Price Fixation: NPPA revises ceiling price of 8 IV fluids including Glucose; Details
NEW DELHI: Through a recent official release, National Pharmaceutical Pricing Authority (NPPA) has informed about the revision in the ceiling price of 8 IV fluids. The revision comes in order to take into account the inflation. As per the NPPA calculation, the new price has been determined after accounting for the Wholesale Price Index at the rate of 4.2662%. The new prices will take effect from April 1, 2019
The formulations whose price has been fixed include Inj 5% Glucose 1000ml, Inj 5% Glucose 500 ml, Inj 0.9% sodium Chloride 100ml and 250ml
Various manufacturers including B.Braun Medical (I) Pvt Ltd, Aculife Healthcare Pvt Ltd, Fresenius Kabi India Pvt Limited, Denis Chem Limited and others are impacted by the move.
The details of the same reads;
Sl No | Medicines | Dosage form and Strength | Unit | Ceiling price (wef 1.4.2019 with WPI @ 4.2662%) |
(1) | (2) | (3) | (4) | (5) |
1 | Glucose | Injection 5% | 1000ml Non Glass with special features | 74.76 |
2 | Glucose | Injection 5% | 500ml Non Glass with special features | 64.68 |
3 | Glucose (A) + Sodium Chloride (B) | Injection 5% (A) + 0.9% (B) | 1000ml Non Glass with special features | 78.56 |
4 | Glucose (A) + Sodium Chloride (B) | Injection 5% (A) + 0.9% (B) | 500ml Non Glass with special features | 67.22 |
5 | Sodium Chloride | Injection 0.9% | 100ml Non Glass with special features | 33.06 |
6 | Sodium Chloride | Injection 0.9% | 250ml Non Glass with special features | 48.82 |
7 | Sodium Chloride | Injection 0.9% | 500ml Non Glass with special features | 69.13 |
8 | Sodium Chloride | Injection 0.9% | 1000ml Non Glass with special features | 77.43 |
The manufactured medicines are sold under the below -mentioned brand names;
Sl. No. | Name of Manufacturer | Product /Brand Name |
(1) | (2) | (3) |
1 | M/s B.Braun Medical (I) Pvt Ltd. | Ecoflac Plus bottle with Eurohead |
2 | M/s Amanta Healthcare Ltd. | Steriport bottle |
3 | M/s Aculife Healthcare Pvt Ltd. | Aculife bottle with Eurohead |
4 | M/s Albert David Limited | Albert David bottle with Eurohead |
5 | M/s Denis Chem Limited | Aquapulse with Eurohead |
6 | M/s Claris Life Sciences Limited | Claris bottle with Eurohead |
7 | M/s Fresenius Kabi India Pvt Limited | Freeflex bags |
8 | M/s Otsuka Pharmaceutical India Private Ltd. (previously known as Claris Otsuka Private Limited) | Unibag |
9 | M/s Aishwarya Lifesciences | Lifusion Eurohead bottle |
10 | M/s Baxter (India) Pvt. Ltd. | Viaflex bags |
11 | M/s Otsuka Pharmaceutical India Private Ltd. (previously known as Claris Otsuka Private Limited) | Eurohead bottle |
12 | M/s Fresenius Kabi India Pvt Limited | Eurohead bottle |
The notice further adds;
- The manufacturers of scheduled formulations, selling abovesaid products/brand name 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
- The 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), may revise the existing R.P. of their formulations, on the basis of WPI @ 4.2662% for year 2018 in accordance with paragraph 16(2) of DPCO, 2013, read with para 13(2) of DPCO, 2013.
- 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
- Any other manufacturer claiming separate ceiling price for Non-Glass with special feature shall apply to NPPA for separate ceiling price approval with details and demonstrate, that such pack has all of the features as (i) self collapsibility and self-sealability (ii) not having air-vent; and (iii) there is no chance of contamination during manufacture/ infusion/ admixing levels along with documentation and
- For other special features claimed or any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulation
- 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
- 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
- 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,
- 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
- 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,
- 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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Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
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