National Pharmaceutical Pricing Authority New Delhi, the 19th December, 2022 ORDER

(Published in Part II, Section 3, Sub-section (ii) of the Gazette of India, Extraordinary) Government of India

Ministry of Chemicals and Fertilizers

Department of Pharmaceuticals

National Pharmaceutical Pricing Authority

New Delhi, the 19th December, 2022

ORDER

S. O. 5938(E):- 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 and SO No 4589(E) dated 29th September, 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:

TABLE

Sl. No.

(1)

(2)

Name of the Scheduled Formulation

Paracetamol

Allopurinol

Hydroxychloroquine

Carbamazepine

Clobazam

Levetiracetam

(3)

Dosage form and strength

Tablet 650mg

Tablet 300mg

Tablet 400mg

Modified Release – Tablet 200mg

Modified Release – Tablet 400mg

Tablet 400mg

Tablet 5mg

Tablet 10mg

Tablet 250mg

Tablet 500mg

Modified Release Tablet 750mg

(4)

Unit

1 Tablet

Ceiling Price (Rs.)

12 Levetiracetam

Tablet 750mg

1 Tablet

(5)

1.78

5.02 12.31

2.14

4.16 3.17 4.94 8.55 5.57

11.40

16.32 16.98

Sl. Name of the No. Scheduled

Formulation

13 Lorazepam

14 Lorazepam

15 Sodium Valproate

16 Mebendazole

Diethylcarbamazine

17 (DEC)

18 Cefadroxil Artemether (A)

19 +Lumefantrine(B) Artemether (A)

20 +Lumefantrine(B)

21 Cefixime

22 Clarithromycin

23 Clarithromycin

24 Cycloserine

25 Ethionamide

26 Levofloxacin

27 Levofloxacin

28 Levofloxacin

29 Linezolid

30 Moxifloxacin

31 Rifampicin

32 Fluconazole

33 Abacavir

Abacavir (A)

34 +Lamivudine(B)

35 Nevirapine

36 Raltegravir

37 Darunavir

38 Entecavir

39 Sofosbuvir

40 Clindamycin

41 Clindamycin

42 Flunarizine

43 Flunarizine

Levodopa (A)

44 +Carbidopa(B)

Levodopa (A)

45 +Carbidopa(B)

46 Levodopa (A)

Dosage form and strength

Unit

1 Tablet 1 Tablet 1 Tablet 1 Tablet

1 Tablet 1 Tablet

1 Tablet

1 Capsule 1 Tablet

1 Tablet

1 Capsule 1 Tablet

1 Tablet

1 Capsule 1 Capsule 1 Tablet

1 Tablet 1 Tablet

Ceiling Price (Rs.)

2.06 2.51 3.98 2.59

1.49 3.99

22.75

11.28 19.71 21.04 34.61 52.79 13.21

4.25

7.85 10.69 31.81 22.79 10.13 26.53 43.34

64.50

14.09 131.81 137.73 116.15 468.32

14.59 25.30 2.21 4.30

2.30

1.57 3.94

Tablet Tablet Tablet Tablet

1mg 2mg 300mg 100 mg

100mg 500mg

Tablet

Tablet 80mg(A)+480mg(B) Tablet 20 mg (A) + 120 mg (B)

Tablet 400mg

Tablet 250mg

Tablet 500mg Capsule250mg

Tablet 250mg

Tablet 500mg

Tablet 750mg

Tablet 600mg

Tablet 400mg

Capsule 600mg

Tablet 400mg

Tablet 300 mg

Tablet 600mg (A) +300mg (B)

Tablet 200 mg

Tablet 400mg

Tablet 600mg

Tablet 1mg

Tablet 400mg

Capsule 150mg Capsule 300mg

Tablet 5mg

Tablet 10mg

Tablet 100 mg (A) + 25 mg (B)

Tablet 100 mg (A) + 10 mg (B)

Tablet 250mg(A)

Sl. Name of the No. Scheduled

Formulation

+Carbidopa(B)

47 Isosorbide dinitrate

48 Amlodipine

49 Amlodipine

50 Amlodipine

51 Ramipril

52 Ramipril

53 Telmisartan

54 Telmisartan

55 Telmisartan

56 Metformin

57 Metformin

58 Glimepiride

59 Glimepiride

60 Donepezil

61 Donepezil

62 Atorvastatin

63 Atorvastatin

64 Atorvastatin

65 Baclofen

66 Baclofen

67 Baclofen

68 Levothyroxine

69 Levothyroxine

70 Levothyroxine

71 Levothyroxine

72 Levothyroxine

73 Levothyroxine

74 Metformin

75 Vecuronium

76 Vecuronium

77 Capecitabine

78 Misoprostol

79 Cholecalciferol

80 Mesna

81 Mefenamic acid

82 Haloperidol

Dosage form and strength

+25mg(B) Tablet 5mg

Tablet 2.5mg

Tablet 5mg

Tablet 10mg

Tablet 2.5 mg

Tablet 5mg

Tablet 20mg

Tablet 40mg

Tablet 80mg

Tablet 1000mg

Tablet 500mg

Tablet 2mg

Tablet 1mg

Tablet 10mg

Tablet 5mg

Tablet 40mg

Tablet 20mg

Tablet 10mg

Tablet 20mg

Tablet 10mg

Tablet 5mg

Tablet 50mcg

Tablet 75mcg

Tablet 88 mcg

Tablet 150 mcg

Tablet 112 mcg

Tablet 25 mcg

Modified release Tablet 1000mg

Powder for injection 10mg

Powder for injection 4 mg Tablet 500mg

Tablet 200mcg

Tablet 1000 IU

Injection 100mg/mL

Oral liquid 100mg/5mL(p) Tablet 1.5mg

Unit

1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet

1 Tablet

Each Vial Each Vial 1 Tablet 1 Tablet 1 Tablet 1 ML

1 ML

1 Tablet

Ceiling Price (Rs.)

0.73 1.59 2.23 4.81 4.65 7.30 3.44 6.03 9.24 3.11 1.77 5.11 3.27

15.24 10.57 16.92 11.01

4.38 14.52 10.39

5.68 0.92 1.28 1.47 1.59 1.48 1.29

3.52

104.67 66.36 100.53 16.92 3.84 13.83 0.50 1.37

Sl. No.

100

101

102

103

104

105

106

Name of the Scheduled Formulation

Haloperidol

Bicalutamide

Letrozole

Mycophenolate mofetil

Amitriptyline

Heparin

Amitriptyline

Fluoxetine

Tacrolimus

Temozolomide

Zolpidem

Loperamide

Risperidone

Dosage form and strength

Tablet 5mg

Tablet 10mg

Tablet 50mg

Tablet 2.5mg

Tablet 500mg

Tablet 50mg

Tablet 75mg

Injection 1000IU/mL

Injection 5000IU/mL

Tablet 25mg

Capsule 20 mg

Capsule 60 mg

Capsule 40 mg

Capsule 10 mg

Capsule 0.5mg

Capsule 1mg

Capsule 2mg

Capsule 20 mg

Capsule 250mg

Tablet 5mg

Tablet 10mg

Tablet 2mg

Tablet 1 mg

Tablet 2 mg

Unit

1 Tablet

1 ML

1 Tablet

1 Capsule

1 Capusle

1 Capsule

1 Tablet

Ceiling Price (Rs.)

107 Risperidone Note:

3.18

4.26 38.62 26.15 65.89

5.34

4.77 18.92 53.48

2.16 3.56 9.90 5.79 2.96

18.43 36.23 75.22

393.60 3838.48 5.44 7.59 2.03 2.66 4.00 Tablet 4 mg 1 Tablet 6.56

(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 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 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 (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.

PN/237/105/2022/F F. No. 8(105)/2022/D.P./NPPA-Div.-II

(Mahaveer Saini) Deputy Director (Pricing)