inHealth care

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.

What do you think?

0 Points
Upvote Downvote

ceilingdetailsdrugsfixesnppapricerevisesscheduled

Written by

Leave a Reply

Your email address will not be published. Required fields are marked *

GIPHY App Key not set. Please check settings

Vijay Deverakonda has the coolest way to go to work; checkout his way of shooting | Video

Blindness Prevention Week 2023: Challenges and Solutions for Addressing Cataracts in India