NPPA revises ceiling prices of 93 scheduled formulations, Details

Published On 2023-01-12 12:30 GMT   |   Update On 2023-10-28 06:35 GMT
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New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemicals & Fertilizers, the Government of India, has revised the ceiling price of 93 scheduled formulation under the Drugs (Price Control) Order,2013.

The list of 93 scheduled formulations includes Sulfasalazine, Digoxin, Ethambutol, Phenytoin, Ceftriaxone, Cefotaxime, Ampicillin, Metoprolol, Fluconazole, Pyrazinamide, Phenobarbitone,
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Amiodarone
, Metronidazole, Acetazolamide, Clonazepam, and others.

Scheduled formulations are 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.

This 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

Sulfasalazine

Tablet 500 mg

1 Tablet

4.21

2

Digoxin

Tablet 0.25mg

1 Tablet

1.19

3

Ethambutol

Tablet 600mg

1 Tablet

3.64

4

Phenytoin

Tablet 300mg

1 Tablet

4.89

5

Atazanavir (A)

+Ritonavir(B)

Tablet 300mg(A) + Tablet 100mg(B)

1 Tablet

89.03

6

Ceftriaxone

Powder for Injection 500 mg

1 Vial

44.84

7

Ceftriaxone

Powder for Injection 250 mg

1 Vial

25.28

8

Ceftriaxone

Powder for Injection 1000mg

1 Vial

55.64

9

Ceftriaxone

Powder for Injection 2000mg

1 Vial

123.18

10

Cefotaxime

Powder for Injection 250 mg

1 Vial

15.80

11

Cefotaxime

Powder for Injection 500 mg

1 Vial

21.74

12

Cefotaxime

Powder for Injection 1000mg

1 Vial

35.64

13

Piperacillin (A)

+Tazobactam(B)

Powder for Injection 1000mg(A)+125mg(B)

1 Vial

88.88

Sl.

No.

Name of the Scheduled Formulation

Dosage form and strength

Unit

Ceiling Price (Rs.)

14

Piperacillin (A)

+Tazobactam(B)

Powder for Injection 2000mg(A)+250mg(B)

1 Vial

170.83

15

Piperacillin (A)

+Tazobactam(B)

Powder for Injection 4000mg(A)+500mg(B)

1 Vial

356.21

16

Ampicillin

Powder for Injection 500 mg

1 Vial

12.71

17

Metoprolol

Tablet 25mg

1 Tablet

3.75

18

Metoprolol

Tablet 50mg

1 Tablet

5.21

19

Propranolol

Tablet 40mg

1 Tablet

2.87

20

Fluconazole

Tablet 200mg

1 Tablet

15.57

21

Ethambutol

Tablet 800mg

1 Tablet

4.42

22

Pyrazinamide

Tablet 1000mg

1 Tablet

9.39

23

Pyrazinamide

Tablet 500mg

1 Tablet

4.36

24

Pyrazinamide

Tablet 750mg

1 Tablet

6.43

25

Phenobarbitone

Tablet 30mg

1 Tablet

1.17

26

Amiodarone

Tablet 200mg

1 Tablet

10.27

27

Ethambutol

Tablet 400mg

1 Tablet

2.33

28

Fluconazole

Tablet 100mg

1 Tablet

6.80

29

Azathioprine

Tablet 50mg

1 Tablet

10.04

30

Allopurinol

Tablet 100mg

1 Tablet

1.69

31

Propranolol

Tablet 10mg

1 Tablet

1.17

32

Hydroxychloroquine

Tablet 200mg

1 Tablet

5.67

33

Carbimazole

Tablet 10mg

1 Tablet

3.80

34

Cefixime

Tablet 200mg

1 Tablet

8.72

35

Imatinib

Tablet 100mg

1 Tablet

62.21

36

Tamoxifen

Tablet 20mg

1 Tablet

2.63

37

Tamoxifen

Tablet 10mg

1 Tablet

1.97

38

L-Asparaginase

Powder for Injection 5000 KU

1 Vial

922.94

39

L-Asparaginase

Powder for Injection 10000KU

1 Vial

1523.03

40

Dacarbazine

Powder for Injection 200mg

1 Vial

340.46

41

Mefloquine

Tablet 250 mg

1 Tablet

46.52

42

Thalidomide

Capsule 50 mg

1 Capsule

27.79

43

Thalidomide

Capsule 100mg

1 Capsule

55.31

44

Clonazepam

Tablet 0.25mg

1 Tablet

1.80

45

Clonazepam

Tablet 0.5mg

1 Tablet

3.08

46

Clonazepam

Tablet 1mg

1 Tablet

4.25

47

Clozapine

Tablet 25mg

1 Tablet

2.48

48

Clozapine

Tablet 50mg

1 Tablet

4.63

49

Clozapine

Tablet 100 mg

1 Tablet

7.54

Sl.

No.

Name of the Scheduled Formulation

Dosage form and strength

Unit

Ceiling Price (Rs.)

50

Metronidazole

Tablet 200mg

1 Tablet

0.73

51

Metronidazole

Tablet 400mg

1 Tablet

1.36

52

Hydroxyurea

Capsule 500mg

1 Capsule

10.81

53

Ibuprofen

Tablet 200mg

1 Tablet

0.63

54

Acetazolamide

Tablet 250mg

1 Tablet

3.62

55

Ciprofloxacin

Tablet 250mg

1 tablet

1.96

56

Salbutamol

Tablet 4 mg

1 Tablet

0.19

57

Salbutamol

Tablet 2 mg

1 Tablet

0.16

58

Metoclopramide

Tablet 10mg

1 Tablet

1.20

59

Amoxicillin (A)

+Clavulanic acid (B)

Tablet 500 mg (A) + 125 mg (B)

1 Tablet

16.32

60

Docetaxel

Powder for Injection 20mg

1 Vial

2558.14

61

Clopidogrel

Tablet 75mg

1 Tablet

5.94

62

Hydrocortisone

Powder for Injection 100mg

1 Vial

39.95

63

Gemcitabine

Powder for Injection 1000mg

1 Vial

4987.65

64

Methotrexate

Tablet 10mg

1 tablet

11.85

65

Methotrexate

Tablet 2.5mg

1 tablet

4.74

66

Diltiazem

Tablet 60mg

1 Tablet

4.87

67

Amiodarone

Tablet 100mg

1 Tablet

5.48

68

Dom1idone

Tablet 10mg

1 Tablet

2.06

69

Quinine

Tablet 300 mg

1 Tablet

5.04

70

Enalapril

Tablet 5mg

1 Tablet

3.30

71

Enalapril

Tablet 2.5mg

1 Tablet

1.95

72

Acyclovir

Tablet 400mg

1 Tablet

12.18

73

Acyclovir

Tablet 200mg

1 Tablet

6.79

74

Rifampicin

Capsule 450mg

1 Capsule

5.06

75

Zidovudine (A)

+Lamivudine(B)

Tablet 300mg(A)+150mg(B)

1 Tablet

18.81

76

Primaquine

Tablet 7.5mg

1 Tablet

2.12

77

Nitrofurantoin

Tablet 100 mg

1 Tablet

7.23

78

Ciprofloxacin

Tablet 500mg

1 tablet

3.79

79

Ondansetron

Tablet 8 mg

1 Tablet

7.94

80

Griseofulvin

Tablet 250mg

1 Tablet

1.58

81

Escitalopram

Tablet 5mg

1 Tablet

4.48

82

Escitalopram

Tablet 10mg

1 Tablet

8.03

83

Escitalopram

Tablet 20mg

1 Tablet

12.81

84

Gemcitabine

Powder for Injection 200 mg

1 Vial

1159.21

85

Ceftazidime

Powder for Injection 1000mg

1 Vial

202.47

86

Diclofenac

Tablet 50mg

1 Tablet

1.83

Sl.

No.

Name of the Scheduled Formulation

Dosage form and strength

Unit

Ceiling Price (Rs.)

87

Carbamazepine

Tablet 200mg

1 Tablet

1.40

88

Amoxicillin (A) + Clavulanic acid (B)

Powder for Injection 1 g (A)

+200mg (B)

1 Vial

125.44

89

Bisacodyl

Tablet 5mg

1 Tablet

1.04

90

Pantoprazole

Injection 40mg

1 Vial

45.00

91

Ethinylestradiol (A)+ Levonorgestrel (B)

Tablet 0.03mg(A) + Tablet 0.15mg(B)

1 Tablet

2.83

92

Norethisterone

Tablet 5mg

1 Tablet

4.81

93

Carbimazole

Tablet 5mg

1 Tablet

1.95

The Notice further added:
(a) 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.
(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 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 (u) of the DPCO 2013 such existing manufacturer shall apply for prior price approval of a 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 the Essential Commodities Act,1955.
(i) Consequent to the issue of the 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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