India: Price Revision Of Ringer Lactate -RL Injection With Special Packaging

On March 25, 2020, the National Pharmaceutical Pricing Authority revised the ceiling price of Ringer Lactate injection in special packaging, by increasing it by 15 percent. The special packaging reduces chances of contamination of the product.

Background

Lactated Ringer's solution, or LR, is one of the two most common intravenous (IV) fluids used for patient care at hospitals. The decision to increase its ceiling price, was recently approved in NPPA's 205th (overall) and 73rd meeting of the authority under DPCO, 2013, after it considered that its committee note on the minor safety innovation in the packaging of the ringer lactate injections.

Price Revision as per 1.88468% increase in Annual Wholesale Price Index (WPI)

1. It is reported a group of manufacturers including M/s Albert David Ltd, M/s Aculife Healthcare Pvt. Ltd, M/s B. Braun Medical (India) Pvt. Ltd, M/s Fresenius Kabi India Pvt. Ltd and M/s Ostuka Pharmaceuticals India Pvt. Ltd had filed a review application against ceiling price fixation of Ringer lactate Injection fixed vide S.O. 2401(E) dated 28.07.2017.
   The ceiling prices are applicable with effect from 01.04.2020 (ceiling prices are inclusive of Wholesale Price Index (WPI) @1.88468% for the year 2019 over 2018).
2. The manufacturers of scheduled formulations, selling above mentioned 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 as specified plus goods and services tax as applicable, if any.
3. The manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price as specified (plus goods and services tax as applicable, if any), may revise the existing M.R.P. of their formulations, on the basis of WPI @ 1.88468% for year 2019 in accordance with paragraph 16(2) of DPCO, 2013, read with para 13(2) of DPCO, 2013.
4. The manufacturers may add goods and services tax only if they have paid it actually or if it is payable to the Government on the ceiling price as fixed.
5. Any other manufacturer claiming separate ceiling price for ringer lactate injection in pack having special features like:
   1. self-collapsibility and self-sealability
   2. not having air-vent
   3. there is no chance of contamination during manufacture/ infusion/ admixing levels
   
   shall apply to NPPA for separate ceiling price approval.
6. For other special features claimed or any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulation.
7. The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price as specified 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.
8. 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, at 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.
9. 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.
10. The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of the 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.
11. 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.
12. 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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