NPPA Fixes Ceiling Price of ringer lactate injection

Written by Dr. Divya Colin Published On 2023-04-28T18:00:30+05:30 | Updated On 28 April 2023 6:00 PM IST

NPPA Fixes Ceiling Price of ringer lactate injection

New Delhi: Through a recent notification, the drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has revised and fixed the ceiling price of ringer lactate injection of 4 different strengths.

The ceiling price for a 100 ml ringer lactate injection has been set at Rs. 29.90, and the ceiling price for a 250 ml ringer lactate injection has been set at Rs. 50.99.

Additionally, the ceiling prices for the ringer lactate injection 500ml and 1000ml have been set at Rs. 64.96 and Rs. 114.19, respectively.

In accordance with the recent notification, the manufacturers are Albert David, Aculife Healthcare, B. Braun Medical (India), Fresenius Kabi India,Ostuka Pharmaceuticals, Denis Chem lab, Amanta Healthcare, Shree Krishna Keshav Laboratories, AxaParenterals, Shree Krishna Keshav Laboratories AxaParenterals, Rusoma Laboratories, R. K. Laboratories, RealcadeLifesciencePvt, Abaris Healthcare Pvt, Higgs Healthcare, Rusoma Laboratories, Puerto Life Sciences Private Limited, Sachin Parenteral Pv.

"Ceiling Price" refers to a price fixed by the Government for Scheduled Formulations in accordance with the provisions of the drugs (prices control) order, 2013. The ceiling Price is the Maximum Price to Retailer (excluding Taxes, if any) for the given product.

Scheduled formulation means any formulation, included in the First Schedule whether referred to by generic versions or brand names (mainly products covered under the National List of Essential Medicines are Scheduled Formulation). In other words, all medicines that are covered in the National List of Essential Medicine, which are notified in Schedule 1, by the Govt. are scheduled formulation.

The notice declared that in exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013, S.O. 1192(E) dated 22nd March, 2016, S.O. 5249(E) dated 11th November, 2022 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) S.O. No. 1501(E) dated 30.03.2022 andS.O. 4592(E) dated 29.09.2022, in so far as it relates toformulation packs mentioned in the Table A below, manufactured by the manufacturers specified in Table B for specified products and pack-sizes, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby revises the price based on Wholesale price index(WPI) of 2022 as specified in column (5) of the Table A herein below as separate ceiling price exclusive of Goods and Services Tax applicable, if any, in respect of the scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form and strength and unit/packaging specified respectively in the corresponding entries in columns (3) and (4) thereof:

Price Revision as per Annual Wholesale Price Index (WPI) @ 12.1218% increase.

Sl No	Medicines	Dosage Form and Strength	Unit	Ceiling price (w.e.f.01.04.2023 with WPI @ 12.1218%)
(1)	(2)	(3)	(4)	(5)
1	Ringer lactate	Injection100 ml	Each 100 ml pack having special features	29.90
2	Ringer lactate	Injection 250 ml	Each 250 ml pack having special features	50.99
3	Ringer lactate	Injection 500 ml	Each 500 ml pack having special features	64.96
4	Ringer lactate	Injection 1000 ml	Each 1000 ml pack having special features	114.19

TABLE ‘B’

Sl. No.	Name of Manufacturer
(1)	(2)
1	M/s Albert David Ltd.
2	M/s Aculife Healthcare Pvt. Ltd.
3	M/s B. Braun Medical (India) Pvt. Ltd.
4	M/s Fresenius Kabi India Pvt. Ltd.
5	M/s Ostuka Pharmaceuticals India Pvt. Ltd.

6	M/s Denis Chem lab Ltd.
7	M/s Amanta Healthcare Ltd.
8	M/s Shree Krishna Keshav Laboratories Ltd.
9	M/s AxaParenterals Ltd.
10	M/s Rusoma Laboratories Pvt. Ltd.
11	M/s R. K. Laboratories Pvt. Ltd.
12	M/s RealcadeLifesciencePvt. Ltd.
13	M/s Abaris Healthcare Pvt. Ltd (Note (b) below)
14	M/s Higgs Healthcare (Note (c) below)
15	M/s Rusoma Laboratories Pvt. Ltd. (Eurohead Bottles with Brand name “Dewdrip”) (Note (b) below)
16	M/s Puerto life Sciences Private Limited (Note (d) below)
17	M/s Sachin Parenteral Pvt. Ltd. (Brand name “SAFE PORT”) (Note (d) below)

Notes:

(a) The ceiling prices are applicable with effect from 01.04.2023 (ceiling prices are inclusive of Wholesale Price Index (WPI) @12.1218% for the year 2022 over 2021).

(b) In the case of M/s Abaris Healthcare Pvt. Ltd(Sl. No. 13 of Table B) &M/s Rusoma Laboratories Pvt. Ltd.(Sl. No. 15 of Table B), only the prices of the formulations specified in Sl. No. 2, and 3&4 of Table A are applicable.

(c) In the case of M/s Higgs Healthcare mentioned in Sl. No. 14 of Table B, only the prices of the formulations specified in Sl. No. 3&4 of Table A are applicable.

(d) In case of M/s Puerto life Sciences Private Limited(Sl. No. 16 of Table B) &M/s Sachin Parenteral Pvt. Ltd.(Sl. No. 17 of Table B), only the prices of the formulations specified in Sl. No. 3 of Table A is applicable.

(e) The manufacturers of scheduled formulations, selling abovesaid products/brand names of scheduled formulations at 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.

(f) The manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price notified vide S.O. No. 1501(E) dated 30.03.2022 and S.O. 4592(E) dated 29.09.2022 (plus Goods and Services Tax as applicable, if any), may revise the existing M.R.P. of their formulations, on the basis of WPI @ 12.1218% for year 2022 over the year 2021 in accordance with paragraph 16(2) of DPCO, 2013.

(g) 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.

(h) Any other manufacturer claiming a separate ceiling price for ringer lactate injection in a pack having special features shall apply to NPPA for separate ceiling price approval.

(i) 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 the information under this subparagraph 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), along with interest thereon from the date of overcharging.

(j) 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 the 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.

(k) 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 a person wishing to consult the same.

(l) 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 a such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.

(m)The manufacturers of above said scheduled formulations shall furnish quarterly returns 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.

(n) 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.

(o) Consequent to the issue of ceiling prices of such formulations 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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NPPACeiling PriceRinger Lactateprice fixation

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.