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
(National Pharmaceuticals Pricing Authority)

New Delhi, the 7^th June, 2013

ORDER

S.O. 1500(E) – In implementation of directions given in order dated 01.06.2011 in W.P (c) 456/2011 (M/s Eli Lilly and Company India Pvt. Ltd. Vs. Union of India & Anr.) by the Hon’ble High Court of Delhi in respect of price fixation order S.O. No. 789(E) dated 10.04.2012 fixing the prices of imported Insulin formulations, the matter has been reconsidered and re-examined by the National Pharmaceutical Pricing Authority (hereinafter mentioned as NPPA) in line with review order passed by the Department of Pharmaceuticals on 17.11.2011 vide letter no. 31015/1/11-PI.I in respect of S.O. No. 3036(E) dated 23.12.2010 for Imported Insulin Humalog.

NPPA in its 132^thAuthority Meeting held on 16.05.2012 duly considered the aforesaid price fixation order and approved the prices of imported formulations considering the CIF prices claimed in Form IV of Drugs (Prices Control) Order, 1995 (hereinafter mentioned as DPCO 1995) and guidelines approved in 121^stAuthority Meeting held on 22.7.2011 in respect of MAPE / Margin for such imported formulations having domestic / indigenous substitute. Accordingly, prices for concerned imported formulations were approved with the margin as applicable to ensure fair and reasonable price to consumer public.

Therefore, in respect of above mentioned price fixation and in exercise of the powers, conferred by sub-paragraph (1)/(2)/(4)/(7) of paragraph 8 of the DPCO 1995 read with S.O. No. 637 (E) dated the 4th 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, (NPPA) S.O. No. 1737(E) dated 26.07.2011, 789(E) dated 10.04.2012, 1635(E) dated 19.07.2012 and 2740(E) dated 16.11.2012, 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 NPPA, hereby fixes/revises the prices as specified in column (4) of the table hereto annexed as the retail price/revised retail price, exclusive of excise duty, Sales Taxes/VAT and local taxes, if any, and in column (5) as equivalent MRP inclusive of excise duty, education cess, Sales Tax/VAT in relation to each of the formulation specified in the corresponding entry in column (2) of the said table with the pack size specified in the corresponding entries in column (3) thereof; manufactured/imported by M/s. Eli Lilly and Company (I) Pvt. Ltd. and M/s. Novo Nordisk.

TABLE

Sl. No.	Name of the formulation	Pack Size	Retail Price without Excise Duty Sales Tax /VAT and Local Tax, if any (Rs.)	Equivalent MRP*(inclusive of all taxes) (Rs.)
(1)	(2)	(3)	(4)	(5)
“1.	Monocomponent Insulin Humalog 100 IU/ml (Insulin Lispro) Each ml contain 100 IU Insulin Lispro Ph. Eur. (r-DNA origin) Batch No. A847484C/ Qty. 5000 Cartridge	3ml Cartridge	407.43	423.73
2.	Monocomponent Insulin Humalog Mix 25 100 IU/ml (Insulin Lispro) Each ml contain 25% Insulin Lispro and 75% Insulin Lispro Protamine suspension, 100 IU Insulin Lispro (r-DNA Origin) Batch No. A834666R / Qty. 5000 Cartridge	3ml Cartridge	407.43	423.73
3.	Monocomponent Insulin Humalog Mix 50 100IU/ml(Insulin Lispro) Each ml contain 50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension, 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) Batch No. A847483A/ Qty. 5000 Cartridge Batch No. A852787A/ Qty. 5000 Cartridge	3ml Cartridge	407.43	423.73
4.	Monocomponent Insulin Humalog Kwik Pen 100 IU/ml (Insulin Lispro) Each ml of Insulin Lispro contians: 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. A829407C/ Qty. 30235 Prefilled Pens	3ml Prefilled Kwik Pen	534.36	555.73
5.	Monocomponent Insulin Humalog Kwik Mix 25 Pen 100 IU/mlEach ml of 25% Insulin Lispro and 75% Insulin Lispro Protamine Suspension contains: 100 IU Insulin Lispro PH. Eur (r-DNA origin) Batch No. A812548D / Qty. 1500 Prefilled Pens	3ml Prefilled Kwik Pen	534.36	555.73
6.	Monocomponent Insulin Humalog Kwik Mix 50 Pen 100 IU/mlEach ml of 50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension contains: 100 IU Insulin Lispro PH. Eur (r-DNA origin) Batch no. A812369D / Qty. 30310 Prefilled Pens Batch no. A812369J / Qty. 14845 Prefilled Pens	3ml Prefilled Kwik Pen	534.36	555.73
7.	Monocomponent Insulin Humalog Mix 25 100 IU/ml (Insulin Lispro) Each ml contains : 25% Insulin Lispro and 75% Insulin Lispro Protamine suspension, 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) Batch no. A917091E / Qty. 1500 Cartridge	3ml Cartridge	407.43	423.73
8.	Monocomponent Insulin Humalog Mix 25 100 IU/ml (Insulin Lispro) Each ml contains : 25% Insulin Lispro and 75% Insulin Lispro Protamine suspension, 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) Batch no. A917091E / Qty. 79535 Cartridge	3ml Cartridge	425.32	442.33
9.	Monocomponent Insulin Humalog Mix 50 100IU/ml (Insulin Lispro) Each ml contain : 50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension, 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) Batch No. A946165E / Qty. 1500 Cartridge	3ml Cartridge	425.32	442.33
10.	Monocomponent Insulin Humalog Kwik Mix 25 Pen 100 IU/ml Each ml of 25% Insulin Lispro and 75% Insulin Lispro Protamine Suspension contains: 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. A897313E/ Qty. 1500 Prefilled Pens	3 ml Prefilled Kwik Pen	534.36	555.73
11.	Monocomponent Insulin Humalog Kwik Mix 50 Pen100 IU/ml Each ml of 50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension contains: 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. A934260F / Qty. 1500 Prefilled Pens	3 ml Prefilled Kwik Pen	534.36	555.73
12.	Monocomponent Insulin Humalog 100IU/ml (Insulin Lispro) Each ml Insulin Lispro contains 100 IU (3.5 mg) Insulin Lispro (r-DNA origin) Batch No. C058177/Qty. 1500 cartridge Batch No. C028433A/Qty. 1500 cartridge Batch No. C028319A/Qty. 1500 cartridge Batch No. A941149D/Qty. 1500 cartridge	3ml Cartridge	425.32	442.33
13.	Monocomponent Insulin Humalog Mix 25 100 IU/ml (Insulin Lispro) Each ml contains : (25% Insulin Lispro and 75% Insulin Lispro Protamine Suspension) 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) B.No. C058178/Qty 1500 cartridge B.No. C023059D/Qty 1500 cartridge B.No. C041974A/Qty 1500 cartridge B.No. C014813G/Qty 1500 cartridg	3ml Cartridge	425.32	442.33
14.	Monocomponent Insulin Humalog Mix 50 100IU/ml (Insulin Lispro) Each ml contain : (50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension), 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) B.No. C037600C/Qty 1500 cartridge	3ml Cartridge	425.32	442.33
15.	Monocomponent Insulin Humalog Kwik Pen 100IU/ml Each ml of Insulin Lispro contains 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. C003605K / Qty. 1500 Prefilled Pens Batch no. A897244C / Qty. 1500 Prefilled Pens	3 ml Prefilled Kwik Pen	534.36	555.73
16.	Monocomponent Insulin Humalog Kwik Mix 25 Pen100 IU/ml Each ml of 25% Insulin Lispro and 75% Insulin Lispro Protamine Suspension contains: 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. C009452L/ Qty. 1500 Prefilled Pens	3 ml Prefilled Kwik Pen	534.36	555.73
17.	Monocomponent Insulin Humalog Kwik Pen 100IU/ml Each ml of Insulin Lispro contains 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. A937085K / Qty. 1500 Prefilled Pens Batch no. A937085E / Qty. 1500 Prefilled Pens	3 ml Prefilled Kwik Pen	534.36	555.73
18.	Monocomponent Insulin Humalog Kwik Mix 50 Pen100 IU/ml Each ml of 50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension contains: 100 IU Insulin Lispro Ph. Eur (r-DNA origin) Batch no. A924327D / Qty. 1500 Prefilled Pens Batch no. A951665F / Qty. 1500 Prefilled Pens	3 ml Prefilled Kwik Pen	534.36	555.73
19.	Monocomponent Insulin Humalog 100IU/ml (Insulin Lispro) Each ml Insulin Lispro contains 100 IU (3.5 mg) Insulin Lispro (r-DNA origin) Batch No. A961259C/ Qty. 1500 Cartridge	3ml Cartridge	425.32	442.33
20.	Monocomponent Insulin Humalog Mix 25 100 IU/ml (Insulin Lispro) Each ml contains : (25% Insulin Lispro and 75% Insulin Lispro Protamine Suspension) 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) Batch no. A969273E / Qty. 1500 Cartridge Batch no. C000055A / Qty. 1500 Cartridge	3ml Cartridge	425.32	442.33
21.	Monocomponent Insulin Humalog Mix 50 100IU/ml(Insulin Lispro) Each ml contain : (50% Insulin Lispro and 50% Insulin Lispro Protamine Suspension), 100 IU Insulin Lispro Ph. Eur. (r-DNA Origin) Batch No. A963311C/ Qty. 1500 Cartridge	3ml Cartridge	425.32	442.33”

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

NOTE :

The above mentioned price revision is applicable only in respect of the specific batch number and for the specific quantity therein against the particular notification indicated in the above table.
The prices fixed are the maximum retail prices in column no. (5) (Inclusive of excise duty, sales tax/VAT and local taxes if any) for the specified pack and packs of similar strength, and companies cannot claim exemption on any ground there from, unless specifically permitted by the Government/NPPA through an order.
The companies / manufacturers may add taxes only if they have paid actually to the Government on the price mentioned in the column (4). 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.
For different packing material used or, different drug delivery systems or any other special features/forms claimed, the retail prices, as specified in Column No. 4 above, shall be applicable unless the companies approaches NPPA for specific price approvals for its formulations.
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.
These prices/revised prices shall be made effective within 15 days of receipt of this order as required under sub para 14(1) of DPCO, 1995. The necessary price-list should also be issued as required under sub-paragraph (3) of paragraph 14 of the Drugs (Prices Control) Order, 1995.
These 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 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 Essential Commodities Act, 1955.

PN/132/2013/F

F.No. 8(41)/2013/D.P./NPPA-Div.II

(MANMOHAN KAUR)
Deputy Director
National Pharmaceutical Pricing Authority

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