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 The National Pharmaceutical Pricing Authority (NPPA) has directed the companies manufacturing or marketing four formulations of intravenous (IV) fluids in certain strengths to submit details on these products in order to fix the ceiling price of these products under the revised Schedule I of the Drugs (Prices Control) Order, 2013.
The information on the pack size, type of packaging, etc. along with the Form II or Form V as well as licenses of these formulations should be submitted within 10 days from the issue of the letter, said the Authority.
Details has to be submitted on glucose injection 5%, 10%, and 50%, combination of glucose 5% and sodium chloride 0.9%, sodium chloride injection 0.9% and 3%, and ringer lacate injection (as per IP).
"In case some companies choose not to respond to this OM, this office will consider available information in this respect while fixing prices," said the Authority in an Office Memorandum released in this regard.
For the purpose of submission, the Moving Annual Turnover (MAT) sales, excluding taxes, for October, 2023 - from November, 2022 to October, 2023 - should be submitted. In case any company has been given separate ceiling price for non-glass with special features, the details should be provided in a separate table in the prescribed format.
The NPPA fixes the ceiling prices of scheduled bulk drugs of IV fluids, including its salts, esters, stereoisomers and derivatives, and currently, the prices are being fixed based on the National List of Essential Medicines (NLEM), 2022. The pricing authority notified the list under the revised Schedule I of the Drugs Prices Control Order, 2013, on November 11, 2022.
The Authority occasionally seeks market-based price data from the manufacturers and marketers of IV fluids falling under the revised Schedule I, in order to fix their ceiling prices.
While these drugs are controlled under the DPCO, 2013, companies submit applications for separate ceiling price for various special features in packaging, and the Authority considers them individually based on the merit of these requests.
It may be noted that the Authority has in the end of last month notified special ceiling prices for certain IV fluids from companies Silica Healthcare, Indbest Healthcare, for their special features in packaging.
As reported earlier, the NPPA has recently approved the methodology of allowing an additional 15% price over the notified ceiling price while fixing the ceiling prices of all IV fluids with special features under the National List of Essential Medicines (NLEM), 2022.
The Authority took the decision agreeing with the recommendations of its Multi-Disciplinary Committee (MDC) of Experts, even though two representations were received on the recommendation, requesting continuation of the separate pricing mechanism for special feature products.
The Authority, while approving the methodology in its meeting held at the end of July, said that it did not find any merit in the representation.
"...the Authority agreed with the recommendations of the Multi-Disciplinary Committee and approved the methodology of allowing an additional 15% over the notified ceiling price while fixing the ceiling prices of all IV fluids with special features under NLEM, 2022 (including glucose 5%, sodium chloride 0.9% and glucose 5% + sodium chloride 0.9%)," it said in the minutes of a recent Authority meeting.
"The Authority directed that necessary action be taken for fixation of ceiling prices of the concerned IV fluids in accordance with the approved methodology," it added.
The MDC's recommendation was following the NPPA's request to the Committee to examine the methodology of ceiling price fixation of IV fluids after identifying an inconsistency in the methodologies followed by the pricing regulator at present.
The ceiling prices of IV fluids formulations have been undergoing revision since 2014, owing to issues relating to pack-size wise pricing, categorisation of packaging materials, admissibility of special features and various directions issued by the Department of Pharmaceuticals through various review orders. Methodologies presently being followed for different IV fluids formulations are different.
Meanwhile, over the years, formulations having "special features" packaging have evolved into a significant market segment with substantial market turnover. Over a period of time, two separate methodologies have developed for fixation of separate ceiling prices of IV fluid formulation packages in non-glass with special features. It was in this context, the Authority sought the MDC to recommend a methodology to fix the ceiling prices of these formulations.
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