National Pharmaceutical Pricing Authority

(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

New Delhi, the 20^th December, 2013

National Pharmaceutical Pricing Authority

ORDER

S.O. 3789(E) – In order to implement the directions given in review order no. 31015/11/2013-PI.I dated 27.11.2013 passed by the Department of Pharmaceuticals for M/s Lupin Ltd. against S.O. No. 1497(E) dated 07.06.2013 in respect of Rifampicin based formulations under DPCO 1995 and in exercise of the powers, conferred by sub-paragraphs (1) and (2) of paragraph 9 of the Drugs (Prices Control) Order, 1995, read with No. S.O. 637 (E) dated the 4^th September, 1997 issued by the Government of India in 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. S.O. 1497(E), dated 7^th June, 2013, 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, hereby fixes the prices as specified in column (5) of the table below as ceiling prices exclusive of excise duty and local tax, if any, and in column (6) of the table below as Equivalent MRP inclusive of excise duty and education cess, sales tax/VAT of each of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and pack size specified respectively in the corresponding entries in columns (3) and (4) thereof:

Table

Sl. No.	Name of the Schedule Formulation	Strength	Unit	Ceiling Price (Rs.)	*Equivalent MRP (inclusive of all taxes) (Rs.)**
(1)	(2)	(3)	(4)	(5)	(6)
--	--	Each Capsule contains	--	--	--
1.	Rifampicin Capsule	Rifampicin -150 mg	10’s Strip/Blister	17.54	19.03
2.	Rifampicin Capsule	Rifampicin -300 mg	10’s Strip/Blister	31.68	34.37
3.	Rifampicin Capsule	Rifampicin -450 mg	10’s Strip/Blister	45.92	49.82
4.	Rifampicin Capsule	Rifampicin -600 mg	10’s Strip/Blister	60.62	65.77
5.	Rifampicin+ Isoniazid Capsule	Rifampicin -450mg Isoniazide -300mg	10’s Strip/Blister	49.34	53.53
--	--	Each dispersible tablet contains	--	--	--
6.	Rifampicin+ Isoniazid Tablets	Rifampicin – 60mg Isoniazide – 30mg	6’s Al_Strip	4.90	5.32
7.	Rifampicin+ Isoniazid Tablets	Rifampicin – 60mg Isoniazide – 30mg	6’s Al_Blister	4.76	5.16
8.	Rifampicin+ Isoniazid Tablets	Rifampicin – 100 mg Isoniazide – 50mg	10’s Strip/Blister	11.66	12.65
9.	Rifampicin+ Isoniazid Tablets	Rifampicin – 100mg Isoniazide – 50mg	10’s Alu_Alu Strip/Blister	12.50	13.56
10.	Rifampicin+ Isoniazid Tablets	Rifampicin – 100mg Isoniazide – 100mg	10’s Al_Strip	13.40	14.54
11.	Rifampicin+ Isoniazid Tablets	Rifampicin – 100mg Isoniazide – 100mg	10’s Al_Blister	13.04	14.15
12.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 100mg Isoniazide – 50mg Pyrazinamide – 300mg	10’s Al_Strip	20.42	22.16
13.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 150mg Isoniazide – 100mg Pyrazinamide – 500mg	10’s Al_Strip	29.62	32.14
14.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 150mg Isoniazide – 100mg Pyrazinamide – 500mg	10’s Al_Blister	29.04	31.51
15.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 60mg Isoniazide – 30mg Pyrazinamide – 150mg	6’s Al_Strip	7.36	7.99
16.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 60mg Isoniazide – 30mg Pyrazinamide – 150mg	6’s Al_Blister	7.12	7.73
--	--	Each film coated tablet contains	--	--	--
17.	Rifampicin+ Isoniazid Tablets	Rifampicin – 150mg Isoniazide – 75mg	6’s Strip/Blister	10.72	11.63
18.	Rifampicin+ Isoniazid Tablets	Rifampicin – 150mg Isoniazide – 75mg	6’s Al_PVDC/PVC Film Blister	10.96	11.89
19.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 225 mg Isoniazide – 150 mg Pyrazinamide – 750 mg	10’s Strip/Blister	42.02	45.59
20.	Rifampicin+ Isoniazid + Pyrazinamide Tablets	Rifampicin – 225 mg Isoniazide – 150 mg Pyrazinamide – 750 mg	10’s Al_PVDC/PVC Film Blister	42.66	46.29
21.	Rifampicin+ Isoniazid + Ethambutol Tablets	Rifampicin – 150 mg Isoniazide – 75 mg Ethambutol HCl – 275 mg	10’s Al_Strip	28.92	31.38
22.	Rifampicin+ Isoniazid + Ethambutol Tablets	Rifampicin – 150 mg Isoniazide – 75 mg Ethambutol HCl – 275 mg	10’s Al_PVDC/PVC Film Blister	29.56	32.07
23.	Rifampicin+ Isoniazid + Ethambutol Tablets	Rifampicin – 450 mg Isoniazide – 300 mg Ethambutol HCl – 800 mg	6’s Strip,/Blister	47.72	51.78
24.	Rifampicin+ Isoniazid + Pyrazinamide+ Tablets Ethambutol Tablets	Rifampicin – 150 mg Isoniazide – 75 mg Pyrazinamide – 400 mg Ethambutol HCl – 275 mg	10’s Al_PVDC/PVC Film Blister	39.12	42.45
25.	Rifampicin+ Isoniazid + Pyrazinamide+ Tablets Ethambutol Tablets	Rifampicin – 225 mg Isoniazide – 150 mg Pyrazinamide – 750 mg Ethambutol HCl – 400 mg	6’s Al_PVDC/PVC Film Blister	35.48	38.50
26.	Rifampicin+ Isoniazid + Pyrazinamide+ Tablets Ethambutol Tablets	Rifampicin – 150 mg Isoniazide – 100 mg Pyrazinamide – 500 mg Ethambutol HCl – 267 mg	3’s Strip/Blister	12.72	13.80
27.	Rifampicin+ Isoniazid Tablets	Rifampicin – 450 mg Isoniazide – 300 mg	10’s Al_Strip	51.38	55.75
28.	Rifampicin+ Isoniazid Tablets	Rifampicin – 450 mg Isoniazide – 300 mg	10’s Al_PVDC/PVC Film Blister	51.88	56.29
29.	Rifampicin+ Isoniazid Tablets	Rifampicin – 600 mg Isoniazide – 300 mg	10’s Strip/Blister	64.14	69.59
30.	Rifampicin+ Isoniazid Tablets	Rifampicin – 600 mg Isoniazide – 300 mg	10’s Al_PVDC/PVC Film Blister	64.78	70.29
--	--	Each Kit Contains	--	--	--
31.	Rifampicin+ Isoniazid + Ethambutol Tablets	1 capsule of Rifampicin-450mg 1 tablet of Ethambutol-800mg & Isoniazide 300mg	2’s Kit (1 Cap +1 Tab.)	8.36	9.07
32.	Rifampicin+ Isoniazid+ Ethambutol+ Pyrazinamide Tablets	1 capsule of Rifampicin-450mg 1 tablet of Ethambutol-800mg & Isoniazide 300mg 2 tablet of Pyrazinamide-750mg	4’s Kit (1 Cap +3 Tab.)	12.14	13.17
33.	Rifampicin+ Isoniazid+ Pyrazinamide+ Ethambutol Tablets	Each film coated tab contains Rifampicin 600mg Isoniazide 300mgEach tablet contain Pyrazinamide-800 mg (2 tablet ) Ethambutol – 1100 mg	10×4’s Al_ PVDC/PVC Film Blister	143.70	155.91
--	--	Each 5ml contains	--	--	--
34.	Rifampicin Suspension	Rifampicin-100mg	200 ml Glass Bottle with M. Cup	64.90	70.42

*Subject to actual payment of Government levies/taxes, as applicable.

Note :

The prices fixed are the maximum retail prices in column (6) (inclusive of excise duty and local taxes if any) for the specified pack and packs of similar strength, and companies cannot claim exemption on any ground therefrom, unless specifically permitted by the Government/NPPA through an order.
The companies / manufacturers may added taxes only if they have paid actually to the Government on the price mentioned in the column (5). If there is any variation in the MRP (inclusive of the taxes), the same may be intimated to the NPPA in the Form-V of DPCO, 1995.
Pro-rata pricing for packs of same composition but of different sizes will be applicable vide S.O. No. 83(E) dated 27.1.1998 for tablet and capsule packed in strip/blister.
For different packing material used or, different drug delivery systems or any other special features/forms claimed, the ceiling prices, as specified in Column No. 5 above, shall be applicable unless the companies approaches NPPA for specific price approvals for its formulations.
The prices fixed/notified hereinabove under the provisions of DPCO, 1995 have to be mandatorily implemented by the manufacturing /marketing company notwithstanding its status of compliance of conditions for such formulation pack under the Drugs and Cosmetics Act, 1940.
The manufacturer and marketing company for the above said formulation shall be required to take the requisite prior approval from the competent Authority for any change in the composition of the above said formulation with written prior intimation to the National Pharmaceutical Pricing Authority.
The ceiling price arrived on the basis of above shall not exceed the MRP by multiplying the ceiling price by a factor of 1.0850 as per the existing rates of excise duty and VAT.
The MRP arrived as above shall be subject to payment of Government levies / taxes as applicable and necessary adjustment in the factor of 1.0850 shall necessarily be required to be made by the manufacturer/marketing company, whenever the existing rate of excise duty and/or VAT undergoes a change, subject to the condition that the excise duty and/or VAT so calculated shall in no case exceed the actual excise duty and/or VAT paid by the manufacturer/marketing company or as applicable as per the factor of 1.0850. The manufacturer/marketing company shall be specifically liable to ensure the compliance of this condition.
Any other formulation / composition not covered in the above table that has any one of the scheduled drugs in Column No. (3) as one of its ingredients, it shall be subject to the price ceiling at respective serial number of the table, as the case may be, unless the manufacturer has got hereafter specific price fixed by the NPPA for that formulation.
The manufacturer or marketing company not complying with the ceiling prices and conditions specified in notes hereinabove within 15 days from the date of above said notification, shall be liable to deposit overcharged amount along with the interest under the provisions of the DPCO, 1995 read with the EC Act, 1955.
Consequent to the issue of ceiling price of the formulation pack(s) in this notification, the price order(s) issued prior to this date of notification stand automatically withdrawn.

PN/142/10/2013/F

F. No. 8(10)/2013/D.P./NPPA-Div.-II

(MANISH GOSWAMI)
Deputy Director

Last Page Updated: 22-01-2019

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