ML	1.4	1.56
38	Dexamethason e	Injection 4mg/mL (Pack of 20 ML)	1 ML	1.2	1.34
39	Dexamethason e	Injection 4mg/mL (Pack of 30ML)	1 ML	0.8	0.89
40	Diazepam	Tablet 2 mg	1 Tablet	1.28	1.43
41	Diazepam	Suppository 5mg	1 Suppositor y	5.52	6.18
42	Dicyclomine	Injection 10mg/mL (Less than 10ML Pack)	1 ML	2.96	3.31
43	Dicyclomine	Injection 10mg/mL (10 ML & more pack))	1 ML	1.87	2.09
44	Digoxin	Oral liquid0.05mg/mL	1 ML	1.31	1.46
45	Digoxin	Injection 0.25mg/mL	1 ML	3.45	3.86
46	Diltiazem	Tablet 30mg	1 Tablet	2.39	2.67

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
47	Diltiazem	Injection 5mg/mL	1 ML	3.12	3.49
48	Dobutamine	Injection 50 mg/ml	1 ML	8.05	9.02
49	Doxorubicin	Injection2mg/mL	1 ML	28.32	31.75
50	Doxycycline	Tablet100mg	1 Tablet	1.09	1.22
51	DPT+ Hib+ Hep B Vaccine	As licensed	Per 0.1 ML	67.47	75.64
52	Efavirenz	Tablet 200 mg (p)	1 Tablet	20.1	22.53
53	Enoxaparin	Injection40mg/0.4mL , injection 60mg/0.6 ml	0.10 ML	99.87	111.97
54	Esmolol	Injection10 mg/mL	1 ML	23.53	26.38
55	Ethambutol	Tablet 200mg	1 Tablet	1.02	1.14
56	Fluconazole	Capsule 200mg	1 Capsule	35.77	40.10
57	Fluconazole	Capsule 150mg	1 Capsule	17.14	19.21
58	Fluconazole	Injection 200mg/100mL	Per 100 ML Vial	82.34	92.32
59	Furosemide	Oralli quid 10mg/mL	1 ML	2.96	3.31
60	Gentamicin	Injection 40mg/mL (Pack of 10ml)	1 ML	1.35	1.51
61	Gentamicin	Injection 40mg/mL (Pack of 20ml)	1 ML	1.38	1.54
62	Gentamicin	Injection 40mg/mL Pack of 30ml)	1 ML	1.1	1.23
63	Glyceryl trinitrate	Sublingual Tablet 0.5mg	1 Tablet	1.13	1.26
64	Haloperidol	Injection 5mg/mL	1 ML	5.81	6.51
65	Haloperidol	Tablet 20mg	1 Tablet	4.78	5.35
66	Hepatitis B immunoglobulin	As Licensed	1 Vial	4903.95	5498.39
67	Hepatitis B vaccine	As Licensed	1 ML	70.3	78.82

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
68	Ifosfamide	Powder for Injection 2000mg	1 Vial	573.59	643.11
69	Ifosfamide	Powder for Injection 1000mg	1 Vial	284.46	318.94
70	Imatinib	Capsule 100mg	1 Capsule	65.54	73.48
71	Insulin (Soluble)	Injection 40 IU/ml	1 ml	15.15	16.98
72	Iohexol	Injection 300mg iodine/mL	1 ML	15.07	16.89
73	Levothyroxine	Tablet 150 mcg	1 Tablet	1.52	1.70
74	Lignocaine	Injection 1%	1 ML	7.91	8.86
75	Lignocaine	Injection 5% with 7.5% glucose	1 ML	3.12	3.49
76	Lignocaine (A) +Adrenaline(B)	Injection2%(A)+1:200000(5 mcg/mL)(B)	1 ML	0.94	1.05
77	Loperamide	Capsule 2mg	1 Capsule	3.38	3.78
78	Lorazepam	Injection 2mg/mL	1 ML	7.22	8.09
79	Mannitol	Injection 10 %	1 ML	0.17	0.19
80	Mefenamic acid	Tablet 250 mg	1 Tablet	1.88	2.10
81	Methotrexate	Tablet 5mg	1 Tablet	8.41	9.42
82	Methylprednisol one	Injection 40mg/mL	1 ML	40.73	45.66
83	Metoclopramide	Injection 5mg/mL (10 ML & More Pack)	1 ML	1.45	1.62
84	Metoclopramide	Oral liquid 5mg/5mL(p)	1 ML	0.45	0.50
85	Metoprolol	Capsule 25mg	1 Capsule	3.69	4.13
86	Metoprolol	Capsule 50mg	1 Capsule	5.19	5.81
87	Nifedipine	Capsule10mg	1 Capsule	0.85	0.95
88	Nitrofurantoin	Capsule 100 mg	1 Capsule	7.71	8.64
89	Nitrofurantoin	Oral liquid 25mg/5mL(p)	1 ML	0.79	0.88

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
90	Omeprazole	Tablet 20 mg	1 Tablet	3.87	4.33
91	Omeprazole	Capsule 10 mg	1 Capsule	2.15	2.41
92	Omeprazole	Powder for oral liquid 20mg	1 GM	1.35	1.51
93	Omeprazole	Tablet 40 mg	1 Tablet	7.54	8.45
94	Ondansetron	Tablet 8 mg	1 Tablet	8.08	9.05
95	Oral rehydration salts	As licensed	1 ML	0.13	0.14
96	Oxytocin	Injection 10IU/mL	1 ML	35.56	39.87
97	Paclitaxel	Injection 30 mg/5 mL, injection 100 mg/16.7 ml	1 ML	192.14	215.43
98	Permethrin	Cream 5%	1 GM	1.65	1.85
99	Permethrin	Lotion 1%	1 ML	0.89	0.99
100	Permethrin	Cream 1%	1 GM	1.34	1.50
101	Permethrin	Lotion 5%	1 ML/GM	0.89	0.99
102	Pheniramine	Injection 22.75mg/mL (2ml)	1 ML	2.46	2.75
103	Pheniramine	Injection 22.75mg/mL (10ml)	1 ML	1.84	2.06
104	Phenytoin	Modified Release Tablet 300mg	1 Tablet	5.86	6.57
105	Phenytoin	Tablet 100mg	1 Tablet	1.57	1.76
106	Phenytoin	Tablet 50mg	1 Tablet	0.75	0.84
107	Phenytoin	Oral liquid 30mg/5 mL(p)	1 ML	0.31	0.34
108	Phenytoin	Oral liquid 125mg/5mL(p)	1 ML	0.98	1.09
109	Phenytoin	Capsule 300mg	1 Capsule	4.15	4.65
110	Phenytoin	Capsule 100mg	1 Capsule	1.63	1.82
111	Phytomenadion e (Vitamin K1)	Tablet 10mg	1 Tablet	12.97	14.54
112	Insulin Premix 30:70 Injection	Injection 40 IU /ml	1 ml	15.15	16.98

Sl. No.	Name of the Scheduled Formulation	Dosage form and strength	Unit	Ceiling Price Fixed under NLEM, 2022 (Rs.)	Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)
	(Regular:NPH)
113	Primaquine	Tablet 2.5mg	1 Tablet	1.56	1.74
114	Propranolol	Capsule 40mg	1 Capsule	3.79	4.24
115	Pyridoxine	Tablet 10mg	1 Tablet	0.1	0.11
116	Quinine	Injection 300 mg/mL	1 ML	8.47	9.49
117	Ramipril	Capsule 2.5mg	1 Capsule	4.16	4.66
118	Ramipril	Capsule 5mg	1 Capsule	6.41	7.18
119	Sevoflurane	Liquid for inhalation	1 ML	27.8	31.16
120	Sodium bicarbonate	Injection (as per IP) – 7.5%	1 ML	0.9	1.00
121	Somatostatin	Powder for Injection 3mg	1 Vial	1212.01	1358.92
122	Tetanus toxoid	As licensed (5ml)	1 Vial	22.77	25.53
123	Tetanus toxoid	As licensed (0.5ml)	1 Vial (0.5ML)	11.12	12.46
124	Tramadol	Capsule 50mg	1 Capsule	4.3	4.82
125	Tramadol	Capsule 100mg	1 Capsule	8.06	9.03
126	Vitamin A	Tablet 50000IU (including Chewable Tablet)	1 Tablet	0.65	0.72
127	Vitamin A	Injection 50000IU/mL	1 ML	2.02	2.26

(a) The above-mentioned ceiling prices as fixed under NLEM 2022 shall be effective from 1st April 2023 after the application of the Wholesale Price Index (WPI) and as specified in column (6) above.

(b) All manufacturers of scheduled formulation, selling the branded or generic or both 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 and then they may further make a corresponding increase in MRP (excluding GST) upto the level of WPI @12.1218% with effect from 1st April 2023 not exceeding ceiling prices as specified in column (6) in the above table.

(c) 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 GST as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013 and they may further make the corresponding increase in MRP upto the level of WPI @12.1218% with the effect from 1st April 2023.

(d) 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 (6) of the above-said table.

(e) The ceiling prices fixed for Enoxaparin Injection 40mg/0.4ml and 60 mg/0.6 ml at S.N. 53are also applicable to any other strengths (such as 300mg/3ml, 80mg/0.8ml, 20mg/0.2ml etc.) of the Enoxaparin with same ratio i.e. 10mg/0.1ml).

(f) The ceiling prices fixed for Paclitaxel Injection 30 mg/5 mL and 100mg/16.7 ml at S.N. 97 are also applicable to any other strengths (300mg/50ml, 260mg/43.4ml, 250mg/41.7ml, 200mg/33.4ml etc.) of the Paclitaxel with same ratio i.e. 6mg/ml).

(g) The ceiling prices fixed for Budesonide Respirator solution for use in nebulizer 0.5mg/mL and Budesonide Respirator solution for use in nebulizer 1mg/mL are also applicable to 2ml respules of 0.5mg and 2ml respules of 1mg by applying 2 times of the ceiling prices of 1 ml respules of 0.5 mg and 1 mg respectively.

(h) Information about the revision, if carried out, shall be forwarded to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision and non-submission of information under this sub-paragraph shall be construed as non revision of maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount charged over and above the pre-revised maximum retail price (MRP), alongwith interest thereon from the date of overcharging.

(i) 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 (6) 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.

(j) As per para 24(4) of DPCO 2013, every retailer and dealer shall display a 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 as to be easily accessible to any person wishing to consult the same.

(k) 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.

(l) 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.

(m) 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.

(n) 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.

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NPPA fixes and revises ceiling price of 127 scheduled drugs, Details

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